Entecavir Patent Expiration

Entecavir was first introduced by Bristol Myers Squibb in its drug Baraclude on Mar 29, 2005. 18 different companies have introduced drugs containing Entecavir.


Entecavir Patents

Given below is the list of patents protecting Entecavir, 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
Baraclude US5206244

(Pediatric)

Hydroxymethyl (methylenecyclopentyl) purines and pyrimidines Aug 21, 2015

(Expired)

Bristol Myers Squibb
Baraclude US5206244 Hydroxymethyl (methylenecyclopentyl) purines and pyrimidines Feb 21, 2015

(Expired)

Bristol Myers Squibb



Entecavir's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Entecavir:

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
Drug-Drug Interaction Study Between Hydronidone and Entecavir, Tenofovir Disoproxil Fumarate, Tenofovir Alafenamide, and Tenofovir Amibufenamide Beijing Continent Pharmaceutical Co, Ltd. NA COMPLETED
(Aug 1, 2026)
PHASE1
Clinical Trial of TQA3605 Tablet in Combination With Nucleos(t)Ide Analogues(NAs) Versus NAs Alone for the Treatment of Patients With Chronic Hepatitis B Virus Infection Who Have Undergone Treatment and Exhibit Low Viral Load or Poor Response Chia Tai Tianqing Pharmaceutical Group Co., Ltd. NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE3
A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus Janssen Research & Development, LLC NA COMPLETED
(Jun 1, 2026)
PHASE2
The Safety and Efficacy of Sequential Treatment of Ropeginterferon Alfa-2b (P1101) and Anti-PD1 in Interferon-Naive Adults With Chronic Hepatitis B or D Infection PharmaEssentia NA COMPLETED
(Jun 1, 2026)
PHASE1
Entecavir Prophylaxis for Hepatitis B Reactivation for CD20 Positive B-cell Lymphoma Patients With Resolved Hepatitis B (Negative Hepatitis B Surface Antigen, Positive Hepatitis B Core Antibody) Sun Yat-sen University NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
Once Daily Dosing of Lonafarnib Co-administered With Ritonavir for Treatment of Chronic Hepatitis D Virus Infection Soroka University Medical Center NA COMPLETED
(Apr 1, 2026)
PHASE3
Chidamide for Maintenance Treatment of HBV-infected Diffuse DLBCL in Patients Initially Treated With R-CHOP Ou Bai, MD/PHD NA RECRUITING
(Mar 1, 2026)
PHASE3


Entecavir Generic API Manufacturers

Several generic applications have been filed for Entecavir. The first generic version for Entecavir was by Teva Pharmaceuticals Usa and was approved on Aug 26, 2014. And the latest generic version is by Conba Usa Inc and was approved on Dec 23, 2024.

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