LYNPARZA Drug Patent Profile

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.

This drug has two hundred and fifty-four patent family members in fifty-two countries.

The generic ingredient in LYNPARZA is olaparib. There are three drug master file entries for this compound. 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 September 8, 2027. This may change due to patent challenges or generic licensing.

There have been seven 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

International Patents:	254
US Patents:	12
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	153
Patent Applications:	4,768
Drug Prices:	Drug price information for LYNPARZA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LYNPARZA
What excipients (inactive ingredients) are in LYNPARZA?	LYNPARZA excipients list
DailyMed Link:	LYNPARZA at DailyMed

See drug prices for LYNPARZA

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

Constraining patent/regulatory exclusivity:

8,247,416

NDA:

206162

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

7,449,464

NDA:

208558

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 LYNPARZA

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

Sponsor	Phase
University Medical Center Groningen	Phase 4
Pamela Munster	Phase 1
Alexander B Olawaiye, MD	Phase 2

See all LYNPARZA clinical trials

Pharmacology for LYNPARZA

Drug Class	Poly(ADP-Ribose) Polymerase Inhibitor
Mechanism of Action	Poly(ADP-Ribose) Polymerase Inhibitors

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 five FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 7,449,464.

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	208558-001	Aug 17, 2017		RX	Yes	No	11,975,001		Y
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017		RX	Yes	Yes	12,178,816		Y
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017		RX	Yes	No	8,475,842		Y
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017		RX	Yes	No
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017		RX	Yes	No	11,970,530
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017		RX	Yes	Yes

Expired US Patents for LYNPARZA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017	9,566,276
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017	9,169,235
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017	8,912,187
Astrazeneca	LYNPARZA	olaparib	CAPSULE;ORAL	206162-001	Dec 19, 2014	7,151,102
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017	8,912,187
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017	7,981,889

EU/EMA Drug Approvals for LYNPARZA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AstraZeneca AB	Lynparza	olaparib	EMEA/H/C/003726Ovarian cancerLynparza is indicated as monotherapy for the:maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.Lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability (see section 5.1).Breast cancerLynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4.2 and 5.1).monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2 negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments (see section 5.1). Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.Adenocarcinoma of the pancreasLynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen.Prostate cancerLynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated (see section 5.1).	Authorised	no	no	no	2014-12-16

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

Austria

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

European Patent Office

Hong Kong

Israel

Japan

Malaysia

Mexico

Montenegro

New Zealand

Norway

Peru

Poland

Portugal

Russian Federation

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 LYNPARZA around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2423279	DERIVES DE PHTALAZINONE (PHTHALAZINONE DERIVATIVES)
Iceland	2813
Brazil	PI0920604
World Intellectual Property Organization (WIPO)	2010041051
Mexico	PA03003218	DERIVADOS DE FTALAZINONA. (PHTHALAZINONE DERIVATIVES.)
Slovenia	2346495

Supplementary Protection Certificates for LYNPARZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1633724	15C0022	France		PRODUCT NAME: OLAPARIB,SELS ET SOLVATES DE CELUI-CI; REGISTRATION NO/DATE: EU 1/14/959 20141218
2346495	300956	Netherlands		PRODUCT NAME: AMORF OLAPARIB OF EEN ZOUT OF SOLVAAT DAARVAN, IN EEN VASTE DISPERSIE; REGISTRATION NO/DATE: EU1/14/959 20180515
1633724	CR 2015 00012	Denmark		PRODUCT NAME: OLAPARIB, OG SALTE OG SOLVATER DERAF; REG. NO/DATE: EU/1/14/959/001 20141216
2346495	LUC00091	Luxembourg		PRODUCT NAME: OLAPARIB AMORPHE OU UN DE SES SELS OU UN DES SES SOLVATES DANS UNE DISPERSION SOLIDE; AUTHORISATION NUMBER AND DATE: EU/1/14/959 20180515
1633724	C01633724/01	Switzerland		PRODUCT NAME: OLAPARIB; REGISTRATION NO/DATE: SWISSMEDIC 65160 14.01.2016
1633724	C20150012 00136	Estonia		PRODUCT NAME: OLAPARIIB;REG NO/DATE: EU/1/14/959 18.12.2014

