Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Harvard Business School
Merck
Medtronic
McKinsey
Express Scripts

Last Updated: October 22, 2019

DrugPatentWatch Database Preview

RELISTOR Drug Profile

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When do Relistor patents expire, 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 nineteen 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.

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
(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
(5|A)-17-(Cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-17-methyl-6-oxomorphinanium Bromide
1356447-13-6
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
AKOS015896214
AN-37324
BDBM50278337
C21H26NO4.Br
CHEBI:136007
CHEMBL1186579
CHEMBL1201770
CHEMBL470617
CS-0762
CTK3E8491
D06618
GTPL7563
HY-75766
I06-1616
IFGIYSGOEZJNBE-KNLJMPJLSA-N
JVLBPIPGETUEET-GAAHOAFPSA-O
Methylnaltrexone
Methylnaltrexone (Bromide)
Methylnaltrexone bromide
Methylnaltrexone bromide (JAN/USAN)
Methylnaltrexone bromide, >=97% (HPLC)
Methylnaltrexone bromide, United States Pharmacopeia (USP) Reference Standard
Methylnaltrexonium
MNTX
MNTX-302
MOA-728
Morphinanium, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-17-methyl-6-oxo-, (5alpha)-
MRZ 2663
MRZ 2663BR
MRZ-2663BR
N-Cyclopropylmethyl-noroxymorphone Methobromide
N-Methyl Naltrexone Bromide
N-Methylnaltrexone
N-Methylnaltrexone Bromide
Naltrexone MB
Naltrexone methobromide
Naltrexone Methyl Bromide
ONO-3849
Quaternary ammonium naltrexone
Relistor (TN)
SCHEMBL2798188
SCHEMBL49356
W-5330
ZINC5764759

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
Salix Pharms RELISTOR methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 021964-002 Sep 27, 2010 RX Yes Yes   Start Trial   Start Trial   Start Trial
Salix Pharms RELISTOR methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 021964-003 Sep 27, 2010 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 RELISTOR methylnaltrexone bromide TABLET;ORAL 208271-001 Jul 19, 2016   Start Trial   Start Trial
Salix Pharms RELISTOR methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 021964-002 Sep 27, 2010   Start Trial   Start Trial
Salix Pharms RELISTOR methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 021964-001 Apr 24, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for RELISTOR
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 150 mg ➤ Subscribe   Start Trial
➤ Subscribe Injection 8 mg/0.4 mL ➤ Subscribe   Start Trial
➤ Subscribe Injection 12 mg/0.6 mL ➤ Subscribe   Start Trial

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Serving leading biopharmaceutical companies globally:

Merck
Colorcon
Mallinckrodt
Harvard Business School
McKesson
Moodys

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