RELISTOR Drug Patent Profile
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Which patents cover Relistor, and what generic alternatives are available?
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® Litigation and Generic Entry Outlook for Relistor
A generic version of RELISTOR was approved as methylnaltrexone bromide by ACTAVIS LLC on August 26th, 2024.
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Summary for RELISTOR
International Patents: | 137 |
US Patents: | 14 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 35 |
Clinical Trials: | 18 |
Patent Applications: | 130 |
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 |
Recent Clinical Trials for RELISTOR
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Alabama at Birmingham | N/A |
Odense University Hospital | Phase 2/Phase 3 |
Asbjørn Mohr Drewes | Phase 2/Phase 3 |
Pharmacology for RELISTOR
Drug Class | Opioid Antagonist |
Mechanism of Action | Opioid Antagonists |
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, 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 RELISTOR
RELISTOR is protected by fourteen US patents.
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 | 8,524,276 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Salix | RELISTOR | methylnaltrexone bromide | TABLET;ORAL | 208271-001 | Jul 19, 2016 | RX | Yes | Yes | 8,420,663 | ⤷ Subscribe | ⤷ Subscribe | ||||
Salix | RELISTOR | methylnaltrexone bromide | TABLET;ORAL | 208271-001 | Jul 19, 2016 | RX | Yes | Yes | 10,307,417 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Salix | RELISTOR | methylnaltrexone bromide | TABLET;ORAL | 208271-001 | Jul 19, 2016 | RX | Yes | Yes | 8,956,651 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
>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 | 10,376,584 | ⤷ Subscribe |
Salix Pharms | RELISTOR | methylnaltrexone bromide | SOLUTION;SUBCUTANEOUS | 021964-003 | Sep 27, 2010 | 9,669,096 | ⤷ Subscribe |
Salix Pharms | RELISTOR | methylnaltrexone bromide | SOLUTION;SUBCUTANEOUS | 021964-001 | Apr 24, 2008 | 6,559,158 | ⤷ Subscribe |
Salix Pharms | RELISTOR | methylnaltrexone bromide | SOLUTION;SUBCUTANEOUS | 021964-002 | Sep 27, 2010 | 10,376,584 | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
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
Patent: 3520
Patent: ANTAGONISTAS DE RECEPTORES OPIOIDES PERIFERICOS Y USOS DE LOS MISMOS
Estimated Expiration: ⤷ Subscribe
Patent: 0491
Patent: FORMULACIONES ORALES Y SALES LIPOFILICAS DE METILNALTREXONA
Estimated Expiration: ⤷ Subscribe
Australia
Patent: 09298500
Patent: Peripheral opioid receptor antagonists and uses thereof
Estimated Expiration: ⤷ Subscribe
Patent: 11224275
Patent: Oral formulations and lipophilic salts of methylnaltrexone
Estimated Expiration: ⤷ Subscribe
Brazil
Patent: 0919539
Patent: antagonistas de receptor de opioide periférico e empregos dos mesmos
Estimated Expiration: ⤷ Subscribe
Patent: 2012022873
Patent: formulações orais e sais lipofílicos de metilnaltrexona
Estimated Expiration: ⤷ Subscribe
Patent: 2020013665
Patent: seringas pré-carregadas compreendendo composição líquida de metilnaltrexona com baixo teor de tungstênio e os usos da dita composição na preparação de seringas pré-carregadas, medicamentos e kits para o tratamento de constipação induzida por opioides
Estimated Expiration: ⤷ Subscribe
Canada
Patent: 76881
Patent: ANTAGONISTES DE RECEPTEURS OPIOIDES PERIPHERIQUES, ET LEURS UTILISATIONS (PERIPHERAL OPIOID RECEPTOR ANTAGONISTS AND USES THEREOF)
Estimated Expiration: ⤷ Subscribe
Patent: 89798
Patent: FORMULATIONS ORALES ET SELS LIPOPHILES DE METHYLNALTREXONE (ORAL FORMULATIONS AND LIPOPHILIC SALTS OF METHYLNALTREXONE)
Estimated Expiration: ⤷ Subscribe
Chile
Patent: 12002192
Patent: Sal de metilnaltrexona cuyo anión es un excipiente anfifílico; composición farmacéutica para administración oral que comprende esta sal y un excipiente anfifílico; método de preparación de la composición farmaceutica; método para reducir efectos secundarios de la terapia opioide; producto; y paquete multidía.
