Application 215866

Type: NDA
Sponsor: ELI LILLY CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MOUNJARO	TIRZEPATIDE	INJECTABLE;INJECTION	2.5MG	No	No
002	MOUNJARO	TIRZEPATIDE	INJECTABLE;INJECTION	5MG	No	No
003	MOUNJARO	TIRZEPATIDE	INJECTABLE;INJECTION	7.5MG	No	No
004	MOUNJARO	TIRZEPATIDE	INJECTABLE;INJECTION	10MG	No	No
005	MOUNJARO	TIRZEPATIDE	INJECTABLE;INJECTION	12.5MG	No	No
006	MOUNJARO	TIRZEPATIDE	INJECTABLE;INJECTION	15MG	No	No
007	MOUNJARO	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	2.5MG/0.5ML (2.5MG/0.5ML)	Yes	Yes
008	MOUNJARO	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	5MG/0.5ML (5MG/0.5ML)	Yes	Yes
009	MOUNJARO	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	7.5MG/0.5ML (7.5MG/0.5ML)	Yes	Yes
010	MOUNJARO	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	10MG/0.5ML (10MG/0.5ML)	Yes	Yes
011	MOUNJARO	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	12.5MG/0.5ML (12.5MG/0.5ML)	Yes	Yes
012	MOUNJARO	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	15MG/0.5ML (15MG/0.5ML)	Yes	Yes
013	MOUNJARO	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	10MG/2.4ML (4.17MG/ML)	Yes	Yes
014	MOUNJARO	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	20MG/2.4ML (8.33MG/ML)	Yes	Yes
015	MOUNJARO	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	30MG/2.4ML (12.5MG/ML)	Yes	Yes
016	MOUNJARO	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	40MG/2.4ML (16.7MG/ML)	Yes	Yes
017	MOUNJARO	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	50MG/2.4ML (20.8MG/ML)	Yes	Yes
018	MOUNJARO	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	60MG/2.4ML (25MG/ML)	Yes	Yes
019	MOUNJARO KWIKPEN	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	10MG/2.4ML (4.17MG/ML)	Yes	Yes
020	MOUNJARO KWIKPEN	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	20MG/2.4ML (8.33MG/ML)	Yes	Yes
021	MOUNJARO KWIKPEN	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	30MG/2.4ML (12.5MG/ML)	Yes	Yes
022	MOUNJARO KWIKPEN	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	40MG/2.4ML (16.7MG/ML)	Yes	Yes
023	MOUNJARO KWIKPEN	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	50MG/2.4ML (20.8MG/ML)	Yes	Yes
024	MOUNJARO KWIKPEN	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	60MG/2.4ML (25MG/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 24 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N215866-001	MOUNJARO (AUTOINJECTOR)	TIRZEPATIDE	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13
N215866-002	MOUNJARO (AUTOINJECTOR)	TIRZEPATIDE	5MG/0.5ML (5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13
N215866-003	MOUNJARO (AUTOINJECTOR)	TIRZEPATIDE	7.5MG/0.5ML (7.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13
N215866-004	MOUNJARO (AUTOINJECTOR)	TIRZEPATIDE	10MG/0.5ML (10MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13
N215866-005	MOUNJARO (AUTOINJECTOR)	TIRZEPATIDE	12.5MG/0.5ML (12.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13
N215866-006	MOUNJARO (AUTOINJECTOR)	TIRZEPATIDE	15MG/0.5ML (15MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13
N215866-007	MOUNJARO	TIRZEPATIDE	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28
N215866-008	MOUNJARO	TIRZEPATIDE	5MG/0.5ML (5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28
N215866-009	MOUNJARO	TIRZEPATIDE	7.5MG/0.5ML (7.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28
N215866-010	MOUNJARO	TIRZEPATIDE	10MG/0.5ML (10MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28
N215866-011	MOUNJARO	TIRZEPATIDE	12.5MG/0.5ML (12.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28
N215866-012	MOUNJARO	TIRZEPATIDE	15MG/0.5ML (15MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28
N215866-013	MOUNJARO	TIRZEPATIDE	10MG/2.4ML (4.17MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07
N215866-014	MOUNJARO	TIRZEPATIDE	20MG/2.4ML (8.33MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07
N215866-015	MOUNJARO	TIRZEPATIDE	30MG/2.4ML (12.5MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07
