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Last Updated: October 21, 2020

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Vasopressin - Generic Drug Details

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What are the generic drug sources for vasopressin and what is the scope of freedom to operate?

Vasopressin is the generic ingredient in three branded drugs marketed by Am Regent, Par Sterile Products, and Parke Davis, and is included in three 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. Two suppliers are listed for this compound.

Recent Clinical Trials for vasopressin

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SponsorPhase
University Hospital, Basel, SwitzerlandPhase 4
The Cleveland ClinicPhase 3
Stanford UniversityEarly Phase 1

See all vasopressin clinical trials

Paragraph IV (Patent) Challenges for VASOPRESSIN
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 vasopressin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Parke Davis PITRESSIN TANNATE vasopressin tannate INJECTABLE;INJECTION 003402-001 Approved Prior to Jan 1, 1982 DISCN Yes No   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 204485-004 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:

Mallinckrodt
McKinsey
Moodys
Colorcon
Boehringer Ingelheim
AstraZeneca

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