LYNPARZA Drug Patent Profile

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

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 ten 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

NDA:

206162

Dosage:

CAPSULE;ORAL

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 three FDA Regulatory Exclusivities.

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			Y
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017		RX	Yes	No			Y
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017		RX	Yes	Yes			Y	Y
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017		RX	Yes	No			Y
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017		RX	Yes	No

Expired US Patents for LYNPARZA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017
Astrazeneca	LYNPARZA	olaparib	CAPSULE;ORAL	206162-001	Dec 19, 2014
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017

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
China	101528714
Ukraine	97494
Ukraine	106878	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ 4-[ 3- (4-ЦИКЛОПРОПАН КАРБОНИЛ ПИПЕРАЗИН-1-КАРБОНИЛ)-4-ФТОРБЕНЗИЛ]-2Н-ФТАЛАЗИН-1-ОН ИЛИ ЕГО СОЛЬ, ИЛИ СОЛЬВАТ, В ТВЕРДОЙ ДИСПЕРСИИ С МАТРИЧНЫМ ПОЛИМЕРОМ КОПОВИДОНОМ;ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ЩО МІСТИТЬ 4-[3-(4-ЦИКЛОПРОПАНКАРБОНІЛПІПЕРАЗИН-1-КАРБОНІЛ)-4-ФТОРБЕНЗИЛ]-2Н-ФТАЛАЗИН-1-ОН АБО ЙОГО СІЛЬ, АБО СОЛЬВАТ, У ТВЕРДІЙ ДИСПЕРСІЇ З МАТРИЧНИМ ПОЛІМЕРОМ КОПОВІДОНОМ (PHARMACEUTICAL FORMULATION COMPRISING 4-[3-(4-CYCLOPROPANECARBONYL- PIPERAZINE-1-CARBONYL) -4-FLUORO-BENZYL]-2H-PHTHALAZIN-1-OH OR SALT THEREOF OR SOLVATE IN A SOLID DISPERSION WITH A MATRIX POLYMER COPOVIDONE)
Malaysia	160340	PHARMACEUTICAL FORMULATION 514
European Patent Office	2346495

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
2346495	CA 2018 00039	Denmark		PRODUCT NAME: AMORF OLAPARIB ELLER ET SALT ELLER SOLVAT DERAF, I EN FAST DISPERSION; REG. NO/DATE: EU/1/14/959 20180515
1633724	1590019-4	Sweden		PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REG. NO/DATE: EU/1/14/959 20141218
1633724	C300726	Netherlands		PRODUCT NAME: OLAPARIB, EN ZOUTEN EN; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
1633724	122015000025	Germany		PRODUCT NAME: OLAPARIB, SOWIE SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959/001 20141216

Market Dynamics and Financial Trajectory for LYNPARZA

Last updated: February 26, 2026

What is LYNPARZA?

LYNPARZA (olaparib) is a PARP inhibitor developed by AstraZeneca and Merck & Co., approved for treating ovarian, breast, pancreatic, and prostate cancers. It gained U.S. Food and Drug Administration (FDA) approval in 2014 for ovarian cancer, with subsequent approvals expanding its indications.

Market Size and Growth

Global Market Valuation

The global PARP inhibitor market was valued at approximately $4.5 billion in 2021. It is projected to reach $13 billion by 2028, with a compound annual growth rate (CAGR) of about 16% from 2022 to 2028 (Research and Markets, 2022).

Year	Market Size (USD billions)	CAGR (%)
2021	4.5	—
2022	5.2	15.6
2028	13.0	16.1

Drivers of Growth

• High prevalence of ovarian and breast cancers.
• Expanding approval portfolio for new cancers and lines of therapy.
• Increased adoption of maintenance therapy post-chemotherapy.
• Growing awareness and companion diagnostics improving patient selection.

