Tenofovir Disoproxil Fumarate Patent Expiration

Tenofovir Disoproxil Fumarate is used for managing chronic hepatitis B and HIV infections in both adults and pediatric patients. It was first introduced by Gilead Sciences Inc in its drug Viread on Oct 26, 2001. 13 different companies have introduced drugs containing Tenofovir Disoproxil Fumarate.


Tenofovir Disoproxil Fumarate Patents

Given below is the list of patents protecting Tenofovir Disoproxil Fumarate, 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
Viread US5922695

(Pediatric)

Antiviral phosphonomethyoxy nucleotide analogs having increased oral bioavarilability Jan 25, 2018

(Expired)

Gilead Sciences Inc
Viread US5935946

(Pediatric)

Nucleotide analog composition and synthesis method Jan 25, 2018

(Expired)

Gilead Sciences Inc
Viread US5977089

(Pediatric)

Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability Jan 25, 2018

(Expired)

Gilead Sciences Inc
Viread US6043230

(Pediatric)

Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability Jan 25, 2018

(Expired)

Gilead Sciences Inc
Viread US5922695 Antiviral phosphonomethyoxy nucleotide analogs having increased oral bioavarilability Jul 25, 2017

(Expired)

Gilead Sciences Inc
Viread US5935946 Nucleotide analog composition and synthesis method Jul 25, 2017

(Expired)

Gilead Sciences Inc
Viread US5977089 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability Jul 25, 2017

(Expired)

Gilead Sciences Inc
Viread US6043230 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability Jul 25, 2017

(Expired)

Gilead Sciences Inc



Tenofovir Disoproxil Fumarate's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Tenofovir Disoproxil Fumarate:

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
Early Metabolic Effects of Antiretroviral Drugs in Healthy volUnteers: a Phase 2 Randomized Study National Institute of Allergy and Infectious Diseases (NIAID) NA RECRUITING
(Sep 9, 2026)
PHASE2
Dolutegravir Versus Dolutegravir in Combination With Tenofovir for the Treatment of HTLV-1 Infection Carlos Brites NA RECRUITING
(May 1, 2026)
PHASE2
Bioequivalence Study of Tenofovir Disoproxil Fumarate Tablets in Healthy Chinese Subjects Haisco Pharmaceutical Group Co., Ltd. NA COMPLETED
(Apr 1, 2026)
PHASE1


Tenofovir Disoproxil Fumarate Generic API Manufacturers

Several generic applications have been filed for Tenofovir Disoproxil Fumarate. The first generic version for Tenofovir Disoproxil Fumarate was by Teva Pharmaceuticals Usa and was approved on Mar 18, 2015. And the latest generic version is by Micro Labs Ltd and was approved on Dec 18, 2025.

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