Relugolix - Generic Drug Details

What are the generic sources for relugolix and what is the scope of patent protection?

Relugolix is the generic ingredient in one branded drug marketed by Sumitomo Pharma and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for relugolix

International Patents:	162
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	54
Clinical Trials:	31
Patent Applications:	225
What excipients (inactive ingredients) are in relugolix?	relugolix excipients list
DailyMed Link:	relugolix at DailyMed

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

Constraining patent/regulatory exclusivity:

10,350,170

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 relugolix

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

Sponsor	Phase
University of Oklahoma	Phase 1
Yale University	Phase 2
University of Kansas Medical Center	Phase 2

See all relugolix clinical trials

Pharmacology for relugolix

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

Anatomical Therapeutic Chemical (ATC) Classes for relugolix

L02BX	Other hormone antagonists and related agents
L02B	HORMONE ANTAGONISTS AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for relugolix

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
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
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	8,058,280		Y	Y

Expired US Patents for relugolix

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 relugolix

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 relugolix

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
China	110248661	前列腺癌的治疗 (TREATMENT OF PROSTATE CANCER)

Supplementary Protection Certificates for relugolix

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
1591446	SPC/GB21/065	United Kingdom		PRODUCT NAME: RELUGOLIX OR A SALT THEREOF; REGISTERED: UK EU/1/21/1565(NI) 20210720; UK FURTHER MA ON IPSUM 20210720

Relugolix Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Relugolix (ORGOVYX)

Introduction to Relugolix

Relugolix, marketed as ORGOVYX, is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist. It has been approved by the FDA for the treatment of advanced prostate cancer and is under regulatory review for women's health indications such as uterine fibroids and endometriosis[1].

Market Collaboration and Partnerships

A significant factor in the market dynamics of relugolix is the collaboration between Myovant Sciences and Pfizer. This partnership, announced in December 2020, aims to develop and commercialize relugolix in oncology and women’s health in the U.S. and Canada. Pfizer also has an exclusive option to commercialize relugolix in oncology outside the U.S. and Canada, excluding certain Asian countries. This collaboration is expected to enhance the financial position of Myovant Sciences and expand its pipeline of potential new medicines[1].

Financial Terms of the Collaboration

Under the terms of the agreement, Myovant Sciences is set to receive up to $4.2 billion, including an upfront payment of $650 million, $200 million in potential regulatory milestones for FDA approvals for the relugolix combination tablet in women’s health, and tiered sales milestones upon reaching certain thresholds up to $2.5 billion in net sales for prostate cancer and combined women’s health indications. If Pfizer exercises the option to commercialize relugolix in oncology outside the U.S. and Canada, Myovant will receive $50 million and be entitled to double-digit royalties on sales[1].

Market Indications and Approval Status

Relugolix is FDA-approved as ORGOVYX for adult patients with advanced prostate cancer. It is also under regulatory review in Europe and the U.S. for women with uterine fibroids and is in development for women with endometriosis. The rapid decrease in testosterone concentrations without the risk of flare, as seen with traditional GnRH agonists like leuprolide, is a significant advantage of relugolix[1][2].

Cost-Effectiveness Analysis

A cost-effectiveness analysis comparing androgen deprivation therapy (ADT) with relugolix to leuprolide revealed mixed results. While relugolix provided a rapid decrease in testosterone without the risk of flare, the analysis indicated that ADT with leuprolide was dominant in 100% of the simulations at a willingness-to-pay threshold of $100,000 per quality-adjusted life-year (QALY). The incremental cost-effectiveness ratio (ICER) for ADT with relugolix was $49,571.1 per QALY, suggesting that, from a cost-effectiveness perspective, relugolix may not offer significant advantages over leuprolide[3].

Patient Support and Financial Assistance

To support patients, the ORGOVYX Support Program offers one-on-one support, tools, and resources to help manage treatment. This includes nurse support, assistance with understanding insurance benefits, and financial support options such as copay assistance for eligible patients. These programs aim to make the treatment more accessible and manageable for patients[5].

Market Trends and Demand

The demand for relugolix is expected to grow due to its unique profile as an oral GnRH receptor antagonist. The market report on relugolix API highlights increasing demand across various indications, driven by its efficacy and convenience compared to traditional injectable GnRH agonists. The report also details competition and demand trends, indicating a positive outlook for the drug's market trajectory[4].