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: LYNPARZA

Last updated: July 27, 2025

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Introduction

LYNPARZA (olaparib) has emerged as a significant player in the oncology therapeutic landscape. As a poly (ADP-ribose) polymerase (PARP) inhibitor, LYNPARZA is designed to target tumors with specific genetic mutations, notably those with BRCA1 and BRCA2 deficiencies. Its approval across various cancer indications has fueled robust market penetration and influenced its financial trajectory. This analysis delineates the prevailing market dynamics, emerging opportunities, competitive landscape, and financial outlook for LYNPARZA.

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Market Overview

Global Oncology Market and PARP Inhibitors Landscape

The oncology market collectively surpasses USD 200 billion annually, with targeted therapies constituting a growing share. PARP inhibitors, including LYNPARZA, have witnessed accelerated adoption owing to their efficacy against hereditary and sporadic cancers associated with DNA repair deficiencies. The global PARP inhibitor market was valued at approximately USD 5 billion in 2022 and is projected to expand at a compounded annual growth rate (CAGR) of 15-20% through 2028 [1].

LYNPARZA holds a leading position within this class, propelled by its broad therapeutic indications and strategic approvals. Its success underscores a shift towards precision medicine, leveraging genetic insights to tailor treatments.

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Market Dynamics Influencing LYNPARZA

1. Expanding Therapeutic Indications

Initially approved in 2014 for BRCA-mutated ovarian cancer, LYNPARZA's indications have expanded significantly. Currently, it is approved for:

• Ovarian cancer (including maintenance therapy post-chemotherapy)
• Breast cancer (metastatic, HR-positive, HER2-negative)
• Prostate cancer (metastatic castration-resistant)
• Pancreatic cancer (BRCA-mutated)

This broadening of indications has been a key driver of revenue growth, with ongoing clinical trials potentially unlocking additional uses, including lung and gastric cancers.

2. Regulatory Approvals and Global Expansion

Major regulatory agencies have validated LYNPARZA’s efficacy:

• FDA approvals for multiple indications, including breakthroughs in ovarian and breast cancers.
• EMA and other European regulators have granted approvals, enhancing market reach.

Expansion into emerging markets (China, India, Brazil) offers opportunities but faces challenges related to reimbursement policies and healthcare infrastructure.

3. Competitive and Patent Landscape

The PARP inhibitor space is highly competitive, with key competitors like AstraZeneca’s lynparza (a branded name for olaparib, officially marketed as LYNPARZA), Pfizer’s Talzenna (talazoparib), and Novartis’s Kisqali. Intellectual property exclusivity and patent protections are central to profitability; however, patent cliffs in the coming years threaten revenue stability.

4. Reimbursement and Pricing

Reimbursement policies significantly impact sales. In wealthier regions, continued access is facilitated through insurance coverage. However, high drug prices, especially in lower-income countries, restrict affordability, influencing overall sales volumes.

5. Biomarker Testing and Patient Stratification

Diagnostic strategies like genetic testing for BRCA mutations enable targeted treatment, ensuring optimal patient selection for LYNPARZA. The integration of companion diagnostics sustains demand but necessitates collaboration with diagnostic firms, influencing operational dynamics.

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Financial Trajectory

Revenue Growth and Market Penetration

In 2022, LYNPARZA generated revenues exceeding USD 2.2 billion, reflecting a compounded annual growth rate (CAGR) of approximately 40% since its initial launch. The growth is driven predominantly by expanded indications and increased adoption in existing markets [2].

Profitability and Margins

Gross margins for LYNPARZA remain high, often exceeding 80% due to the nature of proprietary biologics and small-molecule manufacturing. However, R&D expenses are substantial given ongoing clinical trials, which are necessary to sustain competitive positioning and obtain new indications.

