Application 218316

Type: NDA
Sponsor: NOVO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	WEGOVY	SEMAGLUTIDE	TABLET;ORAL	1.5MG	Yes	Yes
002	WEGOVY	SEMAGLUTIDE	TABLET;ORAL	4MG	Yes	Yes
003	WEGOVY	SEMAGLUTIDE	TABLET;ORAL	9MG	Yes	Yes
004	WEGOVY	SEMAGLUTIDE	TABLET;ORAL	25MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N218316-001	WEGOVY	SEMAGLUTIDE	1.5MG	TABLET / ORAL	RLD, RS	2025-12-22
N218316-002	WEGOVY	SEMAGLUTIDE	4MG	TABLET / ORAL	RLD, RS	2025-12-22
N218316-003	WEGOVY	SEMAGLUTIDE	9MG	TABLET / ORAL	RLD, RS	2025-12-22
N218316-004	WEGOVY	SEMAGLUTIDE	25MG	TABLET / ORAL	RLD, RS	2025-12-22

Orange Book patents#

Current patent rows page 1 of 1 · 34 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N218316-001	8536122	2026-03-20		Drug substance, Drug product	2026-02-04
N218316-001	8129343	2031-12-05		Drug substance, Drug product	2026-02-04
N218316-001	11382957	2031-12-16		Drug product	2026-01-16
N218316-001	11033499	2033-06-19	U-4496	Drug product	2026-05-07
N218316-001	10278923	2034-05-02	U-4389		2026-01-16
N218316-001	12239739	2034-05-02	U-4388		2026-01-16
N218316-001	11833248	2039-02-01	U-4387	Drug product	2026-01-16
N218316-001	12396953	2039-02-01	U-4387	Drug product	2026-01-16
N218316-002	8536122	2026-03-20		Drug substance, Drug product	2026-02-04
N218316-002	8129343	2031-12-05		Drug substance, Drug product	2026-02-04
N218316-002	11382957	2031-12-16		Drug product	2026-01-16
N218316-002	11033499	2033-06-19	U-4496	Drug product	2026-05-07
N218316-002	10278923	2034-05-02	U-4389		2026-01-16
N218316-002	12239739	2034-05-02	U-4388		2026-01-16
N218316-002	11833248	2039-02-01	U-4387	Drug product	2026-01-16
N218316-002	12396953	2039-02-01	U-4387	Drug product	2026-01-16
N218316-003	8536122	2026-03-20		Drug substance, Drug product	2026-02-04
N218316-003	8129343	2031-12-05		Drug substance, Drug product	2026-02-04
N218316-003	11382957	2031-12-16		Drug product	2026-01-16
N218316-003	9278123	2031-12-16	U-4389	Drug product	2026-02-05
N218316-003	11033499	2033-06-19	U-4496	Drug product	2026-05-07
N218316-003	10278923	2034-05-02	U-4389		2026-01-16
N218316-003	12239739	2034-05-02	U-4388		2026-01-16
N218316-003	11833248	2039-02-01	U-4387	Drug product	2026-01-16
N218316-003	12396953	2039-02-01	U-4387	Drug product	2026-01-16
N218316-004	8536122	2026-03-20		Drug substance, Drug product	2026-02-04
N218316-004	8129343	2031-12-05		Drug substance, Drug product	2026-02-04
N218316-004	11382957	2031-12-16		Drug product	2026-01-16
N218316-004	9278123	2031-12-16	U-4389	Drug product	2026-01-16
N218316-004	11033499	2033-06-19	U-4496	Drug product	2026-05-07
N218316-004	10278923	2034-05-02	U-4389		2026-01-16
N218316-004	12239739	2034-05-02	U-4388		2026-01-16
N218316-004	11833248	2039-02-01	U-4387	Drug product	2026-01-16
N218316-004	12396953	2039-02-01	U-4387	Drug product	2026-01-16

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 8 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N218316-001	I-935	2027-03-08
N218316-001	NP	2028-12-22
N218316-002	I-935	2027-03-08
N218316-002	NP	2028-12-22
N218316-003	I-935	2027-03-08
N218316-003	NP	2028-12-22
N218316-004	I-935	2027-03-08
N218316-004	NP	2028-12-22

