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Serving leading biopharmaceutical companies globally:

Medtronic
Dow
Teva
Farmers Insurance
Baxter
Argus Health
US Army
Cipla
Mallinckrodt
Cerilliant

Generated: January 19, 2018

DrugPatentWatch Database Preview

Gralise Drug Profile

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When do Gralise patents expire, and what generic 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 nine suppliers are listed for this compound. Additional details are available on the gabapentin profile page.

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

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Expired US Patents for Gralise

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

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Paragraph IV (Patent) Challenges for GRALISE
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 300 mg and 600 mg ➤ Subscribe 10/31/2011

Non-Orange Book US Patents for 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
8,409,613 Gastric retained gabapentin dosage form ➤ Subscribe
8,802,157 Methods of treatment using a gastric retained gabapentin dosage form ➤ Subscribe
7,612,112 Methods of treatment using a gastric retained gabapentin dosage ➤ Subscribe
8,529,955 Methods of treatment using a gastric retained gabapentin dosage ➤ Subscribe
8,119,166 Methods of treatment using a gastric retained gabapentin dosage ➤ Subscribe
8,440,232 Methods of treatment using a gastric retained gabapentin dosage ➤ Subscribe
8,333,991 Gastric retained gabapentin dosage form ➤ Subscribe
8,231,905 Gastric retained gabapentin dosage form ➤ Subscribe
8,592,481 Gastric retentive gabapentin dosage forms and methods for using same ➤ Subscribe
8,475,813 Methods of treatment using a gastric retained gabapentin dosage ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for Gralise

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Serving leading biopharmaceutical companies globally:

US Department of Justice
Cantor Fitzgerald
Medtronic
Queensland Health
Johnson and Johnson
Cipla
AstraZeneca
Argus Health
Federal Trade Commission

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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