Estimated Expiration: ⤷ Subscribe
China
Patent: 2307874
Patent: Peripheral opioid receptor antagonists and uses thereof
Estimated Expiration: ⤷ Subscribe
Patent: 2918039
Patent: Oral formulations and lipophilic salts of methylnaltrexone
Estimated Expiration: ⤷ Subscribe
Patent: 3833634
Patent: Peripheral opioid receptor antagonists and uses thereof
Estimated Expiration: ⤷ Subscribe
Patent: 5399673
Patent: Peripheral Opioid Receptor Antagonists And Uses Thereof
Estimated Expiration: ⤷ Subscribe
Patent: 7308125
Patent: 甲基纳曲酮的口服制剂和亲脂盐 (Oral formulations and lipophilic salts of methylnaltrexone)
Estimated Expiration: ⤷ Subscribe
Colombia
Patent: 30134
Patent: Formulación orales y sales lipofílicas de metilnaltrexona
Estimated Expiration: ⤷ Subscribe
Costa Rica
Patent: 120476
Patent: FORMULACIONES ORALES Y SALES LIPOFÍLICAS DE METILNALTREXONA
Estimated Expiration: ⤷ Subscribe
Ecuador
Patent: 12012208
Patent: FORMULACIONES ORALES Y SALES LIPOFÍLICAS DE METILNALTREXONA
Estimated Expiration: ⤷ Subscribe
Eurasian Patent Organization
Patent: 9096
Patent: ТВЕРДАЯ ЛЕКАРСТВЕННАЯ ФОРМА ДЛЯ ПЕРОРАЛЬНОГО ВВЕДЕНИЯ, СОДЕРЖАЩАЯ МЕТИЛНАЛТРЕКСОН (SOLID DOSAGE FORM FOR ORAL ADMINISTRATION COMPRISING METHYLNALTREXONE)
Estimated Expiration: ⤷ Subscribe
Patent: 1270741
Patent: ПЕРОРАЛЬНЫЕ КОМПОЗИЦИИ И ЛИПОФИЛЬНЫЕ СОЛИ МЕТИЛНАЛТРЕКСОНА
Estimated Expiration: ⤷ Subscribe
European Patent Office
Patent: 56119
Patent: ANTAGONISTES DE RÉCEPTEURS OPIOÏDES PÉRIPHÉRIQUES ET LEURS UTILISATIONS (PERIPHERAL OPIOID RECEPTOR ANTAGONISTS AND USES THEREOF)
Estimated Expiration: ⤷ Subscribe
Patent: 71357
Patent: Formulations orales et sels lipophiles de la méthylnaltrexone (Oral formulations and lipophilic salts of methylnaltrexone)
Estimated Expiration: ⤷ Subscribe
Patent: 86997
Patent: Antagonistes de récepteur opioïde périphérique et leurs utilisations (Peripheral opioid receptor antagonists and uses thereof)
Estimated Expiration: ⤷ Subscribe
Patent: 78472
Patent: FORMULATIONS ORALES DE LA MÉTHYLNALTREXONE (ORAL FORMULATIONS OF METHYLNALTREXONE)
Estimated Expiration: ⤷ Subscribe
Patent: 08322
Patent: SERINGUE CONTENANT DU BROMURE DE NMTX (SYRINGE CONTAINING NMTX BROMIDE)
Estimated Expiration: ⤷ Subscribe
Patent: 71151
Patent: SERINGUE CONTENANT DU BROMURE DE NMTX (SYRINGE CONTAINING NMTX BROMIDE)
Estimated Expiration: ⤷ Subscribe
Georgia, Republic of
Patent: 01606550
Patent: ORAL FORMULATIONS AND LIPOPHILIC SALTS OF METHYLNALTREXONE
Estimated Expiration: ⤷ Subscribe
Guatemala
Patent: 1200247
Patent: FORMULACIONES ORALES Y SALES LIPOFÍLICAS DE METILNALTREXONA
