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:	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

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 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			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			Y
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017		RX	Yes	Yes			Y
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017		RX	Yes	Yes			Y
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017		RX	Yes	Yes			Y	Y
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	CAPSULE;ORAL	206162-001	Dec 19, 2014
Astrazeneca	LYNPARZA	olaparib	CAPSULE;ORAL	206162-001	Dec 19, 2014
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	208558-002	Aug 17, 2017
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	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
Argentina	063320
Brazil	PI0417056	inibidores de reparo de dano no dna para tratamento de cáncer
Norway	341963
Canada	2533332	COMPOSES THERAPEUTIQUES (TRICYCLIC PARP INHIBITORS)
Japan	2013136607
Poland	2346495
South Korea	20140011425

Supplementary Protection Certificates for olaparib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1633724	1590019-4	Sweden		PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REG. NO/DATE: EU/1/14/959 20141218
1633724	122015000025	Germany		PRODUCT NAME: OLAPARIB, SOWIE SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
1633724	PA2015016	Lithuania		PRODUCT NAME: OLAPARIBUM; REGISTRATION NO/DATE: EU/1/14/959 20141216
2346495	122018000124	Germany		PRODUCT NAME: AMORPHES OLAPARIB, ODER EIN SALZ ODER SOLVAT DAVON, IN EINER FESTEN DISPERSION; REGISTRATION NO/DATE: EU/1/14/959/002-005 20180508
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	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
1633724	596	Finland

Market Dynamics and Financial Trajectory for Olaparib

Last updated: April 14, 2026

What Is Olaparib and Its Approved Uses?

Olaparib is an oral PARP (poly ADP ribose polymerase) inhibitor developed by AstraZeneca. It primarily treats cancers with BRCA1/2 mutations, including ovarian, breast, prostate, and pancreatic cancers. It received approval from the FDA in 2014 for ovarian cancer and expanded to other indications over time, including maintenance therapy and metastatic cases.

Market Size and Growth Trends

Indicator	2022 Data	Projected 2027 Data	Growth Rate (CAGR) (2022-2027)	Source
Global oncology drug market	$195 billion	$286 billion	8.2%	Grand View Research [1]
PARP inhibitor market	$4.6 billion	$12.3 billion	22.2%	Fact.MR [2]
Olaparib’s sales contribution	Approx. $2.2 billion (2022)	> $6.5 billion (2027)	--	Company reports [3]

Olaparib commands a significant share within the PARP inhibitor segment, which itself is rapidly expanding due to high unmet needs in BRCA-mutated cancers. The launch of new indications and geographic expansion are key drivers of its revenue growth.

Competitive and Regulatory Landscape

Major Competitors

• Lynparza (olaparib competitor): Developed by Merck Sharp & Dohme (MSD), approved globally, aggressive marketing and multiple indications bolster its market share.
• Talzenna (talazoparib): Pfizer’s PARP inhibitor, approved for breast and ovarian cancers, capturing a portion of the same patient demographic.
• Rucaparib: Clovis Oncology, indicated for ovarian and prostate cancers.

Regulatory Approvals and Pipeline

• Expanded indications from ovarian to prostate, pancreatic, and breast cancers.
• Ongoing phase 3 trials for earlier lines of therapy aim to extend its scope.
• Regulatory pathways like accelerated approvals and breakthrough designations facilitate faster market penetration.

Market Penetration and Geographic Expansion

Region	Market Share (2022)	Growth Initiatives	Notes
North America	65%	Reimbursement policies, clinical guidelines	Largest known revenue share.
Europe	20%	Market access, orphan drug designations	Growing due to pipeline and approvals.
Asia-Pacific	10%	Registration in Japan, China	Rapidly expanding with new trials and approvals.

Expansion in Asia-Pacific driven by increasing cancer incidence and rising healthcare investment. Local manufacturing partnerships strengthen distribution.

Pricing and Revenue Model

• List prices for olaparib vary by region, with US prices around $13,000-$15,000 per month (per patient).
• Price discounts and insurance negotiations influence actual revenue realization.
• Revenue depends heavily on the number of eligible patients, which is increasing due to expanded indications.

R&D and Pipeline Outlook

• Multiple ongoing trials target earlier cancer stages and combination therapies with immunotherapies.
• Development of biosimilars and generics may impact pricing and profit margins over time.
• AstraZeneca invests approximately 15-20% of pipeline R&D budget into PARP inhibitors, focusing on new combinations and biomarkers to expand usability.

Financial Trajectory and Investment Outlook

Year	Revenue Estimate	Key Risks	Opportunities
2023	$2.5-$3 billion	Patent cliffs, generic competition	Additional indications, all major markets open.
2024	$3-$4 billion	Pricing pressure, pipeline delays	Combination therapy approvals boost sales.
2027	>$6.5 billion	Market saturation, regulatory hurdles	Expansion in Asia-Pacific, personalized medicine.

Increased market penetration, particularly in prostate and pancreatic indications, combined with global expansion, should sustain high revenue growth. Patent protections expected until 2028, after which biosimilars and generics may threaten pricing and margins.

Key Takeaways

• Olaparib remains a dominant PARP inhibitor with growing indications, expanding geography, and increasing revenues.
• Market competition intensifies, especially from Lynparza, which maintains a leading position globally.
• The expanding cancer treatment landscape, including combination therapies, offers growth opportunities but introduces pricing and patent risks.
• Revenue forecasts depend heavily on regulatory approvals, healthcare reimbursement policies, and patient access, notably in emerging markets.
• R&D efforts aim to maintain competitive advantage via new indications, drug combinations, and personalized medicine innovations.

FAQs

1. How does olaparib compare to other PARP inhibitors in the market?
Olaparib holds the largest market share globally due to early approval and broad indications. Lynparza follows closely, backed by extensive trials and global reach. Talazoparib and rucaparib serve niche markets but are expanding.

2. What are the primary factors influencing olaparib’s pricing?
Pricing is driven by regional healthcare policies, patent status, competition, and the severity of indications. US prices hover around $13,000-$15,000/month, but negotiations and discounts reduce actual revenue.

3. What are the key risks to olaparib’s market growth?
Patent expirations, competition from biosimilars, regulatory hurdles, and pricing pressures in major markets pose risks. Clinical development delays or failure to expand indications also impact growth.

4. Which markets are most promising for olaparib’s expansion?
Asia-Pacific, especially China and Japan, represent high-growth opportunities due to rising cancer rates. Europe remains critical, with ongoing approval processes.

5. How will future pipeline developments influence olaparib's financial trajectory?
New indications and combination therapies can significantly boost revenue, especially if approved in earlier lines of treatment. Pipeline progress sustains investor confidence and long-term growth prospects.

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References

[1] Grand View Research. (2022). Oncology Drugs Market Size, Share & Trends Analysis.

[2] Fact.MR. (2022). PARP Inhibitors Market Insights and Forecast.

[3] AstraZeneca. (2022). Annual Financial Reports and Pipeline Announcements.