Question 1

Is there a generic for Vasopressin?

Accepted Answer

Yes. The FDA Orange Book lists 10 approved generic (ANDA) applications for Vasopressin, referencing the brand VASOPRESSIN IN SODIUM CHLORIDE 0.9%. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

What is the reference-listed drug for Vasopressin?

Accepted Answer

VASOPRESSIN IN SODIUM CHLORIDE 0.9% (NDA 217766, LONG GROVE PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Vasopressin?

Accepted Answer

The Orange Book lists 16 patents against Vasopressin products, with the earliest listed expiry in 2035. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

What dosage forms of Vasopressin are approved?

Accepted Answer

Vasopressin is approved in the following dosage form: solution.

Product	Applicant	Application	TE	Approved
VASOPRESSIN IN SODIUM CHLORIDE 0.9%RLD×3	LONG GROVE PHARMS	NDA 217766	—	Jul 11, 2024
VASOPRESSIN IN SODIUM CHLORIDE 0.9%RLD×2	BAXTER HLTHCARE CORP	NDA 217569	—	Sep 29, 2023
VASOPRESSINRLD×2	AM REGENT	NDA 212593	—	Aug 03, 2020
VASOSTRICTRLD×6	PH HEALTH	NDA 204485	AP	Apr 17, 2014

Product	Applicant	Application	TE	Approved
VASOPRESSIN	SANDOZ	ANDA 212068	AP	May 06, 2026
VASOPRESSIN	SANDOZ	ANDA 212069	AP	May 06, 2026
VASOPRESSIN×2	DR REDDYS	ANDA 213988	AP	May 08, 2024
VASOPRESSIN×2	GLAND	ANDA 216963	AP	Feb 09, 2024
VASOPRESSIN	CIPLA	ANDA 217987	AP	Dec 06, 2023
VASOPRESSIN	FRESENIUS KABI USA	ANDA 213206	AP	May 26, 2023
VASOPRESSIN	EUGIA PHARMA	ANDA 214314	AP	Aug 15, 2022
VASOPRESSIN	AMNEAL	ANDA 212944	AP	Aug 05, 2022
VASOPRESSIN	AMPHASTAR PHARMS INC	ANDA 211857	AP	Jul 18, 2022
VASOPRESSIN	EAGLE PHARMS	ANDA 211538	—	Dec 15, 2021

Patent	Expires	In	Type
9744209	Jan 30, 2035	in 8 yr 9 mo	U-1857
9375478	Jan 30, 2035	in 8 yr 9 mo	U-1857
9744239	Jan 30, 2035	in 8 yr 9 mo	U-1857
9687526	Jan 30, 2035	in 8 yr 9 mo	U-1857
9750785	Jan 30, 2035	in 8 yr 9 mo	Product
10010575	Jan 30, 2035	in 8 yr 9 mo	U-1857
9981006	Jan 30, 2035	in 8 yr 9 mo	U-1857
9974827	Jan 30, 2035	in 8 yr 9 mo	U-1857
9968649	Jan 30, 2035	in 8 yr 9 mo	U-1857
9962422	Jan 30, 2035	in 8 yr 9 mo	U-1857
9925234	Jan 30, 2035	in 8 yr 9 mo	U-1857
9925233	Jan 30, 2035	in 8 yr 9 mo	U-1857
12186362	Jan 30, 2035	in 8 yr 9 mo	Product
9919026	Jan 30, 2035	in 8 yr 9 mo	Product
9937223	Jan 30, 2035	in 8 yr 9 mo	U-1857
12447190	Sep 27, 2044	in 18 yr 7 mo	Product

Vasopressin

Brand (NDA) products · solution

Generic (ANDA) products (10)

Listed patents (16)

Vasopressin — frequently asked questions

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