N215866-016	MOUNJARO	TIRZEPATIDE	40MG/2.4ML (16.7MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07
N215866-017	MOUNJARO	TIRZEPATIDE	50MG/2.4ML (20.8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07
N215866-018	MOUNJARO	TIRZEPATIDE	60MG/2.4ML (25MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07
N215866-019	MOUNJARO KWIKPEN	TIRZEPATIDE	10MG/2.4ML (4.17MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20
N215866-020	MOUNJARO KWIKPEN	TIRZEPATIDE	20MG/2.4ML (8.33MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20
N215866-021	MOUNJARO KWIKPEN	TIRZEPATIDE	30MG/2.4ML (12.5MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20
N215866-022	MOUNJARO KWIKPEN	TIRZEPATIDE	40MG/2.4ML (16.7MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20
N215866-023	MOUNJARO KWIKPEN	TIRZEPATIDE	50MG/2.4ML (20.8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20
N215866-024	MOUNJARO KWIKPEN	TIRZEPATIDE	60MG/2.4ML (25MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20

Orange Book patents#

Current patent rows page 1 of 6 · 480 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215866-001	9474780	2036-05-13	U-4374	Drug substance, Drug product	2022-06-09
N215866-001	11357820	2039-06-14		Drug product	2022-06-30
N215866-001	12453755	2039-06-14	U-4375		2025-11-17
N215866-001	12453755	2039-06-14	U-4376		2025-11-17
N215866-001	12453755	2039-06-14	U-4377		2025-11-17
N215866-001	12453755	2039-06-14	U-4378		2025-11-17
N215866-001	12453755	2039-06-14	U-4379		2025-11-17
N215866-001	12453755	2039-06-14	U-4380		2025-11-17
N215866-001	12453755	2039-06-14	U-4381		2025-11-17
N215866-001	12453755	2039-06-14	U-4382		2025-11-17
N215866-001	12453755	2039-06-14	U-4383		2025-11-17
N215866-001	12453755	2039-06-14	U-4384		2025-11-17
N215866-001	12453755	2039-06-14	U-4385		2025-11-17
N215866-001	12453755	2039-06-14	U-4386		2025-11-17
N215866-001	12453756	2039-06-14		Drug product	2025-11-17
N215866-001	12629404	2039-06-14	U-4533	Drug product	2026-06-05
N215866-001	12629404	2039-06-14	U-4534	Drug product	2026-06-05
N215866-001	12343382	2039-07-22	U-4229		2025-07-25
N215866-001	12343382	2039-07-22	U-4230		2025-07-25
N215866-001	12343382	2039-07-22	U-4231		2025-07-25
N215866-001	12343382	2039-07-22	U-4232		2025-07-25
N215866-001	12343382	2039-07-22	U-4400		2025-07-25
N215866-001	12343382	2039-07-22	U-4401		2025-07-25
N215866-001	12616740	2039-07-22	U-4500		2026-05-05
N215866-001	12616740	2039-07-22	U-4501		2026-05-05
N215866-001	12616740	2039-07-22	U-4502		2026-05-05
N215866-001	12295987	2041-12-30	U-4192		2025-06-11
N215866-001	12295987	2041-12-30	U-4193		2025-06-11
N215866-002	9474780	2036-05-13	U-4374	Drug substance, Drug product	2022-06-09
N215866-002	11357820	2039-06-14		Drug product	2022-06-30
N215866-002	12453755	2039-06-14	U-4375		2025-11-17
N215866-002	12453755	2039-06-14	U-4376		2025-11-17
N215866-002	12453755	2039-06-14	U-4377		2025-11-17
N215866-002	12453755	2039-06-14	U-4378		2025-11-17
N215866-002	12453755	2039-06-14	U-4379		2025-11-17
N215866-002	12453755	2039-06-14	U-4380		2025-11-17
N215866-002	12453755	2039-06-14	U-4381		2025-11-17
N215866-002	12453755	2039-06-14	U-4382		2025-11-17
N215866-002	12453755	2039-06-14	U-4383		2025-11-17
N215866-002	12453755	2039-06-14	U-4384		2025-11-17
N215866-002	12453755	2039-06-14	U-4385		2025-11-17
N215866-002	12453755	2039-06-14	U-4386		2025-11-17
N215866-002	12453756	2039-06-14		Drug product	2025-11-17
N215866-002	12629404	2039-06-14	U-4533	Drug product	2026-06-05
N215866-002	12629404	2039-06-14	U-4534	Drug product	2026-06-05
N215866-002	12343382	2039-07-22	U-4229		2025-07-25
N215866-002	12343382	2039-07-22	U-4230		2025-07-25
N215866-002	12343382	2039-07-22	U-4231		2025-07-25
N215866-002	12343382	2039-07-22	U-4232		2025-07-25
N215866-002	12343382	2039-07-22	U-4400		2025-07-25
N215866-002	12343382	2039-07-22	U-4401		2025-07-25
N215866-002	12616740	2039-07-22	U-4500		2026-05-05
N215866-002	12616740	2039-07-22	U-4501		2026-05-05
N215866-002	12616740	2039-07-22	U-4502		2026-05-05
N215866-002	12295987	2041-12-30	U-4192		2025-06-11
