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Last Updated: March 19, 2024

Gabapentin - Generic Drug Details


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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, 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

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Drug Sales Revenue Trends for gabapentin

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Recent Clinical Trials for gabapentin

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

SponsorPhase
Yale UniversityPhase 3
Boston Medical CenterPhase 2/Phase 3
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Phase 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
Sun Pharm Inds Ltd GABAPENTIN gabapentin CAPSULE;ORAL 077242-001 Aug 24, 2006 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aci GABAPENTIN gabapentin TABLET;ORAL 203244-002 Jul 12, 2013 AB1 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Granules GABAPENTIN gabapentin TABLET;ORAL 217116-002 Mar 28, 2023 AB1 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alkem Labs Ltd GABAPENTIN gabapentin TABLET;ORAL 206402-001 Dec 23, 2015 AB1 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ivax Sub Teva Pharms GABAPENTIN gabapentin TABLET;ORAL 076017-003 Apr 28, 2004 AB1 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Ltd GABAPENTIN gabapentin TABLET;ORAL 200651-002 Oct 6, 2011 AB1 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Laurus GABAPENTIN gabapentin CAPSULE;ORAL 217546-001 May 12, 2023 AB RX No 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
Almatica GRALISE gabapentin TABLET;ORAL 022544-002 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
Viatris NEURONTIN gabapentin CAPSULE;ORAL 020235-002 Dec 30, 1993 ⤷  Try a Trial ⤷  Try a Trial
Almatica GRALISE gabapentin TABLET;ORAL 022544-001 Jan 28, 2011 ⤷  Try a Trial ⤷  Try a Trial
Almatica GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011 ⤷  Try a Trial ⤷  Try a Trial
Almatica GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011 ⤷  Try a Trial ⤷  Try a Trial
Viatris NEURONTIN gabapentin CAPSULE;ORAL 020235-001 Dec 30, 1993 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for gabapentin

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 03035040 ⤷  Try a Trial
Denmark 1439825 ⤷  Try a Trial
China 101484153 ⤷  Try a Trial
Japan 2009522294 ⤷  Try a Trial
Canada 2635466 ⤷  Try a Trial
Mexico PA04003946 METODOS DE TRATAMIENTO USANDO UNA FORMA DE DOSIS DE GABAPENTINA DE RETENCION GASTRICA. (METHODS OF TREATMENT USING A GASTRIC RETAINED GABAPENTIN DOSAGE.) ⤷  Try a Trial
Australia 2005267738 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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.