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Last Updated: April 5, 2020

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RELISTOR Drug 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 twenty-five 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.

US ANDA Litigation and 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 ten 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 is one tentative approval 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

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 Missouri-ColumbiaPhase 4
Tufts Medical CenterPhase 4
University of FloridaPhase 4

See all RELISTOR clinical trials

Recent Litigation for RELISTOR

Identify potential future generic entrants

District Court Litigation
Case NameDate
BAUSCH HEALTH COMPANIES INC. v. ACTAVIS LABORATORIES FL, INC.2019-06-13
VALEANT PHARMACEUTICALS INTERNATIONAL, INC. v. ACTAVIS LABORATORIES FL, INC.2017-12-08
VALEANT PHARMACEUTICALS INTERNATIONAL, INC. v. MYLAN PHARAMACEUTICALS, INC.2017-09-01

See all RELISTOR litigation

Pharmacology for RELISTOR
Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists
Synonyms for RELISTOR
(17R)-17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-17-methyl-6- oxomorphinanium bromide
(17R)-Methylnaltrexone bromide
(17RS)-17-(Cyclopropylmethyl)-4,5-alpha-epoxy-3,14-dihydroxy-17-methyl-6- oxomorphinanium bromide
(3R,4R,4aS,7aR,12bS)-3-Cyclopropylmethyl- 4a,9-dihydroxy-3-methyl-7-oxo-2,3,4,4a,5,6,7,7a-octahydro-1H-4,12- methanobenzofuro[3,2-e]isoquinolin-3-ium bromide
(4R,4aS,7aR,12bS)-3-(cyclopropylmethyl)-4a,9-dihydroxy-3-methyl-2,4,5,6,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinoline-3-ium-7-one
(4R,4aS,7aR,12bS)-3-(cyclopropylmethyl)-4a,9-dihydroxy-3-methyl-2,4,5,6,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinoline-3-ium-7-one,bromide
(R)-N-Methylnaltrexone bromide
(R)-Naltrexone methobromide
(R)-Naltrexone methylbromide
17-(Cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxymorphinanium-6-one
17-(Cyclopropylmethyl)-4,5alpha-epoxy-3,14-dihydroxy-17-methyl-6-oxomorphinanium
3844AH
73232-52-7
77061-EP2305652A2
77061-EP2308509A1
83387-25-1
916055-92-0
AKOS015896214
BDBM50278337
C21H26NO4.Br
CHEBI:136007
CHEMBL1186579
CHEMBL1201770
CHEMBL470617
CS-0762
CTK3E8491
D06618
DTXSID20873339
DTXSID30868236
GTPL7563
HY-75766
IFGIYSGOEZJNBE-KNLJMPJLSA-N
JVLBPIPGETUEET-GAAHOAFPSA-O
Methylnaltrexone
Methylnaltrexone (Bromide)
Methylnaltrexone bromide
Methylnaltrexone bromide (JAN/USAN)
Methylnaltrexone bromide [USAN:INN:BAN]
Methylnaltrexone bromide, >=97% (HPLC)
Methylnaltrexone bromide, United States Pharmacopeia (USP) Reference Standard
Methylnaltrexonium
MNTX
MNTX-302
MOA 728
MOA-728
Morphinanium, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-17- methyl-6-oxo-,bromide,(5alpha)-
Morphinanium, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-17-methyl-6-oxo-, (5alpha)-
Morphinanium, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-17-methyl-6-oxo-, bromide, (5alpha)-
MRZ 2663
MRZ 2663BR
Mrz-2663
MRZ-2663BR
N-Cyclopropylmethyl-noroxymorphone Methobromide
N-Methylnaltrexone
N-Methylnaltrexone Bromide
Naltrexone (R)-methobromide
Naltrexone MB
Naltrexone methobromide
ONO-3849
Q27288096
Q411515
Quaternary ammonium naltrexone
Relistor (TN)
RFO6IL3D3M
SCHEMBL2798188
SCHEMBL49356
UNII-RFO6IL3D3M
UNII-RFO6IL3D3M component IFGIYSGOEZJNBE-NQMNLMSRSA-N
W-5330
ZINC5764759
Paragraph IV (Patent) Challenges for RELISTOR
Tradename Dosage Ingredient NDA Submissiondate
RELISTOR TABLET;ORAL methylnaltrexone bromide 208271 2016-09-06
RELISTOR SOLUTION;SUBCUTANEOUS methylnaltrexone bromide 021964 2015-09-08
RELISTOR SOLUTION;SUBCUTANEOUS methylnaltrexone bromide 021964 2015-07-22

US Patents and Regulatory Information for 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   Start Trial   Start Trial Y   Start Trial
Salix RELISTOR methylnaltrexone bromide TABLET;ORAL 208271-001 Jul 19, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Salix RELISTOR methylnaltrexone bromide TABLET;ORAL 208271-001 Jul 19, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Salix RELISTOR methylnaltrexone bromide TABLET;ORAL 208271-001 Jul 19, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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   Start Trial   Start Trial
Salix Pharms RELISTOR methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 021964-002 Sep 27, 2010   Start Trial   Start Trial
Salix RELISTOR methylnaltrexone bromide TABLET;ORAL 208271-001 Jul 19, 2016   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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.