RELISTOR Drug Patent Profile

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-seven patent family members in thirty-eight 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 twelve 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

Summary for RELISTOR

International Patents:	137
US Patents:	14
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	18
Patent Applications:	1,216
Drug Prices:	Drug price information for RELISTOR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RELISTOR
What excipients (inactive ingredients) are in RELISTOR?	RELISTOR excipients list
DailyMed Link:	RELISTOR at DailyMed

See drug prices for RELISTOR

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for RELISTOR

NDA:

021964

Dosage:

SOLUTION;SUBCUTANEOUS

NDA:

208271

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

Sponsor	Phase
University of Alabama at Birmingham	N/A
University Hospital Bispebjerg and Frederiksberg	Phase 2/Phase 3
Odense University Hospital	Phase 2/Phase 3

See all RELISTOR clinical trials

Pharmacology for RELISTOR

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for RELISTOR

A06AH	Peripheral opioid receptor antagonists
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

N07BB	Drugs used in alcohol dependence
N07B	DRUGS USED IN ADDICTIVE DISORDERS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

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.

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

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			Y
Salix	RELISTOR	methylnaltrexone bromide	TABLET;ORAL	208271-001	Jul 19, 2016		RX	Yes	Yes
Salix	RELISTOR	methylnaltrexone bromide	TABLET;ORAL	208271-001	Jul 19, 2016		RX	Yes	Yes			Y
Salix	RELISTOR	methylnaltrexone bromide	TABLET;ORAL	208271-001	Jul 19, 2016		RX	Yes	Yes			Y
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-002	Sep 27, 2010		RX	Yes	Yes
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-003	Sep 27, 2010		RX	Yes	Yes			Y
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-003	Sep 27, 2010		RX	Yes	Yes			Y

Expired US Patents for RELISTOR

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

EU/EMA Drug Approvals for RELISTOR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bausch Health Ireland Limited	Relistor	methylnaltrexone bromide	EMEA/H/C/000870 Treatment of opioid-induced constipation in advanced-illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient.	Authorised	no	no	no	2008-07-01

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

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Ecuador

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Guatemala

Hong Kong

Hungary

Israel

Japan

Malaysia

Mexico

Morocco

New Zealand

Peru

Poland

Portugal

Russian Federation

Singapore

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

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
South Korea	20130010900	ORAL FORMULATIONS AND LIPOPHILIC SALTS OF METHYLNALTREXONE
Malaysia	160727	ORAL FORMULATIONS AND LIPOPHILIC SALTS OF METHYLNALTREXONE
Russian Federation	2011117335	АНГОНИСТЫ ПЕРИФЕРИЧЕСКИХ РЕЦЕПТОРОВ ОПИОИДОВ И ИХ ПРИМЕНЕНИЯ
European Patent Office	4071151	SERINGUE CONTENANT DU BROMURE DE NMTX (SYRINGE CONTAINING NMTX BROMIDE)
Japan	6947713
Israel	221452	הרכבים למתן דרך הפה ומלחים ליפופילים של מתילנלטרקסון (Oral formulations and lipophilic salts of methylnaltrexone)
Spain	2914884