Terbinafine Patent Expiration

Terbinafine was first introduced by Karo Healthcare Inc in its drug Lamisil on Apr 29, 1998. Another drug containing Terbinafine is Lamisil At.


Terbinafine Patents

Given below is the list of patents protecting Terbinafine, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Lamisil US5681849

(Pediatric)

Pharmaceutical composition for topical applications Apr 28, 2015

(Expired)

Karo Hlthcare
Lamisil At US5681849

(Pediatric)

Pharmaceutical composition for topical applications Apr 28, 2015

(Expired)

Karo Hlthcare
Lamisil US5681849 Pharmaceutical composition for topical applications Oct 28, 2014

(Expired)

Karo Hlthcare
Lamisil At US5681849 Pharmaceutical composition for topical applications Oct 28, 2014

(Expired)

Karo Hlthcare
Lamisil US5856355

(Pediatric)

Pharmaceutical composition Nov 18, 2012

(Expired)

Karo Hlthcare
Lamisil US6005001

(Pediatric)

Pharmaceutical composition Nov 18, 2012

(Expired)

Karo Hlthcare
Lamisil At US5856355

(Pediatric)

Pharmaceutical composition Nov 18, 2012

(Expired)

Karo Hlthcare



Terbinafine's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Terbinafine:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro) Swiss Cancer Institute NA RECRUITING
(Jul 1, 2026)
PHASE2
Terbinafine for CSA-AKI Prevention Guangdong Provincial People's Hospital NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2


Terbinafine Generic API Manufacturers

Given below is the list of companies who have filed for Terbinafine generic, along with the locations of their manufacturing plants worldwide.