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Last Updated: March 29, 2024

GABAPENTIN - Generic Drug Details


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

Gabapentin is the generic ingredient in four branded drugs marketed by ACI, Actavis Elizabeth, Alkem, Amneal Pharms Ny, Ascent Pharms Inc, Aurobindo Pharma, Chartwell Rx, Cspc Ouyi, Granules, Graviti Pharms, Hikma, Invagen Pharms, Ipca Labs Ltd, Laurus, Marksans Pharma, Mylan, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Ltd, Sun Pharm Industries, Taro, Teva Pharms, Watson Labs, Zhejiang Yongtai, Viatris, Acella Pharms Llc, Amneal Pharms, Annora Pharma, Belcher, Mission Pharmacal, Pai Holdings Pharm, Rubicon, Alkem Labs Ltd, Apotex, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Hikma Pharms, Invatech, Ivax Sub Teva Pharms, Lupin Ltd, Mylan Pharms Inc, Ranbaxy, Rising, Teva, Teva Pharms Usa, Zydus Pharms, Zydus Pharms Usa Inc, Almatica, and Azurity, and is included in sixty-five NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Gabapentin has twenty-four patent family members in nine countries.

There are twenty-nine drug master file entries for gabapentin. Seventy-five 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
Yale UniversityPhase 3
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Phase 2/Phase 3
Boston Medical CenterPhase 2/Phase 3

See all GABAPENTIN clinical trials

Generic filers with tentative approvals for GABAPENTIN
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial600MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial300MGTABLET; ORAL
⤷  Try a Trial⤷  Try a 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 Strength NDA ANDAs Submitted Submissiondate
GRALISE Tablets gabapentin 300 mg and 600 mg 022544 1 2011-10-31

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
Ascent Pharms Inc GABAPENTIN gabapentin CAPSULE;ORAL 214956-002 May 10, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma GABAPENTIN gabapentin CAPSULE;ORAL 078150-003 Sep 25, 2007 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chartwell Rx GABAPENTIN gabapentin CAPSULE;ORAL 091008-001 Oct 26, 2017 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Almatica GRALISE gabapentin TABLET;ORAL 022544-003 Apr 18, 2023 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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
Viatris NEURONTIN gabapentin SOLUTION;ORAL 021129-001 Mar 2, 2000 ⤷  Try a Trial ⤷  Try a Trial
Almatica GRALISE gabapentin TABLET;ORAL 022544-001 Jan 28, 2011 ⤷  Try a Trial ⤷  Try a Trial
Viatris NEURONTIN gabapentin TABLET;ORAL 020882-002 Oct 9, 1998 ⤷  Try a Trial ⤷  Try a Trial
Almatica GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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