relistor Drug Patent 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 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.
Patents protecting relistor
Oral formulations and lipophilic salts of methylnaltrexone
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Patent Expiration: ⤷ Sign Up
Oral formulations and lipophilic salts of methylnaltrexone
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Stable pharmaceutical formulations of methylnaltrexone
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Patented Use: TREATMENT OF OPIOID-INDUCED CONSTIPATION
Peripheral opioid receptor antagonists and uses thereof
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Patented Use: TREATMENT OF OPIOID-INDUCED CONSTIPATION
Peripheral opioid receptor antagonists and uses thereof
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Patented Use: TREATMENT OF OPIOID-INDUCED CONSTIPATION
Oral formulations and lipophilic salts of methylnaltrexone
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Stable methylnaltrexone preparation
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Peripheral opioid receptor antagonists and uses thereof
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF OPIOID-INDUCED CONSTIPATION
Oral formulations and lipophilic salts of methylnal trexone
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Peripheral opioid receptor antagonists and uses thereof
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF OPIOID-INDUCED CONSTIPATION
Oral formulations and lipophilic salts of methylnaltrexone
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Patent Expiration: ⤷ Sign Up
Peripheral opioid receptor antagonists and uses thereof
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Patented Use: TREATMENT OF OPIOID-INDUCED CONSTIPATION
Stable pharmaceutical formulations of methylnaltrexone
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Peripheral opioid receptor antagonists and uses thereof
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Patented Use: TREATMENT OF OPIOID-INDUCED CONSTIPATION
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 | RELISTOR | methylnaltrexone bromide | TABLET;ORAL | 208271-001 | Jul 19, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Salix | RELISTOR | methylnaltrexone bromide | TABLET;ORAL | 208271-001 | Jul 19, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
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 | 021964-002 | Sep 27, 2010 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 | ||
>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 | ⤷ 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 |
>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: ⤷ Sign Up
Patent: 0491
Patent: FORMULACIONES ORALES Y SALES LIPOFILICAS DE METILNALTREXONA
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 09298500
Patent: Peripheral opioid receptor antagonists and uses thereof
Estimated Expiration: ⤷ Sign Up
Patent: 11224275
Patent: Oral formulations and lipophilic salts of methylnaltrexone
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Brazil
Patent: 0919539
Patent: antagonistas de receptor de opioide periférico e empregos dos mesmos
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Patent: 2012022873
Patent: formulações orais e sais lipofílicos de metilnaltrexona
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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: ⤷ Sign Up
Canada
Patent: 76881
Patent: ANTAGONISTES DE RECEPTEURS OPIOIDES PERIPHERIQUES, ET LEURS UTILISATIONS (PERIPHERAL OPIOID RECEPTOR ANTAGONISTS AND USES THEREOF)
Estimated Expiration: ⤷ Sign Up
Patent: 89798
Patent: FORMULATIONS ORALES ET SELS LIPOPHILES DE METHYLNALTREXONE (ORAL FORMULATIONS AND LIPOPHILIC SALTS OF METHYLNALTREXONE)
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
China
Patent: 2307874
Patent: Peripheral opioid receptor antagonists and uses thereof
Estimated Expiration: ⤷ Sign Up
Patent: 2918039
Patent: Oral formulations and lipophilic salts of methylnaltrexone
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Patent: 3833634
Patent: Peripheral opioid receptor antagonists and uses thereof
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Patent: 5399673
Patent: Peripheral Opioid Receptor Antagonists And Uses Thereof
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Patent: 7308125
Patent: 甲基纳曲酮的口服制剂和亲脂盐 (Oral formulations and lipophilic salts of methylnaltrexone)
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Colombia
Patent: 30134
