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Details for Generic Name: terbinafine

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Terbinafine is the generic ingredient in three branded drugs marketed by Glaxosmithkline Cons, Novartis, Taro, Apotex, Aurobindo Pharma, Breckenridge Pharm, Cipla Ltd, Dr Reddys Labs Inc, Gedeon Richter Usa, Glenmark Generics, Harris Pharm, Invagen Pharms, Mylan, Orchid Hlthcare, Roxane, Teva, and Wockhardt, and is included in twenty-four NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for terbinafine. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: terbinafine

Drug Master File Entries: see list23
Suppliers / Packaging: see list2
Formulation / Manufacturing:see details

Tentative approvals for TERBINAFINE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORALEQ 250MG BASE

Clinical Trials for: terbinafine

Safety and Pharmacokinetics of Terbinafine Hydrogen Chloride (HCl) Nail Lacquer in Patients With Onychomycosis
Status: Completed Condition: Onychomycosis/Onycholysis and Tinea Pedis

Iontophoretic Application of Terbinafine Gel to the Large Toe Nail
Status: Completed Condition: Onychomycosis

Terbinafine Compared to Griseofulvin in Children With Tinea Capitis
Status: Completed Condition: Tinea Capitis

Optimizing the Treatment of Toenail Onychomycosis Using a New Transdermal Patch Combined With Terbinafine/Ketoconazole
Status: Recruiting Condition: Onychomycosis

Bioequivalence Study of Terbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Under Fed Conditions
Status: Completed Condition: Healthy

Bioequivalence Study of Terbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Under Fasting Conditions
Status: Completed Condition: Fasting

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Breckenridge Pharm
terbinafine hydrochloride
TABLET;ORAL077714-001Jun 4, 2010RXNo<disabled><disabled>
terbinafine hydrochloride
TABLET;ORAL078229-001Jul 2, 2007DISCNNo<disabled><disabled>
Dr Reddys Labs Inc
terbinafine hydrochloride
TABLET;ORAL076390-001Jul 2, 2007RXNo<disabled><disabled>
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Non-Orange Book Patents for Generic Ingredient: terbinafine

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,856,355 Pharmaceutical composition<disabled in preview>
6,121,314 Pharmaceutical composition<disabled in preview>
6,005,001 Pharmaceutical composition<disabled in preview>
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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