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Last Updated: July 2, 2020

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VASOSTRICT Drug Profile


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When do Vasostrict patents expire, and what generic alternatives are available?

Vasostrict is a drug marketed by Par Sterile Products and is included in one NDA. There are fourteen patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in VASOSTRICT is vasopressin. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the vasopressin profile page.

US ANDA Litigation and Generic Entry Outlook for Vasostrict

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 30, 2035. This may change due to patent challenges or generic licensing.

There have been eight patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (vasopressin), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for VASOSTRICT
Drug Prices for VASOSTRICT

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Generic Entry Opportunity Date for VASOSTRICT
Generic Entry Date for VASOSTRICT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for VASOSTRICT

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

SponsorPhase
Endo PharmaceuticalsPhase 1
Advocate Health CareN/A

See all VASOSTRICT clinical trials

Paragraph IV (Patent) Challenges for VASOSTRICT
Tradename Dosage Ingredient NDA Submissiondate
VASOSTRICT SOLUTION;INTRAVENOUS vasopressin 204485 2018-06-29
VASOSTRICT SOLUTION;INTRAVENOUS vasopressin 204485 2018-03-23

US Patents and Regulatory Information for VASOSTRICT

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 204485-001 Apr 17, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Par Sterile Products VASOSTRICT vasopressin SOLUTION;INTRAVENOUS 204485-004 Apr 15, 2020 RX Yes Yes   Start Trial   Start Trial   Start Trial
Par Sterile Products VASOSTRICT vasopressin SOLUTION;INTRAVENOUS 204485-002 Dec 17, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Par Sterile Products VASOSTRICT vasopressin SOLUTION;INTRAVENOUS 204485-003 Apr 15, 2020 RX Yes Yes   Start Trial   Start Trial   Start Trial
Par Sterile Products VASOSTRICT vasopressin SOLUTION;INTRAVENOUS 204485-001 Apr 17, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Par Sterile Products VASOSTRICT vasopressin SOLUTION;INTRAVENOUS 204485-003 Apr 15, 2020 RX Yes Yes   Start Trial   Start Trial   Start Trial
Par Sterile Products VASOSTRICT vasopressin SOLUTION;INTRAVENOUS 204485-004 Apr 15, 2020 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
Harvard Business School
Moodys
AstraZeneca
Merck
Boehringer Ingelheim

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