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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 Healthcare Ltd, Actavis Elizabeth, Alkem, Amneal Pharms Ny, Aurobindo Pharma Ltd, Cspc Ouyi, Epic Pharma Llc, Granules India Ltd, 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, Amneal Pharms, Hi Tech Pharma, 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-six NDAs. There are fourteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Gabapentin has one hundred and six patent family members in forty-seven countries.

There are twenty-nine drug master file entries for gabapentin. Seventy-five suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for gabapentin

International Patents:	106
US Patents:	14
Tradenames:	4
Applicants:	43
NDAs:	56
Drug Master File Entries:	29
Suppliers / Packagers:	75
Bulk Api Vendors:	129
Clinical Trials:	420
Patent Applications:	4,804
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
DailyMed Link:	gabapentin at DailyMed

See drug prices for gabapentin

See drug sales revenues for gabapentin

Recent Clinical Trials for gabapentin

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

Sponsor	Phase
NYU Langone Health	Phase 4
University of South Florida	Phase 3
Gia Dinh People Hospital	N/A

See all gabapentin clinical trials

Generic filers with tentative approvals for GABAPENTIN

Applicant	Application No.	Strength	Dosage Form
		600MG	TABLET; ORAL
		300MG	TABLET; 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	NDA	Submissiondate
GRALISE	TABLET;ORAL	gabapentin	022544	2011-10-31
NEURONTIN	CAPSULE;ORAL	gabapentin	020235
NEURONTIN	TABLET;ORAL	gabapentin	020882
NEURONTIN	SOLUTION;ORAL	gabapentin	021129

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
Jiangsu Hengrui Med	GABAPENTIN	gabapentin	CAPSULE;ORAL	091008-002	Oct 26, 2017		DISCN	No	No
Sciegen Pharms Inc	GABAPENTIN	gabapentin	TABLET;ORAL	205101-001	Feb 4, 2016	AB	RX	No	No
Invagen Pharms	GABAPENTIN	gabapentin	CAPSULE;ORAL	090705-002	Dec 30, 2009	AB	RX	No	No
Apotex Inc	GABAPENTIN	gabapentin	TABLET;ORAL	077894-001	Oct 10, 2006	AB	RX	No	No
Ivax Sub Teva Pharms	GABAPENTIN	gabapentin	TABLET;ORAL	076017-004	Apr 29, 2005		DISCN	No	No
Amneal Pharms Ny	GABAPENTIN	gabapentin	CAPSULE;ORAL	078428-002	Jul 25, 2007	AB	RX	No	No
Strides Pharma	GABAPENTIN	gabapentin	CAPSULE;ORAL	211314-001	Oct 16, 2018	AB	RX	No	No

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
Upjohn	NEURONTIN	gabapentin	SOLUTION;ORAL	021129-001	Mar 2, 2000
Upjohn	NEURONTIN	gabapentin	CAPSULE;ORAL	020235-001	Dec 30, 1993
Upjohn	NEURONTIN	gabapentin	TABLET;ORAL	020882-002	Oct 9, 1998
Upjohn	NEURONTIN	gabapentin	TABLET;ORAL	020882-001	Oct 9, 1998
Upjohn	NEURONTIN	gabapentin	CAPSULE;ORAL	020235-003	Dec 30, 1993
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-001	Jan 28, 2011

International Patents for gabapentin

Country	Patent Number	Estimated Expiration
Japan	5421511
Slovenia	1395242
Spain	2213108
China	1509165
Norway	20035200
Iceland	2428
Hong Kong	1062646