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GRALISE Drug Profile

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

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

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

Summary for Tradename: GRALISE

Patents:9
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Drug Prices: :see details

Pharmacology for Tradename: GRALISE

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Depomed Inc
GRALISE
gabapentin
TABLET;ORAL022544-001Jan 28, 2011RXYes7,438,927► subscribe ► subscribe
Depomed Inc
GRALISE
gabapentin
TABLET;ORAL022544-002Jan 28, 2011RXYes7,731,989► subscribeY ► subscribe
Depomed Inc
GRALISE
gabapentin
TABLET;ORAL022544-001Jan 28, 2011RXYes6,340,475► 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, 20116,635,280► subscribe
Depomed Inc
GRALISE
gabapentin
TABLET;ORAL022544-001Jan 28, 20116,340,475► subscribe
Depomed Inc
GRALISE
gabapentin
TABLET;ORAL022544-002Jan 28, 20116,635,280► subscribe
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Paragraph IV activity 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
8,802,157Methods of treatment using a gastric retained gabapentin dosage form► subscribe
7,612,112Methods of treatment using a gastric retained gabapentin dosage► subscribe
8,409,613Gastric 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
Germany60101581► subscribe
Japan2009040787► subscribe
Canada2364845► 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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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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