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Last Updated: April 26, 2024

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, 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, Humanwell, 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-eight 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-six suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for GABAPENTIN

International Patents:	24
US Patents:	6
Tradenames:	4
Applicants:	51
NDAs:	68
Drug Master File Entries:	29
Finished Product Suppliers / Packagers:	76
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	511
Patent Applications:	5,173
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for GABAPENTIN
Drug Sales Revenues:	Drug sales revenues for GABAPENTIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GABAPENTIN
What excipients (inactive ingredients) are in GABAPENTIN?	GABAPENTIN excipients list
DailyMed Link:	GABAPENTIN at DailyMed

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

Sponsor	Phase
Yale University	Phase 3
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2/Phase 3
Boston Medical Center	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 Trial	600MG	TABLET; ORAL
⤷ Try a Trial	⤷ Try a Trial	300MG	TABLET; ORAL
⤷ Try a Trial	⤷ Try a Trial	600MG	TABLET, 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

Drug Class	Anti-epileptic Agent
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

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

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Glossary

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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	076606-003	Oct 7, 2005		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sandoz	GABAPENTIN	gabapentin	CAPSULE;ORAL	075428-001	Jan 24, 2006		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Taro	GABAPENTIN	gabapentin	CAPSULE;ORAL	077261-002	Aug 2, 2013	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Graviti Pharms	GABAPENTIN	gabapentin	CAPSULE;ORAL	207099-001	Mar 24, 2017	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
Rubicon	GABAPENTIN	gabapentin	TABLET;ORAL	077661-005	Sep 13, 2006	AB1	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	NEURONTIN	gabapentin	TABLET;ORAL	020882-001	Oct 9, 1998	⤷ 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	022544-001	Jan 28, 2011	⤷ Try a Trial	⤷ Try a Trial
Viatris	NEURONTIN	gabapentin	CAPSULE;ORAL	020235-002	Dec 30, 1993	⤷ Try a Trial	⤷ Try a Trial
Viatris	NEURONTIN	gabapentin	CAPSULE;ORAL	020235-002	Dec 30, 1993	⤷ 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

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	03035040		⤷ Try a Trial
Australia	2002348828		⤷ Try a Trial
European Patent Office	1439825	MÉTHODES DE TRAITEMENT À L'AIDE D'UN DOSAGE DE GABAPENTINE À RETENUE GASTRIQUE (METHODS OF TREATMENT USING A GASTRIC RETAINED GABAPENTIN DOSAGE FORM)	⤷ Try a Trial
Japan	2008508317		⤷ Try a Trial
European Patent Office	1773311		⤷ 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
>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.