Application 217806

Type: NDA
Sponsor: ELI LILLY AND CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZEPBOUND (AUTOINJECTOR)	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	2.5MG/0.5ML (2.5MG/0.5ML)	Yes	Yes
002	ZEPBOUND (AUTOINJECTOR)	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	5MG/0.5ML (5MG/0.5ML)	Yes	Yes
003	ZEPBOUND (AUTOINJECTOR)	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	7.5MG/0.5ML (7.5MG/0.5ML)	Yes	Yes
004	ZEPBOUND (AUTOINJECTOR)	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	10MG/0.5ML (10MG/0.5ML)	Yes	Yes
005	ZEPBOUND (AUTOINJECTOR)	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	12.5MG/0.5ML (12.5MG/0.5ML)	Yes	Yes
006	ZEPBOUND (AUTOINJECTOR)	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	15MG/0.5ML (15MG/0.5ML)	Yes	Yes
007	ZEPBOUND	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	2.5MG/0.5ML (2.5MG/0.5ML)	Yes	Yes
008	ZEPBOUND	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	5MG/0.5ML (5MG/0.5ML)	Yes	Yes
009	ZEPBOUND	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	7.5MG/0.5ML (7.5MG/0.5ML)	Yes	Yes
010	ZEPBOUND	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	10MG/0.5ML (10MG/0.5ML)	Yes	Yes
011	ZEPBOUND	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	12.5MG/0.5ML (12.5MG/0.5ML)	Yes	Yes
012	ZEPBOUND	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	15MG/0.5ML (15MG/0.5ML)	Yes	Yes
013	ZEPBOUND	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	10MG/2.4ML (4.17MG/ML)	Yes	Yes
014	ZEPBOUND	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	20MG/2.4ML (8.33MG/ML)	Yes	Yes
015	ZEPBOUND	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	30MG/2.4ML (12.5MG/ML)	Yes	Yes
016	ZEPBOUND	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	40MG/2.4ML (16.7MG/ML)	Yes	Yes
017	ZEPBOUND	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	50MG/2.4ML (20.8MG/ML)	Yes	Yes
018	ZEPBOUND	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	60MG/2.4ML (25MG/ML)	Yes	Yes
019	ZEPBOUND KWIKPEN	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	10MG/2.4ML (4.17MG/ML)	Yes	Yes
020	ZEPBOUND KWIKPEN	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	20MG/2.4ML (8.33MG/ML)	Yes	Yes
021	ZEPBOUND KWIKPEN	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	30MG/2.4ML (12.5MG/ML)	Yes	Yes
022	ZEPBOUND KWIKPEN	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	40MG/2.4ML (16.7MG/ML)	Yes	Yes
023	ZEPBOUND KWIKPEN	TIRZEPATIDE	SOLUTION;SUBCUTANEOUS	50MG/2.4ML (20.8MG/ML)	Yes	Yes
024	ZEPBOUND 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
N217806-001	ZEPBOUND (AUTOINJECTOR)	TIRZEPATIDE	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-11-08
N217806-002	ZEPBOUND (AUTOINJECTOR)	TIRZEPATIDE	5MG/0.5ML (5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-11-08
N217806-003	ZEPBOUND (AUTOINJECTOR)	TIRZEPATIDE	7.5MG/0.5ML (7.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-11-08
N217806-004	ZEPBOUND (AUTOINJECTOR)	TIRZEPATIDE	10MG/0.5ML (10MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-11-08
N217806-005	ZEPBOUND (AUTOINJECTOR)	TIRZEPATIDE	12.5MG/0.5ML (12.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-11-08
N217806-006	ZEPBOUND (AUTOINJECTOR)	TIRZEPATIDE	15MG/0.5ML (15MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-11-08
N217806-007	ZEPBOUND	TIRZEPATIDE	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-03-28
N217806-008	ZEPBOUND	TIRZEPATIDE	5MG/0.5ML (5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-03-28
N217806-009	ZEPBOUND	TIRZEPATIDE	7.5MG/0.5ML (7.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-03-28
N217806-010	ZEPBOUND	TIRZEPATIDE	10MG/0.5ML (10MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-03-28
N217806-011	ZEPBOUND	TIRZEPATIDE	12.5MG/0.5ML (12.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-03-28
N217806-012	ZEPBOUND	TIRZEPATIDE	15MG/0.5ML (15MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-03-28