N215866-002	12295987	2041-12-30	U-4193		2025-06-11
N215866-003	9474780	2036-05-13	U-4374	Drug substance, Drug product	2022-06-09
N215866-003	11357820	2039-06-14		Drug product	2022-06-30
N215866-003	12453755	2039-06-14	U-4375		2025-11-17
N215866-003	12453755	2039-06-14	U-4376		2025-11-17
N215866-003	12453755	2039-06-14	U-4377		2025-11-17
N215866-003	12453755	2039-06-14	U-4378		2025-11-17
N215866-003	12453755	2039-06-14	U-4379		2025-11-17
N215866-003	12453755	2039-06-14	U-4380		2025-11-17
N215866-003	12453755	2039-06-14	U-4381		2025-11-17
N215866-003	12453755	2039-06-14	U-4382		2025-11-17
N215866-003	12453755	2039-06-14	U-4383		2025-11-17
N215866-003	12453755	2039-06-14	U-4384		2025-11-17
N215866-003	12453755	2039-06-14	U-4385		2025-11-17
N215866-003	12453755	2039-06-14	U-4386		2025-11-17
N215866-003	12453756	2039-06-14		Drug product	2025-11-17
N215866-003	12629404	2039-06-14	U-4533	Drug product	2026-06-05
N215866-003	12629404	2039-06-14	U-4534	Drug product	2026-06-05
N215866-003	12343382	2039-07-22	U-4229		2025-07-25
N215866-003	12343382	2039-07-22	U-4230		2025-07-25
N215866-003	12343382	2039-07-22	U-4231		2025-07-25
N215866-003	12343382	2039-07-22	U-4232		2025-07-25
N215866-003	12343382	2039-07-22	U-4400		2025-07-25
N215866-003	12343382	2039-07-22	U-4401		2025-07-25
N215866-003	12616740	2039-07-22	U-4500		2026-05-05

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 42 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215866-001	NCE	2027-05-13
N215866-001	NPP	2028-12-19
N215866-002	NCE	2027-05-13
N215866-002	NPP	2028-12-19
N215866-003	NCE	2027-05-13
N215866-003	NPP	2028-12-19
N215866-004	NCE	2027-05-13
N215866-004	NPP	2028-12-19
N215866-005	NCE	2027-05-13
N215866-006	NCE	2027-05-13
N215866-007	NCE	2027-05-13
N215866-007	NPP	2028-12-19
N215866-008	NCE	2027-05-13
N215866-008	NPP	2028-12-19
N215866-009	NCE	2027-05-13
N215866-009	NPP	2028-12-19
N215866-010	NCE	2027-05-13
N215866-010	NPP	2028-12-19
N215866-011	NCE	2027-05-13
N215866-012	NCE	2027-05-13
N215866-013	NCE	2027-05-13
N215866-013	NPP	2028-12-19
N215866-014	NCE	2027-05-13
N215866-014	NPP	2028-12-19
N215866-015	NCE	2027-05-13
N215866-015	NPP	2028-12-19
N215866-016	NCE	2027-05-13
N215866-016	NPP	2028-12-19
N215866-017	NCE	2027-05-13
N215866-017	NPP	2028-12-19
N215866-018	NCE	2027-05-13
N215866-018	NPP	2028-12-19
N215866-019	NCE	2027-05-13
N215866-019	NPP	2028-12-19
N215866-020	NCE	2027-05-13
N215866-020	NPP	2028-12-19
N215866-021	NCE	2027-05-13
N215866-021	NPP	2028-12-19
N215866-022	NCE	2027-05-13
N215866-022	NPP	2028-12-19
N215866-023	NCE	2027-05-13
N215866-024	NCE	2027-05-13

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 9 · 324 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N215866-001	MOUNJARO (AUTOINJECTOR)	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-002	MOUNJARO (AUTOINJECTOR)	5MG/0.5ML (5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-003	MOUNJARO (AUTOINJECTOR)	7.5MG/0.5ML (7.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-004	MOUNJARO (AUTOINJECTOR)	10MG/0.5ML (10MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-005	MOUNJARO (AUTOINJECTOR)	12.5MG/0.5ML (12.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-006	MOUNJARO (AUTOINJECTOR)	15MG/0.5ML (15MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-007	MOUNJARO	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-008	MOUNJARO	5MG/0.5ML (5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-009	MOUNJARO	7.5MG/0.5ML (7.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-010	MOUNJARO	10MG/0.5ML (10MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-011	MOUNJARO	12.5MG/0.5ML (12.