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GRALISE Drug Profile

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When do Gralise patents expire, and what generic alternatives are available?

Gralise is a drug marketed by Almatica and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-four patent family members in sixteen countries.

The generic ingredient in GRALISE is gabapentin. There are twenty-nine drug master file entries for this compound. Seventy-two suppliers are listed for this compound. Additional details are available on the gabapentin profile page.

US ANDA Litigation and Generic Entry Outlook for Gralise

A generic version of GRALISE was approved as gabapentin by ACTAVIS ELIZABETH on September 12^th, 2003.

Summary for GRALISE

International Patents:	54
US Patents:	7
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	126
Clinical Trials:	10
Patent Applications:	4,694
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for GRALISE
Drug Sales Revenues:	Drug sales revenues for GRALISE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GRALISE
DailyMed Link:	GRALISE at DailyMed

See drug prices for GRALISE

See drug sales revenues for GRALISE

Pharmacology for GRALISE

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

Paragraph IV (Patent) Challenges for GRALISE

Tradename	Dosage	Ingredient	NDA	Submissiondate
GRALISE	TABLET;ORAL	gabapentin	022544	2011-10-31

US Patents and Regulatory Information for GRALISE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-001	Jan 28, 2011	BX	RX	Yes	Yes			Y
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-001	Jan 28, 2011	BX	RX	Yes	Yes			Y
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-001	Jan 28, 2011	BX	RX	Yes	Yes			Y
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-002	Jan 28, 2011	BX	RX	Yes	Yes			Y
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-002	Jan 28, 2011	BX	RX	Yes	Yes
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-002	Jan 28, 2011	BX	RX	Yes	Yes			Y

Expired US Patents for GRALISE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-001	Jan 28, 2011
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-002	Jan 28, 2011
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-001	Jan 28, 2011
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-002	Jan 28, 2011

International Patents for GRALISE

Country	Patent Number	Estimated Expiration
Japan	2013006863
World Intellectual Property Organization (WIPO)	2007079195
European Patent Office	1976503
European Patent Office	1439825
Canada	2464322
World Intellectual Property Organization (WIPO)	2006015294