CLOMIPRAMINE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Clomipramine Hydrochloride, and what generic alternatives are available?
Clomipramine Hydrochloride is a drug marketed by Ajanta Pharma Ltd, Alembic, Amneal Pharms Co, Aurobindo Pharma, Chartwell Rx, Chemistry Hlth, Jubilant Cadista, Lupin Ltd, Mankind Pharma, Micro Labs, Mylan, Rk Pharma, Sandoz, Taro, Teva, Tulex Pharms Inc, Unique, Watson Labs, and Zydus Pharms. and is included in twenty-one NDAs.
The generic ingredient in CLOMIPRAMINE HYDROCHLORIDE is clomipramine hydrochloride. There are eleven drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the clomipramine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Clomipramine Hydrochloride
A generic version of CLOMIPRAMINE HYDROCHLORIDE was approved as clomipramine hydrochloride by CHARTWELL RX on March 29th, 1996.
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Summary for CLOMIPRAMINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 19 |
| NDAs: | 21 |
| Finished Product Suppliers / Packagers: | 23 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 23 |
| What excipients (inactive ingredients) are in CLOMIPRAMINE HYDROCHLORIDE? | CLOMIPRAMINE HYDROCHLORIDE excipients list |
| DailyMed Link: | CLOMIPRAMINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for CLOMIPRAMINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Roma La Sapienza | Phase 3 |
| Fidia Farmaceutici s.p.a. | Phase 4 |
| Assiut University | Phase 3 |
Pharmacology for CLOMIPRAMINE HYDROCHLORIDE
| Drug Class | Tricyclic Antidepressant |
Medical Subject Heading (MeSH) Categories for CLOMIPRAMINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for CLOMIPRAMINE HYDROCHLORIDE
US Patents and Regulatory Information for CLOMIPRAMINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Taro | CLOMIPRAMINE HYDROCHLORIDE | clomipramine hydrochloride | CAPSULE;ORAL | 074694-002 | Dec 31, 1996 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan | CLOMIPRAMINE HYDROCHLORIDE | clomipramine hydrochloride | CAPSULE;ORAL | 074947-002 | Apr 30, 1998 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Tulex Pharms Inc | CLOMIPRAMINE HYDROCHLORIDE | clomipramine hydrochloride | CAPSULE;ORAL | 210653-001 | Apr 3, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Watson Labs | CLOMIPRAMINE HYDROCHLORIDE | clomipramine hydrochloride | CAPSULE;ORAL | 074751-003 | Sep 30, 1998 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva | CLOMIPRAMINE HYDROCHLORIDE | clomipramine hydrochloride | CAPSULE;ORAL | 074849-002 | Apr 4, 1997 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Tulex Pharms Inc | CLOMIPRAMINE HYDROCHLORIDE | clomipramine hydrochloride | CAPSULE;ORAL | 210653-002 | Apr 3, 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 |
