Methylnaltrexone bromide - Generic Drug Details

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What are the generic sources for methylnaltrexone bromide and what is the scope of patent protection?

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

Methylnaltrexone bromide has one hundred and thirty-seven patent family members in thirty-eight countries.

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

Summary for methylnaltrexone bromide

International Patents:	137
US Patents:	14
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	17
Patent Applications:	1,781
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for methylnaltrexone bromide
What excipients (inactive ingredients) are in methylnaltrexone bromide?	methylnaltrexone bromide excipients list
DailyMed Link:	methylnaltrexone bromide at DailyMed

Recent Clinical Trials for methylnaltrexone bromide

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

Sponsor	Phase
University of Alabama at Birmingham	N/A
Bausch Health Americas, Inc.	Phase 2/Phase 3
Karolinska University Hospital	Phase 4

See all methylnaltrexone bromide clinical trials

Generic filers with tentative approvals for METHYLNALTREXONE BROMIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	12MG/0.6ML	SOLUTION;SUBCUTANEOUS
⤷ Sign Up	⤷ Sign Up	12MG/0.6ML	INJECTABLE;SUBCUTANEOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for methylnaltrexone bromide

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for methylnaltrexone bromide

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 METHYLNALTREXONE BROMIDE

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, Single Dose Prefilled Syringe	021964	1	2015-09-08
RELISTOR	Injection	methylnaltrexone bromide	12 mg/0.6 mL, Single Dose Vial	021964	1	2015-07-22

US Patents and Regulatory Information for methylnaltrexone bromide

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Glossary

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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	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-001	Apr 24, 2008		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-003	Sep 27, 2010	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-001	Apr 24, 2008		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-001	Apr 24, 2008		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-001	Apr 24, 2008		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Actavis Llc	METHYLNALTREXONE BROMIDE	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	208112-001	Aug 26, 2024	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 methylnaltrexone bromide

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix	RELISTOR	methylnaltrexone bromide	TABLET;ORAL	208271-001	Jul 19, 2016	⤷ Sign Up	⤷ Sign Up
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-003	Sep 27, 2010	⤷ Sign Up	⤷ Sign Up
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-001	Apr 24, 2008	⤷ Sign Up	⤷ Sign Up
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-002	Sep 27, 2010	⤷ Sign Up	⤷ Sign Up
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-002	Sep 27, 2010	⤷ Sign Up	⤷ Sign Up
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-001	Apr 24, 2008	⤷ Sign Up	⤷ Sign Up
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-001	Apr 24, 2008	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for methylnaltrexone bromide

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for methylnaltrexone bromide

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Country	Patent Number	Title	Estimated Expiration
Poland	2368554		⤷ Sign Up
Russian Federation	2005134361	ФАРМАЦЕВТИЧЕСКАЯ ПРЕПАРАТИВНАЯ ФОРМА	⤷ Sign Up
Japan	6947713		⤷ Sign Up
Cyprus	1116272		⤷ Sign Up
China	105399673	Peripheral Opioid Receptor Antagonists And Uses Thereof	⤷ Sign Up
Australia	2004229463	Pharmaceutical formulations containing methylnaltrexone	⤷ Sign Up
Japan	6429955		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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