Lamivudine Patent Expiration

Lamivudine is Used for treating hepatitis B infection. It was first introduced by Viiv Healthcare Co in its drug Epivir on Nov 17, 1995. Another drug containing Lamivudine is Epivir-Hbv. 18 different companies have introduced drugs containing Lamivudine.


Lamivudine Patents

Given below is the list of patents protecting Lamivudine, 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
Epivir US6004968

(Pediatric)

Pharmaceutical compositions containing lamivudine Sep 20, 2018

(Expired)

Viiv Hlthcare
Epivir-hbv US6004968

(Pediatric)

Pharmaceutical compositions containing lamivudine Sep 20, 2018

(Expired)

Glaxosmithkline
Epivir US6004968 Pharmaceutical compositions containing lamivudine Mar 20, 2018

(Expired)

Viiv Hlthcare
Epivir-hbv US6004968 Pharmaceutical compositions containing lamivudine Mar 20, 2018

(Expired)

Glaxosmithkline
Epivir US5905082

(Pediatric)

Crystalline oxathiolane derivatives Nov 18, 2016

(Expired)

Viiv Hlthcare
Epivir-hbv US5905082

(Pediatric)

Crystalline oxathiolane derivatives Nov 18, 2016

(Expired)

Glaxosmithkline
Epivir US5905082 Crystalline oxathiolane derivatives May 18, 2016

(Expired)

Viiv Hlthcare
Epivir US5905082 Crystalline oxathiolane derivatives May 18, 2016

(Expired)

Viiv Hlthcare
Epivir-hbv US5905082 Crystalline oxathiolane derivatives May 18, 2016

(Expired)

Glaxosmithkline
Epivir-hbv USRE39155

(Pediatric)

Use of 1,3-oxathiolane nucleoside analogues in the treatment of hepatitis B Jan 02, 2014

(Expired)

Glaxosmithkline
Epivir-hbv USRE39155 Use of 1,3-oxathiolane nucleoside analogues in the treatment of hepatitis B Jul 02, 2013

(Expired)

Glaxosmithkline



Lamivudine's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Lamivudine:

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
Dolutegravir/Lamivudine Dual Therapy for ART-naïve People With HIV and TB Receiving Rifampin-based TB Treatment Johns Hopkins University NA RECRUITING
(Sep 1, 2026)
PHASE3
Reducing Vertical Transmission of Hepatitis B in Africa University of Alabama at Birmingham NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
Lamivudine for Solid Tumors Thomas Marron NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
A Study of Exercise and Pharmacologic Intervention on Systemic Inflammation Icahn School of Medicine at Mount Sinai NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1
Lamivudine/Dolutegravir in Virologically Suppressed Subjects With Expected or Confirmed Resistance to Lamivudine Fundacion SEIMC-GESIDA NA COMPLETED
(Jul 1, 2026)
PHASE2
STARLITE for Unresectable High-Grade Gliomas University of Miami NA RECRUITING
(Jun 1, 2026)
PHASE1
Lamivudine as a Novel Clinical Effort for Rett Syndrome Maria Denise Fernandes Carvalho de Andrade NA ENROLLING BY INVITATION
(Jun 1, 2026)
PHASE2


Lamivudine Generic API Manufacturers

Several generic applications have been filed for Lamivudine. The first generic version for Lamivudine was by Aurobindo Pharma Ltd and was approved on Nov 17, 2011. And the latest generic version is by Hetero Labs Ltd Unit Iii and was approved on Oct 6, 2023.

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


Lamivudine News

The antiviral drugs market is expected to reach $89.68 billion by 2033, with a compound annual growth rate (CAGR) of 3.9%.

14 Oct, 2024

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