LYNPARZA Drug Patent Profile

When do Lynparza patents expire, 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 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
Astrazeneca	LYNPARZA	olaparib	CAPSULE;ORAL	206162-001	Dec 19, 2014		DISCN	Yes	No	8,143,241

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	9,169,235
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017	8,912,187
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017	9,566,276
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	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	7,151,102
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017	9,169,235

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
Argentina	116035
New Zealand	545307	Use of RNAI inhibiting parp activity for the manufacture of a medicament for the treatment of cancer
Austria	E528296
China	1856572	Use of RNAi inhibiting parp activtiy for the manufacture of a medicament for the treatment of cancer
Japan	5719471
United Kingdom	2384776	Phthalazinone derivatives
Brazil	PI0412909	uso de rnai inibindo atividade de parp para a fabricação de um medicamento para o tratamento de cáncer

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	2018C/042	Belgium		PRODUCT NAME: L'OLAPARIB AMORPHE OU SEL OU SOLVATES, EN DISPERSION SOLIDE; AUTHORISATION NUMBER AND DATE:
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
2346495	PA2018014	Lithuania		PRODUCT NAME: AMORFINIS OLAPARIBAS ARBA JO DRUSKA ARBA SOLVATAS KIETOJE DISPERSIJOJE; REGISTRATION NO/DATE: EU/1/14/959 20180508
1633724	213 50005-2015	Slovakia		PRODUCT NAME: OLAPARIB; REGISTRATION NO/DATE: EU/1/14/959 20141218
1633724	S1500012	Hungary		PRODUCT NAME: OLAPARIB
1633724	92680	Luxembourg		PRODUCT NAME: OLAPARIB AINSI QUE DES SELS ET DES SOLVATES DE CELUI-CI. FIRST REGISTRATION: 20141218

Market Dynamics and Financial Trajectory for LYNPARZA (Olaparib)

Last updated: December 28, 2025

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Executive Summary

LYNPARZA (olaparib), developed by AstraZeneca and Merck & Co., is a groundbreaking PARP inhibitor approved for multiple cancer indications, including ovarian, breast, pancreatic, and prostate cancers. The drug's innovative mechanism targeting homologous recombination deficiency (HRD) has positioned it at the forefront of personalized oncology, driving significant revenue growth. This report analyzes the evolving market environment, key drivers shaping LYNPARZA’s growth trajectory, competitive landscape, and financial outlook.

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Introduction

LYNPARZA is a first-in-class poly(ADP-ribose) polymerase (PARP) inhibitor approved by the U.S. Food and Drug Administration (FDA) in 2014 for BRCA-mutated ovarian cancer and subsequently expanded for other cancers. Its strategic positioning in genetically defined oncologic niches leverages the rise of precision medicine. The convergence of rising cancer prevalence, improved diagnostics, and expanding indications forecasts a compelling growth phase over the next decade.

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Market Overview

Parameter	Details
Global Oncology Market (2022)	$235 billion (Source: GlobalData)
PARP Inhibitors Market (2022)	$4.8 billion (approximate, projected CAGR 15%)
LYNPARZA’s Market Share (2022)	Estimated 45% within PARP class (Source: EvaluatePharma)

LYNPARZA's positioning within personalized treatment markets is influenced by its broadening approved indications, which currently include:

• Ovarian cancer (initial approval 2014)
• Breast cancer (2018, gBRCA-positive)
• Pancreatic cancer (2019)
• Prostate cancer (2020)

Market Drivers

Increasing Cancer Prevalence

Global cancer incidences are rising, with WHO estimating 19.3 million new cases in 2020. Ovarian cancer (~238,700 cases globally, 2020) and breast, pancreatic, and prostate cancers are primary markets for LYNPARZA.

Advances in Precision Oncology

The shift towards biomarker-driven treatments enhances drug adoption. LYNPARZA’s efficacy in BRCA-mutant and HRD-positive tumors makes it integral to personalized regimens.

Regulatory Approvals and Expanding Indications

• FDA expansions: A continuous pipeline of approvals, including earlier-line treatment options.
• EMA and other regulators endorsing similar indications bolster market penetration.

Competitive Landscape

Major Competitors	Notable Drugs	Indications	Market Share (2022)
Rucaparib	Rubraca	Ovarian, prostate	25%
Niraparib	Zejula	Ovarian, breast	20%
Talazoparib	Talzenna	Breast	10%
Others	Various	Limited	10%

LYNPARZA remains dominant owing to earlier approvals and broader label coverage.

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Revenue Trajectory

Financial Year	Global revenues (USD millions)	Growth Rate	Notes
2014	$25	N/A	Initial launch; limited indications
2018	$600	2,300%	Expanded indications, increased adoption
2020	$2,100	250%	COVID-19 impact mitigated, new approvals
2022	$3,750	78.5%	Several new indications, higher market penetration
Projected 2025	$6,200	~50%	Continued indication expansion, pipeline contribution

Source: Company financial reports and analyst projections.

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Pipeline and Indications Expansion

Stage	Indication	Expected Approval Year	Significance
Phase III	Colorectal and other solid tumors	2023-2024	Potential new markets
Pre-Clinical	Combination therapies with immunotherapies	N/A	Long-term growth avenues

The ongoing trials aim to solidify LYNPARZA's role across various tumor types, especially in combination regimens with immune checkpoint inhibitors, an area expected to contribute disproportionately to future revenues.

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Regulatory and Policy Environment

• FDA’s Breakthrough Therapy Designation promotes faster review pathways.
• EMA’s Conditional Approvals facilitate rapid access in Europe.
• Pricing and reimbursement policies increasingly favor value-based care, influencing net pricing.

Compliance with regional pricing policies, such as the Inflation Reduction Act in the US, may impact profit margins and discount strategies.

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Competitive Advantages and Challenges

Advantages	Challenges
First-mover advantage in multiple indications	Patent cliffs and generic erosion expected post-2030
Strong pipeline	Competition from emerging biomarker-driven therapies
Broad clinical data supporting efficacy	High drug development and marketing costs
Strategic collaborations (e.g., AstraZeneca/Merck)	Regulatory hurdles in emerging markets

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Financial Outlook and Future Trends

Forecasts (2023-2027)	Details
Compound Annual Growth Rate (CAGR)	Estimated 16%
Key growth drivers	Additional indications, geographic expansion, combo therapies
Potential risks	Market saturation, patent expiration, regulatory delays

Analysts project that LYNPARZA will cross the $6 billion revenue mark by 2025, driven by its expanding label and strategic pipeline.

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Comparison with Peers

Parameter	LYNPARZA	Rucaparib	Niraparib	Talazoparib
Initial Approval Year	2014	2016	2017	2018
Indications Covered	4 (expanding)	2	2	1
Market Share (2022)	45%	25%	20%	10%
Revenue (2022, USD millions)	3,750	1,500	900	300

LYNPARZA’s broad indication portfolio and early market entry provide a competitive edge over peers with narrower approval footprints.

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Key Takeaways

• Market Position: LYNPARZA’s early entry into oncology and broadening indications sustain a leading market position.
• Revenue Growth: Predicted to grow at a CAGR of ~16% through 2027, reaching over $6 billion.
• Pipeline Significance: Ongoing trials and newly approved indications will be critical to future financial success.
• Competitive Landscape: Dominant but facing increasing competition, emphasizing the need for sustained innovation.
• Policy Impact: Favorable regulatory environments and value-based pricing are critical drivers, with potential pricing pressures on the horizon.

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FAQs

1. What are the key indications driving LYNPARZA’s revenues?
The primary revenue drivers are ovarian, breast, pancreatic, and prostate cancers, especially in BRCA-mutant and HRD-positive populations.

2. How does LYNPARZA compare to other PARP inhibitors?
LYNPARZA has a broader indication portfolio and earlier market entry, giving it a significant competitive edge over rivals such as Rucaparib and Niraparib, although competition is intensifying.

3. What are upcoming indications for LYNPARZA?
Potential approvals include colorectal cancers, combination therapies with immunotherapies, and expanded solid tumor applications.

4. How might regulatory policies impact LYNPARZA’s growth?
Fast-track approvals, reimbursements, and pricing policies foster growth, but evolving pricing negotiations and patent expiries pose risks.

5. What role does pipeline development play in LYNPARZA’s future?
Pipeline expansion, including combination strategies and new indications, is vital for sustaining long-term revenue growth and offsetting patent cliff effects.

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References

1. AstraZeneca Annual Reports (2014-2022).
2. EvaluatePharma Oncology Market Data (2022).
3. World Health Organization (WHO). Cancer Statistics, 2020.
4. GlobalData Reports on Oncology & PARP Inhibitor Markets, 2022.
5. FDA and EMA approval announcements and drug labels.