Estimated Expiration: ⤷ Subscribe
Hong Kong
Patent: 99442
Patent: 周邊的鴉片受體拮抗藥及其用途 (PERIPHERAL OPIOID RECEPTOR ANTAGONISTS AND USES THEREOF)
Estimated Expiration: ⤷ Subscribe
Patent: 45673
Patent: 甲基納曲酮的口服製劑和親脂鹽 (ORAL FORMULATIONS AND LIPOPHILIC SALTS OF METHYLNALTREXONE)
Estimated Expiration: ⤷ Subscribe
Hungary
Patent: 33133
Estimated Expiration: ⤷ Subscribe
Israel
Patent: 1865
Patent: אנטאגוניסטים לקולטן חיצוני של אופיואיד ושימושיהם (Peripheral opioid receptor antagonists and uses thereof)
Estimated Expiration: ⤷ Subscribe
Patent: 1452
Patent: הרכבים למתן דרך הפה ומלחים ליפופילים של מתילנלטרקסון (Oral formulations and lipophilic salts of methylnaltrexone)
Estimated Expiration: ⤷ Subscribe
Patent: 9507
Patent: אנטאגוניסטים לקולטן חיצוני של אופיואיד ושימושיהם (Peripheral opioid receptor antagonists and uses thereof)
Estimated Expiration: ⤷ Subscribe
Japan
Patent: 19773
Estimated Expiration: ⤷ Subscribe
Patent: 43409
Estimated Expiration: ⤷ Subscribe
Patent: 29955
Estimated Expiration: ⤷ Subscribe
Patent: 47368
Estimated Expiration: ⤷ Subscribe
Patent: 47713
Estimated Expiration: ⤷ Subscribe
Patent: 11190259
Patent: ORAL FORMULATION AND LIPOPHILIC SALT OF METHYLNALTREXONE
Estimated Expiration: ⤷ Subscribe
Patent: 12504635
Estimated Expiration: ⤷ Subscribe
Patent: 15129144
Patent: 末梢オピオイド受容体アンタゴニストおよびその使用 (PERIPHERAL OPIOID RECEPTOR ANTAGONISTS AND USES THEREOF)
Estimated Expiration: ⤷ Subscribe
Patent: 16029054
Patent: メチルナルトレキソンの経口製剤および親油性塩 (ORAL FORMULATIONS AND LIPOPHILIC SALTS OF METHYLNALTREXONE)
Estimated Expiration: ⤷ Subscribe
Patent: 17101053
Patent: 末梢オピオイド受容体アンタゴニストおよびその使用 (PERIPHERAL OPIOID RECEPTOR ANTAGONISTS AND USES THEREOF)
Estimated Expiration: ⤷ Subscribe
Patent: 17206553
Patent: メチルナルトレキソンの経口製剤および親油性塩 (ORAL FORMULATIONS AND LIPOPHILIC SALTS OF METHYLNALTREXONE)
Estimated Expiration: ⤷ Subscribe
Patent: 19031536
Patent: 末梢オピオイド受容体アンタゴニストおよびその使用 (PERIPHERAL OPIOID RECEPTOR ANTAGONISTS AND USES THEREOF)
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Patent: 19034958
Patent: メチルナルトレキソンの経口製剤および親油性塩 (ORAL FORMULATIONS AND LIPOPHILIC SALTS OF METHYLNALTREXONE)
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Patent: 20196733
Patent: 末梢オピオイド受容体アンタゴニストおよびその使用 (PERIPHERAL OPIOID RECEPTOR ANTAGONISTS AND USES THEREOF)
Estimated Expiration: ⤷ Subscribe
Malaysia
Patent: 0727
Patent: ORAL FORMULATIONS AND LIPOPHILIC SALTS OF METHYLNALTREXONE
Estimated Expiration: ⤷ Subscribe
Mexico
Patent: 9145
Patent: FORMULACIONES ORALES Y SALES LIPOFILICAS DE METILNALTREXONA. (ORAL FORMULATIONS AND LIPOPHILIC SALTS OF METHYLNALTREXONE.)
Estimated Expiration: ⤷ Subscribe
Patent: 8805
Patent: FORMULACIONES ORALES Y SALES LIPOFÍLICAS EN METILNALTREXONA. (ORAL FORMULATIONS AND LIPOPHILIC SALTS OF METHYLNALTREXONE.)
Estimated Expiration: ⤷ Subscribe
Patent: 11003400
Patent: ANTAGONISTAS DE RECEPTORES DE OPIACEOS PERIFERICOS Y USO DE LOS MISMOS. (PERIPHERAL OPIOID RECEPTOR ANTAGONISTS AND USES THEREOF.)
Estimated Expiration: ⤷ Subscribe
Patent: 12009125
Patent: FORMULACIONES ORALES Y SALES LIPOFILICAS DE METILNALTREXONA. (ORAL FORMULATIONS AND LIPOPHILIC SALTS OF METHYLNALTREXONE.)
Estimated Expiration: ⤷ Subscribe
Patent: 18015087
Patent: ANTAGONISTAS DE RECEPTORES DE OPIACEOS PERIFERICOS Y USOS DE LOS MISMOS. (PERIPHERAL OPIOID RECEPTOR ANTAGONISTS AND USES THEREOF.)
Estimated Expiration: ⤷ Subscribe
Morocco
Patent: 146
Patent: FORMULATIONS ORALLES ET SELS LIPOPHILES DE METHYLNALTREXONE
Estimated Expiration: ⤷ Subscribe
New Zealand
Patent: 1859
Patent: PERIPHERAL OPIOID RECEPTOR ANTAGONISTS AND USES THEREOF
Estimated Expiration: ⤷ Subscribe
Patent: 1595
Patent: Oral formulations and lipophilic salts of methylnaltrexone
Estimated Expiration: ⤷ Subscribe
Patent: 2667
Patent: Peripheral opioid receptor antagonists and uses thereof
Estimated Expiration: ⤷ Subscribe
Patent: 9972
Patent: Peripheral opioid receptor antagonists and uses thereof
Estimated Expiration: ⤷ Subscribe
Patent: 2826
Patent: Oral formulations and lipophilic salts of methylnaltrexone
Estimated Expiration: ⤷ Subscribe
Patent: 3564
Patent: Oral formulations and lipophilic salts of methylnaltrexone
Estimated Expiration: ⤷ Subscribe
Patent: 0085
Patent: Peripheral opioid receptor antagonists and uses thereof
Estimated Expiration: ⤷ Subscribe
Peru
Patent: 130063
Patent: FORMULACIONES ORALES Y SALES LIPOFILICAS DE METILNALTREXONA
Estimated Expiration: ⤷ Subscribe
Poland
Patent: 71357
Estimated Expiration: ⤷ Subscribe
Patent: 78472
Estimated Expiration: ⤷ Subscribe
Patent: 08322
Estimated Expiration: ⤷ Subscribe
Portugal
Patent: 08322
Estimated Expiration: ⤷ Subscribe
Russian Federation
Patent: 11117335
Patent: АНГОНИСТЫ ПЕРИФЕРИЧЕСКИХ РЕЦЕПТОРОВ ОПИОИДОВ И ИХ ПРИМЕНЕНИЯ
Estimated Expiration: ⤷ Subscribe
Patent: 13157119
Patent: АНТАГОНИСТЫ ПЕРИФЕРИЧЕСКИХ РЕЦЕПТОРОВ ОПИОИДОВ И ИХ ПРИМЕНЕНИЯ
Estimated Expiration: ⤷ Subscribe
Singapore
Patent: 3133
Patent: ORAL FORMULATIONS AND LIPOPHILIC SALTS OF METHYLNALTREXONE
Estimated Expiration: ⤷ Subscribe
Patent: 4393
Patent: PERIPHERAL OPIOID RECEPTOR ANTAGONISTS AND USES THEREOF
