Ascorbic Acid Patent Expiration

Ascorbic Acid was first introduced by Mcguff Pharmaceuticals Inc in its drug Ascor on Oct 2, 2017. 4 different companies have introduced drugs containing Ascorbic Acid.


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Clinical Trials

Recent Clinical Trials on Ascorbic Acid:

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
Study to Evaluate ARINA-1 in the Prevention of Bronchiolitis Obliterans Progression in Participants With Bilateral Lung Transplant Renovion, Inc. NA RECRUITING
(Aug 1, 2026)
PHASE3
A Study of CA201A Eye Drops to Prevent Corneal Endothelial Cell Loss in Patients Undergoing Cataract Surgery Caravel Oculus Pty Ltd NA RECRUITING
(Aug 1, 2026)
PHASE2
Evaluation of the Efficacy of Topical Application of Liquid Nitrogen and Ascorbic Acid in Treatment of Gingival Pigmentation Al-Azhar University NA ENROLLING BY INVITATION
(Aug 1, 2026)
PHASE3
A Phase 2 Study Adding Ascorbate to Chemotherapy and Radiation Therapy for NSCLC Joseph J. Cullen, MD, FACS NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
The Potential Effect of the Local Administration of Vitamins C and E on Orthodontic Treatment: A Randomized Clinical Trial University of Baghdad NA COMPLETED
(Jul 1, 2026)
PHASE1
High Dose Ascorbic Acid (HDAA) in Patients With Plasma Cell Disorders University of Arkansas NA RECRUITING
(Jun 1, 2026)
PHASE1
Efficacy of Early Intravenous High-dose Vitamin C in Post-cardiac Arrest Shock. Centre Hospitalier de Bethune NA RECRUITING
(May 1, 2026)
PHASE2
Gingival Hyperpigmentation Treatment Cairo University NA RECRUITING
(May 1, 2026)
PHASE2
High-Dose Vitamin C in G6PDA and Pyruvate Kinase Deficiency: A Safety Study University of Utah NA NOT YET RECRUITING
(May 1, 2026)
PHASE1
Ascorbic Acid and Chemotherapy for the Treatment of Relapsed or Refractory Lymphoma, CCUS, and Chronic Myelomonocytic Leukemia Mayo Clinic NA RECRUITING
(Apr 1, 2026)
PHASE2
Reducing Frailty for Older Cancer Survivors Using Supplements University of Rochester NA COMPLETED
(Apr 1, 2026)
PHASE2
Efficacy and Safety oF FErric CarboxymalTose in Patients With Advanced Gastric Cancer(EFFECT-AGC) Asan Medical Center NA RECRUITING
(Apr 1, 2026)
PHASE3
Comparison of Ferrous Salt vs. Liposomal Iron in Adult Women With Iron-Deficiency Anemia Hospital General de Mexico NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE3


Ascorbic Acid Generic API Manufacturers

Several generic applications have been filed for Ascorbic Acid. The first generic version for Ascorbic Acid was by Fresenius Kabi Usa Llc and was approved on Aug 7, 2025. And the latest generic version is by Zydus Pharmaceuticals Usa Inc and was approved on Aug 20, 2026.

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