MOVANTIK Drug Patent Profile

Which patents cover Movantik, and when can generic versions of Movantik launch?

Movantik is a drug marketed by Valinor and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-nine patent family members in forty-four countries.

The generic ingredient in MOVANTIK is naloxegol oxalate. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the naloxegol oxalate profile page.

DrugPatentWatch^® Generic Entry Outlook for Movantik

Movantik was eligible for patent challenges on September 16, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 2, 2032. This may change due to patent challenges or generic licensing.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for MOVANTIK

International Patents:	89
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	14
Patent Applications:	77
Drug Prices:	Drug price information for MOVANTIK
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MOVANTIK
What excipients (inactive ingredients) are in MOVANTIK?	MOVANTIK excipients list
DailyMed Link:	MOVANTIK at DailyMed

See drug prices for MOVANTIK

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for MOVANTIK

NDA:

204760

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 MOVANTIK

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

Sponsor	Phase
University of Missouri-Columbia	Phase 4
Camille Ladanyi MD	N/A
University of Tennessee, Chattanooga	N/A

See all MOVANTIK clinical trials

Pharmacology for MOVANTIK

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

Paragraph IV (Patent) Challenges for MOVANTIK

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MOVANTIK	Tablets	naloxegol oxalate	12.5 mg and 25 mg	204760	2	2018-09-17

US Patents and Regulatory Information for MOVANTIK

MOVANTIK is protected by two US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014		RX	Yes	No			Y	Y
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014		RX	Yes	Yes			Y	Y
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014		RX	Yes	No			Y	Y
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014		RX	Yes	Yes			Y	Y

Expired US Patents for MOVANTIK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014

International Patents for MOVANTIK

When does loss-of-exclusivity occur for MOVANTIK?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cuba

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Guatemala

Hong Kong

Hungary

Japan

Malaysia

Mexico

Montenegro

New Zealand

Nicaragua

Peru

Poland

Portugal

San Marino

Saudi Arabia

Serbia

Singapore

Slovenia

South Korea

Spain

Taiwan

Ukraine

Uruguay

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 MOVANTIK around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2010202277	Chemically modified small molecules
China	101805343	Chemically modified small molecules
Eurasian Patent Organization	018427	ХИМИЧЕСКИ МОДИФИЦИРОВАННЫЙ НАЛОКСОН (CHEMICALLY MODIFIED NALOXONE)
Chile	2013000866	Sales cristalinas oxalato y fosfato del conjugado naloxolpolietilenglicol; metodo de preparacion; composicion farmaceutica que lo comprende; y su uso para el tratamiento del dolor.

Supplementary Protection Certificates for MOVANTIK

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1694363	2015/024	Ireland		PRODUCT NAME: NALOXEGOL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE OXALATE SALT OF THE ALPHA-EPIMER OF NALOXEGOL; REGISTRATION NO/DATE: EU/1/14/962 20141208
1694363	PA2015019,C1694363	Lithuania		PRODUCT NAME: NALOKSEGOLAS, KONKRECIAI NALOKSEGOLO OKSALATO DRUSKA; REGISTRATION NO/DATE: EU/1/14/962 20141208
1694363	27/2015	Austria		PRODUCT NAME: NALOXEGOL, GEGEBENENFALLS IN FORM EINES THERAPEUTISCH VERTRAEGLICHEN SALZES, INSBESONDERE ALS OXALAT; REGISTRATION NO/DATE: EU/1/14/962 20141208
1694363	C 2015 022	Romania		PRODUCT NAME: NALOXEGOL SI SARURILE SALE ACCEPTABILE FARMACEUTIC, IN SPECIAL SAREA OXALAT A NALOXEGOLULUI; NATIONAL AUTHORISATION NUMBER: EU/1/14/962; DATE OF NATIONAL AUTHORISATION: 20141208; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/962; DATE OF FIRST AUTHORISATION IN EEA: 20141208

Market Dynamics and Financial Trajectory for Movantik

Introduction to Movantik

Movantik, also known as Moventig outside of the U.S., is a peripherally acting mu-opioid receptor antagonist (PAMORA) indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. Developed using Nektar Therapeutics' oral small-molecule polymer conjugate technology, Movantik has undergone significant changes in its ownership and market dynamics over the years.

Initial Ownership and Commercialization

AstraZeneca initially acquired the global rights to Movantik from Nektar Therapeutics in 2009. In the U.S., AstraZeneca entered into a co-commercialization agreement with Daiichi Sankyo, Inc. for Movantik in 2015. By 2019, Movantik generated $96 million in sales in the U.S.[1].

Divestment to RedHill Biopharma

In February 2020, AstraZeneca divested its global rights to Movantik, excluding Europe, Canada, and Israel, to RedHill Biopharma. This move was part of AstraZeneca's strategy to focus on its main therapy areas and realize value from mature or non-core products. RedHill Biopharma made an upfront payment of $52.5 million and a further non-contingent payment of $15 million in 2021[1].

Market Performance Under RedHill Biopharma

Under RedHill Biopharma, Movantik continued to show strong market performance. In Q2/2022, Movantik delivered a 4% growth in new prescriptions, representing the highest quarterly prescribing volume since RedHill acquired the product rights. Movantik held a firm grip on its PAMORA class leadership position, with over 70% market share and positive growth trends in the PAMORA class[3].

Financial Impact

RedHill Biopharma's financial results were significantly influenced by Movantik. For the six months ended June 30, 2022, Movantik contributed to net revenues of $31.5 million. However, following the divestiture of Movantik in February 2023, RedHill Biopharma's net revenues and cost of revenues for the product were discontinued. This divestiture resulted in a significant decrease in net revenues but also led to other income recognition, including $35.5 million from the divestiture and $7.5 million from transitional services fees[2][5].

Divestment from RedHill Biopharma to Grünenthal

In February 2023, RedHill Biopharma divested Movantik, and by July 2024, Grünenthal acquired the U.S.-based Valinor Pharma, becoming the global owner of Movantik. This acquisition was part of Grünenthal's strategy to expand its portfolio of established medicines and strengthen its footprint in the U.S. market. The deal value was approximately $250 million, inclusive of all royalty obligations[4].

Market and Financial Impact Under Grünenthal

Grünenthal's acquisition of Movantik marked a significant milestone in the drug's market dynamics. With gross sales from Movantik reaching over $200 million in the U.S. in 2023, the product aligns perfectly with Grünenthal's focus on pain management. Grünenthal's existing customer base and complementary product portfolio are expected to further enhance Movantik's market presence[4].

Financial Trajectory

The financial trajectory of Movantik has been marked by several key transactions:

• AstraZeneca: Generated $96 million in U.S. sales in 2019 before the divestment to RedHill Biopharma[1].
• RedHill Biopharma: Contributed significantly to RedHill's revenues until its divestiture in February 2023. The divestiture led to a one-time gain but reduced ongoing revenues[2][5].
• Grünenthal: With the acquisition, Grünenthal expects to leverage Movantik's strong market position to enhance its revenue and profitability. The acquisition is part of Grünenthal's broader strategy of investing over €2 billion in M&A transactions since 2017 to strengthen its portfolio and profitability[4].

Market Leadership and Growth Trends

Movantik has consistently held a leadership position in the PAMORA class. Under RedHill Biopharma, it maintained over 70% market share and benefited from positive growth trends in the PAMORA class, which grew by 7% in the three months ending August 2022 compared to the same period in the previous year[3].

Clinical and Commercial Highlights

• Clinical Efficacy: Movantik has demonstrated healthcare-related quality of life (HR-QOL) and clinically meaningful symptom improvements in patients with OIC, as shown in analyses from pooled data from two Phase 3 studies presented at PAINWeek in September 2022[3].
• Commercial Coverage: Movantik retains best-in-class coverage with Preferred Status in two of the three largest Commercial PBMs and 92% Preferred Status within Medicare Part D[3].

Key Takeaways

• Ownership Changes: Movantik has transitioned from AstraZeneca to RedHill Biopharma and finally to Grünenthal, each change reflecting strategic shifts in the companies' focus areas.
• Market Performance: Movantik has consistently shown strong market performance, leading the PAMORA class with over 70% market share.
• Financial Impact: The divestitures and acquisitions have resulted in significant financial transactions, including upfront payments, non-contingent payments, and one-time gains.
• Growth Trends: The PAMORA class has seen positive growth trends, benefiting Movantik's market position.
• Clinical Efficacy: Movantik has demonstrated clinical efficacy in improving HR-QOL and symptom management for patients with OIC.

FAQs

What is Movantik used for?

Movantik is used for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.

Who are the current owners of Movantik?

As of July 2024, Grünenthal is the global owner of Movantik, having acquired it through the purchase of Valinor Pharma.

How has the market performance of Movantik been?

Movantik has consistently shown strong market performance, holding over 70% market share in the PAMORA class and benefiting from positive growth trends.

What were the financial implications of the divestitures?

The divestitures resulted in significant financial transactions, including upfront payments, non-contingent payments, and one-time gains, which impacted the financial statements of the involved companies.

What is the current market position of Movantik under Grünenthal?

Under Grünenthal, Movantik is expected to further enhance its market presence, leveraging Grünenthal's existing customer base and complementary product portfolio in pain management.

Sources

1. AstraZeneca Press Release: "AstraZeneca divests global rights to Movantik" - February 25, 2020.
2. RedHill Biopharma Press Release: "RedHill Biopharma Provides H1/23 Financial Results and Operational Highlights" - August 17, 2023.
3. RedHill Biopharma Press Release: "RedHill Biopharma Provides H1/22 Highlights and Q3/22 Estimates" - November 7, 2022.
4. Grünenthal Press Release: "Grünenthal acquires US-company Valinor Pharma and becomes global owner of Movantik" - July 22, 2024.
5. RedHill Biopharma Press Release: "RedHill Biopharma Announces Q1/2023 Financial Results and Operational Highlights" - June 12, 2023.

Last updated: 2024-12-16