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ORGOVYX Drug Patent Profile

When do Orgovyx patents expire, and when can generic versions of Orgovyx launch?

Orgovyx is a drug marketed by Sumitomo Pharma and is included in one NDA. There are nine patents protecting this drug.

This drug has one hundred and sixty-two patent family members in thirty-six countries.

The generic ingredient in ORGOVYX is relugolix. One supplier is listed for this compound. Additional details are available on the relugolix profile page.

DrugPatentWatch^® Generic Entry Outlook for Orgovyx

Orgovyx was eligible for patent challenges on December 18, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 25, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ORGOVYX

International Patents:	162
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	54
Clinical Trials:	9
Patent Applications:	109
Drug Prices:	Drug price information for ORGOVYX
What excipients (inactive ingredients) are in ORGOVYX?	ORGOVYX excipients list
DailyMed Link:	ORGOVYX at DailyMed

See drug prices for ORGOVYX

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

Constraining patent/regulatory exclusivity:

10,350,170

NDA:

214621

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 ORGOVYX

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

Sponsor	Phase
Yale University	Phase 2
University of Kansas Medical Center	Phase 2
Han Xu, M.D., Ph.D., Non-Investigator, IRB Chair	Phase 2/Phase 3

See all ORGOVYX clinical trials

Pharmacology for ORGOVYX

Drug Class	Gonadotropin Releasing Hormone Receptor Antagonist
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2B6 Inducers Cytochrome P450 3A Inducers Gonadotropin Releasing Hormone Receptor Antagonists P-Glycoprotein Inhibitors
Physiological Effect	Decreased GnRH Secretion

US Patents and Regulatory Information for ORGOVYX

ORGOVYX is protected by nine US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 10,350,170.

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
Sumitomo Pharma	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020		RX	Yes	Yes	11,583,526
Sumitomo Pharma	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020		RX	Yes	Yes	11,795,178		Y	Y
Sumitomo Pharma	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020		RX	Yes	Yes	10,449,191
Sumitomo Pharma	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020		RX	Yes	Yes	10,350,170		Y

Expired US Patents for ORGOVYX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sumitomo Pharma	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020	8,735,401

EU/EMA Drug Approvals for ORGOVYX

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Accord Healthcare S.L.U.	Orgovyx	relugolix	EMEA/H/C/005353 Orgovyx is indicated for the treatment of adult patients with advanced hormone-sensitive prostate cancer.	Authorised	no	no	no	2022-04-29

International Patents for ORGOVYX

When does loss-of-exclusivity occur for ORGOVYX?

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

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Finland

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

New Zealand

Poland

Portugal

Serbia

Slovenia

Spain

Taiwan

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 ORGOVYX around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2023029608	女性不妊の治療方法
Norway	2021052
Serbia	58703	METODA PROIZVODNJE DERIVATA TIENOPIRIMIDINA (PRODUCTION METHOD OF THIENOPYRIMIDINE DERIVATIVE)
Russian Federation	2005127052	СОЕДИНЕНИЯ ТИЕНОПИРИМИДИНА И ИХ ПРИМЕНЕНИЕ

Supplementary Protection Certificates for ORGOVYX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1591446	2190051-9	Sweden		PRODUCT NAME: RELUGOLIX OR A SALT THEREOF; REG. NO/DATE: EU/1/21/1565 20210720
1591446	301158	Netherlands		PRODUCT NAME: RELUGOLIX OF EEN ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1565 20210720
1591446	132021000000188	Italy		PRODUCT NAME: RELUGOLIX O UN SUO SALE(RYEQO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1565, 20210720
1591446	C 2021 047	Romania		PRODUCT NAME: RELUGOLIX SAU O SARE A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/21/1565; DATE OF NATIONAL AUTHORISATION: 20210716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1565; DATE OF FIRST AUTHORISATION IN EEA: 20210716

ORGOVYX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ORGOVYX

Introduction to ORGOVYX

ORGOVYX (relugolix) is a groundbreaking oral gonadotropin-releasing hormone (GnRH) receptor antagonist, approved by the FDA on December 18, 2020, for the treatment of advanced prostate cancer. Developed by Myovant Sciences, ORGOVYX marks a significant shift in the treatment paradigm by offering a daily oral pill alternative to traditional injections or implants[1][4].

Mechanism of Action and Clinical Significance

ORGOVYX works by blocking the pituitary gland's production of luteinizing hormone and follicle-stimulating hormone, thereby reducing testosterone levels in the body. This mechanism is crucial in managing advanced prostate cancer, as testosterone can stimulate the growth of cancer cells. The Phase III HERO study demonstrated ORGOVYX's efficacy in rapidly reducing testosterone levels without an initial hormonal surge, and its safety profile has been well-received by clinicians[1].

Market Impact and Adoption

Since its launch, ORGOVYX has shown promising market traction. In its first launch quarter, Myovant Sciences reported $3.6 million in product revenue, with over 2,000 prescriptions filled by April 2021. This momentum continued, with net product revenues reaching $10.5 million in the first quarter of 2021, exceeding analyst expectations[1].

