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Last Updated: December 7, 2021

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Doxepin hydrochloride - Generic Drug Details

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

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, Chartwell Rx, 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, Watson Labs, Watson Labs Teva, Pfizer, Pharm Assoc, Teva Pharms, Wockhardt Bio Ag, Mylan, Actavis Elizabeth, Rk Pharma, Strides Arcolab Ltd, and Currax, and is included in sixty-seven NDAs. There are fourteen 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-two 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
State University of New York - Upstate Medical UniversityPhase 3
Aalborg UniversityN/A
University of BalamandPhase 4

See all doxepin hydrochloride clinical trials

Generic filers with tentative approvals for DOXEPIN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free6MGTABLET; ORAL
⤷  Try it Free⤷  Try it Free3MGTABLET; 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
Taro Pharm Inds Ltd DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 213063-001 Jul 1, 2020 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Purepac Pharm DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 072387-001 Sep 8, 1988 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 AB RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Leading Pharma Llc DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 211619-003 Mar 9, 2021 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 022036-001 Mar 17, 2010 ⤷  Try it Free ⤷  Try it Free
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 ⤷  Try it Free ⤷  Try it Free
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-007 Approved Prior to Jan 1, 1982 ⤷  Try it Free ⤷  Try it Free
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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