Diclofenac Patent Expiration

Diclofenac is Used for managing pain. It was first introduced by Zyla Life Sciences Us Inc in its drug Zorvolex on Oct 18, 2013.


Diclofenac Patents

Given below is the list of patents protecting Diclofenac, 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
Zorvolex US8679544 Formulation of diclofenac Apr 23, 2030 Zyla
Zorvolex US8999387 Formulation of diclofenac Apr 23, 2030 Zyla
Zorvolex US9017721 Formulation of diclofenac Apr 23, 2030 Zyla
Zorvolex US9173854 Formulation of diclofenac Apr 23, 2030 Zyla
Zorvolex US9180095 Formulation of diclofenac Apr 23, 2030 Zyla
Zorvolex US9180096 Formulation of diclofenac Apr 23, 2030 Zyla
Zorvolex US9186328 Formulation of diclofenac Apr 23, 2030 Zyla



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Diclofenac's patents.

Given below is the list recent legal activities going on the following patents of Diclofenac.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Yr, Small Entity 10 Sep, 2025 US8679544(Litigated)
Payment of Maintenance Fee, 8th Yr, Small Entity 17 May, 2023 US9186328
Payment of Maintenance Fee, 8th Yr, Small Entity 10 May, 2023 US9180095
Payment of Maintenance Fee, 8th Yr, Small Entity 10 May, 2023 US9180096
Payment of Maintenance Fee, 8th Yr, Small Entity 03 May, 2023 US9173854
Payment of Maintenance Fee, 8th Yr, Small Entity 28 Oct, 2022 US9017721
Payment of Maintenance Fee, 8th Yr, Small Entity 07 Oct, 2022 US8999387
Applicant Has Filed a Verified Statement of Small Entity Status in Compliance with 37 CFR 1.27 07 Jul, 2022 US8999387
Applicant Has Filed a Verified Statement of Small Entity Status in Compliance with 37 CFR 1.27 07 Jul, 2022 US9017721
Payment of Maintenance Fee, 8th Yr, Small Entity 27 Sep, 2021 US8679544(Litigated)


Diclofenac's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Diclofenac:

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 of PHN131 in Patients After Surgery PhytoHealth Corporation NA COMPLETED
(Sep 1, 2026)
PHASE2, PHASE3
Diclofenac Dose Response Study University of Maryland, Baltimore NA COMPLETED
(Sep 1, 2026)
PHASE1
Evaluation of the Safety and Efficacy of Parecoxib in Patients With Subarachnoid Hemorrhage St. Anne's University Hospital Brno, Czech Republic NA RECRUITING
(Aug 1, 2026)
PHASE2
Effectiveness of Mitragynine Topical Patch for Pain Reduction in Myofascial Pain Syndrome Prince of Songkla University NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE3
ASKC200 for Knee Osteoarthritis Pain Jiangsu Aosaikang Pharmaceutical Co., Ltd. NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
A Study to Evaluate Efficacy and Safety of AMZ001 for the Treatment of Knee Osteoarthritis Symptoms Amzell NA COMPLETED
(Jun 1, 2026)
PHASE3
Acetylsalicylic Acid Versus Placebo as an add-on Treatment to Local Non-steroidal Anti-inflammatory Drug for the Management of Thrombotic Episodes in Superficial Venous Malformations in Children Aged 6 to 17 Years. University Hospital, Tours NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE2
Intra-nasal Ketorolac for Acute Ureteral Stent-associated Pain Following Ureteroscopy for Stone Disease University of Texas Southwestern Medical Center NA RECRUITING
(May 1, 2026)
PHASE1, PHASE2
Comparative Clinical Study to Evaluate the Possible Efficacy and Safety of Oral N-Acetyl Cysteine Versus Rectal Diclofenac in the Prevention of Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis Tanta University NA COMPLETED
(Mar 1, 2026)
PHASE1, PHASE2
Long Duration High Frequency Ultrasound for the Treatment of Osteoarthritis ZetrOZ, Inc. NA NOT YET RECRUITING
(Mar 1, 2026)
PHASE2


Diclofenac Generic API Manufacturers

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