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Last Updated: August 8, 2020

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SINEQUAN Drug Profile

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

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

The generic ingredient in SINEQUAN is doxepin hydrochloride. There are seven drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Sinequan

A generic version of SINEQUAN was approved as doxepin hydrochloride by MYLAN PHARMS INC on May 13th, 1986.

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Summary for SINEQUAN
Drug patent expirations by year for SINEQUAN
Recent Clinical Trials for SINEQUAN

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

SponsorPhase
University of BalamandPhase 4

See all SINEQUAN clinical trials

US Patents and Regulatory Information for SINEQUAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-003 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Pfizer SINEQUAN doxepin hydrochloride CONCENTRATE;ORAL 017516-001 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-006 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-001 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-002 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-007 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-005 Approved Prior to Jan 1, 1982 DISCN Yes No   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

Expired US Patents for SINEQUAN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-007 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-003 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-005 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-006 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Pfizer SINEQUAN doxepin hydrochloride CONCENTRATE;ORAL 017516-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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