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

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Harvard Business School
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Mallinckrodt

Last Updated: December 14, 2019

DrugPatentWatch Database Preview

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 one branded drug marketed by Salix Pharms and Salix, and is included in two 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 twenty patent family members in thirty-seven countries.

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

Recent Clinical Trials for methylnaltrexone bromide

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

SponsorPhase
Bausch Health Americas, Inc.Phase 2/Phase 3
Karolinska University HospitalPhase 4
University Medicine GreifswaldPhase 1

See all methylnaltrexone bromide clinical trials

Recent Litigation for methylnaltrexone bromide

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 methylnaltrexone bromide litigation

Generic filers with tentative approvals for METHYLNALTREXONE BROMIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial12MG/0.6MLINJECTABLE;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 ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists
Synonyms for methylnaltrexone bromide
(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
(17S)-N-Methylnaltrexone 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,bromide
(5|A)-17-(Cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-17-methyl-6-oxomorphinanium Bromide
(R)-N-Methylnaltrexone bromide
(R)-Naltrexone methobromide
(R)-Naltrexone methylbromide
(S)-Naltrexone methobromide
1055877-28-5
1378943-67-9
3844AH
73232-52-7
916045-21-1
916055-92-0
AKOS015896214
AN-37324
BC276097
C21H26NO4.Br
CDW853B60I
CHEMBL1201770
CS-0762
D06618
HY-75766
I06-1616
IFGIYSGOEZJNBE-KNLJMPJLSA-N
Methylnaltrexone
Methylnaltrexone (Bromide)
Methylnaltrexone bromide (JAN/USAN)
Methylnaltrexone bromide [USAN:INN:BAN]
Methylnaltrexone bromide, (17S)-
Methylnaltrexone bromide, >=97% (HPLC)
Methylnaltrexone bromide, United States Pharmacopeia (USP) Reference Standard
MNTX
MNTX-302
MOA 728
MOA-728
Morphinan-17-ium-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-17-methyl-, bromide, (5alpha,17S)-
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-, bromide, (5alpha)-
Morphinanium, 17-(cyclopropylmethyl)-4,5-epoxy-3,9-dihydroxy-17-methyl-6-oxo-, bromide (1:1), (17S)-
MRZ 2663BR
MRZ-2663BR
N-Cyclopropylmethyl-noroxymorphone Methobromide
N-Methyl Naltrexone Bromide
N-Methylnaltrexone Bromide
Naltrexone (R)-methobromide
Naltrexone (S)-methobromide
Naltrexone methobromide
Naltrexone Methyl Bromide
ONO-3849
Relistor
Relistor (TN)
RFO6IL3D3M
SCHEMBL2798188
UNII-CDW853B60I
UNII-RFO6IL3D3M
UNII-RFO6IL3D3M component IFGIYSGOEZJNBE-LHJYHSJWSA-N
UNII-RFO6IL3D3M component IFGIYSGOEZJNBE-NQMNLMSRSA-N
W-5330
Paragraph IV (Patent) Challenges for METHYLNALTREXONE BROMIDE
Tradename Dosage Ingredient NDA Submissiondate
RELISTOR TABLET;ORAL methylnaltrexone bromide 208271 2016-09-06
RELISTOR SOLUTION;SUBCUTANEOUS methylnaltrexone bromide 021964 2015-09-08

US Patents and Regulatory Information for methylnaltrexone bromide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Salix Pharms RELISTOR methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 021964-001 Apr 24, 2008 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
Salix Pharms RELISTOR methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 021964-003 Sep 27, 2010 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Salix Pharms RELISTOR methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 021964-001 Apr 24, 2008 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   Start Trial
Salix Pharms RELISTOR methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 021964-003 Sep 27, 2010 RX Yes Yes   Start Trial   Start Trial   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 methylnaltrexone bromide

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

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Dow
Merck
Harvard Business School
Moodys
Baxter

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