LYNPARZA Drug Patent Profile

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

Lynparza is a drug marketed by Astrazeneca and is included in two NDAs. There are twelve patents protecting this drug and one Paragraph IV challenge.

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

DrugPatentWatch^® Generic Entry Outlook for Lynparza

Lynparza was eligible for patent challenges on December 19, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 12, 2027. This may change due to patent challenges or generic licensing.

There have been fourteen 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.

There are three tentative approvals for the generic drug (olaparib), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for LYNPARZA

US Patents:	12
Applicants:	1
NDAs:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LYNPARZA

Paragraph IV (Patent) Challenges for LYNPARZA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LYNPARZA	Tablets	olaparib	100 mg and 150 mg	208558	1	2022-11-01

US Patents and Regulatory Information for LYNPARZA

LYNPARZA is protected by sixty US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 8,143,241.

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
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017		RX	Yes	Yes	11,975,001		Y
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017		RX	Yes	No	11,975,001		Y
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017		RX	Yes	Yes	7,449,464		Y	Y
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017		RX	Yes	No	8,475,842		Y

International Patents for LYNPARZA

When does loss-of-exclusivity occur for LYNPARZA?

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

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Finland

Honduras

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

New Zealand

Nicaragua

Norway

Peru

Poland

Portugal

Saudi Arabia

Serbia

Slovenia

South Africa

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 LYNPARZA around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	496034
Australia	2001295789
Australia	9578901
Brazil	0115062

Supplementary Protection Certificates for LYNPARZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1633724	C 2015 011	Romania		PRODUCT NAME: OLAPARIB; NATIONAL AUTHORISATION NUMBER: EU/1/14/959/001; DATE OF NATIONAL AUTHORISATION: 20141216; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/959/001; DATE OF FIRST AUTHORISATION IN EEA: 20141216
1633724	PA2015016,C1633724	Lithuania		PRODUCT NAME: OLAPARIBAS IR JO DRUSKOS IR SOLVATAI; REGISTRATION NO/DATE: EU/1/14/959 20141216
1633724	2015/016	Ireland		PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
1633724	S1500012	Hungary		PRODUCT NAME: OLAPARIB

LYNPARZA: Investment Outlook and Fundamental Analysis

Last updated: February 19, 2026

Executive Summary

Lynparza (olaparib) is a PARP inhibitor developed by AstraZeneca and Merck & Co. The drug demonstrates efficacy in treating various cancers, including ovarian, breast, prostate, and pancreatic cancers, primarily in patients with BRCA mutations. Its market potential is significant, driven by expanding indications, a growing understanding of tumor genetics, and a competitive landscape that is still developing. Key investment considerations include patent expiries, emerging competition, and regulatory hurdles for new indications.

LYNPARZA: Market Landscape and Commercial Performance

Lynparza's commercial performance is robust, reflecting its established efficacy and expanding therapeutic applications. As of the most recent reporting periods, the drug has generated substantial revenue, positioning it as a leading oncology therapy.

Global Sales Performance (USD Millions):

Year	Sales
2021	2,162
2022	2,458
2023	2,767

(Source: AstraZeneca Annual Reports)

The growth trajectory is primarily attributed to its use in maintenance therapy for ovarian cancer, treatment for metastatic castration-resistant prostate cancer (mCRPC), and its expansion into other solid tumors. The co-development and commercialization agreement between AstraZeneca and Merck is critical to its global reach. Merck handles commercialization in the United States and Canada, while AstraZeneca manages the rest of the world. This partnership leverages the distinct strengths of both companies in oncology markets.

LYNPARZA: Clinical Development and Expanding Indications

Lynparza's clinical pipeline is a key driver of its future value. The drug's mechanism of action, targeting DNA repair pathways in cancer cells, offers broad applicability.

