DOXEPIN HYDROCHLORIDE Drug Patent Profile
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When do Doxepin Hydrochloride patents expire, and what generic alternatives are available?
Doxepin Hydrochloride is a drug marketed by Ajanta Pharma Ltd, Alembic, Amneal Pharms Co, Appco, Aurobindo Pharma Ltd, Chartwell Rx, Chemistry Hlth, Contract Pharmacal, Dava Pharms Inc, Edenbridge Pharms, Epic Pharma Llc, Jubilant Cadista, Lannett Co Inc, Leading, Mankind Pharma, Micro Labs, MSN, Mylan Pharms Inc, New River, Par Pharm, Purepac Pharm, Quantum Pharmics, Sandoz, Sun Pharm Industries, Taro, Unique Pharm, Watson Labs, Watson Labs Teva, Zydus Lifesciences, Pharm Assoc, Pharmobedient Cnsltg, Teva Pharms, Amneal, Actavis Elizabeth, Rk Pharma, Strides Pharma, and Zydus Pharms. and is included in seventy-five NDAs.
The generic ingredient in DOXEPIN HYDROCHLORIDE is doxepin hydrochloride. There are seven drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Doxepin Hydrochloride
A generic version of DOXEPIN HYDROCHLORIDE was approved as doxepin hydrochloride by MYLAN PHARMS INC on May 13th, 1986.
Summary for DOXEPIN HYDROCHLORIDE
US Patents: | 0 |
Applicants: | 37 |
NDAs: | 75 |
Finished Product Suppliers / Packagers: | 46 |
Raw Ingredient (Bulk) Api Vendors: | 156 |
Clinical Trials: | 21 |
Patent Applications: | 912 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DOXEPIN HYDROCHLORIDE |
What excipients (inactive ingredients) are in DOXEPIN HYDROCHLORIDE? | DOXEPIN HYDROCHLORIDE excipients list |
DailyMed Link: | DOXEPIN HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for DOXEPIN HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Hematology Center after Prof. R. Yeolyan | Phase 1/Phase 2 |
E2Bio Life Sciences, LLC | Phase 1/Phase 2 |
State University of New York - Upstate Medical University | Phase 3 |
Pharmacology for DOXEPIN HYDROCHLORIDE
Drug Class | Tricyclic Antidepressant |
Medical Subject Heading (MeSH) Categories for DOXEPIN HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Micro Labs | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 217688-004 | Jun 27, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Purepac Pharm | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 072387-001 | Sep 8, 1988 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Dava Pharms Inc | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 071685-001 | Jan 5, 1988 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 |
---|---|---|---|---|---|---|---|
New River | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 016987-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
New River | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 016987-002 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
New River | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 016987-004 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |