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, 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

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
Boston Medical Center	Phase 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
		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
Hikma Pharms	GABAPENTIN	gabapentin	TABLET;ORAL	078782-001	Jul 21, 2011		DISCN	No	No
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-001	Apr 6, 2011		RX	Yes	Yes			Y	Y
Amneal Pharms Ny	GABAPENTIN	gabapentin	CAPSULE;ORAL	078428-002	Jul 25, 2007	AB	RX	No	No

Expired US Patents for GABAPENTIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	NEURONTIN	gabapentin	CAPSULE;ORAL	020235-001	Dec 30, 1993
Viatris	NEURONTIN	gabapentin	CAPSULE;ORAL	020235-001	Dec 30, 1993
Viatris	NEURONTIN	gabapentin	SOLUTION;ORAL	021129-001	Mar 2, 2000

International Patents for GABAPENTIN

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2007079195
Japan	5421511
Japan	2010254713	METHOD OF TREATMENT USING GASTRIC RETAINED GABAPENTIN DOSAGE