Application 209296

Type: NDA
Sponsor: HERON THERAPS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CINVANTI	APREPITANT	EMULSION;INTRAVENOUS	130MG/18ML (7.2MG/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N209296-001	CINVANTI	APREPITANT	130MG/18ML (7.2MG/ML)	EMULSION / INTRAVENOUS		RLD, RS	2017-11-09

Orange Book patents#

Current patent rows page 1 of 1 · 13 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209296-001	10500208	2035-09-18		Drug product	2019-12-23
N209296-001	10624850	2035-09-18	U-2161		2020-04-30
N209296-001	10953018	2035-09-18	U-2161		2021-04-08
N209296-001	11173118	2035-09-18		Drug product	2021-12-13
N209296-001	11744800	2035-09-18		Drug product	2023-10-02
N209296-001	12115254	2035-09-18		Drug product	2024-11-07
N209296-001	12115255	2035-09-18		Drug product	2024-11-07
N209296-001	12290520	2035-09-18		Drug product	2025-05-12
N209296-001	9561229	2035-09-18	U-2161	Drug product	2017-12-05
N209296-001	9808465	2035-09-18	U-2161		2017-12-05
N209296-001	9974742	2035-09-18		Drug product	2018-06-19
N209296-001	9974793	2035-09-18		Drug product	2018-06-19
N209296-001	9974794	2035-09-18	U-2161	Drug product	2018-06-19

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N209296-001	CINVANTI	130MG/18ML (7.2MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2017-11-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209296-001	CINVANTI	130MG/18ML (7.2MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2017-11-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209296-001	CINVANTI	130MG/18ML (7.2MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2017-11-09	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209296-001	CINVANTI	130MG/18ML (7.2MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2017-11-09	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 423 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N209296-001	10500208	2035-09-18		Drug product	2019-12-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209296-001	10624850	2035-09-18	U-2161		2020-04-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209296-001	10953018	2035-09-18	U-2161		2021-04-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209296-001	11173118	2035-09-18		Drug product	2021-12-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209296-001	11744800	2035-09-18		Drug product	2023-10-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209296-001	12115254	2035-09-18		Drug product	2024-11-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209296-001	12115255	2035-09-18		Drug product	2024-11-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209296-001	12290520	2035-09-18		Drug product	2025-05-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209296-001	9561229	2035-09-18	U-2161	Drug product	2017-12-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209296-001	9808465	2035-09-18	U-2161		2017-12-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209296-001	9974742	2035-09-18		Drug product	2018-06-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209296-001	9974793	2035-09-18		Drug product	2018-06-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209296-001	9974794	2035-09-18	U-2161	Drug product	2018-06-19	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N209296-001	10500208	2035-09-18		Drug product	2019-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209296-001	10624850	2035-09-18	U-2161		2020-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209296-001	10953018	2035-09-18	U-2161		2021-04-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209296-001	11173118	2035-09-18		Drug product	2021-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209296-001	11744800	2035-09-18		Drug product	2023-10-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209296-001	12115254	2035-09-18		Drug product	2024-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209296-001	12115255	2035-09-18		Drug product	2024-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209296-001	12290520	2035-09-18		Drug product	2025-05-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209296-001	9561229	2035-09-18	U-2161	Drug product	2017-12-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209296-001	9808465	2035-09-18	U-2161		2017-12-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209296-001	9974742	2035-09-18		Drug product	2018-06-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209296-001	9974793	2035-09-18		Drug product	2018-06-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209296-001	9974794	2035-09-18	U-2161	Drug product	2018-06-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209296-001	10500208	2035-09-18		Drug product	2019-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209296-001	10624850	2035-09-18	U-2161		2020-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209296-001	10953018	2035-09-18	U-2161		2021-04-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209296-001	11173118	2035-09-18		Drug product	2021-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209296-001	11744800	2035-09-18		Drug product	2023-10-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209296-001	12115254	2035-09-18		Drug product	2024-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209296-001	12115255	2035-09-18		Drug product	2024-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209296-001	12290520	2035-09-18		Drug product	2025-05-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209296-001	9561229	2035-09-18	U-2161	Drug product	2017-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209296-001	9808465	2035-09-18	U-2161		2017-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209296-001	9974742	2035-09-18		Drug product	2018-06-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209296-001	9974793	2035-09-18		Drug product	2018-06-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209296-001	9974794	2035-09-18	U-2161	Drug product	2018-06-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209296-001	10500208	2035-09-18		Drug product	2019-12-23	`011fe1cb6892…`

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
CINVANTI	APREPITANT	Heron Therapeutics, Inc.	4c218d3a-a508-4abc-9ed8-a6e8e191d1b4	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209296 application number: NDA209296 ndc (product): 47426-201

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47426-201	CINVANTI	aprepitant	Heron Therapeutics, Inc.	NDA	Current
47426-201	CINVANTI	aprepitant	Heron Therapeutics, Inc.	NDA	Current
47426-201	CINVANTI	aprepitant	Heron Therapeutics, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77721	SUPPL	2024-03-05
77716	SUPPL	2024-03-05
70796	SUPPL	2022-04-20
70522	SUPPL	2022-03-15
60632	SUPPL	2019-10-22
60630	SUPPL	2019-10-22
57833	SUPPL	2019-02-28
57823	SUPPL	2019-02-27
52881	ORIG	2018-03-09
50385	ORIG	2017-11-13
50368	ORIG	2017-11-13