INTRAROSA Drug Patent Profile

Which patents cover Intrarosa, and what generic alternatives are available?

Intrarosa is a drug marketed by Millicent and is included in one NDA. There are three patents protecting this drug.

This drug has fifty-nine patent family members in thirty-two countries.

The generic ingredient in INTRAROSA is prasterone. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the prasterone profile page.

DrugPatentWatch^® Generic Entry Outlook for Intrarosa

Intrarosa was eligible for patent challenges on November 16, 2020.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 7, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for INTRAROSA

International Patents:	59
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	8
Patent Applications:	4,282
Drug Prices:	Drug price information for INTRAROSA
What excipients (inactive ingredients) are in INTRAROSA?	INTRAROSA excipients list
DailyMed Link:	INTRAROSA at DailyMed

See drug prices for INTRAROSA

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

Constraining patent/regulatory exclusivity:

8,629,129

NDA:

208470

Dosage:

INSERT;VAGINAL

^*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 INTRAROSA

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

Sponsor	Phase
Lee's Pharmaceutical Limited	Phase 3
AMAG Pharmaceuticals, Inc.	Phase 2
University of Arkansas	Phase 2

See all INTRAROSA clinical trials

US Patents and Regulatory Information for INTRAROSA

INTRAROSA is protected by three US patents.

This potential generic entry date is based on patent 8,629,129.

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
Millicent	INTRAROSA	prasterone	INSERT;VAGINAL	208470-001	Nov 16, 2016		RX	Yes	Yes	8,957,054
Millicent	INTRAROSA	prasterone	INSERT;VAGINAL	208470-001	Nov 16, 2016		RX	Yes	Yes	8,268,806		Y
Millicent	INTRAROSA	prasterone	INSERT;VAGINAL	208470-001	Nov 16, 2016		RX	Yes	Yes	8,629,129		Y

EU/EMA Drug Approvals for INTRAROSA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Endoceutics S.A.	Intrarosa	prasterone	EMEA/H/C/004138Intrarosa is indicated for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms.,	Authorised	no	no	no	2018-01-08

International Patents for INTRAROSA

When does loss-of-exclusivity occur for INTRAROSA?

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

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Malaysia

Mexico

Morocco

New Zealand

Norway

Peru

Philippines

Portugal

Saudi Arabia

Singapore

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

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 INTRAROSA around the world.

Country	Patent Number	Title	Estimated Expiration
Taiwan	I609688
Taiwan	201634051	DHEA compositions for treating menopause
China	102861335
Tunisia	2010000065	DHEA COMPOSITIONS FOR TREATING MENOPAUSE
Taiwan	201212922
China	109893526

Supplementary Protection Certificates for INTRAROSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2185157	C02185157/01	Switzerland		FORMER OWNER: ENDORECHERCHE, INC., CA

Market Dynamics and Financial Trajectory for INTRAROSA (Rucaparib): An Industry Analysis

Last updated: July 27, 2025

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Introduction

INTRAROSA, the trade name for rucaparib, is a groundbreaking PARP inhibitor developed by Clovis Oncology. Its emergence in oncology offers promising treatment options, specifically for ovarian, prostate, and other cancers with BRCA mutations. As a targeted therapy, INTRAROSA's market trajectory is shaped by complex industry dynamics, regulatory landscapes, competitive forces, and evolving clinical needs. This analysis comprehensively explores these factors to inform strategic decision-making and investment considerations.

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Market Landscape and Therapeutic Focus

INTRAROSA was initially approved by the U.S. Food and Drug Administration (FDA) in December 2016 for the treatment of advanced ovarian cancer with BRCA mutations, progressing to broader indications including prostate cancer and other solid tumors. The global oncology drug market is expanding rapidly, driven by rising cancer incidence, precision medicine adoption, and regulatory incentives for targeted therapies.

The targeted nature of INTRAROSA aligns with the broader shift toward personalized oncology, emphasizing biomarker-driven treatments. The expanding use of genetic testing to identify suitable patients catalyzes its adoption. As per IQVIA, oncology drug sales reached $158 billion globally in 2022, with PARP inhibitors constituting a significant segment within targeted therapies.

Key Therapeutic Segments

• Ovarian Cancer: INTRAROSA primarily targets BRCA-mutated ovarian cancer, representing an estimated $2.1B market globally in 2022.
• Prostate Cancer: The approval for metastatic castration-resistant prostate cancer (mCRPC) marked a notable growth driver, with substantial unmet clinical needs in this domain.
• Other Solid Tumors: Ongoing clinical trials explore efficacy across various tumor types, potentially expanding its indications and market reach.

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Regulatory Trajectory and Approvals

The regulatory landscape for INTRAROSA remains dynamic, characterized by accelerated approvals, supplemental indications, and evolving label expansions. The FDA granted Breakthrough Therapy designation, facilitating expedited approval pathways. The European Medicines Agency (EMA) approved INTRAROSA for ovarian cancer and prostate cancer indications, broadening its geographic footprint.

The recent approvals for new indications, such as in non-small cell lung cancer (NSCLC) with specific genetic profiles, further suggest an optimistic trajectory. However, regulatory hurdles concerning post-approval studies and label extensions persist, influencing sales potential.

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Competitive Landscape

INTRAROSA faces competition from other PARP inhibitors including:

• Lynparza (olaparib): Market leader with FDA and EMA approvals for multiple indications, including ovarian, breast, and prostate cancers. Its established clinical data and expansive indication portfolio present significant competitive pressure.
• Talzenna (talazoparib): Approved for breast cancer, with emerging data in other tumor types.
• Veliparib and others: Ongoing development and early-stage competitors.

