Application 202799

Type: NDA
Sponsor: TAKEDA PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OMONTYS PRESERVATIVE FREE	PEGINESATIDE ACETATE	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML)	No	No
002	OMONTYS PRESERVATIVE FREE	PEGINESATIDE ACETATE	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML)	No	No
003	OMONTYS PRESERVATIVE FREE	PEGINESATIDE ACETATE	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	No	No
004	OMONTYS PRESERVATIVE FREE	PEGINESATIDE ACETATE	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML)	No	No
005	OMONTYS PRESERVATIVE FREE	PEGINESATIDE ACETATE	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML)	No	No
006	OMONTYS PRESERVATIVE FREE	PEGINESATIDE ACETATE	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	EQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML)	No	No
007	OMONTYS	PEGINESATIDE ACETATE	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	No	No
008	OMONTYS	PEGINESATIDE ACETATE	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N202799-001	OMONTYS PRESERVATIVE FREE	PEGINESATIDE ACETATE	EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27
N202799-002	OMONTYS PRESERVATIVE FREE	PEGINESATIDE ACETATE	EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27
N202799-003	OMONTYS PRESERVATIVE FREE	PEGINESATIDE ACETATE	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27
N202799-004	OMONTYS PRESERVATIVE FREE	PEGINESATIDE ACETATE	EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27
N202799-005	OMONTYS PRESERVATIVE FREE	PEGINESATIDE ACETATE	EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27
N202799-006	OMONTYS PRESERVATIVE FREE	PEGINESATIDE ACETATE	EQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27
N202799-007	OMONTYS	PEGINESATIDE ACETATE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27
N202799-008	OMONTYS	PEGINESATIDE ACETATE	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27

Orange Book patents#

Current patent rows page 1 of 1 · 16 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N202799-001	7550433	2026-06-02	U-1238		2012-04-25
N202799-001	7919461	2026-06-02	U-1238		2012-04-25
N202799-002	7550433	2026-06-02	U-1238
N202799-002	7919461	2026-06-02	U-1238
N202799-003	7550433	2026-06-02	U-1238
N202799-003	7919461	2026-06-02	U-1238
N202799-004	7550433	2026-06-02	U-1238
N202799-004	7919461	2026-06-02	U-1238
N202799-005	7550433	2026-06-02	U-1238
N202799-005	7919461	2026-06-02	U-1238
N202799-006	7550433	2026-06-02	U-1238
N202799-006	7919461	2026-06-02	U-1238
N202799-007	7550433	2026-06-02	U-1238
N202799-007	7919461	2026-06-02	U-1238
N202799-008	7550433	2026-06-02	U-1238
N202799-008	7919461	2026-06-02	U-1238

