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Serving leading biopharmaceutical companies globally:

Moodys
Accenture
Deloitte
Cantor Fitzgerald
Julphar
QuintilesIMS
Fuji
Daiichi Sankyo
AstraZeneca
Fish and Richardson

Generated: November 19, 2017

DrugPatentWatch Database Preview

Gralise Drug Profile

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What is the patent landscape for Gralise, and what generic Gralise alternatives are available?

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

This drug has sixty-seven patent family members in seventeen countries.

The generic ingredient in GRALISE is gabapentin. There are twenty-eight drug master file entries for this compound. One hundred and seven suppliers are listed for this compound. Additional details are available on the gabapentin profile page.
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Depomed Inc
GRALISE
gabapentin
TABLET;ORAL022544-001Jan 28, 2011BXRXYesYes► Subscribe► Subscribe ► Subscribe
Depomed Inc
GRALISE
gabapentin
TABLET;ORAL022544-002Jan 28, 2011BXRXYesYes► Subscribe► SubscribeY ► Subscribe
Depomed Inc
GRALISE
gabapentin
TABLET;ORAL022544-001Jan 28, 2011BXRXYesYes► Subscribe► SubscribeY ► Subscribe
Depomed Inc
GRALISE
gabapentin
TABLET;ORAL022544-001Jan 28, 2011BXRXYesYes► Subscribe► SubscribeY ► Subscribe
Depomed Inc
GRALISE
gabapentin
TABLET;ORAL022544-002Jan 28, 2011BXRXYesYes► Subscribe► SubscribeY ► Subscribe
Depomed Inc
GRALISE
gabapentin
TABLET;ORAL022544-002Jan 28, 2011BXRXYesYes► Subscribe► Subscribe► Subscribe
Depomed Inc
GRALISE
gabapentin
TABLET;ORAL022544-001Jan 28, 2011BXRXYesYes► Subscribe► SubscribeY ► Subscribe
Depomed Inc
GRALISE
gabapentin
TABLET;ORAL022544-002Jan 28, 2011BXRXYesYes► Subscribe► SubscribeY ► Subscribe
Depomed Inc
GRALISE
gabapentin
TABLET;ORAL022544-002Jan 28, 2011BXRXYesYes► Subscribe► SubscribeY ► Subscribe
Depomed Inc
GRALISE
gabapentin
TABLET;ORAL022544-002Jan 28, 2011BXRXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Tradename: GRALISE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Depomed Inc
GRALISE
gabapentin
TABLET;ORAL022544-001Jan 28, 2011► Subscribe► Subscribe
Depomed Inc
GRALISE
gabapentin
TABLET;ORAL022544-002Jan 28, 2011► Subscribe► Subscribe
Depomed Inc
GRALISE
gabapentin
TABLET;ORAL022544-002Jan 28, 2011► Subscribe► Subscribe
Depomed Inc
GRALISE
gabapentin
TABLET;ORAL022544-001Jan 28, 2011► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for GRALISE

Drugname Dosage Strength RLD Submissiondate
gabapentinTablets300 mg and 600 mgGralise10/31/2011

Non-Orange Book Patents for Tradename: GRALISE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,475,813Methods of treatment using a gastric retained gabapentin dosage► Subscribe
7,612,112Methods of treatment using a gastric retained gabapentin dosage► Subscribe
8,333,991Gastric retained gabapentin dosage form► Subscribe
8,592,481Gastric retentive gabapentin dosage forms and methods for using same► Subscribe
8,440,232Methods of treatment using a gastric retained gabapentin dosage► Subscribe
8,231,905Gastric retained gabapentin dosage form► Subscribe
8,529,955Methods of treatment using a gastric retained gabapentin dosage► Subscribe
8,119,166Methods of treatment using a gastric retained gabapentin dosage► Subscribe
8,409,613Gastric retained gabapentin dosage form► Subscribe
8,802,157Methods of treatment using a gastric retained gabapentin dosage form► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: GRALISE

Country Document Number Estimated Expiration
Japan2010254713► Subscribe
Austria256455► Subscribe
World Intellectual Property Organization (WIPO)2007079195► Subscribe
Taiwan200800155► Subscribe
Japan2005532985► Subscribe
Japan2009522294► Subscribe
Australia2002337974► Subscribe
Canada2290624► Subscribe
Canada2575555► Subscribe
Japan2005507400► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Moodys
US Army
Cerilliant
Cipla
Baxter
Julphar
Dow
McKinsey
Daiichi Sankyo
US Department of Justice

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 verifification 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.

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