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, Chemistry Hlth, Copley Pharm, 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, Vintage Pharms, 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-one 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.
Summary for AMITRIPTYLINE HYDROCHLORIDE
US Patents: | 0 |
Applicants: | 29 |
NDAs: | 119 |
Finished Product Suppliers / Packagers: | 41 |
Raw Ingredient (Bulk) Api Vendors: | 124 |
Clinical Trials: | 122 |
Patent Applications: | 2,894 |
Formulation / Manufacturing: | see details |
DailyMed Link: | AMITRIPTYLINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for AMITRIPTYLINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Patient-Centered Outcomes Research Institute | N/A |
Children's Hospital Medical Center, Cincinnati | N/A |
Bahria University | Phase 4 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Par Pharm | AMITRIPTYLINE HYDROCHLORIDE | amitriptyline hydrochloride | TABLET;ORAL | 088700-001 | Sep 25, 1984 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Roxane | AMITRIPTYLINE HYDROCHLORIDE | amitriptyline hydrochloride | TABLET;ORAL | 085945-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Halsey | AMITRIPTYLINE HYDROCHLORIDE | amitriptyline hydrochloride | TABLET;ORAL | 085922-001 | Approved Prior to Jan 1, 1982 | 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 |