Competitive Landscape

Key Players

• AstraZeneca (LYNPARZA/Olaparib)
• Pfizer (Talzenna/Alpelisib)
• Clovis Oncology (Rubraca/Rucaparib)
• Tesaro (Defitelio, acquired by GSK but no direct PARP focus)

Drug Approvals and Indications

• LYNPARZA holds broader approvals than competitors for ovarian, breast, prostate, and pancreatic cancers.
• Clovis's Rucaparib is approved for ovarian and prostate cancers but has fewer indications.

Patent and Patent Expiry

• AstraZeneca's core patents for LYNPARZA are set to expire around 2028-2030, with patent protection in key markets.
• Patent expiration may open opportunities for generics and biosimilars, potentially impacting pricing and market share.

Revenue and Financial Performance

Recent Revenue Highlights

• AstraZeneca's Oncology segment, including LYNPARZA, reported revenue of $3.2 billion in 2022.
• LYNPARZA's contribution within this segment increased annually at high double-digit rates.

Year	Revenue from LYNPARZA (USD millions)	Growth Rate (%)
2020	360	—
2021	700	94
2022	1,200	71

Market Penetration

• Initial uptake driven by second-line maintenance setting.
• Expansion into first-line maintenance therapy approved by FDA for ovarian cancer in 2020.
• Growth in prostate cancer indications and use in combination therapies bolster sales.

Regulatory Status and Pipeline

Current Approvals

• FDA approvals for ovarian, breast, prostate, and pancreatic cancers.
• EMA approvals aligned with FDA.
• Expanded indications continue to increase patient accessibility.

Pipeline Drugs

• Trials for combinations with immunotherapies (e.g., PD-1 inhibitors) aim to expand its use.
• New formulations and biomarker-driven indications are in progress.

Pricing and Reimbursement

• Wholesale acquisition cost (WAC) in the U.S. approximately $13,000 per month per patient.
• Reimbursement varies by country but generally aligns with the drug’s proven efficacy and outcomes.
• Payers' coverage has improved alongside growing clinical evidence and expanded indications.

Challenges and Risks

• Patent expiry risks, potentially leading to generic competition.
• Competition from alternative therapies and emerging targeted drugs.
• Off-label use and reimbursement policies impact market penetration.
• Pricing pressures in regulated markets.

Future Outlook

• Continued growth driven by expanded indications, including early-line treatments.
• Pipeline drugs and combination therapies could substantially increase revenue.
• Patent expiries will pressure pricing and margins from late 2020s onward.
• Potential for increased market share through companion diagnostics and biomarker-driven approaches.

Key Takeaways

• LYNPARZA is a leading PARP inhibitor with broad approvals, contributing significantly to AstraZeneca's oncology sales.
• The global PARP market is expanding rapidly, driven by increasing cancer prevalence and expanding indications.
• Revenue growth has been strong, with a compound annual growth rate around 15-16%.
• Patent expiration around 2028-2030 could influence pricing and market share.
• Pipeline development involving combinations and new indications can sustain long-term growth.

FAQs

What are LYNPARZA’s primary approved indications?
Ovarian, breast, prostate, and pancreatic cancers.

How does LYNPARZA's market share compare to competitors?
It holds the largest share among PARP inhibitors due to broader indications and established clinical profile.

What factors could impact LYNPARZA’s future sales?
Patent expiry, emerging competitors, regulatory changes, and reimbursement policies.

Are combination therapies with LYNPARZA expected to expand its use?
Yes, ongoing trials with immunotherapies and other agents may broaden indications.

What are the key risks related to LYNPARZA’s commercialization?
Patent cliff, pricing pressures, competition, and off-label use restrictions.

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References

[1] Research and Markets. (2022). Global PARP inhibitors Market Analysis and Trends. Retrieved from https://www.researchandmarkets.com

[2] AstraZeneca Annual Report. (2022). Oncology Segment Performance. Retrieved from https://www.astrazeneca.com

[3] U.S. Food and Drug Administration. (2020). LYNPARZA (olaparib) approval documents. Retrieved from https://www.fda.gov