TERBINAFINE HYDROCHLORIDE Drug Patent Profile
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When do Terbinafine Hydrochloride patents expire, and when can generic versions of Terbinafine Hydrochloride launch?
Terbinafine Hydrochloride is a drug marketed by Taro, Aurobindo Pharma, Breckenridge Pharm, Chartwell, Cipla, Dr Reddys Labs Inc, Emed Medcl, Gedeon Richter Usa, Glenmark Pharms Ltd, Heritage Pharma Avet, Invagen Pharms, Mylan, Natco Pharma, Orbion Pharms, Roxane, and Wockhardt. and is included in sixteen NDAs.
The generic ingredient in TERBINAFINE HYDROCHLORIDE is terbinafine hydrochloride. There are twenty-seven drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the terbinafine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Terbinafine Hydrochloride
A generic version of TERBINAFINE HYDROCHLORIDE was approved as terbinafine hydrochloride by TARO on July 2nd, 2007.
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Questions you can ask:
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Summary for TERBINAFINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 16 |
| NDAs: | 16 |
| Finished Product Suppliers / Packagers: | 41 |
| Raw Ingredient (Bulk) Api Vendors: | 115 |
| Clinical Trials: | 45 |
| Patent Applications: | 1,655 |
| DailyMed Link: | TERBINAFINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for TERBINAFINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Dhaka Medical College | Phase 2/Phase 3 |
| Moberg Pharma AB | Phase 3 |
| IQVIA Biotech | Phase 3 |
Pharmacology for TERBINAFINE HYDROCHLORIDE
| Drug Class | Allylamine Antifungal |
Anatomical Therapeutic Chemical (ATC) Classes for TERBINAFINE HYDROCHLORIDE
US Patents and Regulatory Information for TERBINAFINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Taro | TERBINAFINE HYDROCHLORIDE | terbinafine hydrochloride | CREAM;TOPICAL | 077511-001 | Jul 2, 2007 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Emed Medcl | TERBINAFINE HYDROCHLORIDE | terbinafine hydrochloride | TABLET;ORAL | 077919-001 | Jul 2, 2007 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Chartwell | TERBINAFINE HYDROCHLORIDE | terbinafine hydrochloride | TABLET;ORAL | 078199-001 | Jul 2, 2007 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan | TERBINAFINE HYDROCHLORIDE | terbinafine hydrochloride | TABLET;ORAL | 077136-001 | Jul 2, 2007 | DISCN | 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 |
