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Methylnaltrexone bromide - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for methylnaltrexone bromide?

Methylnaltrexone bromide is the generic ingredient in one branded drug marketed by Salix Pharms and Salix Pharms Inc, and is included in two NDAs. There are ten patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Methylnaltrexone bromide has ninety-one patent family members in thirty-three countries.

There are three drug master file entries for methylnaltrexone bromide. One supplier is listed for this compound.

Summary for Generic Name: methylnaltrexone bromide

Tradenames:1
Patents:10
Applicants:2
NDAs:2
Drug Master File Entries: see list3
Suppliers / Packagers: see list1
Bulk Api Vendors: see list23
Clinical Trials: see list103
Patent Applications: see list948
Drug Prices:see low prices
DailyMed Link:methylnaltrexone bromide at DailyMed

Pharmacology for Ingredient: methylnaltrexone bromide

Ingredient-typeQuaternary Ammonium Compounds
Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Salix Pharms Inc
RELISTOR
methylnaltrexone bromide
TABLET;ORAL208271-001Jul 19, 2016RXYesYes6,559,158► Subscribe ► Subscribe
Salix Pharms Inc
RELISTOR
methylnaltrexone bromide
TABLET;ORAL208271-001Jul 19, 2016RXYesYes9,314,461► SubscribeY ► Subscribe
Salix Pharms
RELISTOR
methylnaltrexone bromide
SOLUTION;SUBCUTANEOUS021964-002Sep 27, 2010RXYesYes8,552,025► SubscribeY ► Subscribe
Salix Pharms Inc
RELISTOR
methylnaltrexone bromide
TABLET;ORAL208271-001Jul 19, 2016RXYesYes8,524,276► SubscribeY ► Subscribe
Salix Pharms
RELISTOR
methylnaltrexone bromide
SOLUTION;SUBCUTANEOUS021964-002Sep 27, 2010RXYesYes8,420,663► Subscribe ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: methylnaltrexone bromide

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
6,274,591 Use of methylnaltrexone and related compounds► Subscribe
9,492,445Peripheral opioid receptor antagonists and uses thereof► Subscribe
8,455,644Peripheral opioid receptor antagonists and uses thereof► Subscribe
6,608,075 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 Ingredient: methylnaltrexone bromide

Country Document Number Estimated Expiration
Taiwan201141479► Subscribe
Mexico2011003400► Subscribe
Israel221452► Subscribe
Japan5719773► Subscribe
Singapore183133► 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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