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Last Updated: May 20, 2022

RELISTOR Drug Patent Profile


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Which patents cover Relistor, and when can generic versions of Relistor launch?

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

This drug has one hundred and thirty-one 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.

DrugPatentWatch® Generic Entry Outlook for Relistor

Relistor was eligible for patent challenges on April 24, 2012.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 31, 2030. This may change due to patent challenges or generic licensing.

There have been eleven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are two tentative approvals for the generic drug (methylnaltrexone bromide), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for RELISTOR
Drug Prices for RELISTOR

See drug prices for RELISTOR

DrugPatentWatch® Estimated Generic Entry Opportunity Date for RELISTOR
Generic Entry Dates for RELISTOR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;SUBCUTANEOUS
Generic Entry Dates for RELISTOR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for RELISTOR

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Alabama at BirminghamN/A
University Hospital Bispebjerg and FrederiksbergPhase 2/Phase 3
Odense University HospitalPhase 2/Phase 3

See all RELISTOR clinical trials

Pharmacology for RELISTOR
Drug ClassOpioid Antagonist
Mechanism of Action Opioid Antagonists
Paragraph IV (Patent) Challenges for RELISTOR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
RELISTOR Tablets methylnaltrexone bromide 150 mg 208271 1 2016-09-06
RELISTOR Injection methylnaltrexone bromide 8 mg/0.4 mL 021964 1 2015-09-08
RELISTOR Injection methylnaltrexone bromide 12 mg/0.6 mL 021964 1 2015-07-22

US Patents and Regulatory Information for RELISTOR

RELISTOR is protected by fourteen US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of RELISTOR is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting RELISTOR

Oral formulations and lipophilic salts of methylnaltrexone
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Oral formulations and lipophilic salts of methylnaltrexone
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Stable pharmaceutical formulations of methylnaltrexone
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF OPIOID-INDUCED CONSTIPATION

Peripheral opioid receptor antagonists and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF OPIOID-INDUCED CONSTIPATION

Peripheral opioid receptor antagonists and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF OPIOID-INDUCED CONSTIPATION

Oral formulations and lipophilic salts of methylnaltrexone
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Stable methylnaltrexone preparation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Peripheral opioid receptor antagonists and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF OPIOID-INDUCED CONSTIPATION

Oral formulations and lipophilic salts of methylnal trexone
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Peripheral opioid receptor antagonists and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF OPIOID-INDUCED CONSTIPATION

Oral formulations and lipophilic salts of methylnaltrexone
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Peripheral opioid receptor antagonists and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF OPIOID-INDUCED CONSTIPATION

Stable pharmaceutical formulations of methylnaltrexone
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Peripheral opioid receptor antagonists and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF OPIOID-INDUCED CONSTIPATION

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Salix RELISTOR methylnaltrexone bromide TABLET;ORAL 208271-001 Jul 19, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Salix RELISTOR methylnaltrexone bromide TABLET;ORAL 208271-001 Jul 19, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Salix RELISTOR methylnaltrexone bromide TABLET;ORAL 208271-001 Jul 19, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for RELISTOR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Salix Pharms RELISTOR methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 021964-001 Apr 24, 2008 See Plans and Pricing See Plans and Pricing
Salix RELISTOR methylnaltrexone bromide TABLET;ORAL 208271-001 Jul 19, 2016 See Plans and Pricing See Plans and Pricing
Salix Pharms RELISTOR methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 021964-002 Sep 27, 2010 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for RELISTOR

When does loss-of-exclusivity occur for RELISTOR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 3520
Estimated Expiration: See Plans and Pricing

Patent: 0491
Estimated Expiration: See Plans and Pricing

Australia

Patent: 09298500
Estimated Expiration: See Plans and Pricing

Patent: 11224275
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0919539
Estimated Expiration: See Plans and Pricing

Patent: 2012022873
Estimated Expiration: See Plans and Pricing

Patent: 2020013665
Estimated Expiration: See Plans and Pricing

Canada

Patent: 76881
Estimated Expiration: See Plans and Pricing

Patent: 89798
Estimated Expiration: See Plans and Pricing

Chile

Patent: 12002192
Estimated Expiration: See Plans and Pricing

China

Patent: 2307874
Estimated Expiration: See Plans and Pricing

Patent: 2918039
Estimated Expiration: See Plans and Pricing

Patent: 3833634
Estimated Expiration: See Plans and Pricing

Patent: 5399673
Estimated Expiration: See Plans and Pricing

Patent: 7308125
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 30134
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 120476
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 12012208
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 9096
Estimated Expiration: See Plans and Pricing

