Gabapentin - Generic Drug Details

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, 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, Belcher, Pai Holdings Pharm, Alkem Labs Ltd, Apotex Inc, Aurobindo Pharma Ltd, 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-two suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for gabapentin

International Patents:	76
US Patents:	12
Tradenames:	4
Applicants:	45
NDAs:	58
Drug Master File Entries:	29
Finished Product Suppliers / Packagers:	72
Raw Ingredient (Bulk) Api Vendors:	139
Clinical Trials:	503
Patent Applications:	6,793
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

See drug sales revenues for gabapentin

Recent Clinical Trials for gabapentin

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

Sponsor	Phase
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2/Phase 3
Boston Medical Center	Phase 2/Phase 3
University of Iowa	Phase 4

See all gabapentin clinical trials

Generic filers with tentative approvals for GABAPENTIN

Applicant	Application No.	Strength	Dosage Form
		600MG	TABLET; ORAL
		300MG	TABLET; ORAL
		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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Granules	GABAPENTIN	gabapentin	CAPSULE;ORAL	075360-003	Apr 6, 2005	AB	RX	No	No
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-002	Jan 28, 2011	BX	RX	Yes	Yes			Y
Sun Pharm Inds Ltd	GABAPENTIN	gabapentin	CAPSULE;ORAL	077242-002	Aug 24, 2006	AB	RX	No	No
Cspc Ouyi	GABAPENTIN	gabapentin	TABLET;ORAL	207057-002	Oct 26, 2017	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
Viatris	NEURONTIN	gabapentin	CAPSULE;ORAL	020235-003	Dec 30, 1993
Viatris	NEURONTIN	gabapentin	SOLUTION;ORAL	021129-001	Mar 2, 2000
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-002	Jan 28, 2011

International Patents for gabapentin

Country	Patent Number	Title	Estimated Expiration
Guatemala	200200089	COMPOSICION FARMACEUTICA LIQUIDA
Australia	2002348828
Serbia	87203
Iceland	2428