N217806-013	ZEPBOUND	TIRZEPATIDE	10MG/2.4ML (4.17MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07
N217806-014	ZEPBOUND	TIRZEPATIDE	20MG/2.4ML (8.33MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07
N217806-015	ZEPBOUND	TIRZEPATIDE	30MG/2.4ML (12.5MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07
N217806-016	ZEPBOUND	TIRZEPATIDE	40MG/2.4ML (16.7MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07
N217806-017	ZEPBOUND	TIRZEPATIDE	50MG/2.4ML (20.8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07
N217806-018	ZEPBOUND	TIRZEPATIDE	60MG/2.4ML (25MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07
N217806-019	ZEPBOUND KWIKPEN	TIRZEPATIDE	10MG/2.4ML (4.17MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20
N217806-020	ZEPBOUND KWIKPEN	TIRZEPATIDE	20MG/2.4ML (8.33MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20
N217806-021	ZEPBOUND KWIKPEN	TIRZEPATIDE	30MG/2.4ML (12.5MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20
N217806-022	ZEPBOUND KWIKPEN	TIRZEPATIDE	40MG/2.4ML (16.7MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20
N217806-023	ZEPBOUND KWIKPEN	TIRZEPATIDE	50MG/2.4ML (20.8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20
N217806-024	ZEPBOUND KWIKPEN	TIRZEPATIDE	60MG/2.4ML (25MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20

Orange Book patents#

Current patent rows page 1 of 5 · 348 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217806-001	9474780	2036-05-13		Drug substance, Drug product	2023-12-07
N217806-001	11357820	2039-06-14		Drug product	2023-12-07
N217806-001	11918623	2039-06-14	U-3855		2024-03-28
N217806-001	12453756	2039-06-14		Drug product	2025-11-17
N217806-001	12629404	2039-06-14	U-4531	Drug product	2026-06-05
N217806-001	12629404	2039-06-14	U-4532	Drug product	2026-06-05
N217806-001	12343382	2039-07-22	U-4227		2025-07-25
N217806-001	12343382	2039-07-22	U-4228		2025-07-25
N217806-001	12343382	2039-07-22	U-4409		2025-07-25
N217806-001	12343382	2039-07-22	U-4410		2025-07-25
N217806-001	12453758	2039-07-22	U-4308		2025-11-17
N217806-001	12453758	2039-07-22	U-4309		2025-11-17
N217806-001	12453758	2039-07-22	U-4310		2025-11-17
N217806-001	12453758	2039-07-22	U-4311		2025-11-17
N217806-001	12616740	2039-07-22	U-4497		2026-05-05
N217806-001	12616740	2039-07-22	U-4498		2026-05-05
N217806-001	12616740	2039-07-22	U-4499		2026-05-05
N217806-002	9474780	2036-05-13		Drug substance, Drug product	2023-12-07
N217806-002	11357820	2039-06-14		Drug product	2023-12-07
N217806-002	11918623	2039-06-14	U-3855		2024-03-28
N217806-002	12453756	2039-06-14		Drug product	2025-11-17
N217806-002	12629404	2039-06-14	U-4531	Drug product	2026-06-05
N217806-002	12629404	2039-06-14	U-4532	Drug product	2026-06-05
N217806-002	12343382	2039-07-22	U-4227		2025-07-25
N217806-002	12343382	2039-07-22	U-4228		2025-07-25
N217806-002	12343382	2039-07-22	U-4409		2025-07-25
N217806-002	12343382	2039-07-22	U-4410		2025-07-25
N217806-002	12453758	2039-07-22	U-4308		2025-11-17
N217806-002	12453758	2039-07-22	U-4309		2025-11-17
N217806-002	12453758	2039-07-22	U-4310		2025-11-17
N217806-002	12453758	2039-07-22	U-4311		2025-11-17
N217806-002	12616740	2039-07-22	U-4497		2026-05-05
N217806-002	12616740	2039-07-22	U-4498		2026-05-05
N217806-002	12616740	2039-07-22	U-4499		2026-05-05
N217806-003	9474780	2036-05-13		Drug substance, Drug product	2023-12-07
N217806-003	11357820	2039-06-14		Drug product	2023-12-07
N217806-003	11918623	2039-06-14	U-3855		2024-03-28
N217806-003	12453756	2039-06-14		Drug product	2025-11-17
N217806-003	12629404	2039-06-14	U-4531	Drug product	2026-06-05
N217806-003	12629404	2039-06-14	U-4532	Drug product	2026-06-05
N217806-003	12343382	2039-07-22	U-4227		2025-07-25
N217806-003	12343382	2039-07-22	U-4228		2025-07-25
N217806-003	12343382	2039-07-22	U-4409		2025-07-25
N217806-003	12343382	2039-07-22	U-4410		2025-07-25
N217806-003	12453758	2039-07-22	U-4308		2025-11-17