Approved Indications:

• Ovarian Cancer: Maintenance treatment for patients with advanced ovarian cancer who are in response to first-line platinum-based chemotherapy, and for patients with platinum-sensitive relapsed ovarian cancer.
• Breast Cancer: Treatment of HER2-negative, germline BRCA-mutated advanced or metastatic breast cancer.
• Prostate Cancer: Treatment of patients with mCRPC who have specific gene alterations and have received prior androgen receptor-directed therapy and taxane-based chemotherapy.
• Pancreatic Cancer: Maintenance treatment for patients with germline BRCA-mutated metastatic pancreatic cancer who have stable disease or demonstrate minimal progressive disease after at least 16 weeks of first-line platinum-based chemotherapy.

Key Ongoing Clinical Trials and Potential Future Indications:

• Early-Stage Breast Cancer: Trials are exploring Lynparza in adjuvant and neoadjuvant settings for BRCA-mutated early breast cancer. Positive results in these settings could significantly expand the patient population.
• Other Solid Tumors: Research continues in areas such as lung cancer, colorectal cancer, and gastric cancer, particularly in subsets with DNA repair deficiencies.
• Combination Therapies: Investigations into Lynparza in combination with other oncological agents, including immunotherapies and chemotherapy regimens, are ongoing to enhance efficacy and overcome resistance mechanisms.

The expansion of Lynparza into earlier lines of therapy and new tumor types represents a significant opportunity for revenue growth and market penetration.

LYNPARZA: Patent Landscape and Exclusivity

The patent landscape for Lynparza is a critical factor for long-term investment. Patent expiries can lead to generic competition, significantly impacting revenue.

Key Patents and Expiry Dates (Estimated):

• Composition of Matter Patents: The primary patents covering the olaparib molecule itself are approaching expiry in major markets.
  • United States: Key patents are expected to expire between 2025 and 2027.
  • Europe: Patent protection is generally expected to expire between 2026 and 2028.
• Method of Use Patents: AstraZeneca has pursued and obtained secondary patents covering specific indications and formulations. These patents can extend market exclusivity for certain applications, even after the core composition of matter patents expire.
  • Examples include patents for maintenance therapy in ovarian cancer or treatment of mCRPC. The expiry dates for these patents vary and are generally staggered, offering a degree of ongoing protection for specific uses.
• Formulation Patents: Patents related to specific drug formulations or delivery methods could also provide extended exclusivity.

Impact of Patent Expiry:

Upon expiry of key patents, generic manufacturers can seek approval to market olaparib. This typically leads to a significant reduction in drug prices and market share for the originator product. The timing and impact of generic entry are crucial for financial forecasting. The strategic filing and defense of method of use and formulation patents are designed to mitigate the impact of core patent expiries.

LYNPARZA: Competitive Environment

The PARP inhibitor class is becoming increasingly crowded, with several competitors vying for market share. Lynparza's competitive position is influenced by its established efficacy, broad indication profile, and ongoing clinical development.

Key Competitors:

• Talzenna (talazoparib) (Pfizer): Approved for BRCA-mutated HER2-negative locally advanced or metastatic breast cancer. It is also being investigated in prostate cancer.
• Zejula (niraparib) (GSK): Approved for maintenance treatment of recurrent ovarian cancer, regardless of BRCA mutation status, and for advanced ovarian cancer in combination with bevacizumab.
• Rubraca (rucaparib) (Clovis Oncology): Approved for BRCA-mutated ovarian cancer and in certain cases of prostate cancer.

Competitive Dynamics:

• Mutation Status: Lynparza's primary indications are for BRCA-mutated cancers. Competitors like Zejula have broader labels that include non-BRCA mutated populations in certain settings, creating differentiation.
• Line of Therapy: Lynparza is approved in both first-line and later-line settings across various cancers. Competitors are also exploring these lines of therapy.
• Combination Therapies: The future of the PARP inhibitor market will likely involve combinations. Lynparza's positioning in combination trials is a key determinant of its long-term success.
• Biomarker Identification: The increasing sophistication of genomic testing allows for more precise patient selection, favoring drugs with strong biomarker-driven efficacy. Lynparza's established link to BRCA mutations remains a core strength.

The competitive landscape necessitates continuous innovation, strategic lifecycle management, and robust clinical trial programs to maintain market leadership.

