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Last Updated: August 7, 2020

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UNISOM Drug Profile

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

Unisom is a drug marketed by Pfizer and Chattem and is included in two NDAs.

The generic ingredient in UNISOM is doxylamine succinate. There are fourteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the doxylamine succinate profile page.

US ANDA Litigation and Generic Entry Outlook for Unisom

A generic version of UNISOM was approved as doxylamine succinate by PERRIGO on September 18th, 1996.

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Summary for UNISOM
Drug patent expirations by year for UNISOM

US Patents and Regulatory Information for UNISOM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer UNISOM doxylamine succinate CAPSULE;ORAL 019440-001 Feb 5, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
Chattem UNISOM doxylamine succinate TABLET;ORAL 018066-001 Approved Prior to Jan 1, 1982 OTC 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:

McKesson
Express Scripts
McKinsey
Merck
Boehringer Ingelheim
Baxter

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