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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Mallinckrodt
Express Scripts
Cantor Fitzgerald
Healthtrust
McKesson
Citi
US Army
Fuji
Accenture

Generated: December 11, 2017

DrugPatentWatch Database Preview

RELISTOR Drug Profile

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When do Relistor patents expire, and when can generic versions of Relistor launch?

Relistor is a drug marketed by Salix Pharms and Salix Pharms Inc and is included in two NDAs. There are twelve patents protecting this drug and three Paragraph IV challenges.

This drug has one hundred and eleven patent family members in thirty-seven countries.

The generic ingredient in RELISTOR is methylnaltrexone bromide. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the methylnaltrexone bromide profile page.

Summary for RELISTOR

Drug patent expirations by year for RELISTOR

Pharmacology for RELISTOR

Ingredient-typeQuaternary Ammonium Compounds
Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Salix Pharms IncRELISTORmethylnaltrexone bromideTABLET;ORAL208271-001Jul 19, 2016RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Salix Pharms IncRELISTORmethylnaltrexone bromideTABLET;ORAL208271-001Jul 19, 2016RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Salix Pharms IncRELISTORmethylnaltrexone bromideTABLET;ORAL208271-001Jul 19, 2016RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Salix PharmsRELISTORmethylnaltrexone bromideSOLUTION;SUBCUTANEOUS021964-002Sep 27, 2010RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Salix PharmsRELISTORmethylnaltrexone bromideSOLUTION;SUBCUTANEOUS021964-003Sep 27, 2010RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Salix Pharms IncRELISTORmethylnaltrexone bromideTABLET;ORAL208271-001Jul 19, 2016RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Salix PharmsRELISTORmethylnaltrexone bromideSOLUTION;SUBCUTANEOUS021964-002Sep 27, 2010RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Salix PharmsRELISTORmethylnaltrexone bromideSOLUTION;SUBCUTANEOUS021964-002Sep 27, 2010RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Salix PharmsRELISTORmethylnaltrexone bromideSOLUTION;SUBCUTANEOUS021964-001Apr 24, 2008RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Salix PharmsRELISTORmethylnaltrexone bromideSOLUTION;SUBCUTANEOUS021964-003Sep 27, 2010RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: RELISTOR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Salix Pharms IncRELISTORmethylnaltrexone bromideTABLET;ORAL208271-001Jul 19, 2016► Subscribe► Subscribe
Salix PharmsRELISTORmethylnaltrexone bromideSOLUTION;SUBCUTANEOUS021964-002Sep 27, 2010► Subscribe► Subscribe
Salix PharmsRELISTORmethylnaltrexone bromideSOLUTION;SUBCUTANEOUS021964-001Apr 24, 2008► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for RELISTOR

Drugname Dosage Strength RLD Submissiondate
methylnaltrexone bromideTablets150 mgRelistor9/6/2016
methylnaltrexone bromideInjection8 mg/0.4 mLRelistor9/8/2015
methylnaltrexone bromideInjection12 mg/0.6 mLRelistor7/22/2015

Non-Orange Book Patents for Tradename: RELISTOR

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
5,972,954 Use of methylnaltrexone and related compounds► Subscribe
8,455,644Peripheral opioid receptor antagonists and uses thereof► Subscribe
6,608,075 Use of methylnaltrexone and related compounds► Subscribe
6,274,591 Use of methylnaltrexone and related compounds► 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: RELISTOR

Country Document Number Estimated Expiration
European Patent Office2356119► Subscribe
Taiwan201622724► Subscribe
Spain2527870► Subscribe
Canada2811272► Subscribe
Hong Kong1082181► Subscribe
Australia2004229463► Subscribe
Cyprus1116373► Subscribe
New Zealand619972► Subscribe
CroatiaP20150038► Subscribe
Denmark2368553► 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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Serving leading biopharmaceutical companies globally:

US Department of Justice
Harvard Business School
Merck
Healthtrust
Express Scripts
Chinese Patent Office
Citi
UBS
Teva
Argus Health

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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