Terbinafine - Generic Drug Details
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What are the generic drug sources for terbinafine and what is the scope of patent protection?
Terbinafine
is the generic ingredient in three branded drugs marketed by Karo Hlthcare, Novartis, 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 twenty-four NDAs. Additional information is available in the individual branded drug profile pages.There are twenty-seven drug master file entries for terbinafine. There are four tentative approvals for this compound.
Summary for terbinafine
| US Patents: | 0 |
| Tradenames: | 3 |
| Applicants: | 18 |
| NDAs: | 24 |
| Drug Master File Entries: | 27 |
| Raw Ingredient (Bulk) Api Vendors: | 91 |
| Clinical Trials: | 45 |
| Patent Applications: | 7,520 |
| Drug Prices: | Drug price trends for terbinafine |
| Drug Sales Revenues: | Drug sales revenues for terbinafine |
| What excipients (inactive ingredients) are in terbinafine? | terbinafine excipients list |
| DailyMed Link: | terbinafine at DailyMed |
Recent Clinical Trials for terbinafine
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 |
Generic filers with tentative approvals for TERBINAFINE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Anatomical Therapeutic Chemical (ATC) Classes for terbinafine
US Patents and Regulatory Information for terbinafine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | LAMISIL | terbinafine hydrochloride | TABLET;ORAL | 020539-001 | May 10, 1996 | DISCN | Yes | 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 | |||
| Gedeon Richter Usa | TERBINAFINE HYDROCHLORIDE | terbinafine hydrochloride | TABLET;ORAL | 077065-001 | Jul 2, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis | LAMISIL | terbinafine hydrochloride | CREAM;TOPICAL | 020192-001 | Dec 30, 1992 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Dr Reddys Labs Inc | TERBINAFINE HYDROCHLORIDE | terbinafine hydrochloride | TABLET;ORAL | 076390-001 | Jul 2, 2007 | 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 |
Expired US Patents for terbinafine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Karo Hlthcare | LAMISIL | terbinafine | GEL;TOPICAL | 020846-001 | Apr 29, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Karo Hlthcare | LAMISIL | terbinafine | GEL;TOPICAL | 020846-001 | Apr 29, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Karo Hlthcare | LAMISIL | terbinafine | GEL;TOPICAL | 020846-001 | Apr 29, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Karo Hlthcare | LAMISIL AT | terbinafine | GEL;TOPICAL | 021958-001 | Jul 24, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Karo Hlthcare | LAMISIL AT | terbinafine | GEL;TOPICAL | 021958-001 | Jul 24, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