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 · 344 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N202799-001	OMONTYS PRESERVATIVE FREE	EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202799-002	OMONTYS PRESERVATIVE FREE	EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202799-003	OMONTYS PRESERVATIVE FREE	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202799-004	OMONTYS PRESERVATIVE FREE	EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202799-005	OMONTYS PRESERVATIVE FREE	EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202799-006	OMONTYS PRESERVATIVE FREE	EQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202799-007	OMONTYS	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202799-008	OMONTYS	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202799-001	OMONTYS PRESERVATIVE FREE	EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202799-002	OMONTYS PRESERVATIVE FREE	EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202799-003	OMONTYS PRESERVATIVE FREE	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202799-004	OMONTYS PRESERVATIVE FREE	EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202799-005	OMONTYS PRESERVATIVE FREE	EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202799-006	OMONTYS PRESERVATIVE FREE	EQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202799-007	OMONTYS	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202799-008	OMONTYS	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202799-001	OMONTYS PRESERVATIVE FREE	EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202799-002	OMONTYS PRESERVATIVE FREE	EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202799-003	OMONTYS PRESERVATIVE FREE	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202799-004	OMONTYS PRESERVATIVE FREE	EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202799-005	OMONTYS PRESERVATIVE FREE	EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202799-006	OMONTYS PRESERVATIVE FREE	EQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202799-007	OMONTYS	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202799-008	OMONTYS	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202799-001	OMONTYS PRESERVATIVE FREE	EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202799-002	OMONTYS PRESERVATIVE FREE	EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202799-003	OMONTYS PRESERVATIVE FREE	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202799-004	OMONTYS PRESERVATIVE FREE	EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202799-005	OMONTYS PRESERVATIVE FREE	EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202799-006	OMONTYS PRESERVATIVE FREE	EQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202799-007	OMONTYS	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202799-008	OMONTYS	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202799-001	OMONTYS PRESERVATIVE FREE	EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202799-002	OMONTYS PRESERVATIVE FREE	EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202799-003	OMONTYS PRESERVATIVE FREE	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202799-004	OMONTYS PRESERVATIVE FREE	EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202799-005	OMONTYS PRESERVATIVE FREE	EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202799-006	OMONTYS PRESERVATIVE FREE	EQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202799-007	OMONTYS	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202799-008	OMONTYS	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS, SUBCUTANEOUS			2012-03-27	`6a471c1ec25d…`

Observed Orange Book patent history#

Patent history page 1 of 46 · 1,808 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	N202799-001	7550433	2026-06-02	U-1238		2012-04-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202799-001	7919461	2026-06-02	U-1238		2012-04-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202799-002	7550433	2026-06-02	U-1238			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202799-002	7919461	2026-06-02	U-1238			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202799-003	7550433	2026-06-02	U-1238			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202799-003	7919461	2026-06-02	U-1238			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202799-004	7550433	2026-06-02	U-1238			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202799-004	7919461	2026-06-02	U-1238			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202799-005	7550433	2026-06-02	U-1238			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202799-005	7919461	2026-06-02	U-1238			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202799-006	7550433	2026-06-02	U-1238			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202799-006	7919461	2026-06-02	U-1238			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202799-007	7550433	2026-06-02	U-1238			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202799-007	7919461	2026-06-02	U-1238			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202799-008	7550433	2026-06-02	U-1238			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202799-008	7919461	2026-06-02	U-1238			`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202799-001	7550433	2026-06-02	U-1238		2012-04-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202799-001	7919461	2026-06-02	U-1238		2012-04-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202799-002	7550433	2026-06-02	U-1238			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202799-002	7919461	2026-06-02	U-1238			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202799-003	7550433	2026-06-02	U-1238			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202799-003	7919461	2026-06-02	U-1238			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202799-004	7550433	2026-06-02	U-1238			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202799-004	7919461	2026-06-02	U-1238			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202799-005	7550433	2026-06-02	U-1238			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202799-005	7919461	2026-06-02	U-1238			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202799-006	7550433	2026-06-02	U-1238			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202799-006	7919461	2026-06-02	U-1238			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202799-007	7550433	2026-06-02	U-1238			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202799-007	7919461	2026-06-02	U-1238			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202799-008	7550433	2026-06-02	U-1238			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202799-008	7919461	2026-06-02	U-1238			`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202799-001	7550433	2026-06-02	U-1238		2012-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202799-001	7919461	2026-06-02	U-1238		2012-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202799-002	7550433	2026-06-02	U-1238			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202799-002	7919461	2026-06-02	U-1238			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202799-003	7550433	2026-06-02	U-1238			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202799-003	7919461	2026-06-02	U-1238			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202799-004	7550433	2026-06-02	U-1238			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202799-004	7919461	2026-06-02	U-1238			`011fe1cb6892…`

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
10110	SUPPL	2012-12-06
40220	SUPPL	2012-12-05
22897	ORIG	2012-05-03
44584	ORIG	2012-03-28
40219	ORIG	2012-03-27
32305	ORIG	2012-03-27
23496	ORIG	2012-03-27