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Last Updated: May 21, 2022

Gabapentin - Generic Drug Details


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What are the generic sources for gabapentin and what is the scope of freedom to operate?

Gabapentin is the generic ingredient in four branded drugs marketed by ACI, Actavis Elizabeth, Alkem, Amneal Pharms Ny, Ascent Pharms Inc, Aurobindo Pharma Ltd, Cspc Ouyi, Granules, Graviti Pharms, Hikma, Invagen Pharms, Jiangsu Pharms, 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, Akorn, Amneal Pharms, Pai Holdings Pharm, Tris Pharma Inc, 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 Azurity, and is included in fifty-eight NDAs. There are twelve patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Gabapentin has seventy-six patent family members in forty-seven countries.

There are twenty-nine drug master file entries for gabapentin. Seventy-eight suppliers are listed 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
Al-Kindy College of MedicinePhase 4
University Hospital, Clermont-FerrandPhase 2
Federation Francophone de Cancerologie DigestivePhase 2

See all gabapentin clinical trials

Pharmacology for gabapentin
Anatomical Therapeutic Chemical (ATC) Classes 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
Ranbaxy GABAPENTIN gabapentin TABLET;ORAL 076605-001 Sep 14, 2005 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Akorn GABAPENTIN gabapentin SOLUTION;ORAL 078974-001 Feb 18, 2011 AA RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hikma GABAPENTIN gabapentin CAPSULE;ORAL 078150-003 Sep 25, 2007 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ranbaxy GABAPENTIN gabapentin TABLET;ORAL 076605-002 Sep 14, 2005 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Graviti Pharms GABAPENTIN gabapentin CAPSULE;ORAL 207099-003 Mar 24, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Strides Pharma GABAPENTIN gabapentin CAPSULE;ORAL 211314-002 Oct 16, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Watson Labs GABAPENTIN gabapentin CAPSULE;ORAL 075485-003 May 11, 2007 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 CAPSULE;ORAL 020235-002 Dec 30, 1993 See Plans and Pricing See Plans and Pricing
Viatris NEURONTIN gabapentin TABLET;ORAL 020882-001 Oct 9, 1998 See Plans and Pricing See Plans and Pricing
Almatica GRALISE gabapentin TABLET;ORAL 022544-001 Jan 28, 2011 See Plans and Pricing See Plans and Pricing
Viatris NEURONTIN gabapentin CAPSULE;ORAL 020235-003 Dec 30, 1993 See Plans and Pricing See Plans and Pricing
Viatris NEURONTIN gabapentin TABLET;ORAL 020882-001 Oct 9, 1998 See Plans and Pricing See Plans and Pricing
Viatris NEURONTIN gabapentin CAPSULE;ORAL 020235-001 Dec 30, 1993 See Plans and Pricing See Plans and Pricing
Viatris NEURONTIN gabapentin TABLET;ORAL 020882-001 Oct 9, 1998 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for gabapentin

Country Patent Number Title Estimated Expiration
Japan 5421511 See Plans and Pricing
Guatemala 200200089 COMPOSICION FARMACEUTICA LIQUIDA See Plans and Pricing
El Salvador 2003001053 COMPOSICION LIQUIDA FARMACEUTICA REF. PC21501 See Plans and Pricing
Austria 334656 See Plans and Pricing
Norway 20035200 See Plans and Pricing
Germany 60213592 See Plans and Pricing
Ecuador SP034853 COMPOSICIÓN FARMACÉUTICA LÍQUIDA See Plans and Pricing
>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.