Patent: 1270741
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 56119
Estimated Expiration: See Plans and Pricing

Patent: 71357
Estimated Expiration: See Plans and Pricing

Patent: 86997
Estimated Expiration: See Plans and Pricing

Patent: 78472
Estimated Expiration: See Plans and Pricing

Patent: 08322
Estimated Expiration: See Plans and Pricing

Georgia, Republic of

Patent: 01606550
Estimated Expiration: See Plans and Pricing

Guatemala

Patent: 1200247
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 99442
Estimated Expiration: See Plans and Pricing

Patent: 45673
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 33133
Estimated Expiration: See Plans and Pricing

Israel

Patent: 1865
Estimated Expiration: See Plans and Pricing

Patent: 1452
Estimated Expiration: See Plans and Pricing

Patent: 9507
Estimated Expiration: See Plans and Pricing

Japan

Patent: 19773
Estimated Expiration: See Plans and Pricing

Patent: 43409
Estimated Expiration: See Plans and Pricing

Patent: 29955
Estimated Expiration: See Plans and Pricing

Patent: 47368
Estimated Expiration: See Plans and Pricing

Patent: 47713
Estimated Expiration: See Plans and Pricing

Patent: 11190259
Estimated Expiration: See Plans and Pricing

Patent: 12504635
Estimated Expiration: See Plans and Pricing

Patent: 15129144
Estimated Expiration: See Plans and Pricing

Patent: 16029054
Estimated Expiration: See Plans and Pricing

Patent: 17101053
Estimated Expiration: See Plans and Pricing

Patent: 17206553
Estimated Expiration: See Plans and Pricing

Patent: 19031536
Estimated Expiration: See Plans and Pricing

Patent: 19034958
Estimated Expiration: See Plans and Pricing

Patent: 20196733
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 0727
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 9145
Estimated Expiration: See Plans and Pricing

Patent: 8805
Estimated Expiration: See Plans and Pricing

Patent: 11003400
Estimated Expiration: See Plans and Pricing

Patent: 12009125
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 146
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 1859
Estimated Expiration: See Plans and Pricing

Patent: 1595
Estimated Expiration: See Plans and Pricing

Patent: 2667
Estimated Expiration: See Plans and Pricing

Patent: 9972
Estimated Expiration: See Plans and Pricing

Patent: 2826
Estimated Expiration: See Plans and Pricing

Patent: 3564
Estimated Expiration: See Plans and Pricing

Patent: 0085
Estimated Expiration: See Plans and Pricing

Peru

Patent: 130063
Estimated Expiration: See Plans and Pricing

Poland

Patent: 71357
Estimated Expiration: See Plans and Pricing

Patent: 78472
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 11117335
Estimated Expiration: See Plans and Pricing

Patent: 13157119
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 3133
Estimated Expiration: See Plans and Pricing

Patent: 4393
Estimated Expiration: See Plans and Pricing

Patent: 201501821R
Estimated Expiration: See Plans and Pricing

Patent: 201606618P
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1808498
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1566675
Estimated Expiration: See Plans and Pricing

Patent: 1913102
Estimated Expiration: See Plans and Pricing

Patent: 1982482
Estimated Expiration: See Plans and Pricing

Patent: 110060967
Estimated Expiration: See Plans and Pricing

Patent: 130010900
Estimated Expiration: See Plans and Pricing

Patent: 140091071
Estimated Expiration: See Plans and Pricing

Patent: 180118260
Estimated Expiration: See Plans and Pricing

Spain

Patent: 23926
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 89293
Estimated Expiration: See Plans and Pricing

Patent: 05814
Estimated Expiration: See Plans and Pricing

Patent: 1141479
Estimated Expiration: See Plans and Pricing

Patent: 1622724
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 12000392
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 1717
Estimated Expiration: See Plans and Pricing

Patent: 3856
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering RELISTOR around the world.

Country Patent Number Title Estimated Expiration
Brazil PI0409133 See Plans and Pricing
Hong Kong 1082181 See Plans and Pricing
Taiwan 201141479 Oral formulations and lipophilic salts of methylnaltrexone See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
McKesson
McKinsey
Medtronic
Baxter
Dow

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 verification 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.