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.
Summary for LAMISIL
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 8 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 91 |
| Clinical Trials: | 19 |
| Patent Applications: | 4,432 |
| Formulation / Manufacturing: | see details |
| 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 |
|---|---|
| The Malassezia Foundation | Early Phase 1 |
| Oregon Health and Science University | Early Phase 1 |
| Pak Emirates Military Hospital | Phase 3 |
Pharmacology for LAMISIL
| Drug Class | Allylamine Antifungal |
Anatomical Therapeutic Chemical (ATC) Classes for LAMISIL
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Novartis | LAMISIL | terbinafine hydrochloride | TABLET;ORAL | 020539-001 | May 10, 1996 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Novartis | LAMISIL | terbinafine hydrochloride | GRANULE;ORAL | 022071-001 | Sep 28, 2007 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 | CREAM;TOPICAL | 020192-001 | Dec 30, 1992 | ⤷ Try a Trial | ⤷ Try a Trial |
| Karo Hlthcare | LAMISIL | terbinafine | GEL;TOPICAL | 020846-001 | Apr 29, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
| Karo Hlthcare | LAMISIL | terbinafine | GEL;TOPICAL | 020846-001 | Apr 29, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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 |
|---|---|---|---|
| Japan | S63313753 | PROPENYLAMINES, MANUFACTURE, DRUG COMPOSITION AND USE AS MEDICINE | ⤷ Try a Trial |
| Luxembourg | 88343 | ⤷ Try a Trial | |
| Slovakia | 281616 | ⤷ Try a Trial | |
| >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 | ⤷ Try a Trial | SPC/GB93/096, EXPIRES: 20050805 |
| 0024587 | 93C0136 | Belgium | ⤷ Try a Trial | 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 |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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