Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 14, 2019

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VASOSTRICT Drug Profile

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When do Vasostrict patents expire, and when can generic versions of Vasostrict launch?

Vasostrict is a drug marketed by Par Sterile Products and is included in one NDA. There are six 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. Three suppliers are listed for this compound. Additional details are available on the vasopressin profile page.

US ANDA Litigation and Generic Entry Outlook for Vasostrict

Vasostrict was eligible for patent challenges on December 31st, 1968.

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

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Historic data indicate that 48% of cases that proceed to trial are decided in favor of the generic patent challenger.

Drug patent expirations by year for VASOSTRICT
Drug Prices for VASOSTRICT

See drug prices for VASOSTRICT

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

Recent Litigation for VASOSTRICT

Identify potential future generic entrants

District Court Litigation
Case NameDate
Par Pharmaceutical, Inc. v. Amneal Pharmaceuticals Company GmbH2019-04-18
Par Pharmaceutical, Inc. v. Amphastar Pharmaceuticals, Inc.2018-12-20
PAR PHARMACEUTICAL, INC. v. SANDOZ INC.2018-10-11

See all VASOSTRICT litigation

Synonyms for VASOSTRICT
11034-16-5
12678-42-1
196116-EP2272972A1
196116-EP2272973A1
196116-EP2277872A1
ADH (hormone)
D00101
EINECS 234-236-2
HSDB 3412
Intertocin
Inyectable de vasopresina [INN-Spanish]
LS-161408
Pitressin (TN)
Pituitrin
Pituitrin P
SCHEMBL1172390
Solute injectable de vasopressine [INN-French]
Tonephin
UNII-Y87Y826H08
Vasopressin (JP17/USP)
Vasopressin, unspecified
Vasopressina
Vasopressina [DCIT]
Vasopressine
Vasopressini injectio [INN-Latin]
Vasopressins
Vasopressinum
Y87Y826H08
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 Y   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 204485-001 Apr 17, 2014 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 204485-001 Apr 17, 2014 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 204485-002 Dec 17, 2016 RX Yes Yes   Start Trial   Start Trial Y   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:

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.