Estimated Expiration: ⤷ Subscribe
Patent: 201501821R
Patent: ORAL FORMULATIONS AND LIPOPHILIC SALTS OF METHYLNALTREXONE
Estimated Expiration: ⤷ Subscribe
Patent: 201606618P
Patent: ORAL FORMULATIONS AND LIPOPHILIC SALTS OF METHYLNALTREXONE
Estimated Expiration: ⤷ Subscribe
South Africa
Patent: 1808498
Patent: ORAL FORMULATIONS AND LIPOPHILIC SALTS OF METHYLNALTREXONE
Estimated Expiration: ⤷ Subscribe
South Korea
Patent: 1566675
Estimated Expiration: ⤷ Subscribe
Patent: 1913102
Estimated Expiration: ⤷ Subscribe
Patent: 1982482
Estimated Expiration: ⤷ Subscribe
Patent: 110060967
Patent: PERIPHERAL OPIOID RECEPTOR ANTAGONISTS AND USES THEREOF
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Patent: 130010900
Patent: ORAL FORMULATIONS AND LIPOPHILIC SALTS OF METHYLNALTREXONE
Estimated Expiration: ⤷ Subscribe
Patent: 140091071
Patent: PERIPHERAL OPIOID RECEPTOR ANTAGONISTS AND USES THEREOF
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Patent: 180118260
Patent: 메틸날트렉손의 경구 제형 및 친유성 염 (ORAL FORMULATIONS AND LIPOPHILIC SALTS OF METHYLNALTREXONE)
Estimated Expiration: ⤷ Subscribe
Spain
Patent: 23926
Estimated Expiration: ⤷ Subscribe
Patent: 14884
Estimated Expiration: ⤷ Subscribe
Taiwan
Patent: 89293
Estimated Expiration: ⤷ Subscribe
Patent: 05814
Estimated Expiration: ⤷ Subscribe
Patent: 1141479
Patent: Oral formulations and lipophilic salts of methylnaltrexone
Estimated Expiration: ⤷ Subscribe
Patent: 1622724
Patent: Oral formulations and lipophilic salts of METHYLNALTREXONE
Estimated Expiration: ⤷ Subscribe
Tunisia
Patent: 12000392
Patent: ORAL FORMULATIONS AND LIPOPHILIC SALTS OF METHYLNALTREXONE
Estimated Expiration: ⤷ Subscribe
Ukraine
Patent: 1717
Patent: СКЛАД ДЛЯ ПЕРОРАЛЬНОГО ВВЕДЕННЯ І ЛІПОФІЛЬНІ СОЛІ МЕТИЛНАЛТРЕКСОНУ
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Patent: 3856
Patent: ФАРМАЦЕВТИЧНІ КОМПОЗИЦІЇ МЕТИЛНАЛТРЕКСОНУ ТА НАТРІЮ ДОДЕЦИЛСУЛЬФАТУ ДЛЯ ПЕРОРАЛЬНОГО ВВЕДЕННЯ
Estimated Expiration: ⤷ Subscribe
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 |
---|---|---|---|
Ukraine | 111717 | СКЛАД ДЛЯ ПЕРОРАЛЬНОГО ВВЕДЕННЯ І ЛІПОФІЛЬНІ СОЛІ МЕТИЛНАЛТРЕКСОНУ | ⤷ Subscribe |
Guatemala | 201200247 | FORMULACIONES ORALES Y SALES LIPOFÍLICAS DE METILNALTREXONA | ⤷ Subscribe |
Hungary | E033133 | ⤷ Subscribe | |
Finland | 1615646 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
RELISTOR Market Analysis and Financial Projection Experimental
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