Olaparib - Generic Drug Details

What are the generic drug sources for olaparib and what is the scope of freedom to operate?

Olaparib is the generic ingredient in one branded drug marketed by Astrazeneca and is included in two NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are three drug master file entries for olaparib. One supplier is listed for this compound. There are three tentative approvals for this compound.

Summary for olaparib

International Patents:	254
US Patents:	12
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	140
Clinical Trials:	424
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for olaparib
What excipients (inactive ingredients) are in olaparib?	olaparib excipients list
DailyMed Link:	olaparib at DailyMed

Recent Clinical Trials for olaparib

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

Sponsor	Phase
Harbin Medical University	NA
National Institutes of Health (NIH)	PHASE1
National Cancer Institute (NCI)	PHASE1

See all olaparib clinical trials

Generic filers with tentative approvals for OLAPARIB

Applicant	Application No.	Strength	Dosage Form
		150MG	TABLET
		150MG	TABLET
		150MG	TABLET

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for olaparib

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

Anatomical Therapeutic Chemical (ATC) Classes for olaparib

L01XK	Poly (ADP-ribose) polymerase (PARP) inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for OLAPARIB

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 olaparib

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

Expired US Patents for olaparib

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

EU/EMA Drug Approvals for olaparib

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 olaparib

Country	Patent Number	Title	Estimated Expiration
Chile	2011000774
United Kingdom	2419882	Use of rnai inhibiting parp activtiy for the manufacture of a medicament for the treatment of cancer
Japan	2013136607
Japan	2009079056	PHTHALAZINONE DERIVATIVE

Supplementary Protection Certificates for olaparib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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:

Market Dynamics and Financial Trajectory for Olaparib

Last updated: November 25, 2025

Introduction

Olaparib, a pioneering PARP (Poly (ADP-ribose) polymerase) inhibitor, has transformed the treatment landscape for certain cancers, notably ovarian and breast cancers harboring BRCA mutations. Since its FDA approval in 2014 for ovarian cancer, Olaparib’s market penetration has expanded across multiple indications, driven by robust clinical data and strategic industry collaborations. This article examines the current market dynamics and forecasts the financial trajectory of Olaparib, considering epidemiological trends, competitive landscape, regulatory developments, and potential growth drivers.

Epidemiological and Clinical Context

The global burden of BRCA-mutated ovarian and breast cancers underpins Olaparib’s commercial potential. According to WHO estimates, ovarian cancer accounts for approximately 5% of cancers among women worldwide, with about 22,000 new cases annually in the U.S. alone. Breast cancer, with over 2.3 million new cases globally in 2020, also includes a subset of patients with hereditary BRCA mutations who benefit from Olaparib-based therapies.

Clinical trials such as SOLO-1 and OlympiAD have demonstrated Olaparib’s efficacy in extending progression-free survival (PFS) in patients with BRCA-mutated cancers, fostering regulatory approvals across multiple lines of therapy. As guidelines increasingly endorse genetic testing for BRCA mutations, the target patient population continues to grow, fueling demand.

Market Dynamics

Regulatory Expansion and Indications Growth

Following initial approval for ovarian cancer in 2014, regulatory agencies expanded Olaparib’s indications to include first-line maintenance therapy, metastatic breast cancer, pancreatic cancer, and prostate cancer. The U.S. FDA approved Olaparib for metastatic breast cancer with germline BRCA mutations in 2018, and subsequent approvals in Europe and other jurisdictions have amplified its market access.

The expanding label substantially enlarges the eligible patient pool, with the global hereditary breast and ovarian cancer (HBOC) population estimated at over 300,000 annually. Moreover, ongoing clinical trials exploring combination therapies and earlier treatment lines could further broaden its indications, especially as preliminary data suggest synergistic benefits with immunotherapies and chemotherapies.

Competitive and Strategic Landscape

Olaparib faces competition from other PARP inhibitors, including Lynparza (oxaliplatin), Talazoparib, and Niraparib. Notably, Lynparza remains the market leader due to its first-mover advantage and robust data supporting multiple indications. However, strategic collaborations, licensing deals, and differential patent protections influence market share.

One key strategic shift involves AstraZeneca’s partnership with Merck (known as MSD outside the U.S.), reinforcing Olaparib’s global distribution and marketing. Additionally, the expiration of some patent protections could open avenues for biosimilar entrants, exerting downward pressure on prices in mature markets.

Pricing and Reimbursement Environment

Olaparib’s high-cost pricing model reflects the chronic nature of cancer treatment and personalized medicine complexity. In the U.S., the average wholesale price (AWP) exceeds $15,000 per month per patient, with actual prices varying based on negotiated rebates and payer arrangements.

Reimbursement policies significantly influence market access. Favorable outcomes from health technology assessments (HTAs), such as NICE in the UK and IQWiG in Germany, validate value-based pricing and expand coverage. Conversely, restrictive reimbursement policies or mandatory prior authorizations could temper growth, especially in cost-sensitive markets.

Market Penetration and Adoption Drivers

Rapid adoption hinges on genetic testing infrastructure, clinician awareness, and patient eligibility. Increasing integration of genetic screening in oncology clinics facilitates identification of suitable candidates, boosting utilization. Furthermore, evolving guidelines recommend testing as standard of care, which enhances Olaparib’s reach.

Patient adherence and side effect profiles also impact market dynamics. Olaparib’s manageable safety profile supports higher compliance, while adverse events like anemia and fatigue require ongoing management but do not significantly restrict use.

Financial Trajectory and Forecasting

Current Market Size and Revenue Streams

In 2022, the Olaparib market was valued at around USD 2.2 billion globally, predominantly driven by the U.S., Europe, and emerging markets. The U.S. accounts for over 50% of revenue, aligned with higher healthcare expenditure and widespread approval.

Revenue streams primarily arise from direct sales, partnerships, and licensing arrangements. The evolving indications contribute to diverse revenue sources, with the first-line maintenance therapy and breast cancer segments emerging as significant contributors.

Growth Drivers and Challenges

Projections indicate a compounded annual growth rate (CAGR) of approximately 12-15% through 2030, driven by:

• Expansion of indications: Inclusion of Olaparib in first-line settings and other cancer types (prostate, pancreatic).
• Increased genetic testing: Rising adoption accelerates patient identification.
• Combination therapies: Trials showing improved efficacy with other agents could lead to label expansions.
• Global market penetration: Emerging markets adopting Olaparib as part of standard treatment.

Potential challenges include:

• Price pressures and biosimilar competition post-patent expiry.
• Regulatory delays or setbacks, potentially restricting access.
• Market saturation in mature indications.

Regional Market Dynamics

• United States: Market leadership with robust reimbursement and early adoption.
• Europe: Gradual expansion driven by HTA assessments; pricing negotiations vary by country.
• Asia-Pacific: Emerging key region owing to rising cancer incidence and improving healthcare infrastructure, projected to witness rapid growth.

Long-Term Financial Outlook

With ongoing clinical research and pipeline development (e.g., combination trials, new indications), Olaparib’s revenue could triple from current levels by 2030. Industry forecasts suggest that by 2030, annual revenues could reach USD 7-8 billion worldwide, assuming regulatory approvals and market access remain favorable.

Conclusion

Olaparib’s market landscape continues to evolve, fueled by expanding indications, increasing adoption of genetic testing, and strategic industry collaborations. While competitive pressures and upcoming patent expirations pose challenges, the strong clinical evidence base and ongoing research promise sustained revenue growth. Industry stakeholders should monitor regulatory developments, regional market dynamics, and technological advancements to optimize financial outcomes.

Key Takeaways

• The global Olaparib market is poised for sustained growth, with a projected CAGR of 12-15% through 2030.
• Expansion of indications and increased genetic testing are primary growth drivers.
• Competitive landscape with other PARP inhibitors necessitates strategic differentiation.
• Price management and reimbursement policies will significantly influence market access and revenue.
• Emerging markets present significant opportunities but require tailored market-entry strategies.

FAQs

1. What are the primary indications for Olaparib?
Olaparib is approved for ovarian, breast, pancreatic, and prostate cancers with germline or somatic BRCA mutations, including maintenance therapy and treatment of metastatic disease.

2. How does Olaparib compare with other PARP inhibitors?
Olaparib was among the first PARP inhibitors and has extensive clinical data supporting multiple indications, providing a competitive advantage, though market share is increasingly contested by competitors like Lynparza and Talazoparib.

3. What are the main factors influencing Olaparib’s pricing and reimbursement?
Pricing hinges on clinical value, competitive landscape, and healthcare system regulations. Reimbursement depends on HTA evaluations, cost-effectiveness analyses, and payer negotiations.

4. What is the outlook for biosimilar competition?
Patent expiry in key markets may facilitate biosimilar entrants, potentially reducing prices and impacting revenues. Strategic IP management and pipeline development are critical to mitigate this effect.

5. How might emerging combination therapies impact Olaparib’s market?
Clinical trials combining Olaparib with immunotherapies and other targeted agents could improve efficacy and expand its use. Successful results may lead to new indications and increased market share.

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References

[1] World Health Organization, Cancer Fact Sheets.
[2] American Cancer Society, Cancer Facts & Figures 2022.
[3] U.S. Food & Drug Administration, Olaparib Approvals.
[4] industry analyst reports, 2023.