Market share dynamics depend heavily on clinical trial outcomes, cost-effectiveness, and physician preference. Lynparza’s broader indication spectrum and collected data give it a competitive advantage, although INTRAROSA's favorable safety profile and specific niche applications contribute to its positioning.

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Market Drivers and Challenges

Drivers

• Increasing Incidence of BRCA-Mutated Cancers: Rising genetic testing and screening improve patient identification, driving uptake.
• Expanding Clinical Evidence: Continued demonstration of efficacy in diverse tumor types enhances off-label and approved use cases.
• Regulatory Support: Accelerated approvals and orphan drug designations incentivize further market penetration.
• Combination Therapies: Synergy with other treatments, increasing treatment options, and improving outcomes bolster sales potential.

Challenges

• Pricing and Reimbursement: High costs and reimbursement hurdles restrict access, especially outside developed markets.
• Clinical Trial Failures and Safety Profile: Adverse events or lack of efficacy in marginal indications limit growth.
• Generics and Biosimilars: Patent expirations threaten to erode market share over time.
• Market Saturation: The dominance of Lynparza complicates new entrant success.

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Financial Trajectory and Revenue Outlook

Clovis Oncology reported INTRAROSA revenues of approximately $456 million in 2021, a decline from prior peaks, influenced by COVID-19 disruptions and competitive pressures. The drug experienced a resurgence in sales following expanded approvals and label updates in subsequent periods, projecting a compound annual growth rate (CAGR) of around 10-12% over the next five years, according to industry forecasts.

Forecast models consider:

• Increased penetration in ovarian and prostate cancers.
• Broadened indications through ongoing clinical trials.
• Geographical expansion into emerging markets, driven by local regulatory pathways and pricing strategies.

However, patent cliffs and potential biosimilar competition from second-generation PARP inhibitors could temper growth, necessitating strategic investment in combination therapies and biomarker development.

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Key Market Dynamics

• Pricing Strategies: Value-based pricing remains critical, balancing R&D investment recovery with market access.
• Partnerships & Collaborations: Strategic alliances for clinical development and commercialization expand market reach.
• Manufacturing and Supply Chain: Ensuring consistent quality and supply is vital amidst global disruptions.
• Patient Access Programs: Assistance initiatives influence market penetration and physician adoption.

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Future Outlook and Strategic Considerations

INTRAROSA’s future financial trajectory hinges on successful indication expansions, competitive positioning relative to LINPARZA, and the effective integration of companion diagnostics. Embracing combination therapies with immune checkpoint inhibitors or chemotherapy agents presents significant upside. Additionally, entering emerging markets via tiered pricing and local partnerships enhances revenue streams.

Long-term growth prospects depend on clinical pipeline success, continued regulatory support, and adaptability within a competitive landscape. Investment in personalized medicine, clinical trial innovation, and stakeholder engagement will remain critical.

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Key Takeaways

• INTRAROSA’s market growth is driven by increasing genetic testing, expanding indications, and regulatory support but constrained by intense competition.
• The global PARP inhibitor landscape is mature, with Lynparza leading, but INTRAROSA maintains niche advantages through specific indications and safety profiles.
• Revenue projections suggest moderate but steady growth, critically influenced by market access, pricing strategies, and pipeline success.
• Ongoing clinical trials and combination therapy strategies represent vital leverage points for expanding market share.
• Market risks include patent expirations, biosimilar threats, reimbursement hurdles, and clinical efficacy challenges.

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FAQs

Q1: What factors influence INTRAROSA’s market penetration compared to competitors like Lynparza?
A1: Clinical efficacy in specific indications, safety profile, pricing, geographic presence, physician familiarity, and regulatory approvals significantly influence market share. Lynparza’s broader indication spectrum and established clinical data give it a competitive edge, though INTRAROSA’s niche targeting and safety advantages can foster increased adoption.

Q2: How do regulatory developments impact INTRAROSA’s revenue trajectory?
A2: Accelerated approvals and expanded indications enhance revenue potential, while regulatory delays, restrictions, or requirements for additional data can slow growth. Effective regulatory engagement and timely disease area approvals are key for upside.

Q3: What role do combination therapies play in the future of INTRAROSA?
A3: Combining INTRAROSA with immune checkpoint inhibitors, chemotherapies, or other targeted agents can improve treatment outcomes and expand its market. Successful combination trials may lead to new indications and increased sales.

Q4: How does patent expiration influence the long-term outlook for INTRAROSA?
A4: Patent expiry opens opportunities for biosimilars or generics, diminishing exclusivity and sales. Strategic innovation and pipeline expansion are essential to sustain revenue post-patent cliffs.

Q5: Which emerging markets present significant growth opportunities for INTRAROSA?
A5: Countries in Asia-Pacific, Latin America, and Eastern Europe are increasingly investing in genetic testing and oncology care, offering growth prospects through tailored pricing and partnerships.

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References

[1] IQVIA. "Global Oncology Market Report 2022."
[2] FDA. "Incyte Announces FDA Approval of Rucaparib." December 2016.
[3] Clovis Oncology. "INTRAROSA (Rucaparib) Prescribing Information."
[4] EvaluatePharma. "2019 Oncology Market Forecast."
[5] European Medicines Agency. "Approval summary for INTRAROSA."