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Express Scripts
Boehringer Ingelheim

Last Updated: July 6, 2020

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LAMISIL Drug Profile


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Drug patent expirations by year for LAMISIL
Drug Prices for LAMISIL

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Drug Sales Revenue Trends for LAMISIL

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Recent Clinical Trials for LAMISIL

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SponsorPhase
Hamilton Academic Health Sciences OrganizationPhase 2
Hamilton Health Sciences CorporationPhase 2
GlaxoSmithKlinePhase 1

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Paragraph IV (Patent) Challenges for LAMISIL
Tradename Dosage Ingredient NDA Submissiondate
LAMISIL TABLET;ORAL terbinafine hydrochloride 020539

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
Glaxosmithkline LAMISIL terbinafine hydrochloride CREAM;TOPICAL 020980-001 Mar 9, 1999 OTC Yes Yes   Start Trial   Start Trial   Start Trial
Novartis LAMISIL terbinafine hydrochloride TABLET;ORAL 020539-001 May 10, 1996 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis LAMISIL terbinafine hydrochloride GRANULE;ORAL 022071-001 Sep 28, 2007 DISCN Yes No   Start Trial   Start Trial   Start Trial
Glaxosmithkline Cons LAMISIL AT terbinafine GEL;TOPICAL 021958-001 Jul 24, 2006 OTC Yes Yes   Start Trial   Start Trial   Start 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
Glaxosmithkline Cons LAMISIL terbinafine GEL;TOPICAL 020846-001 Apr 29, 1998   Start Trial   Start Trial
Glaxosmithkline LAMISIL terbinafine hydrochloride CREAM;TOPICAL 020980-001 Mar 9, 1999   Start Trial   Start Trial
Glaxosmithkline Cons LAMISIL terbinafine GEL;TOPICAL 020846-001 Apr 29, 1998   Start Trial   Start Trial
Glaxosmithkline Cons LAMISIL terbinafine hydrochloride SOLUTION;TOPICAL 020749-001 Oct 17, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for LAMISIL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0024587 SPC/GB93/096 United Kingdom   Start Trial SPC/GB93/096, EXPIRES: 20050805
0024587 93C0136 Belgium   Start 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

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Serving leading biopharmaceutical companies globally:

Medtronic
Harvard Business School
Mallinckrodt
Moodys
Express Scripts
Boehringer Ingelheim

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