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Last Updated: July 28, 2021

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DOXEPIN HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for doxepin hydrochloride and what is the scope of patent protection?

Doxepin hydrochloride is the generic ingredient in four branded drugs marketed by Ajanta Pharma Ltd, Alembic Pharms Ltd, Amneal Pharms Co, Appco, Aurobindo Pharma Ltd, Contract Pharmacal, Dava Pharms Inc, Epic Pharma Llc, Lannett Co Inc, Leading Pharma Llc, Mylan Pharms Inc, New River, Par Pharm, Purepac Pharm, Quantum Pharmics, Sandoz, Sun Pharm Industries, Taro Pharm Inds Ltd, Upsher Smith Labs, Watson Labs, Watson Labs Teva, Pfizer, Pharm Assoc, Teva Pharms, Wockhardt Bio Ag, Mylan, Actavis Elizabeth, Par Pharm Inc, Rk Pharma, and Currax, and is included in sixty-seven NDAs. There are twelve patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Doxepin hydrochloride has sixteen patent family members in four countries.

There are seven drug master file entries for doxepin hydrochloride. Thirty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for DOXEPIN HYDROCHLORIDE

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

SponsorPhase
Aalborg UniversityN/A
University of BalamandPhase 4
Haining Health-Coming Biotech Co., Ltd.Phase 2

See all DOXEPIN HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for DOXEPIN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever Trial6MGTABLET; ORAL
⤷  Free Forever Trial⤷  Free Forever Trial3MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for DOXEPIN HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for DOXEPIN HYDROCHLORIDE
Paragraph IV (Patent) Challenges for DOXEPIN HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
SILENOR TABLET;ORAL doxepin hydrochloride 022036 2010-09-16

US Patents and Regulatory Information for DOXEPIN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 AB RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 AB RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Amneal Pharms Co DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 207482-004 Jun 28, 2017 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 AB RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Watson Labs DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 072986-001 Mar 29, 1991 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Taro Pharm Inds Ltd DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 213063-004 Jul 1, 2020 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 DOXEPIN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 ⤷  Free Forever Trial ⤷  Free Forever Trial
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-003 Approved Prior to Jan 1, 1982 ⤷  Free Forever Trial ⤷  Free Forever Trial
Mylan ZONALON doxepin hydrochloride CREAM;TOPICAL 020126-001 Apr 1, 1994 ⤷  Free Forever Trial ⤷  Free Forever Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 ⤷  Free Forever Trial ⤷  Free Forever Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 ⤷  Free Forever Trial ⤷  Free Forever Trial
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-007 Approved Prior to Jan 1, 1982 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Baxter
Medtronic
Moodys
Johnson and Johnson
Dow
McKesson

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