AMITRIPTYLINE Drug Patent Profile
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When do Amitriptyline patents expire, and when can generic versions of Amitriptyline launch?
Amitriptyline is a drug marketed by Watson Labs, Accord Hlthcare, Aiping Pharm Inc, Am Therap, Ani Pharms, Aurobindo Pharma Usa, Breckenridge, Copley Pharm, Halsey, Lederle, Mankind Pharma, Mutual Pharm, Par Pharm, Ph Health, Pliva, Purepac Pharm, Rising, Roxane, Rubicon Research, Sandoz, Sun Pharm Inds Inc, Superpharm, Teva, Ucb Inc, Unichem, Unique Pharm, Usl Pharma, Vangard, West Ward, and Zydus Pharms. and is included in one hundred and twenty NDAs.
The generic ingredient in AMITRIPTYLINE is amitriptyline hydrochloride. There are thirteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the amitriptyline hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Amitriptyline
A generic version of AMITRIPTYLINE was approved as amitriptyline hydrochloride by SUN PHARM INDS INC on July 14th, 1987.
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Questions you can ask:
- What is the 5 year forecast for AMITRIPTYLINE?
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Summary for AMITRIPTYLINE
| US Patents: | 0 |
| Applicants: | 30 |
| NDAs: | 120 |
| Drug Prices: | Drug price information for AMITRIPTYLINE |
| Drug Sales Revenues: | Drug sales revenues for AMITRIPTYLINE |
| DailyMed Link: | AMITRIPTYLINE at DailyMed |
US Patents and Regulatory Information for AMITRIPTYLINE
| 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 | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Rising | AMITRIPTYLINE HYDROCHLORIDE | amitriptyline hydrochloride | TABLET;ORAL | 217411-005 | May 19, 2023 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Halsey | AMITRIPTYLINE HYDROCHLORIDE | amitriptyline hydrochloride | TABLET;ORAL | 085922-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |



