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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 26^th, 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

Drug patent expirations by year for RELISTOR

Recent Clinical Trials for RELISTOR

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

Sponsor	Phase
University of Alabama at Birmingham	N/A
Asbjørn Mohr Drewes	Phase 2/Phase 3
Hvidovre University Hospital	Phase 2/Phase 3

See all RELISTOR clinical trials

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.

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Glossary

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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
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-002	Sep 27, 2010	AP	RX	Yes	Yes	8,420,663	⤷ Subscribe				⤷ Subscribe
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-003	Sep 27, 2010	AP	RX	Yes	Yes	8,822,490	⤷ Subscribe	Y			⤷ Subscribe
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-003	Sep 27, 2010	AP	RX	Yes	Yes	8,552,025	⤷ 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

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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
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-003	Sep 27, 2010	10,376,584	⤷ Subscribe
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-003	Sep 27, 2010	8,552,025	⤷ Subscribe
Salix	RELISTOR	methylnaltrexone bromide	TABLET;ORAL	208271-001	Jul 19, 2016	6,559,158	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for RELISTOR

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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
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Patent: 0491
Patent: FORMULACIONES ORALES Y SALES LIPOFILICAS DE METILNALTREXONA
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Australia

Patent: 09298500
Patent: Peripheral opioid receptor antagonists and uses thereof
Estimated Expiration: ⤷ Subscribe

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: ⤷ 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)
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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.
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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)
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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
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)
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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
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)
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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)
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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
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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)
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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)
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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)
Estimated Expiration: ⤷ Subscribe

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.)
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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
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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
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Peru

Patent: 130063
Patent: FORMULACIONES ORALES Y SALES LIPOFILICAS DE METILNALTREXONA
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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
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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
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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
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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)
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.

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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
Mexico	2011003400	ANTAGONISTAS DE RECEPTORES DE OPIACEOS PERIFERICOS Y USO DE LOS MISMOS. (PERIPHERAL OPIOID RECEPTOR ANTAGONISTS AND USES THEREOF.)	⤷ Subscribe
Israel	229507	אנטאגוניסטים לקולטן חיצוני של אופיואיד ושימושיהם (Peripheral opioid receptor antagonists and uses thereof)	⤷ Subscribe
Australia	758416		⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

RELISTOR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for RELISTOR

Introduction

RELISTOR (methylnaltrexone bromide) is a prescription medication specifically designed to treat opioid-induced constipation (OIC) in adults with long-lasting non-cancer pain or those with advanced illness. Here, we delve into the market dynamics and financial trajectory of this crucial drug.

Market Segmentation and Dominance

The global opioid-induced constipation market is segmented based on active ingredients, treatment types, modes of administration, and end-users. RELISTOR, being a mu-opioid receptor antagonist, is expected to hold a significant market share within this segment. Mu-opioid receptor antagonists, including RELISTOR, Naldemedine (Symproic), Naloxegol (Movantik), and Alvimopan (Entereg), are anticipated to dominate the market due to their effectiveness and the ongoing research activities in this area[1].

Product Efficacy and Clinical Significance

RELISTOR works by targeting the constipating effect of opioids on the gut without impacting opioid pain relief in the central nervous system. This mechanism makes it an effective and safe first-line therapy for OIC, as highlighted in studies such as the one published in Future Medicine in June 2020, which praised Naldemedine but also underscores the efficacy of RELISTOR[1][3].

Market Size and Growth Projections

The global opioid-induced constipation drugs market, which includes RELISTOR, was valued at USD 2.69 billion in 2023 and is projected to reach USD 4.52 billion by 2031, with a Compound Annual Growth Rate (CAGR) of 6.7% during the forecast period of 2024 to 2031. This growth is driven by increasing research and development efforts, advanced healthcare infrastructure, and earlier drug approvals[4].

Regional Market Performance

North America is expected to dominate the market due to the presence of major product manufacturers and robust research and development activities. The region's substantial healthcare expenditure on gastrointestinal disorders, including OIC, further supports the demand for effective OIC drugs like RELISTOR. Asia-Pacific is also anticipated to witness significant growth due to advancements in healthcare infrastructure and the accelerated drug approval initiatives by regulatory bodies[4].

Financial Performance of RELISTOR

Lantheus Holdings, the company associated with RELISTOR, has reported significant financial milestones. For the fourth quarter of 2023, Lantheus achieved a $15.0 million RELISTOR milestone, contributing to their overall revenue. The company's worldwide revenue for the fourth quarter of 2023 totaled $354.0 million, with a gross profit of $229.869 million. The RELISTOR royalties alone contributed $13.2 million in revenue for the first six months of 2023[2][5].

Revenue and Profitability

Lantheus Holdings has seen a notable increase in revenue and profitability. For the year 2023, the company's total revenues were $1.296 billion, up from $935.061 million in 2022, representing a 38.6% increase. The operating income for 2023 was $364.642 million, significantly higher than the $36.195 million in 2022. Adjusted net income per share for 2023 was $6.23, up from $4.22 in 2022[2].

Strategic Partnerships and Market Expansion

The financial trajectory of RELISTOR is also influenced by strategic partnerships and market expansion efforts. For instance, RedHill Biopharma Ltd.'s agreements with Cosmo Pharmaceuticals NV to manufacture key products, including Movantik (another mu-opioid receptor antagonist), highlight the collaborative efforts in the OIC market. Such partnerships can enhance production capabilities and market reach, contributing to the overall financial performance of RELISTOR[1].

Regulatory Environment

The accelerated drug approval initiative by the U.S. FDA has been a significant factor in the market growth of OIC drugs, including RELISTOR. Earlier approvals and the availability of advanced healthcare infrastructure have facilitated the launch and adoption of these drugs, thereby impacting their financial performance positively[1][4].

Patient Access and Affordability

RELISTOR's financial success is also tied to patient access and affordability. The drug is available in both tablet and subcutaneous injection forms, making it more accessible to a broader patient population. Additionally, co-pay cards and other financial assistance programs can reduce the cost burden on patients, increasing the drug's adoption rate and contributing to its revenue[3].

Key Takeaways

Market Dominance: RELISTOR is expected to hold a significant market share within the mu-opioid receptor antagonists segment.
Financial Performance: Lantheus Holdings has reported substantial revenue and profitability growth, partly due to RELISTOR milestones.
Regional Growth: North America and Asia-Pacific are key regions driving the market growth of OIC drugs.
Regulatory Support: Accelerated FDA approvals have facilitated the market expansion of RELISTOR.
Patient Access: Availability in multiple forms and financial assistance programs enhance patient access and affordability.

FAQs

What is RELISTOR used for?

RELISTOR (methylnaltrexone bromide) is used to treat opioid-induced constipation (OIC) in adults with long-lasting non-cancer pain or those with advanced illness.

Which companies are associated with RELISTOR?

Lantheus Holdings is the company associated with RELISTOR, although it was originally developed by other entities.

What is the projected market size for OIC drugs by 2031?

The global opioid-induced constipation drugs market is projected to reach USD 4.52 billion by 2031, with a CAGR of 6.7% during the forecast period of 2024 to 2031.

How does RELISTOR work?

RELISTOR works by targeting the constipating effect of opioids on the gut without impacting opioid pain relief in the central nervous system.

What are the key regions driving the market growth of OIC drugs?

North America and Asia-Pacific are the key regions driving the market growth of OIC drugs due to robust research and development activities and advanced healthcare infrastructure.

Sources

Global Opioid Induced Constipation Market Trends - Mordor Intelligence
Lantheus Reports Fourth Quarter and Full Year 2023 Financial Results - Lantheus Holdings
OIC Medication | RELISTOR® (methylnaltrexone bromide) - RELISTOR
Global Opioid Induced Constipation Drugs Market Size & Statistics By 2031 - Data Bridge Market Research
Form 8-K for Lantheus Holdings INC filed 08/03/2023 - Lantheus Holdings

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