Research & Development Investments

Continued investment exceeds USD 1 billion annually, focusing on combination therapies, new indications, and biomarker-driven trials. These investments, while temporarily impacting margins, aim to secure future revenue streams through label expansions.

Pipeline Potential and Future Revenue Streams

Ongoing pivotal trials target additional cancers and combination regimens with immunotherapies and chemotherapies. Success in these trials could catalyze new approval pathways, further fueling financial growth.

Impact of Patent Exclusivity

The current patent estate for LYNPARZA extends into the late 2020s, but biosimilar or generic entrants could erode market share post-patent expiry, similar to trends seen with other oncology drugs.

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Market Challenges and Opportunities

Challenges

• Patent Expiry Risks: Exposure to biosimilar competition post-2029.
• Pricing Pressures: Increasing pressure from payers for value-based pricing models.
• Clinical Trial Failures: Risk of negative trial outcomes impacting future approvals.
• Market Saturation: Maturation in some indications may temper growth.

Opportunities

• Combination Therapies: Synergistic regimens with immunotherapies or chemotherapy could expand label indications.
• Biomarker Expansion: Detection of homologous recombination deficiency (HRD) across diverse tumor types could broaden target patient populations.
• Geographic Expansion: Penetration into emerging markets with high unmet needs.
• Precision Medicine Initiatives: Growing adoption of genetic testing facilitates patient stratification, optimizing treatment outcomes.

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Strategic Outlook

LYNPARZA's financial and market trajectory is poised for continued expansion, buoyed by its leadership position, ongoing clinical advances, and broadening indications. However, sustainability hinges on navigating patent challenges, maintaining competitive parity, and integrating innovative combination therapies. Companies investing strategically in biomarker research, global markets, and patient access will likely see favorable returns.

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Key Takeaways

• Robust Revenue Growth: LYNPARZA’s revenues have sustained a high growth trajectory driven by multiple approved indications and pipeline expansion.
• Market Leadership in PARP Inhibition: As a pioneer in PARP inhibitor therapy, LYNPARZA commands significant market share amid competitive pressures.
• Pipeline and Combination Strategies: Future success hinges on clinical trial outcomes and the ability to develop effective combination regimens.
• Patent and Price Pressures: The upcoming patent cliffs necessitate diversification strategies, including indications beyond ovarian and breast cancers.
• Global and Diagnostic Expansion: Emerging markets and the integration of companion diagnostics offer substantial growth avenues.

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FAQs

1. What are the key drivers behind LYNPARZA’s market growth?
The primary drivers include expanding indications across various cancers, regulatory approvals worldwide, and increased integration of genetic testing to identify suitable patients. Additionally, ongoing clinical trials exploring new combinations and indications support future growth.

2. How does LYNPARZA compare with its competitors?
LYNPARZA maintains a competitive edge due to its early market entry, extensive clinical data, and broad indication portfolio. However, competitors like talazoparib and emerging biosimilars pose challenges, emphasizing the need for continuous innovation.

3. What are potential risks to LYNPARZA’s financial trajectory?
Patent expiration, pricing pressures from payers, clinical trial failures, and increased generic competition could threaten revenue stability. Additionally, regulatory setbacks in new indications or markets pose risks.

4. How significant are combination therapies for LYNPARZA’s future?
Extremely significant. Combining LYNPARZA with immunotherapies and chemotherapies has shown promising efficacy, potentially leading to new approvals and increased market share.

5. What strategies should pharmaceutical companies consider to capitalize on LYNPARZA’s market?
Focus on expanding indications, investing in biomarker research, penetrating emerging markets, forming strategic partnerships for combination therapies, and proactively managing patent portfolios.

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References:

[1] MarketsandMarkets. “PARP Inhibitors Market by Drug Type and Region - Global Forecast to 2028,” 2022.
[2] Company Financial Reports (AstraZeneca). “LYNPARZA Revenue and Earnings Report, 2022.”