LYNPARZA: Regulatory and Reimbursement Considerations

Navigating the regulatory and reimbursement landscape is paramount for Lynparza's continued success.

Regulatory Approvals:

Lynparza has received approvals from major regulatory bodies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Obtaining approvals for new indications or expanding existing ones requires extensive clinical data demonstrating safety and efficacy.

• FDA: Approvals have been granted across multiple indications, with ongoing reviews for potential new uses.
• EMA: Similar to the FDA, the EMA has provided approvals for key indications.

Reimbursement:

The drug's high cost necessitates favorable reimbursement policies from public and private payers. Pricing and market access strategies are crucial for ensuring broad patient access and commercial viability.

• Payer Scrutiny: Oncological therapies, particularly targeted agents like Lynparza, are subject to intense scrutiny by payers regarding cost-effectiveness and clinical value.
• Value-Based Agreements: Discussions and negotiations with payers often involve evidence of real-world outcomes and comparative effectiveness.
• Geographic Variations: Reimbursement policies vary significantly by country, impacting global sales potential and market access strategies.

Key Considerations:

• Oncology Drug Pricing: The overall trend of rising oncology drug prices creates a challenging environment for market access.
• Evidence Generation: Post-market studies and real-world evidence are increasingly important for maintaining reimbursement and demonstrating ongoing value.
• Health Technology Assessment (HTA): In many European countries, HTA bodies evaluate the clinical and economic benefits of new drugs, influencing their availability and reimbursement levels.

Key Takeaways

Lynparza is a significant revenue-generating oncology asset with a well-defined clinical profile and an expanding indication base. Its market leadership is challenged by an evolving competitive landscape and the looming threat of patent expiries. Key investment considerations include the success of ongoing clinical trials for new indications, the impact of generic competition, and the ability to secure favorable reimbursement in key global markets. The strategic partnership between AstraZeneca and Merck is instrumental in its commercialization and R&D efforts.

Frequently Asked Questions

1. What is the primary mechanism of action for Lynparza? Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor. It works by blocking the PARP enzyme, which is involved in DNA repair. In cancer cells with specific DNA repair deficiencies (such as BRCA mutations), inhibiting PARP leads to an accumulation of DNA damage and cell death.
2. When are the key composition of matter patents for Lynparza expected to expire in the United States and Europe? Key composition of matter patents for Lynparza are estimated to expire in the United States between 2025 and 2027 and in Europe between 2026 and 2028.
3. Which cancer types is Lynparza currently approved to treat? Lynparza is approved for specific types of ovarian cancer, breast cancer, prostate cancer, and pancreatic cancer, primarily in patients with germline BRCA mutations.
4. Who are the main competitors to Lynparza in the PARP inhibitor market? Key competitors include Talzenna (talazoparib) from Pfizer, Zejula (niraparib) from GSK, and Rubraca (rucaparib) from Clovis Oncology.
5. What is the significance of method of use patents for Lynparza? Method of use patents cover specific ways a drug can be used, such as for treating a particular disease or in a specific patient population. These patents can extend market exclusivity for Lynparza for certain approved indications even after the core molecule patents expire, providing a degree of continued protection against generic competition for those specific uses.

Citations

[1] AstraZeneca. (2022). AstraZeneca Annual Report and Form 20-F 2021. [2] AstraZeneca. (2023). AstraZeneca Annual Report and Form 20-F 2022. [3] AstraZeneca. (2024). AstraZeneca Annual Report and Form 20-F 2023. [4] U.S. Food and Drug Administration. (n.d.). Drug Approvals Database. Retrieved from https://www.fda.gov/drugs/development-approval-process-drugs/drug-approvals-and-databases [5] European Medicines Agency. (n.d.). European Public Assessment Reports. Retrieved from https://www.ema.europa.eu/en/medicines/human/EPARs [6] Pfizer Inc. (n.d.). Talzenna Product Information. [7] GlaxoSmithKline plc. (n.d.). Zejula Product Information. [8] Clovis Oncology. (n.d.). Rubraca Product Information.