Pregabalin Patent Expiration

Pregabalin is Used for treating neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia. It was first introduced by Upjohn Us 2 Llc in its drug Lyrica on Dec 30, 2004. Another drug containing Pregabalin is Lyrica Cr. 41 different companies have introduced drugs containing Pregabalin.


Pregabalin Patents

Given below is the list of patents protecting Pregabalin, 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
Lyrica Cr US10022447

(Pediatric)

Solid pharmaceutical compositions containing pregabalin May 02, 2027 Upjohn
Lyrica Cr US8945620

(Pediatric)

Solid pharmaceutical compositions containing pregabalin May 02, 2027 Upjohn
Lyrica Cr US9144559

(Pediatric)

Solid pharmaceutical compositions containing pregabalin May 02, 2027 Upjohn
Lyrica Cr US10022447 Solid pharmaceutical compositions containing pregabalin Nov 02, 2026 Upjohn
Lyrica Cr US8945620 Solid pharmaceutical compositions containing pregabalin Nov 02, 2026 Upjohn
Lyrica Cr US9144559 Solid pharmaceutical compositions containing pregabalin Nov 02, 2026 Upjohn
Lyrica US6001876

(Pediatric)

Isobutylgaba and its derivatives for the treatment of pain Jun 30, 2019

(Expired)

Upjohn
Lyrica US6197819

(Pediatric)

Gamma amino butyric acid analogs and optical isomers Jun 30, 2019

(Expired)

Upjohn
Lyrica USRE41920

(Pediatric)

Isobutylgaba and its derivatives for the treatment of pain Jun 30, 2019

(Expired)

Upjohn
Lyrica Cr US6197819

(Pediatric)

Gamma amino butyric acid analogs and optical isomers Jun 30, 2019

(Expired)

Upjohn
Lyrica Cr USRE41920

(Pediatric)

Isobutylgaba and its derivatives for the treatment of pain Jun 30, 2019

(Expired)

Upjohn
Lyrica US6001876 Isobutylgaba and its derivatives for the treatment of pain Dec 30, 2018

(Expired)

Upjohn
Lyrica US6197819 Gamma amino butyric acid analogs and optical isomers Dec 30, 2018

(Expired)

Upjohn
Lyrica USRE41920 Isobutylgaba and its derivatives for the treatment of pain Dec 30, 2018

(Expired)

Upjohn
Lyrica Cr US6197819 Gamma amino butyric acid analogs and optical isomers Dec 30, 2018

(Expired)

Upjohn
Lyrica Cr USRE41920 Isobutylgaba and its derivatives for the treatment of pain Dec 30, 2018

(Expired)

Upjohn
Lyrica US5563175 GABA and L-glutamic acid analogs for antiseizure treatment Oct 08, 2013

(Expired)

Upjohn



About Veterinary Pregabalin

Pregabalin is used in drugs marketed by 2 different companies: Orion Corp, Triviumvet.

Other drugs containing Pregabalin are: Bonqat , Liavium ca1 .

Veterinary Pregabalin Patents

Given below is the list of patents protecting Pregabalin, along with the drug name that holds that patent and the company owning that drug.

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Drug Used In Drug Patent Number Drug Patent Expiry Drug Owner
Patent Data
Bonqat US12558331 ORION CORP.

Pregabalin's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Pregabalin:

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
Efficacy and Safety of Pregabalin Combined With Educational and Behavioral Intervention for Bladder Pain Syndrome/Interstitial Cystitis Beijing Tiantan Hospital NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1
A Clinical Trial to Evaluate the Efficacy and Safety of HL-1186 Tablet in the Treatment of Postherpetic Neuralgia Shanghai Yidian Pharmaceutical Technology Development Co., Ltd. NA RECRUITING
(Aug 1, 2026)
PHASE2
Extended-release Pregabalin for the Treatment of Neuropathic Pain in Patients With Diabetic Peripheral Neuropathy and Postherpetic Neuralgia Brainfarma Industria Química e Farmacêutica S/A NA RECRUITING
(Jul 1, 2026)
PHASE3
Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy Vertex Pharmaceuticals Incorporated NA RECRUITING
(Jun 1, 2026)
PHASE3
Y-4 to Treat the Postherpetic Neuralgia Neurodawn Pharmaceutical Co., Ltd. NA RECRUITING
(May 1, 2026)
PHASE2
Pharmacokinetics of Y-4 Tablets With Pregabalin Capsules and Riluzole Tablets in U.S. Healthy Participants Neurodawn Pharmaceutical Co., Ltd. NA NOT YET RECRUITING
(May 1, 2026)
PHASE1
Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral Neuropathy Vertex Pharmaceuticals Incorporated NA RECRUITING
(Apr 1, 2026)
PHASE2
A Study of HRS-2129 in Patients With Diabetic Peripheral Neuropathic Pain Shandong Suncadia Medicine Co., Ltd. NA RECRUITING
(Apr 1, 2026)
PHASE1


Pregabalin Generic API Manufacturers

Several generic applications have been filed for Pregabalin. The first generic version for Pregabalin was by Watson Laboratories Inc and was approved on Jul 3, 2012. And the latest generic version is by Aiping Pharmaceutical Inc and was approved on Jun 24, 2026.

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


Pregabalin News

Misuse of Medications: Codeine Cough Syrup, Tramadol, Pregabalin, and Other Frequently Abused Substances...

26 Jan, 2026

Countrywide Operation Targets Narcotics Trade: Significant Seizures of Codeine Syrup

07 Dec, 2025

Nationwide Enforcement Efforts Increase: Confiscation of Codeine Cough Syrups and Opioid Medications on the Rise...

05 Dec, 2025

Action Taken Against Drug Trafficking Operations: Significant Seizures of Codeine Cough Syrup

04 Dec, 2025

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