Vasopressin - Generic Drug Details

What are the generic drug sources for vasopressin and what is the scope of patent protection?

Vasopressin is the generic ingredient in four branded drugs marketed by Am Regent, Amneal, Amphastar Pharms Inc, Cipla, Eagle Pharms, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Baxter Hlthcare Corp, Par Sterile Products, and Parke Davis, and is included in eleven NDAs. There are fourteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for vasopressin. Thirteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for vasopressin

US Patents:	14
Tradenames:	4
Applicants:	11
NDAs:	11
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	13
Clinical Trials:	245
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for vasopressin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for vasopressin
What excipients (inactive ingredients) are in vasopressin?	vasopressin excipients list
DailyMed Link:	vasopressin at DailyMed

See drug prices for vasopressin

Recent Clinical Trials for vasopressin

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Alberta	Phase 1
Qianfoshan Hospital	N/A
Erzincan Military Hospital	Phase 4

See all vasopressin clinical trials

Generic filers with tentative approvals for VASOPRESSIN

Applicant	Application No.	Strength	Dosage Form
		200UNITS/10ML(20UNITS/ML)	INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for vasopressin

Physiological Effect

Decreased Diuresis Vasoconstriction

Paragraph IV (Patent) Challenges for VASOPRESSIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VASOSTRICT	Injection	vasopressin	20 units/100 mL	204485	1	2022-12-20
VASOSTRICT	Injection	vasopressin	40 units/100 mL and 60 units/100 mL	204485	1	2022-02-28
VASOSTRICT	Injection	vasopressin	200 units/10 mL	204485	1	2018-06-29
VASOSTRICT	Injection	vasopressin	20 units/mL, 1 mL	204485	1	2018-03-23

US Patents and Regulatory Information for vasopressin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Par Sterile Products	VASOSTRICT	vasopressin	SOLUTION;INTRAVENOUS	204485-004	Apr 15, 2020		DISCN	Yes	No
Par Sterile Products	VASOSTRICT	vasopressin	SOLUTION;INTRAVENOUS	204485-005	Apr 21, 2021	AP	RX	Yes	Yes
Par Sterile Products	VASOSTRICT	vasopressin	SOLUTION;INTRAVENOUS	204485-005	Apr 21, 2021	AP	RX	Yes	Yes
Par Sterile Products	VASOSTRICT	vasopressin	SOLUTION;INTRAVENOUS	204485-001	Apr 17, 2014	AP	RX	Yes	Yes