PROTRIPTYLINE HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for protriptyline hydrochloride and what is the scope of freedom to operate?
Protriptyline hydrochloride
is the generic ingredient in two branded drugs marketed by Epic Pharma Llc, Hikma, Sigmapharm Labs Llc, Chartwell Rx, and Teva Womens, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.There are five drug master file entries for protriptyline hydrochloride. Three suppliers are listed for this compound.
Summary for PROTRIPTYLINE HYDROCHLORIDE
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 5 |
NDAs: | 6 |
Drug Master File Entries: | 5 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 58 |
Clinical Trials: | 2 |
Patent Applications: | 1,069 |
What excipients (inactive ingredients) are in PROTRIPTYLINE HYDROCHLORIDE? | PROTRIPTYLINE HYDROCHLORIDE excipients list |
DailyMed Link: | PROTRIPTYLINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for PROTRIPTYLINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Federal University of São Paulo | Phase 4 |
Fundação de Amparo à Pesquisa do Estado de São Paulo | Phase 4 |
Roxane Laboratories | N/A |
Pharmacology for PROTRIPTYLINE HYDROCHLORIDE
Drug Class | Tricyclic Antidepressant |
Medical Subject Heading (MeSH) Categories for PROTRIPTYLINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for PROTRIPTYLINE HYDROCHLORIDE
US Patents and Regulatory Information for PROTRIPTYLINE HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Teva Womens | VIVACTIL | protriptyline hydrochloride | TABLET;ORAL | 016012-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Chartwell Rx | VIVACTIL | protriptyline hydrochloride | TABLET;ORAL | 073645-001 | Aug 24, 1995 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Epic Pharma Llc | PROTRIPTYLINE HYDROCHLORIDE | protriptyline hydrochloride | TABLET;ORAL | 202220-002 | Nov 19, 2012 | 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 |
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