Patent: Formulación orales y sales lipofílicas de metilnaltrexona
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Costa Rica
Patent: 120476
Patent: FORMULACIONES ORALES Y SALES LIPOFÍLICAS DE METILNALTREXONA
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Ecuador
Patent: 12012208
Patent: FORMULACIONES ORALES Y SALES LIPOFÍLICAS DE METILNALTREXONA
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 9096
Patent: ТВЕРДАЯ ЛЕКАРСТВЕННАЯ ФОРМА ДЛЯ ПЕРОРАЛЬНОГО ВВЕДЕНИЯ, СОДЕРЖАЩАЯ МЕТИЛНАЛТРЕКСОН (SOLID DOSAGE FORM FOR ORAL ADMINISTRATION COMPRISING METHYLNALTREXONE)
Estimated Expiration: ⤷ Sign Up
Patent: 1270741
Patent: ПЕРОРАЛЬНЫЕ КОМПОЗИЦИИ И ЛИПОФИЛЬНЫЕ СОЛИ МЕТИЛНАЛТРЕКСОНА
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European Patent Office
Patent: 56119
Patent: ANTAGONISTES DE RÉCEPTEURS OPIOÏDES PÉRIPHÉRIQUES ET LEURS UTILISATIONS (PERIPHERAL OPIOID RECEPTOR ANTAGONISTS AND USES THEREOF)
Estimated Expiration: ⤷ Sign Up
Patent: 71357
Patent: Formulations orales et sels lipophiles de la méthylnaltrexone (Oral formulations and lipophilic salts of methylnaltrexone)
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Patent: 86997
Patent: Antagonistes de récepteur opioïde périphérique et leurs utilisations (Peripheral opioid receptor antagonists and uses thereof)
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Patent: 78472
Patent: FORMULATIONS ORALES DE LA MÉTHYLNALTREXONE (ORAL FORMULATIONS OF METHYLNALTREXONE)
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Patent: 08322
Patent: SERINGUE CONTENANT DU BROMURE DE NMTX (SYRINGE CONTAINING NMTX BROMIDE)
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Patent: 71151
Patent: SERINGUE CONTENANT DU BROMURE DE NMTX (SYRINGE CONTAINING NMTX BROMIDE)
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Georgia, Republic of
Patent: 01606550
Patent: ORAL FORMULATIONS AND LIPOPHILIC SALTS OF METHYLNALTREXONE
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Guatemala
Patent: 1200247
Patent: FORMULACIONES ORALES Y SALES LIPOFÍLICAS DE METILNALTREXONA
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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: ⤷ Sign Up
Patent: 45673
Patent: 甲基納曲酮的口服製劑和親脂鹽 (ORAL FORMULATIONS AND LIPOPHILIC SALTS OF METHYLNALTREXONE)
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Hungary
Patent: 33133
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 1865
Patent: אנטאגוניסטים לקולטן חיצוני של אופיואיד ושימושיהם (Peripheral opioid receptor antagonists and uses thereof)
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Patent: 1452
Patent: הרכבים למתן דרך הפה ומלחים ליפופילים של מתילנלטרקסון (Oral formulations and lipophilic salts of methylnaltrexone)
Estimated Expiration: ⤷ Sign Up
Patent: 9507
Patent: אנטאגוניסטים לקולטן חיצוני של אופיואיד ושימושיהם (Peripheral opioid receptor antagonists and uses thereof)
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Japan
Patent: 19773
Estimated Expiration: ⤷ Sign Up
Patent: 43409
Estimated Expiration: ⤷ Sign Up
Patent: 29955
Estimated Expiration: ⤷ Sign Up
Patent: 47368
Estimated Expiration: ⤷ Sign Up
Patent: 47713
Estimated Expiration: ⤷ Sign Up
Patent: 11190259
Patent: ORAL FORMULATION AND LIPOPHILIC SALT OF METHYLNALTREXONE
Estimated Expiration: ⤷ Sign Up
Patent: 12504635
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
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)
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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: ⤷ Sign Up
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: ⤷ Sign Up
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)
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Malaysia
Patent: 0727
Patent: ORAL FORMULATIONS AND LIPOPHILIC SALTS OF METHYLNALTREXONE
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 9145
Patent: FORMULACIONES ORALES Y SALES LIPOFILICAS DE METILNALTREXONA. (ORAL FORMULATIONS AND LIPOPHILIC SALTS OF METHYLNALTREXONE.)
Estimated Expiration: ⤷ Sign Up
Patent: 8805
Patent: FORMULACIONES ORALES Y SALES LIPOFÍLICAS EN METILNALTREXONA. (ORAL FORMULATIONS AND LIPOPHILIC SALTS OF METHYLNALTREXONE.)
Estimated Expiration: ⤷ Sign Up
Patent: 11003400
Patent: ANTAGONISTAS DE RECEPTORES DE OPIACEOS PERIFERICOS Y USO DE LOS MISMOS. (PERIPHERAL OPIOID RECEPTOR ANTAGONISTS AND USES THEREOF.)
Estimated Expiration: ⤷ Sign Up
Patent: 12009125
Patent: FORMULACIONES ORALES Y SALES LIPOFILICAS DE METILNALTREXONA. (ORAL FORMULATIONS AND LIPOPHILIC SALTS OF METHYLNALTREXONE.)