Competitive Landscape

The competitive landscape for GnRH receptor antagonists is evolving, with relugolix positioning itself as a novel oral treatment option. Traditional GnRH agonists like leuprolide have been the standard of care, but the convenience and rapid action of relugolix are likely to capture a significant market share. The partnership with Pfizer, a major pharmaceutical company, further strengthens the competitive position of relugolix[1].

Regulatory and Clinical Development

Myovant Sciences remains responsible for regulatory interactions, drug supply, and leading clinical development for the relugolix combination tablet. The ongoing regulatory reviews in Europe and the U.S. for women’s health indications are critical for expanding the drug's market reach. Any favorable regulatory outcomes will significantly impact the financial trajectory of relugolix[1].

Financial Projections and Milestones

The financial trajectory of relugolix is heavily influenced by the milestones and sales targets outlined in the collaboration agreement. Achieving regulatory approvals and reaching sales thresholds will trigger significant payments to Myovant Sciences. The potential for double-digit royalties on sales outside the U.S. and Canada adds another layer of financial upside[1].

Patient Outcomes and Adherence

Maximizing patient outcomes and adherence is crucial for the long-term success of relugolix. The ORGOVYX Support Program and other patient management strategies are designed to improve medication adherence and overall patient outcomes. Effective counseling, monitoring parameters, and patient support can enhance the drug's market performance by ensuring better treatment compliance and satisfaction[2].

Conclusion

The market dynamics and financial trajectory of relugolix are shaped by its unique clinical profile, strategic partnerships, and regulatory milestones. While cost-effectiveness analyses suggest some limitations compared to traditional treatments, the convenience, rapid action, and expanding indications position relugolix for significant market growth. The collaboration with Pfizer and ongoing regulatory efforts are key drivers of its financial success.

Key Takeaways

• Strategic Partnership: Myovant Sciences and Pfizer's collaboration enhances the drug's market reach and financial potential.
• Regulatory Approvals: FDA approval for advanced prostate cancer and ongoing reviews for women’s health indications are critical.
• Cost-Effectiveness: Mixed results in cost-effectiveness analyses compared to traditional GnRH agonists.
• Patient Support: Programs like the ORGOVYX Support Program improve patient adherence and outcomes.
• Market Trends: Increasing demand driven by the drug's unique profile and convenience.

FAQs

What is relugolix (ORGOVYX) used for?

Relugolix, marketed as ORGOVYX, is used for the treatment of advanced prostate cancer in adults and is under review for women’s health indications such as uterine fibroids and endometriosis[1].

How does the collaboration between Myovant Sciences and Pfizer impact relugolix?

The collaboration allows for joint development and commercialization of relugolix, with Pfizer providing significant financial support and expanding the drug's market reach. Myovant Sciences stands to receive up to $4.2 billion, including upfront payments, regulatory milestones, and sales milestones[1].

What are the key financial milestones for relugolix?

Key financial milestones include an upfront payment of $650 million, $200 million in potential regulatory milestones, and tiered sales milestones up to $2.5 billion. Additionally, Myovant Sciences is entitled to double-digit royalties if Pfizer exercises the option to commercialize relugolix outside the U.S. and Canada[1].

How does relugolix compare to traditional GnRH agonists in terms of cost-effectiveness?

A cost-effectiveness analysis showed that while relugolix offers a rapid decrease in testosterone without the risk of flare, it is not a cost-effective choice compared to leuprolide at a willingness-to-pay threshold of $100,000 per QALY[3].

What support programs are available for patients taking ORGOVYX?

The ORGOVYX Support Program offers one-on-one support, nurse advice, assistance with understanding insurance benefits, and financial support options such as copay assistance for eligible patients[5].

What are the potential side effects of ORGOVYX?

Common side effects include weight gain, decreased sex drive, and erectile function problems. Serious side effects can also occur, and patients should report any side effects to their healthcare provider[5].

Sources

1. Myovant Sciences and Pfizer Announce Collaboration to Develop and Commercialize Relugolix in Oncology and Women’s Health. Pfizer, December 28, 2020.
2. Androgen Deprivation Therapy with Relugolix (Orgovyx®). NCODA.
3. Cost-effectiveness analysis of androgen deprivation therapy with 120 mg relugolix against 7.5 mg leuprolide for the treatment of APC. PubMed, 2022.
4. Research Report on Relugolix API Market Size 2024-2030: Trends, Sales Channel, Distributors, and Porter’s Five Forces Analysis. River Country News Channel Nebraska.
5. Cost & Support | ORGOVYX® (relugolix) | Patient Website. ORGOVYX.