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-012	MOUNJARO	15MG/0.5ML (15MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-013	MOUNJARO	10MG/2.4ML (4.17MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-014	MOUNJARO	20MG/2.4ML (8.33MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-015	MOUNJARO	30MG/2.4ML (12.5MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-016	MOUNJARO	40MG/2.4ML (16.7MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-017	MOUNJARO	50MG/2.4ML (20.8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-018	MOUNJARO	60MG/2.4ML (25MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-019	MOUNJARO KWIKPEN	10MG/2.4ML (4.17MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-020	MOUNJARO KWIKPEN	20MG/2.4ML (8.33MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-021	MOUNJARO KWIKPEN	30MG/2.4ML (12.5MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-022	MOUNJARO KWIKPEN	40MG/2.4ML (16.7MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-023	MOUNJARO KWIKPEN	50MG/2.4ML (20.8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-024	MOUNJARO KWIKPEN	60MG/2.4ML (25MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215866-001	MOUNJARO (AUTOINJECTOR)	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215866-002	MOUNJARO (AUTOINJECTOR)	5MG/0.5ML (5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215866-003	MOUNJARO (AUTOINJECTOR)	7.5MG/0.5ML (7.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215866-004	MOUNJARO (AUTOINJECTOR)	10MG/0.5ML (10MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215866-005	MOUNJARO (AUTOINJECTOR)	12.5MG/0.5ML (12.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215866-006	MOUNJARO (AUTOINJECTOR)	15MG/0.5ML (15MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215866-007	MOUNJARO	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215866-008	MOUNJARO	5MG/0.5ML (5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215866-009	MOUNJARO	7.5MG/0.5ML (7.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215866-010	MOUNJARO	10MG/0.5ML (10MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215866-011	MOUNJARO	12.5MG/0.5ML (12.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215866-012	MOUNJARO	15MG/0.5ML (15MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215866-013	MOUNJARO	10MG/2.4ML (4.17MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215866-014	MOUNJARO	20MG/2.4ML (8.33MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215866-015	MOUNJARO	30MG/2.4ML (12.5MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215866-016	MOUNJARO	40MG/2.4ML (16.7MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07	`011fe1cb6892…`

Observed Orange Book patent history#

Patent history page 1 of 57 · 2,250 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N215866-001	9474780	2036-05-13	U-4374	Drug substance, Drug product	2022-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-001	11357820	2039-06-14		Drug product	2022-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-001	12453755	2039-06-14	U-4375		2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-001	12453755	2039-06-14	U-4376		2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-001	12453755	2039-06-14	U-4377		2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-001	12453755	2039-06-14	U-4378		2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-001	12453755	2039-06-14	U-4379		2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-001	12453755	2039-06-14	U-4380		2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-001	12453755	2039-06-14	U-4381		2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-001	12453755	2039-06-14	U-4382		2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-001	12453755	2039-06-14	U-4383		2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-001	12453755	2039-06-14	U-4384		2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-001	12453755	2039-06-14	U-4385		2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-001	12453755	2039-06-14	U-4386		2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-001	12453756	2039-06-14		Drug product	2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-001	12629404	2039-06-14	U-4533	Drug product	2026-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-001	12629404	2039-06-14	U-4534	Drug product	2026-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-001	12343382	2039-07-22	U-4401		2025-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-001	12343382	2039-07-22	U-4229		2025-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-001	12343382	2039-07-22	U-4230		2025-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-001	12343382	2039-07-22	U-4231		2025-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-001	12343382	2039-07-22	U-4232		2025-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-001	12343382	2039-07-22	U-4400		2025-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-001	12616740	2039-07-22	U-4500		2026-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-001	12616740	2039-07-22	U-4501		2026-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-001	12616740	2039-07-22	U-4502		2026-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-001	12295987	2041-12-30	U-4192		2025-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-001	12295987	2041-12-30	U-4193		2025-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-002	9474780	2036-05-13	U-4374	Drug substance, Drug product	2022-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-002	11357820	2039-06-14		Drug product	2022-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-002	12453755	2039-06-14	U-4376		2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-002	12453755	2039-06-14	U-4383		2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-002	12453755	2039-06-14	U-4379		2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-002	12453755	2039-06-14	U-4375		2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-002	12453755	2039-06-14	U-4380		2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-002	12453755	2039-06-14	U-4382		2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-002	12453755	2039-06-14	U-4377		2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-002	12453755	2039-06-14	U-4381		2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-002	12453755	2039-06-14	U-4384		2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-002	12453755	2039-06-14	U-4385		2025-11-17	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 9 · 342 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N215866-001	NCE	2027-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-001	NPP	2028-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-002	NCE	2027-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-002	NPP	2028-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-003	NCE	2027-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-003	NPP	2028-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-004	NCE	2027-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-004	NPP	2028-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-005	NCE	2027-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-006	NCE	2027-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-007	NCE	2027-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-007	NPP	2028-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-008	NCE	2027-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-008	NPP	2028-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-009	NCE	2027-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-009	NPP	2028-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-010	NCE	2027-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-010	NPP	2028-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-011	NCE	2027-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-012	NCE	2027-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-013	NCE	2027-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-013	NPP	2028-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-014	NCE	2027-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-014	NPP	2028-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-015	NCE	2027-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-015	NPP	2028-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-016	NCE	2027-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-016	NPP	2028-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-017	NCE	2027-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-017	