AMITRIPTYLINE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Amitriptyline Hydrochloride, and what generic alternatives are available?
Amitriptyline Hydrochloride is a drug marketed by Watson Labs, Accord Hlthcare, Aiping Pharm Inc, Am Therap, Ani Pharms, Aurobindo Pharma Usa, Breckenridge, Copley Pharm, Endo Operations, Halsey, Lederle, Mankind Pharma, Mutual Pharm, Par Pharm, Pliva, Purepac Pharm, Rising, Roxane, Rubicon, Sandoz, Sun Pharm Inds Inc, Superpharm, Teva, Ucb Inc, Unichem, Usl Pharma, Vangard, West Ward, and Zydus Pharms. and is included in one hundred and nineteen NDAs.
The generic ingredient in AMITRIPTYLINE HYDROCHLORIDE is amitriptyline hydrochloride. There are thirteen drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the amitriptyline hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Amitriptyline Hydrochloride
A generic version of AMITRIPTYLINE HYDROCHLORIDE was approved as amitriptyline hydrochloride by SUN PHARM INDS INC on July 14th, 1987.
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Questions you can ask:
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Summary for AMITRIPTYLINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 29 |
| NDAs: | 119 |
| Finished Product Suppliers / Packagers: | 43 |
| Raw Ingredient (Bulk) Api Vendors: | 124 |
| Clinical Trials: | 125 |
| Patent Applications: | 2,828 |
| DailyMed Link: | AMITRIPTYLINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for AMITRIPTYLINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Shalamar Institute of Health Sciences | N/A |
| Beni-Suef University | Phase 2 |
| Children's Hospital Medical Center, Cincinnati | N/A |
Pharmacology for AMITRIPTYLINE HYDROCHLORIDE
| Drug Class | Tricyclic Antidepressant |
Medical Subject Heading (MeSH) Categories for AMITRIPTYLINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for AMITRIPTYLINE HYDROCHLORIDE
US Patents and Regulatory Information for AMITRIPTYLINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mutual Pharm | AMITRIPTYLINE HYDROCHLORIDE | amitriptyline hydrochloride | TABLET;ORAL | 085743-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Rising | AMITRIPTYLINE HYDROCHLORIDE | amitriptyline hydrochloride | TABLET;ORAL | 217411-005 | May 19, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Endo Operations | AMITRIPTYLINE HYDROCHLORIDE | amitriptyline hydrochloride | TABLET;ORAL | 040218-002 | Sep 11, 1997 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Breckenridge | AMITRIPTYLINE HYDROCHLORIDE | amitriptyline hydrochloride | TABLET;ORAL | 216243-005 | Jun 6, 2022 | 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 |
