Olaparib - Generic Drug Details

What are the generic 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:	426
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

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

Constraining patent/regulatory exclusivity:

8,247,416

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

7,449,464

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 olaparib

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

Sponsor	Phase
Shanghai SciBrunch Therapeutics Co., Ltd.	PHASE1
Harbin Medical University	NA
National Institutes of Health (NIH)	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	208558-001	Aug 17, 2017		RX	Yes	No	8,475,842		Y
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017		RX	Yes	Yes	12,144,810		Y
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017		RX	Yes	Yes	7,449,464		Y	Y
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017		RX	Yes	Yes	8,071,579

Expired US Patents for olaparib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017	9,169,235
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	9,566,276

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
China	1788000	Phthalazinone derivatives
South Korea	20060123403	DNA DAMAGE REPAIR INHIBITORS FOR TREATMENT OF CANCER
South Korea	101668499
Serbia	55157	FARMACEUTSKA FORMULACIJA 514 (PHARMACEUTICAL FORMULATION 514)

Supplementary Protection Certificates for olaparib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1633724	213 50005-2015	Slovakia		PRODUCT NAME: OLAPARIB; REGISTRATION NO/DATE: EU/1/14/959 20141218
2346495	2018C/042	Belgium		PRODUCT NAME: L'OLAPARIB AMORPHE OU SEL OU SOLVATES, EN DISPERSION SOLIDE; AUTHORISATION NUMBER AND DATE:
1633724	15C0022	France		PRODUCT NAME: OLAPARIB,SELS ET SOLVATES DE CELUI-CI; REGISTRATION NO/DATE: EU 1/14/959 20141218
1633724	1590019-4	Sweden		PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REG. NO/DATE: EU/1/14/959 20141218

Market Dynamics and Financial Trajectory for Olaparib

Last updated: March 10, 2026

Olaparib is a PARP inhibitor developed by AstraZeneca, approved primarily for ovarian, breast, prostate, and pancreatic cancers with BRCA mutations. The drug generated $953 million in global sales in 2022, indicating strong market presence. The market is driven by increasing prevalence of targeted cancer therapies and expanding indications, with significant growth projected over the next decade.

Current Market Overview

Metric	Figure	Source
2022 Global Sales	$953 million	AstraZeneca financial reports (2022)
Leading Indications	Ovarian, breast, prostate, pancreatic	FDA approvals, EMA approvals
Market Share (2022)	~40% in PARP inhibitor class	IQVIA, EvaluatePharma
Competitors	Niraparib, Rucaparib, Talazoparib	Market reports, peer-reviewed analysis
Approved Regions	US, EU, Japan, China	Regulatory filings

Market Drivers

• Expanding Indications: Olaparib’s approval expanded into prostate and pancreatic cancers, increasing potential patient populations. New approvals in early-stage settings are under review, which could open additional revenue streams.

• Biomarker-Driven Treatment: Rising use of BRCA mutation testing enables more personalized treatments, supporting drug uptake.

• Pipeline Diversification: AstraZeneca is investigating olaparib in combination with immunotherapies and chemotherapies across multiple tumor types, potentially broadening its application.

Market Challenges

• Patent Expiry and Biosimilar Entry: Patent protection in major markets is set to expire around 2029. Biologic and biosimilar competitors could erode market share, especially in Europe and the US.

• Pricing Pressures: Governments and insurers seek value-based pricing frameworks. This could lead to price reductions, especially in price-sensitive markets like China and India.

• Competition from Other PARP Inhibitors: Niraparib, rucaparib, and talazoparib are approved for similar indications with comparable efficacy. Market differentiation depends on label breadth, dosing, and side-effect profiles.

Revenue Outlook

Year	Estimated Sales	Growth Rate	Assumptions
2023	$1.2 billion	25%	Launch of new indications, expanded biomarkers testing
2025	$1.8 billion	50%	Additional approvals, combination trials yielding new combos
2030	$2.5–3 billion	20-30%	Patent expiration, biosimilar entry, pipeline success

Forecasts are contingent on regulatory timelines, successful clinical trial outcomes, and competitive responses. Demand remains robust in regions where biomarker testing is integrated into standard care. Emerging markets like China are expected to see accelerated adoption due to higher cancer prevalence and increasing healthcare infrastructure investments.

Investment Implications

• Growth Opportunities: Pipeline expansion into earlier lines of therapy and combination regimens is a key driver of future revenue.

• Market Risks: Patent cliffs and biosimilar competition necessitate innovation and Life Cycle Management strategies.

• Pricing Strategies: Negotiations with payers and regional authorities could impact profitability margins.

Regulatory Landscape

Region	Key Dates	Status
US	Approved since 2014; New indications under review	Market leader, competitive pressure increasing
EU	Approved since 2015; ongoing extensions	Patent expiry set for 2029; biosimilar entry anticipated
Japan	Approved 2016	Expanding use in additional indications
China	Approved 2021	Rapid uptake post-approval; potential price negotiations

Conclusion

Olaparib is positioned as a leading PARP inhibitor with significant growth prospects driven by expanding indications and ongoing clinical research. Competitive pressures and patent expiry will influence its financial trajectory, calling for continual product innovation and strategic market expansion.

Key Takeaways

• Revenue exceeding $950 million in 2022, with expected continued growth.
• Pipeline and label expansions are critical for sustaining growth.
• Patent protection remaining until 2029 gives AstraZeneca time to solidify market share.
• Competition from biosimilars and other PARP inhibitors remains a significant risk.
• Regional market access strategies will influence overall global sales.

FAQs

1. When does AstraZeneca’s patent protection for olaparib expire?
Patent expiration is expected around 2029 in major markets, post which biosimilar competition may impact sales.

2. What are the primary clinical trial initiatives for olaparib?
Trials explore combinations with immunotherapies, use in earlier disease stages, and expansion into additional tumor types.

3. How does olaparib differentiate from competitors?
Differentiation hinges on approved indications, dosing schedules, side-effect profiles, and biomarker testing integration.

4. Which regions are most vital for olaparib sales?
The US and Europe dominate current sales; China and emerging markets offer substantial growth potential.

5. What is the potential impact of biosimilars on olaparib’s market share?
Biosimilars could significantly reduce premiums where patent exclusivity ends, particularly in Europe and the US.

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References

[1] AstraZeneca. (2022). Annual Report 2022.
[2] EvaluatePharma. (2022). Oncology pipeline and sales forecasts.
[3] IQVIA. (2022). Global oncology market analysis.
[4] US Food and Drug Administration. (2022). Approval reports for PARP inhibitors.
[5] European Medicines Agency. (2022). Regulatory status of olaparib.