DOXEPIN HYDROCHLORIDE Drug Patent Profile
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Which patents cover Doxepin Hydrochloride, and what generic alternatives are available?
Doxepin Hydrochloride is a drug marketed by Adaptis, Aiping Pharm Inc, Ajanta Pharma Ltd, Alembic, Amneal Pharms Co, Appco, Aurobindo Pharma Ltd, Chartwell Rx, Dava Pharms Inc, Endo Operations, Epic Pharma Llc, Jubilant Cadista, Lannett Co Inc, Leading, Mankind Pharma, Micro Labs, MSN, Mylan Pharms Inc, New River, Purepac Pharm, Quantum Pharmics, Sandoz, Sun Pharm Industries, Taro, Unique Pharm, Velzen Pharma Pvt, Watson Labs, Watson Labs Teva, Zydus Lifesciences, Pharm Assoc, Pharmobedient Cnsltg, Teva Pharms, Amneal, Actavis Elizabeth, Rk Pharma, and Strides Pharma. and is included in seventy-seven NDAs.
The generic ingredient in DOXEPIN HYDROCHLORIDE is doxepin hydrochloride. There are seven drug master file entries for this compound. Fifty 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.
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Questions you can ask:
- What is the 5 year forecast for DOXEPIN HYDROCHLORIDE?
- What are the global sales for DOXEPIN HYDROCHLORIDE?
- What is Average Wholesale Price for DOXEPIN HYDROCHLORIDE?
Summary for DOXEPIN HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 36 |
| NDAs: | 77 |
| Finished Product Suppliers / Packagers: | 48 |
| Raw Ingredient (Bulk) Api Vendors: | 156 |
| Clinical Trials: | 22 |
| Patent Applications: | 902 |
| 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 |
|---|---|
| Nanfang Hospital, Southern Medical University | N/A |
| Hematology Center after Prof. R. Yeolyan | Phase 1/Phase 2 |
| E2Bio Life Sciences, LLC | Phase 1/Phase 2 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mankind Pharma | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 215710-004 | Feb 9, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Quantum Pharmics | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 070972-001 | Sep 29, 1987 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Dava Pharms Inc | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 071675-001 | Jan 5, 1988 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Chartwell Rx | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 210268-001 | Sep 4, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| New River | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 016987-006 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| New River | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 016987-004 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| New River | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 016987-003 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