N217806-003	12453758	2039-07-22	U-4309		2025-11-17
N217806-003	12453758	2039-07-22	U-4310		2025-11-17
N217806-003	12453758	2039-07-22	U-4311		2025-11-17
N217806-003	12616740	2039-07-22	U-4497		2026-05-05
N217806-003	12616740	2039-07-22	U-4498		2026-05-05
N217806-003	12616740	2039-07-22	U-4499		2026-05-05
N217806-004	9474780	2036-05-13		Drug substance, Drug product	2023-12-07
N217806-004	11357820	2039-06-14		Drug product	2023-12-07
N217806-004	11918623	2039-06-14	U-3855		2024-03-28
N217806-004	12453756	2039-06-14		Drug product	2025-11-17
N217806-004	12629404	2039-06-14	U-4531	Drug product	2026-06-05
N217806-004	12629404	2039-06-14	U-4532	Drug product	2026-06-05
N217806-004	12343382	2039-07-22	U-4227		2025-07-25
N217806-004	12343382	2039-07-22	U-4228		2025-07-25
N217806-004	12343382	2039-07-22	U-4409		2025-07-25
N217806-004	12343382	2039-07-22	U-4410		2025-07-25
N217806-004	12453758	2039-07-22	U-4308		2025-11-17
N217806-004	12453758	2039-07-22	U-4309		2025-11-17
N217806-004	12453758	2039-07-22	U-4310		2025-11-17
N217806-004	12453758	2039-07-22	U-4311		2025-11-17
N217806-004	12616740	2039-07-22	U-4497		2026-05-05
N217806-004	12616740	2039-07-22	U-4498		2026-05-05
N217806-004	12616740	2039-07-22	U-4499		2026-05-05
N217806-005	9474780	2036-05-13		Drug substance, Drug product	2023-12-07
N217806-005	11357820	2039-06-14		Drug product	2023-12-07
N217806-005	11918623	2039-06-14	U-3855		2024-03-28
N217806-005	12453756	2039-06-14		Drug product	2025-11-17
N217806-005	12629404	2039-06-14	U-4531	Drug product	2026-06-05
N217806-005	12629404	2039-06-14	U-4532	Drug product	2026-06-05
N217806-005	12343382	2039-07-22	U-4227		2025-07-25
N217806-005	12343382	2039-07-22	U-4228		2025-07-25
N217806-005	12343382	2039-07-22	U-4409		2025-07-25
N217806-005	12343382	2039-07-22	U-4410		2025-07-25
N217806-005	12453758	2039-07-22	U-4308		2025-11-17
N217806-005	12453758	2039-07-22	U-4309		2025-11-17

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 78 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217806-001	NP	2026-11-08
N217806-001	NCE	2027-05-13
N217806-001	M-82	2027-10-18
N217806-001	I-958	2027-12-20
N217806-002	NP	2026-11-08
N217806-002	NCE	2027-05-13
N217806-002	M-82	2027-10-18
N217806-002	I-958	2027-12-20
N217806-003	NP	2026-11-08
N217806-003	NCE	2027-05-13
N217806-003	M-82	2027-10-18
N217806-003	I-958	2027-12-20
N217806-004	NP	2026-11-08
N217806-004	NCE	2027-05-13
N217806-004	M-82	2027-10-18
N217806-004	I-958	2027-12-20
N217806-005	NP	2026-11-08
N217806-005	NCE	2027-05-13
N217806-005	M-82	2027-10-18
N217806-005	I-958	2027-12-20
N217806-006	NP	2026-11-08
N217806-006	NCE	2027-05-13
N217806-006	M-82	2027-10-18
N217806-006	I-958	2027-12-20
N217806-007	NCE	2027-05-13
N217806-007	M-82	2027-10-18
N217806-007	I-958	2027-12-20
N217806-008	NCE	2027-05-13
N217806-008	M-82	2027-10-18
N217806-008	I-958	2027-12-20
N217806-009	NCE	2027-05-13
N217806-009	M-82	2027-10-18
N217806-009	I-958	2027-12-20
N217806-010	NCE	2027-05-13
N217806-010	M-82	2027-10-18
N217806-010	I-958	2027-12-20
N217806-011	NCE	2027-05-13
N217806-011	M-82	2027-10-18
N217806-011	I-958	2027-12-20
N217806-012	NCE	2027-05-13
N217806-012	M-82	2027-10-18
N217806-012	I-958	2027-12-20
N217806-013	NCE	2027-05-13
N217806-013	M-82	2027-10-18
N217806-013	I-958	2027-12-20
N217806-014	NCE	2027-05-13
N217806-014	M-82	2027-10-18
N217806-014	I-958	2027-12-20
N217806-015	NCE	2027-05-13
N217806-015	M-82	2027-10-18
N217806-015	I-958	2027-12-20
N217806-016	NCE	2027-05-13
N217806-016	M-82	2027-10-18
N217806-016	I-958	2027-12-20
N217806-017	NCE	2027-05-13
N217806-017	M-82	2027-10-18
N217806-017	I-958	2027-12-20
N217806-018	NCE	2027-05-13
N217806-018	M-82	2027-10-18
N217806-018	I-958	2027-12-20
N217806-019	NCE	2027-05-13
N217806-019	M-82	2027-10-18
N217806-019	I-958	2027-12-20
N217806-020	NCE	2027-05-13
N217806-020	M-82	2027-10-18
N217806-020	I-958	2027-12-20
N217806-021	NCE	2027-05-13
N217806-021	M-82	2027-10-18
N217806-021	I-958	2027-12-20
N217806-022	NCE	2027-05-13
N217806-022	M-82	2027-10-18
N217806-022	I-958	2027-12-20
N217806-023	NCE	2027-05-13
N217806-023	M-82	2027-10-18
N217806-023	I-958	2027-12-20
N217806-024	NCE	2027-05-13
N217806-024	M-82	2027-10-18
N217806-024	I-958	2027-12-20

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 7 · 246 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	N217806-001	ZEPBOUND (AUTOINJECTOR)	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-002	ZEPBOUND (AUTOINJECTOR)	5MG/0.5ML (5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-003	ZEPBOUND (AUTOINJECTOR)	7.5MG/0.5ML (7.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-004	ZEPBOUND (AUTOINJECTOR)	10MG/0.5ML (10MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-005	ZEPBOUND (AUTOINJECTOR)	12.5MG/0.5ML (12.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-006	ZEPBOUND (AUTOINJECTOR)	15MG/0.5ML (15MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-007	ZEPBOUND	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-008	ZEPBOUND	5MG/0.5ML (5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-009	ZEPBOUND	7.5MG/0.5ML (7.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-010	ZEPBOUND	10MG/0.5ML (10MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-011	ZEPBOUND	12.5MG/0.5ML (12.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-012	ZEPBOUND	15MG/0.5ML (15MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-013	ZEPBOUND	10MG/2.4ML (4.17MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-014	ZEPBOUND	20MG/2.4ML (8.33MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-015	ZEPBOUND	30MG/2.4ML (12.5MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-016	ZEPBOUND	40MG/2.4ML (16.7MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-017	ZEPBOUND	50MG/2.4ML (20.8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-018	ZEPBOUND	60MG/2.4ML (25MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-019	ZEPBOUND KWIKPEN	10MG/2.4ML (4.17MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-020	ZEPBOUND KWIKPEN	20MG/2.4ML (8.33MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-021	ZEPBOUND KWIKPEN	30MG/2.4ML (12.5MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-022	ZEPBOUND KWIKPEN	40MG/2.4ML (16.7MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-023	ZEPBOUND KWIKPEN	50MG/2.4ML (20.8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-024	ZEPBOUND KWIKPEN	60MG/2.4ML (25MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217806-001	ZEPBOUND (AUTOINJECTOR)	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217806-002	ZEPBOUND (AUTOINJECTOR)	5MG/0.5ML (5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217806-003	ZEPBOUND (AUTOINJECTOR)	7.5MG/0.5ML (7.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217806-004	ZEPBOUND (AUTOINJECTOR)	10MG/0.5ML (10MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217806-005	ZEPBOUND (AUTOINJECTOR)	12.5MG/0.5ML (12.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217806-006	ZEPBOUND (AUTOINJECTOR)	15MG/0.5ML (15MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2023-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217806-007	ZEPBOUND	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217806-008	ZEPBOUND	5MG/0.5ML (5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217806-009	ZEPBOUND	7.5MG/0.5ML (7.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217806-010	ZEPBOUND	10MG/0.5ML (10MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217806-011	ZEPBOUND	12.5MG/0.5ML (12.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217806-012	ZEPBOUND	15MG/0.5ML (15MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217806-013	ZEPBOUND	10MG/2.4ML (4.17MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217806-014	ZEPBOUND	20MG/2.4ML (8.33MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217806-015	ZEPBOUND	30MG/2.4ML (12.5MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217806-016	ZEPBOUND	40MG/2.4ML (16.7MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-01-07	`011fe1cb6892…`

Observed Orange Book patent history#

Patent history page 1 of 37 · 1,452 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	N217806-001	9474780	2036-05-13		Drug substance, Drug product	2023-12-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-001	11357820	2039-06-14		Drug product	2023-12-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-001	11918623	2039-06-14	U-3855		2024-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-001	12453756	2039-06-14		Drug product	2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-001	12629404	2039-06-14	U-4531	Drug product	2026-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-001	12629404	2039-06-14	U-4532	Drug product	2026-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-001	12343382	2039-07-22	U-4228		2025-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-001	12343382	2039-07-22	U-4227		2025-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-001	12343382	2039-07-22	U-4409		2025-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-001	12343382	2039-07-22	U-4410		2025-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-001	12453758	2039-07-22	U-4308		2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-001	12453758	2039-07-22	U-4311		2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-001	12453758	2039-07-22	U-4310		2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-001	12453758	2039-07-22	U-4309		2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-001	12616740	2039-07-22	U-4497		2026-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-001	12616740	2039-07-22	U-4498		2026-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-001	12616740	2039-07-22	U-4499		2026-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-002	9474780	2036-05-13		Drug substance, Drug product	2023-12-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-002	11357820	2039-06-14		Drug product	2023-12-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-002	11918623	2039-06-14	U-3855		2024-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-002	12453756	2039-06-14		Drug product	2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-002	12629404	2039-06-14	U-4531	Drug product	2026-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-002	12629404	2039-06-14	U-4532	Drug product	2026-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-002	12343382	2039-07-22	U-4228		2025-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-002	12343382	2039-07-22	U-4227		2025-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-002	12343382	2039-07-22	U-4410		2025-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-002	12343382	2039-07-22	U-4409		2025-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-002	12453758	2039-07-22	U-4311		2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-002	12453758	2039-07-22	U-4310		2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-002	12453758	2039-07-22	U-4309		2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-002	12453758	2039-07-22	U-4308		2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-002	12616740	2039-07-22	U-4497		2026-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-002	12616740	2039-07-22	U-4498		2026-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-002	12616740	2039-07-22	U-4499		2026-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-003	9474780	2036-05-13		Drug substance, Drug product	2023-12-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-003	11357820	2039-06-14		Drug product	2023-12-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-003	11918623	2039-06-14	U-3855		2024-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-003	12453756	2039-06-14		Drug product	2025-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-003	12629404	2039-06-14	U-4531	Drug product	2026-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-003	12629404	2039-06-14	U-4532	Drug product	2026-06-05	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 15 · 588 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	N217806-001	NP	2026-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-001	NCE	2027-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-001	M-82	2027-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-001	I-958	2027-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-002	NP	2026-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-002	NCE	2027-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-002	M-82	2027-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-002	I-958	2027-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-003	NP	2026-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-003	NCE	2027-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-003	M-82	2027-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-003	I-958	2027-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-004	NP	2026-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-004	NCE	2027-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-004	M-82	2027-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-004	I-958	2027-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-005	NP	2026-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-005	NCE	2027-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-005	M-82	2027-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-005	I-958	2027-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-006	NP	2026-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-006	NCE	2027-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-006	M-82	2027-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-006	I-958	2027-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-007	NCE	2027-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-007	M-82	2027-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-007	I-958	2027-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-008	NCE	2027-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-008	M-82	2027-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-008	I-958	2027-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-009	NCE	2027-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-009	M-82	2027-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-009	I-958	2027-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-010	NCE	2027-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-010	M-82	2027-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-010	I-958	2027-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-011	NCE	2027-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-011	M-82	2027-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-011	I-958	2027-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217806-012	NCE	2027-05-13	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zepbound	TIRZEPATIDE	Eli Lilly and Company	487cd7e7-434c-4925-99fa-aa80b1cc776b	2026-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 217806 application number: NDA217806

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85860	SUPPL	2026-05-11
85191	SUPPL	2026-03-02
85180	SUPPL	2026-02-27
84796	SUPPL	2026-01-21
84795	SUPPL	2026-01-21
84791	SUPPL	2026-01-21
84790	SUPPL	2026-01-21
84724	SUPPL	2026-01-08
84723	SUPPL	2026-01-08
84715	SUPPL	2026-01-08
83555	SUPPL	2025-09-26
83542	SUPPL	2025-09-26
81191	SUPPL	2025-02-10
81181	SUPPL	2025-02-10
80713	SUPPL	2024-12-26
80675	SUPPL	2024-12-20
80674	SUPPL	2024-12-20
79952	SUPPL	2024-10-21
79938	SUPPL	2024-10-21
79937	SUPPL	2024-10-21
79936	SUPPL	2024-10-21
79935	SUPPL	2024-10-21
79930	SUPPL	2024-10-21
79929	SUPPL	2024-10-21
79928	SUPPL	2024-10-21
79927	SUPPL	2024-10-21
79926	SUPPL	2024-10-21
79925	SUPPL	2024-10-21
78149	ORIG	2024-04-16
78043	SUPPL	2024-04-03
78015	SUPPL	2024-04-01
76547	ORIG	2023-11-13
76538	ORIG	2023-11-08