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Last Updated: January 27, 2023

Doxepin hydrochloride - Generic Drug Details


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What are the generic 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, Edenbridge Pharms, Epic Pharma Llc, Jubilant Cadista, Lannett Co Inc, Leading, Mankind Pharma, MSN, 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 Pharma, and Currax, and is included in seventy-one NDAs. There are fifteen 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 is one drug master file entry for doxepin hydrochloride. Thirty-nine 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
E2Bio Life Sciences, LLCPhase 1/Phase 2
Hematology Center after Prof. R. YeolyanPhase 1/Phase 2
State University of New York - Upstate Medical UniversityPhase 3

See all doxepin hydrochloride clinical trials

Generic filers with tentative approvals for DOXEPIN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing6MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing3MGTABLET; 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 Strength NDA ANDAs Submitted Submissiondate
SILENOR Tablets doxepin hydrochloride 3 mg and 6 mg 022036 2 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
Chartwell Rx DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 210268-002 Sep 4, 2020 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan ZONALON doxepin hydrochloride CREAM;TOPICAL 020126-001 Apr 1, 1994 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Leading DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 211619-001 Mar 9, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Quantum Pharmics DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 070932-001 Sep 29, 1987 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Watson Labs DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 070952-001 Mar 4, 1987 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sandoz DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 071562-001 Mar 2, 1987 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Pfizer SINEQUAN doxepin hydrochloride CONCENTRATE;ORAL 017516-001 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 See Plans and Pricing See Plans and Pricing
Pfizer SINEQUAN doxepin hydrochloride CAPSULE;ORAL 016798-005 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 See Plans and Pricing See Plans and Pricing
New River DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 016987-001 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for doxepin hydrochloride

Country Patent Number Title Estimated Expiration
Japan 2013237694 METHOD OF USING LOW-DOSE DOXEPIN FOR IMPROVEMENT OF SLEEP See Plans and Pricing
Canada 2687124 FORMULATIONS DE DOXEPINE A FAIBLE DOSE, INCLUANT DES FORMULATIONS BUCCALES, SUBLINGUALES ET A DISSOLUTION RAPIDE, ET LEURS UTILISATIONS POUR TRAITER L'INSOMNIE (LOW DOSE DOXEPIN FORMULATIONS, INCLUDING BUCCAL, SUBLINGUAL AND FASTMELT FORMULATIONS, AND USES OF THE SAME TO TREAT INSOMNIA) See Plans and Pricing
Canada 2721133 FORMULATIONS DE DOXEPINE A FAIBLE DOSE ET PROCEDE DE PREPARATION ET D'UTILISATION DE CELLE-CI (LOW-DOSE DOXEPIN FORMULATIONS AND METHODS OF MAKING AND USING THE SAME) See Plans and Pricing
Japan 2009537553 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2008011150 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2008128115 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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Moodys

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