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Patent: 18015087
Patent: ANTAGONISTAS DE RECEPTORES DE OPIACEOS PERIFERICOS Y USOS DE LOS MISMOS. (PERIPHERAL OPIOID RECEPTOR ANTAGONISTS AND USES THEREOF.)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 146
Patent: FORMULATIONS ORALLES ET SELS LIPOPHILES DE METHYLNALTREXONE
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 1859
Patent: PERIPHERAL OPIOID RECEPTOR ANTAGONISTS AND USES THEREOF
Estimated Expiration: ⤷ Sign Up
Patent: 1595
Patent: Oral formulations and lipophilic salts of methylnaltrexone
Estimated Expiration: ⤷ Sign Up
Patent: 2667
Patent: Peripheral opioid receptor antagonists and uses thereof
Estimated Expiration: ⤷ Sign Up
Patent: 9972
Patent: Peripheral opioid receptor antagonists and uses thereof
Estimated Expiration: ⤷ Sign Up
Patent: 2826
Patent: Oral formulations and lipophilic salts of methylnaltrexone
Estimated Expiration: ⤷ Sign Up
Patent: 3564
Patent: Oral formulations and lipophilic salts of methylnaltrexone
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Patent: 0085
Patent: Peripheral opioid receptor antagonists and uses thereof
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Peru
Patent: 130063
Patent: FORMULACIONES ORALES Y SALES LIPOFILICAS DE METILNALTREXONA
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 71357
Estimated Expiration: ⤷ Sign Up
Patent: 78472
Estimated Expiration: ⤷ Sign Up
Patent: 08322
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 08322
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 11117335
Patent: АНГОНИСТЫ ПЕРИФЕРИЧЕСКИХ РЕЦЕПТОРОВ ОПИОИДОВ И ИХ ПРИМЕНЕНИЯ
Estimated Expiration: ⤷ Sign Up
Patent: 13157119
Patent: АНТАГОНИСТЫ ПЕРИФЕРИЧЕСКИХ РЕЦЕПТОРОВ ОПИОИДОВ И ИХ ПРИМЕНЕНИЯ
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 3133
Patent: ORAL FORMULATIONS AND LIPOPHILIC SALTS OF METHYLNALTREXONE
Estimated Expiration: ⤷ Sign Up
Patent: 4393
Patent: PERIPHERAL OPIOID RECEPTOR ANTAGONISTS AND USES THEREOF
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Patent: 201501821R
Patent: ORAL FORMULATIONS AND LIPOPHILIC SALTS OF METHYLNALTREXONE
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Patent: 201606618P
Patent: ORAL FORMULATIONS AND LIPOPHILIC SALTS OF METHYLNALTREXONE
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1808498
Patent: ORAL FORMULATIONS AND LIPOPHILIC SALTS OF METHYLNALTREXONE
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1566675
Estimated Expiration: ⤷ Sign Up
Patent: 1913102
Estimated Expiration: ⤷ Sign Up
Patent: 1982482
Estimated Expiration: ⤷ Sign Up
Patent: 110060967
Patent: PERIPHERAL OPIOID RECEPTOR ANTAGONISTS AND USES THEREOF
Estimated Expiration: ⤷ Sign Up
Patent: 130010900
Patent: ORAL FORMULATIONS AND LIPOPHILIC SALTS OF METHYLNALTREXONE
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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)
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Spain
Patent: 23926
Estimated Expiration: ⤷ Sign Up
Patent: 14884
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 89293
Estimated Expiration: ⤷ Sign Up
Patent: 05814
Estimated Expiration: ⤷ Sign Up
Patent: 1141479
Patent: Oral formulations and lipophilic salts of methylnaltrexone
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Patent: 1622724
Patent: Oral formulations and lipophilic salts of METHYLNALTREXONE
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Tunisia
Patent: 12000392
Patent: ORAL FORMULATIONS AND LIPOPHILIC SALTS OF METHYLNALTREXONE
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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
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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 |
---|---|---|---|
South Korea | 101982482 | ⤷ Sign Up | |
Poland | 2368553 | ⤷ Sign Up | |
South Korea | 101566675 | ⤷ Sign Up | |
Israel | 229507 | אנטאגוניסטים לקולטן חיצוני של אופיואיד ושימושיהם (Peripheral opioid receptor antagonists and uses thereof) | ⤷ Sign Up |
Peru | 20130063 | FORMULACIONES ORALES Y SALES LIPOFILICAS DE METILNALTREXONA | ⤷ Sign Up |
Denmark | 1615646 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |