Allopurinol Patent Expiration

Allopurinol was first introduced by Abbott Laboratories Pharmaceutical Products Div in its drug Lopurin on Approved Prior to Jan 1, 1982. Other drugs containing Allopurinol are Allopurinol, Zyloprim. 25 different companies have introduced drugs containing Allopurinol.


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Clinical Trials

Recent Clinical Trials on Allopurinol:

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
Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia Alliance for Clinical Trials in Oncology NA RECRUITING
(Sep 1, 2026)
PHASE3
Comparative Clinical and Biochemical Study Evaluating the Effectiveness of Metformin Versus Febuxostat on Gouty Obese Non-Diabetic Patients Mostafa Bahaa NA COMPLETED
(Sep 1, 2026)
PHASE2
Allopurinol and Pathogenesis of Cirrhosis Tanta University NA COMPLETED
(Sep 1, 2026)
PHASE1, PHASE2
Allopurinol Versus Atorvastatin to Prevent Complications of Liver Cirrhosis Tanta University NA COMPLETED
(Aug 1, 2026)
PHASE2, PHASE3
Allopurinol Improves Heart Function in African Americans With Resistant Hypertension VA Office of Research and Development NA COMPLETED
(Aug 1, 2026)
PHASE2
A Study of Dotinurad Versus Allopurinol in Participants With Gout Crystalys Therapeutics NA RECRUITING
(Aug 1, 2026)
PHASE3
A Study of Dotinurad Versus Allopurinol in Tophaceous Gout Crystalys Therapeutics NA RECRUITING
(Aug 1, 2026)
PHASE3
Allopurinol in Depression Tanta University NA RECRUITING
(Aug 1, 2026)
PHASE2, PHASE3
HMA-Venetoclax Induction in Newly Diagnosed AML Pakistan Blood and Marrow Transplant (PBMT) Group NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
An Innovative Chinese Herbal Formula for the Treatment of Gout Chinese University of Hong Kong NA COMPLETED
(Jul 1, 2026)
PHASE2
Allo HSCT Using RIC and PTCy for Hematological Diseases Masonic Cancer Center, University of Minnesota NA RECRUITING
(Jul 1, 2026)
PHASE2
Combination of Lenalidomide and Rituximab in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL-SLL) M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
Loncastuximab Tesirine and Venetoclax for Relapsed/ Refractory Non-Hodgkin Lymphoma Paolo Caimi, MD NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE1
Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients With Hyperuricemia Urica Therapeutics Inc. NA COMPLETED
(Jun 1, 2026)
PHASE1, PHASE2
Pirtobrutinib and Venetoclax in Waldenström Macroglobulinemia Dana-Farber Cancer Institute NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
The OPAL Study: AVM0703 for Treatment of Lymphoid Malignancies AVM Biotechnology Inc NA RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
Drug-Drug Interaction Study of ABP-671 in Gout Patients Atom Therapeutics Co., Ltd NA RECRUITING
(Apr 1, 2026)
PHASE1
Effect of Extended Release Torsemide in Patients With Congestive Heart Failure and Overactive Bladder Sarfez Pharmaceuticals, Inc. NA COMPLETED
(Mar 1, 2026)
PHASE2


Allopurinol Generic API Manufacturers

Several generic applications have been filed for Allopurinol. The first generic version for Allopurinol was by Puracap Pharmaceutical Llc and was approved on Dec 10, 1985. And the latest generic version is by Zydus Pharmaceuticals Usa Inc and was approved on Jun 13, 2025.

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