Gabapentin Patent Expiration

Gabapentin was first introduced by Viatris Specialty Llc in its drug Neurontin on Dec 30, 1993. Another drug containing Gabapentin is Gralise. 49 different companies have introduced drugs containing Gabapentin.


Gabapentin Patents

Given below is the list of patents protecting Gabapentin, 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
Gralise US7438927 Methods of treatment using a gastric retained gabapentin dosage Feb 26, 2024

(Expired)

Almatica
Neurontin US7256216

(Pediatric)

Liquid pharmaceutical compositions Nov 28, 2022

(Expired)

Viatris
Gralise US7731989 Gastric retained gabapentin dosage form Oct 25, 2022

(Expired)

Almatica
Gralise US8192756 Gastric retained gabapentin dosage form Oct 25, 2022

(Expired)

Almatica
Gralise US8252332 Gastric retained gabapentin dosage form Oct 25, 2022

(Expired)

Almatica
Gralise US8333992 Gastric retained gabapentin dosage form Oct 25, 2022

(Expired)

Almatica
Neurontin US7256216 Liquid pharmaceutical compositions May 28, 2022

(Expired)

Viatris
Gralise US6723340 Optimal polymer mixtures for gastric retentive tablets Oct 25, 2021

(Expired)

Almatica
Gralise US6488962 Tablet shapes to enhance gastric retention of swellable controlled-release oral dosage forms Jun 20, 2020

(Expired)

Almatica
Neurontin US6054482

(Pediatric)

Lactam-free amino acids Oct 25, 2017

(Expired)

Viatris
Neurontin US6054482 Lactam-free amino acids Apr 25, 2017

(Expired)

Viatris
Gralise US6340475 Extending the duration of drug release within the stomach during the fed mode Sep 19, 2016

(Expired)

Almatica
Gralise US6635280 Extending the duration of drug release within the stomach during the fed mode Sep 19, 2016

(Expired)

Almatica



Gabapentin's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Gabapentin:

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
Vitamin D in Diabetic Neuropathy Tanta University NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2, PHASE3
Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders Medical University of South Carolina NA COMPLETED
(Aug 1, 2026)
PHASE2
Effects of Curcumin-Piperine Supplementation in Fibromyalgia Ain Shams University NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
Emergency Department-Initiated Medications for Alcohol Use Disorder Yale University NA RECRUITING
(Jul 1, 2026)
PHASE3
Efficacy of an Intraoperative Periradicular Application of Platelet Rich Fibrin (PRF) on the Intensity of Residual Post-surgical Neuropathic Pain After a Surgery for Disc Herniation University Hospital, Strasbourg, France NA RECRUITING
(Jun 1, 2026)
PHASE3
High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer Alliance for Clinical Trials in Oncology NA RECRUITING
(May 1, 2026)
PHASE3
Gabapentin, Methadone, and Oxycodone With or Without Venlafaxine Hydrochloride in Managing Pain in Participants With Stage II-IV Squamous Cell Head and Neck Cancer Undergoing Chemoradiation Therapy Roswell Park Cancer Institute NA COMPLETED
(Apr 1, 2026)
PHASE2


Gabapentin Generic API Manufacturers

Several generic applications have been filed for Gabapentin. The first generic version for Gabapentin was by Actavis Elizabeth Llc and was approved on Sep 12, 2003. And the latest generic version is by Actavis Elizabeth Llc and was approved on Jun 23, 2026.

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