TERBINAFINE HYDROCHLORIDE - Generic Drug Details
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What are the generic sources for terbinafine hydrochloride and what is the scope of patent protection?
Terbinafine hydrochloride
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-two NDAs. Additional information is available in the individual branded drug profile pages.There are twenty-five drug master file entries for terbinafine hydrochloride. Forty-five suppliers are listed for this compound. There are four tentative approvals for this compound.
Summary for TERBINAFINE HYDROCHLORIDE
US Patents: | 0 |
Tradenames: | 3 |
Applicants: | 18 |
NDAs: | 22 |
Drug Master File Entries: | 25 |
Finished Product Suppliers / Packagers: | 45 |
Raw Ingredient (Bulk) Api Vendors: | 115 |
Clinical Trials: | 45 |
Patent Applications: | 2,563 |
What excipients (inactive ingredients) are in TERBINAFINE HYDROCHLORIDE? | TERBINAFINE HYDROCHLORIDE excipients list |
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 |
Generic filers with tentative approvals for TERBINAFINE HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | EQ 250MG BASE | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | EQ 250MG BASE | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | EQ 250MG BASE | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Wockhardt | TERBINAFINE HYDROCHLORIDE | terbinafine hydrochloride | TABLET;ORAL | 078229-001 | Jul 2, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Cipla | TERBINAFINE HYDROCHLORIDE | terbinafine hydrochloride | TABLET;ORAL | 077137-001 | Jul 2, 2007 | 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 | |||
Karo Hlthcare | LAMISIL AT | terbinafine hydrochloride | SOLUTION;TOPICAL | 021124-001 | Mar 17, 2000 | OTC | Yes | Yes | ⤷ 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 HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Karo Hlthcare | LAMISIL AT | terbinafine hydrochloride | SPRAY;TOPICAL | 021124-002 | Mar 17, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Karo Hlthcare | LAMISIL | terbinafine hydrochloride | SOLUTION;TOPICAL | 020749-001 | Oct 17, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Karo Hlthcare | LAMISIL AT | terbinafine hydrochloride | SOLUTION;TOPICAL | 021124-001 | Mar 17, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Karo Hlthcare | LAMISIL AT | terbinafine hydrochloride | SPRAY;TOPICAL | 021124-002 | Mar 17, 2000 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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