Partnership and Distribution

Myovant Sciences partnered with Pfizer to co-market ORGOVYX, a deal worth over $650 million. This partnership has been instrumental in expanding the drug's reach, particularly in targeting healthcare providers and building payer coverage. As of July 1, 2021, ORGOVYX had achieved significant commercial and Medicare Part D coverage, with over 60% and 70% coverage respectively[1].

Financial Performance of Myovant Sciences and Sumitomo Pharma

Myovant Sciences

The early success of ORGOVYX has been a financial boon for Myovant Sciences. The company's focus on building a strong foundation for long-term growth is evident from its consistent positive feedback from clinicians and the rapid adoption of the drug. The partnership with Pfizer has also contributed to the drug's financial success[1].

Sumitomo Pharma

Sumitomo Pharma, which has a stake in the distribution and marketing of ORGOVYX, has seen a significant increase in revenue driven by the success of this and other key products. Despite facing financial challenges, including a high net debt to equity ratio and ongoing losses, Sumitomo Pharma's revenue has increased by ¥28.1 billion from the prior year, largely due to the success of ORGOVYX, MYFEMBREE, and GEMTESA in the North American market. ORGOVYX alone saw a 26% increase in sales, contributing substantially to the company's revenue growth[3].

Revenue Growth and Projections

Sumitomo Pharma's recent financial performance highlights a strong trajectory, with revenue reaching ¥180.7 billion. The company anticipates a steady growth of 4% per year, outpacing the average market growth, driven by the continued success of its key products. Effective cost management, including reductions in SG&A and R&D expenses, has also supported this growth[3].

Challenges and Regulatory Hurdles

Despite the positive financial trajectory, Sumitomo Pharma faces several challenges. Regulatory uncertainties, such as ongoing discussions with the PMDA and the potential impact of volatile foreign exchange rates, pose significant threats. Additionally, the introduction of generic products could alter market dynamics and affect ORGOVYX's sales. However, the company's strategic initiatives and market positioning are expected to help navigate these challenges[3].

Patient Access and Healthcare Provider Engagement

Biologics by McKesson, an independent specialty pharmacy, has been instrumental in providing access to ORGOVYX. Their patient-centric approach, which includes pharmacists, nurses, and financial counselors, ensures that patients receive comprehensive care. This model has been particularly beneficial during the COVID-19 pandemic, highlighting the importance of oral treatments that reduce the need for clinic visits and injections[4].

Future Prospects and Growth Avenues

Sumitomo Pharma's future growth is promising, driven by strategic collaborations, such as the joint venture with Sumitomo Chemical, aimed at advancing drug discovery in regenerative medicine and cell therapy. The company's commitment to cost reduction and efficiency improvements is also expected to enhance operational efficiency and support a V-shaped recovery. Despite financial and regulatory challenges, ORGOVYX remains a key asset propelling Sumitomo Pharma forward[3].

Key Takeaways

• Innovative Treatment Option: ORGOVYX is the first oral GnRH receptor antagonist for advanced prostate cancer, offering a convenient and effective treatment alternative.
• Strong Market Adoption: The drug has seen rapid adoption, with significant revenue growth and broad payer coverage.
• Financial Impact: ORGOVYX has contributed substantially to the revenue growth of both Myovant Sciences and Sumitomo Pharma.
• Challenges: Despite success, the companies face regulatory, financial, and competitive challenges that need to be addressed.
• Future Growth: Strategic initiatives and market positioning are expected to drive continued growth and navigate challenges.

FAQs

What is ORGOVYX and how does it work?

ORGOVYX (relugolix) is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist that blocks the production of luteinizing hormone and follicle-stimulating hormone, reducing testosterone levels in the body, which is crucial for managing advanced prostate cancer.

Who developed and approved ORGOVYX?

ORGOVYX was developed by Myovant Sciences and approved by the FDA on December 18, 2020.

How has ORGOVYX impacted the market?

ORGOVYX has shown strong market traction since its launch, with significant revenue growth and broad payer coverage, making it a new standard of care in androgen deprivation therapy.

What are the financial challenges faced by Sumitomo Pharma despite the success of ORGOVYX?

Sumitomo Pharma faces financial challenges including a high net debt to equity ratio, ongoing losses, and regulatory uncertainties, despite the revenue growth driven by ORGOVYX.

How does Biologics by McKesson support patient access to ORGOVYX?

Biologics by McKesson provides a patient-centric approach with a team of pharmacists, nurses, and financial counselors, ensuring comprehensive care and streamlined access to ORGOVYX, particularly beneficial during the COVID-19 pandemic.

Cited Sources

1. Pharmaceutical Executive: "Formidable Option: Orgovyx" - September 14, 2021
2. Sumitomo Pharma: "Presentation" - January 31, 2024
3. Simply Wall St: "Sumitomo Pharma (TSE:4506) Eyes Growth with ORGOVYX Success and Key Alliances" - December 8, 2024
4. McKesson: "ORGOVYX (relugolix), the First FDA-Approved Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer Available Through Biologics by McKesson" - January 21, 2021
5. Sumitomo Pharma: "Conference on Q2 FY2024 Financial Results" - October 30, 2024