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N218316-001	WEGOVY	1.5MG	TABLET / ORAL	RLD, RS	2025-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-002	WEGOVY	4MG	TABLET / ORAL	RLD, RS	2025-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-003	WEGOVY	9MG	TABLET / ORAL	RLD, RS	2025-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-004	WEGOVY	25MG	TABLET / ORAL	RLD, RS	2025-12-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218316-001	WEGOVY	1.5MG	TABLET / ORAL	RLD, RS	2025-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218316-002	WEGOVY	4MG	TABLET / ORAL	RLD, RS	2025-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218316-003	WEGOVY	9MG	TABLET / ORAL	RLD, RS	2025-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218316-004	WEGOVY	25MG	TABLET / ORAL	RLD, RS	2025-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218316-001	WEGOVY	1.5MG	TABLET / ORAL	RLD	2025-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218316-002	WEGOVY	4MG	TABLET / ORAL	RLD	2025-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218316-003	WEGOVY	9MG	TABLET / ORAL	RLD	2025-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218316-004	WEGOVY	25MG	TABLET / ORAL	RLD, RS	2025-12-22	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218316-001	WEGOVY	1.5MG	TABLET / ORAL	RLD, RS	2025-12-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218316-002	WEGOVY	4MG	TABLET / ORAL	RLD, RS	2025-12-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218316-003	WEGOVY	9MG	TABLET / ORAL	RLD, RS	2025-12-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218316-004	WEGOVY	25MG	TABLET / ORAL	RLD, RS	2025-12-22	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N218316-001	8536122	2026-03-20		Drug substance, Drug product	2026-02-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-001	8129343	2031-12-05		Drug substance, Drug product	2026-02-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-001	11382957	2031-12-16		Drug product	2026-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-001	11033499	2033-06-19	U-4496	Drug product	2026-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-001	10278923	2034-05-02	U-4389		2026-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-001	12239739	2034-05-02	U-4388		2026-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-001	11833248	2039-02-01	U-4387	Drug product	2026-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-001	12396953	2039-02-01	U-4387	Drug product	2026-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-002	8536122	2026-03-20		Drug substance, Drug product	2026-02-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-002	8129343	2031-12-05		Drug substance, Drug product	2026-02-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-002	11382957	2031-12-16		Drug product	2026-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-002	11033499	2033-06-19	U-4496	Drug product	2026-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-002	10278923	2034-05-02	U-4389		2026-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-002	12239739	2034-05-02	U-4388		2026-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-002	11833248	2039-02-01	U-4387	Drug product	2026-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-002	12396953	2039-02-01	U-4387	Drug product	2026-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-003	8536122	2026-03-20		Drug substance, Drug product	2026-02-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-003	8129343	2031-12-05		Drug substance, Drug product	2026-02-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-003	11382957	2031-12-16		Drug product	2026-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-003	9278123	2031-12-16	U-4389	Drug product	2026-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-003	11033499	2033-06-19	U-4496	Drug product	2026-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-003	10278923	2034-05-02	U-4389		2026-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-003	12239739	2034-05-02	U-4388		2026-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-003	11833248	2039-02-01	U-4387	Drug product	2026-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-003	12396953	2039-02-01	U-4387	Drug product	2026-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-004	8536122	2026-03-20		Drug substance, Drug product	2026-02-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-004	8129343	2031-12-05		Drug substance, Drug product	2026-02-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-004	11382957	2031-12-16		Drug product	2026-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-004	9278123	2031-12-16	U-4389	Drug product	2026-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-004	11033499	2033-06-19	U-4496	Drug product	2026-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-004	10278923	2034-05-02	U-4389		2026-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-004	12239739	2034-05-02	U-4388		2026-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-004	11833248	2039-02-01	U-4387	Drug product	2026-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-004	12396953	2039-02-01	U-4387	Drug product	2026-01-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218316-001	8536122	2026-03-20		Drug substance, Drug product	2026-02-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218316-001	8129343	2031-12-05		Drug substance, Drug product	2026-02-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218316-001	11382957	2031-12-16		Drug product	2026-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218316-001	11033499	2033-06-19	U-4496	Drug product	2026-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218316-001	10278923	2034-05-02	U-4389		2026-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218316-001	12239739	2034-05-02	U-4388		2026-01-16	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N218316-001	I-935	2027-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-001	NP	2028-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-002	I-935	2027-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-002	NP	2028-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-003	I-935	2027-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-003	NP	2028-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-004	I-935	2027-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218316-004	NP	2028-12-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218316-001	I-935	2027-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218316-001	NP	2028-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218316-002	I-935	2027-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218316-002	NP	2028-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218316-003	I-935	2027-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218316-003	NP	2028-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218316-004	I-935	2027-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218316-004	NP	2028-12-22	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218316-001	I-935	2027-03-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218316-001	NP	2028-12-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218316-002	I-935	2027-03-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218316-002	NP	2028-12-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218316-003	I-935	2027-03-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218316-003	NP	2028-12-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218316-004	I-935	2027-03-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218316-004	NP	2028-12-22	`a50c72e98297…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ozempic	SEMAGLUTIDE	A-S Medication Solutions	42bdd912-2393-44c4-b7e0-47672ca28991	2026-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SEMAGLUTIDE
WEGOVY	SEMAGLUTIDE	A-S Medication Solutions	f5e548d0-cc79-4c34-a3f5-e20a5b8b6564	2024-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: WEGOVY generic name: SEMAGLUTIDE
Ozempic	SEMAGLUTIDE	A-S Medication Solutions	979e4df4-0597-48ea-b51c-0f699fa6d166	2023-11-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SEMAGLUTIDE
OZEMPIC	SEMAGLUTIDE	A-S Medication Solutions	e6da837c-0da0-41d6-973c-5559bf764367	2023-11-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SEMAGLUTIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85893	SUPPL	2026-05-12
85516	SUPPL	2026-03-24
85500	SUPPL	2026-03-24
85453	SUPPL	2026-03-23
85194	SUPPL	2026-03-02
85179	SUPPL	2026-02-27
84941	SUPPL	2026-02-05
84886	SUPPL	2026-01-30
84543	ORIG	2025-12-23
84499	ORIG	2025-12-23