LAMISIL Drug Patent Profile
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Which patents cover Lamisil, and what generic alternatives are available?
Lamisil is a drug marketed by Karo Hlthcare and Novartis and is included in eight NDAs.
The generic ingredient in LAMISIL is terbinafine. There are twenty-seven drug master file entries for this compound. Additional details are available on the terbinafine profile page.
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Summary for LAMISIL
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 8 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 91 |
| Clinical Trials: | 19 |
| Patent Applications: | 4,641 |
| Drug Prices: | Drug price information for LAMISIL |
| What excipients (inactive ingredients) are in LAMISIL? | LAMISIL excipients list |
| DailyMed Link: | LAMISIL at DailyMed |
Recent Clinical Trials for LAMISIL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Oregon Health and Science University | Early Phase 1 |
| The Malassezia Foundation | Early Phase 1 |
| Pak Emirates Military Hospital | Phase 3 |
Pharmacology for LAMISIL
| Drug Class | Allylamine Antifungal |
US Patents and Regulatory Information for LAMISIL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Karo Hlthcare | LAMISIL | terbinafine hydrochloride | CREAM;TOPICAL | 020980-001 | Mar 9, 1999 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis | LAMISIL | terbinafine hydrochloride | TABLET;ORAL | 020539-001 | May 10, 1996 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis | LAMISIL | terbinafine hydrochloride | GRANULE;ORAL | 022071-001 | Sep 28, 2007 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Karo Hlthcare | LAMISIL AT | terbinafine | GEL;TOPICAL | 021958-001 | Jul 24, 2006 | OTC | Yes | Yes | ⤷ 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 | ||||
| Karo Hlthcare | LAMISIL | terbinafine | GEL;TOPICAL | 020846-001 | Apr 29, 1998 | 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 |
Expired US Patents for LAMISIL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | LAMISIL | terbinafine hydrochloride | TABLET;ORAL | 020539-001 | May 10, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | LAMISIL | terbinafine hydrochloride | TABLET;ORAL | 020539-001 | May 10, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Karo Hlthcare | LAMISIL | terbinafine hydrochloride | CREAM;TOPICAL | 020980-001 | Mar 9, 1999 | ⤷ 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 | terbinafine | GEL;TOPICAL | 020846-001 | Apr 29, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for LAMISIL
See the table below for patents covering LAMISIL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Cyprus | 1942 | Topical composition containing terbinafine | ⤷ Sign Up |
| Australia | 1631792 | ⤷ Sign Up | |
| Hungary | 223343 | Allil-amin-származékot tartalmazó gyógyászati készítmények és eljárás azok előállítására (COMPOSITIONS COMPRISING ALLYLAMINE DERIVATIVES, AND PROCESS FOR THEIR PREPARATION) | ⤷ Sign Up |
| European Patent Office | 0024587 | PROPENYLAMINES, PROCESSES FOR THEIR PRODUCTION, PHARMACEUTICAL COMPOSITIONS CONTAINING THEM AND THEIR USE AS PHARMACEUTICALS | ⤷ Sign Up |
| Canada | 1157023 | PROPENYLAMINES, PROCEDE DE PRODUCTION, COMPOSES PHARMACEUTIQUES LES CONTENANT ET APPLICATION EN PHARMACIE (PROPENYLAMINES, PROCESSES FOR THEIR PRODUCTION, PHARMACEUTICAL COMPOSITIONS CONTAINING THEM AND THEIR USE AS PHARMACEUTICALS) | ⤷ Sign Up |
| Philippines | 22166 | PROPENYLAMINES, METHOD OF USE, PHARMACEUTICAL COMPOSITION CONTAINING THEM | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LAMISIL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0024587 | SPC/GB93/096 | United Kingdom | ⤷ Sign Up | SPC/GB93/096, EXPIRES: 20050805 |
| 0024587 | 93C0136 | Belgium | ⤷ Sign Up | PRODUCT NAME: TERBINAFINE (250 MG) SOUS FORME DE CHLORHYDRATE (281,25 MG); NAT. REG.: 616 S 201 F3 19911031; FIRST REG.: GB PL 0101/0304 19901003 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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