➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

McKinsey
Mallinckrodt
Dow
Merck
Boehringer Ingelheim
AstraZeneca

Last Updated: October 26, 2021

DrugPatentWatch Database Preview

Gabapentin - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing

« Back to Dashboard

What are the generic sources for gabapentin and what is the scope of patent protection?

Gabapentin is the generic ingredient in four branded drugs marketed by Aci Healthcare Ltd, Actavis Elizabeth, Alkem, Amneal Pharms Ny, Ascent Pharms Inc, Aurobindo Pharma Ltd, Cspc Ouyi, Granules, Graviti Pharms, Hikma, Invagen Pharms, Jiangsu Hengrui Med, Marksans Pharma, Mylan, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Ltd, Sun Pharm Industries, Taro, Teva Pharms, Watson Labs, Zhejiang Yongtai, Upjohn, Acella Pharms Llc, Akorn, Amneal Pharms, Tris Pharma Inc, Vistapharm, Alkem Labs Ltd, Apotex Inc, Glenmark Pharms Ltd, Hikma Pharms, Invatech, Ivax Sub Teva Pharms, Lupin Ltd, Mylan Pharms Inc, Ranbaxy, Rubicon, Teva, Teva Pharms Usa, Zydus Pharms Usa Inc, Almatica, and Arbor Pharms Llc, and is included in fifty-seven NDAs. There are thirteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Gabapentin has eighty-seven patent family members in forty-seven countries.

There are twenty-nine drug master file entries for gabapentin. Seventy-six suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for gabapentin

See drug prices for gabapentin

Drug Sales Revenue Trends for gabapentin

See drug sales revenues for gabapentin

Recent Clinical Trials for gabapentin

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
David CochranPhase 4
Eagles Autism FoundationPhase 4
Thomas Jefferson UniversityPhase 3

See all gabapentin clinical trials

Generic filers with tentative approvals for GABAPENTIN
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever Trial600MGTABLET; ORAL
⤷  Free Forever Trial⤷  Free Forever Trial300MGTABLET; ORAL
⤷  Free Forever Trial⤷  Free Forever Trial600MGTABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for gabapentin
Paragraph IV (Patent) Challenges for GABAPENTIN
Tradename Dosage Ingredient NDA Submissiondate
GRALISE TABLET;ORAL gabapentin 022544 2011-10-31
NEURONTIN TABLET;ORAL gabapentin 020882
NEURONTIN SOLUTION;ORAL gabapentin 021129
NEURONTIN CAPSULE;ORAL gabapentin 020235

US Patents and Regulatory Information for gabapentin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Invagen Pharms GABAPENTIN gabapentin CAPSULE;ORAL 090705-001 Dec 30, 2009 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Tris Pharma Inc GABAPENTIN gabapentin SOLUTION;ORAL 091286-001 Mar 14, 2016 AA RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Sandoz GABAPENTIN gabapentin TABLET;ORAL 076120-001 Jan 27, 2006 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for gabapentin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Almatica GRALISE gabapentin TABLET;ORAL 022544-001 Jan 28, 2011 ⤷  Free Forever Trial ⤷  Free Forever Trial
Upjohn NEURONTIN gabapentin TABLET;ORAL 020882-001 Oct 9, 1998 ⤷  Free Forever Trial ⤷  Free Forever Trial
Upjohn NEURONTIN gabapentin SOLUTION;ORAL 021129-001 Mar 2, 2000 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Mallinckrodt
Dow
Merck
Boehringer Ingelheim
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.