NPP	2028-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-018	NCE	2027-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-018	NPP	2028-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-019	NCE	2027-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-019	NPP	2028-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-020	NCE	2027-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-020	NPP	2028-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-021	NCE	2027-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-021	NPP	2028-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-022	NCE	2027-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215866-022	NPP	2028-12-19	`caaa826d4ba7…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MOUNJARO	TIRZEPATIDE	A-S Medication Solutions	78b268b4-9215-44b4-b565-fcec315d027c	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215866 application number: NDA215866
MOUNJARO	TIRZEPATIDE	A-S Medication Solutions	c1ceb7ca-9976-4ac1-b45c-3975de8aac4c	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215866 application number: NDA215866
MOUNJARO	TIRZEPATIDE	A-S Medication Solutions	78aad975-4971-49fa-b4b0-6aa39f76d2e7	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215866 application number: NDA215866
MOUNJARO	TIRZEPATIDE	A-S Medication Solutions	7dd5ae1d-2156-44c1-a2d0-4be1bc76420e	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215866 application number: NDA215866
MOUNJARO	TIRZEPATIDE	A-S Medication Solutions	f4edc99a-ecdb-4a68-bcb4-69fbba2190e8	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215866 application number: NDA215866
MOUNJARO	TIRZEPATIDE	A-S Medication Solutions	0818426a-53eb-4db7-9609-bbae1e7a3964	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215866 application number: NDA215866
Mounjaro	TIRZEPATIDE	Eli Lilly and Company	d2d7da5d-ad07-4228-955f-cf7e355c8cc0	2026-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215866 application number: NDA215866 ndc (product): 0002-1457 ndc (product): 0002-1484 ndc (product): 0002-1460 ndc (product): 0002-1471 ndc (product): 0002-1506 ndc (product): 0002-1495

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0002-1457	MOUNJARO	tirzepatide	Eli Lilly and Company	NDA	Current
0002-1457	MOUNJARO	tirzepatide	Eli Lilly and Company	NDA	Current
0002-1457	MOUNJARO	tirzepatide	Eli Lilly and Company	NDA	Current
0002-1460	MOUNJARO	tirzepatide	Eli Lilly and Company	NDA	Current
0002-1460	MOUNJARO	tirzepatide	Eli Lilly and Company	NDA	Current
0002-1460	MOUNJARO	tirzepatide	Eli Lilly and Company	NDA	Current
0002-1471	MOUNJARO	tirzepatide	Eli Lilly and Company	NDA	Current
0002-1471	MOUNJARO	tirzepatide	Eli Lilly and Company	NDA	Current
0002-1471	MOUNJARO	tirzepatide	Eli Lilly and Company	NDA	Current
0002-1484	MOUNJARO	tirzepatide	Eli Lilly and Company	NDA	Current
0002-1484	MOUNJARO	tirzepatide	Eli Lilly and Company	NDA	Current
0002-1484	MOUNJARO	tirzepatide	Eli Lilly and Company	NDA	Current
0002-1495	MOUNJARO	tirzepatide	Eli Lilly and Company	NDA	Current
0002-1495	MOUNJARO	tirzepatide	Eli Lilly and Company	NDA	Current
0002-1495	MOUNJARO	tirzepatide	Eli Lilly and Company	NDA	Current
0002-1506	MOUNJARO	tirzepatide	Eli Lilly and Company	NDA	Current
0002-1506	MOUNJARO	tirzepatide	Eli Lilly and Company	NDA	Current
0002-1506	MOUNJARO	tirzepatide	Eli Lilly and Company	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84798	SUPPL	2026-01-21
84797	SUPPL	2026-01-21
84788	SUPPL	2026-01-21
84787	SUPPL	2026-01-21
84722	SUPPL	2026-01-08
84721	SUPPL	2026-01-08
84716	SUPPL	2026-01-08
84514	SUPPL	2025-12-23
84507	SUPPL	2025-12-23
83557	SUPPL	2025-09-26
83541	SUPPL	2025-09-26
82379	SUPPL	2025-06-02
82350	SUPPL	2025-05-29
80489	SUPPL	2024-12-04
80138	SUPPL	2024-11-05
80137	SUPPL	2024-11-05
80136	SUPPL	2024-11-05
80132	SUPPL	2024-11-05
80131	SUPPL	2024-11-05
80130	SUPPL	2024-11-05
74960	SUPPL	2023-07-31
74959	SUPPL	2023-07-31
74957	SUPPL	2023-07-31
74956	SUPPL	2023-07-31
71307	ORIG	2022-06-15
71073	ORIG	2022-05-16
71068	ORIG	2022-05-13