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	208558-001	Aug 17, 2017		RX	Yes	No
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017		RX	Yes	Yes
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017		RX	Yes	No	7,449,464		Y	Y
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017		RX	Yes	Yes	12,178,816		Y
Astrazeneca	LYNPARZA	olaparib	CAPSULE;ORAL	206162-001	Dec 19, 2014		DISCN	Yes	No	8,247,416			Y
Astrazeneca	LYNPARZA	olaparib	CAPSULE;ORAL	206162-001	Dec 19, 2014		DISCN	Yes	No	8,143,241

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	7,981,889
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017	9,169,235
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017	8,912,187
Astrazeneca	LYNPARZA	olaparib	CAPSULE;ORAL	206162-001	Dec 19, 2014	8,912,187
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017	8,912,187
Astrazeneca	LYNPARZA	olaparib	CAPSULE;ORAL	206162-001	Dec 19, 2014	7,151,102

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	073792
Argentina	116035
Australia	2009300866
Brazil	122021018683
Brazil	PI0920604
Canada	2737400

Supplementary Protection Certificates for olaparib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1633724	596	Finland
1633724	S1500012	Hungary		PRODUCT NAME: OLAPARIB
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
1633724	1590019-4	Sweden		PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REG. NO/DATE: EU/1/14/959 20141218
1633724	C20150012 00136	Estonia		PRODUCT NAME: OLAPARIIB;REG NO/DATE: EU/1/14/959 18.12.2014
1633724	C300726	Netherlands		PRODUCT NAME: OLAPARIB, EN ZOUTEN EN; REGISTRATION NO/DATE: EU/1/14/959/001 20141216

Last updated: June 19, 2026

Olaparib Market Dynamics and Financial Trajectory (R&D, Patent, and Competition Outlook)

Olaparib (Lynparza; AstraZeneca) is a high-revenue PARP inhibitor with a mature but still growing franchise driven by expanded oncology indications, steady oral regimen adoption, and ongoing combination strategies (including immuno-oncology and targeted therapy pairings). Near-term financial trajectory is shaped less by first-line market creation and more by (1) label expansion into earlier lines and broader biomarker-defined populations, (2) competitive pressure from other PARP inhibitors and emerging “PARP-like” mechanisms, and (3) patent and exclusivity milestones that govern generic and biosimilar-analog entry risk for small-molecule generics. From a patent and litigation standpoint, olaparib’s exclusivity and enforceable claims vary by dosage form and jurisdiction, with the practical economic risk concentrated in the post-primary-exclusivity window and in any settlement-constrained generic timelines.

How fast is olaparib growing and what is driving revenue performance?

Olaparib’s revenue profile historically tracks a combination of: (a) continued uptake in ovarian cancer and breast cancer settings defined by homologous recombination deficiency or germline mutations, (b) penetration of combinations (particularly with anti-angiogenic agents and other targeted therapies), and (c) incremental growth from line-of-therapy expansion where clinicians move from later-line PARP use toward earlier relapse settings.

Which indications contribute most to the olaparib revenue base?

• Ovarian cancer: maintenance and treatment settings in BRCA-mutated and HRD biomarker-defined populations.
• Breast cancer: germline BRCA-mutated HER2-negative metastatic breast cancer, with additional use cases tied to biomarker status and prior therapy exposure.
• Prostate cancer: HRR-mutated metastatic castration-resistant prostate cancer and other defined subpopulations.
• Pancreatic cancer: biomarker-defined combinations and later-line settings.

The revenue engine is typically strongest where olaparib has durable guideline adoption and where regulatory expansion creates “new patient volumes” rather than only shifting market share within a narrow subgroup.

What utilization patterns drive market dynamics for an oral PARP inhibitor?

• Sustained monthly oral dosing makes persistence and dose intensity a key real-world factor.
• Biomarker testing (BRCA1/2, HRD assays) affects patient eligibility and forecastable addressable volumes.
• Combination regimens increase total addressable therapy occasions, even when PARP monotherapy growth slows.

What are the key market dynamics affecting olaparib’s competitive position?

Olaparib’s market dynamics reflect a mature class with head-to-head competition among PARP inhibitors, plus structural changes created by treatment sequencing (monotherapy PARP vs combination PARP).

Which competitors pressure olaparib in PARP inhibition?

The PARP inhibitor landscape includes multiple marketed agents that compete for overlapping biomarker-defined populations. Pressure comes from:

• Earlier use in relapse settings, when PARP inhibitors are deployed sooner.
• Better tolerated or easier-to-manage regimens.
• Differences in label breadth for HRD/BRCA subtypes and line-of-therapy inclusion.
• Combination strategies that produce “regimen loyalty” with oncology providers.

How does combination therapy change olaparib’s market share economics?

Combinations tend to:

• Increase overall regimen spending per patient (PARP plus partner).
• Make payer and clinician decisions less about PARP monotherapy efficacy alone and more about comparative effectiveness of the full regimen.
• Create stability by locking in multi-drug pathways, reducing substitution to a single-agent PARP inhibitor unless there is clear regimen superiority.

When does olaparib lose exclusivity and what generic entry risks exist?

For a small-molecule drug like olaparib, generic entry risk centers on patent term expiration, regulatory exclusivity expirations, and any Paragraph IV filing outcomes. The economic impact depends on (1) how many Orange Book-listed patents remain enforceable for the exact dosage forms and strengths, (2) whether generic sponsors reach “at-risk” launch dates, and (3) any authorized generic or settlement-driven timing.

Orange Book-driven exclusivity and patent expiry mechanics

Generic entry is blocked until:

• The latest listed patent covering the relevant formulation/method expires or is cleared.
• Any statutory exclusivity periods end (if applicable), including marketing exclusivity tied to approvals.

Paragraph IV risks for olaparib

Paragraph IV challenges can lead to:

• Temporary injunctions against launch while litigation proceeds.
• A settlement that moves generic launch dates beyond statutory triggers.
• A scenario where some generic launches occur earlier for non-infringing strengths/forms if patent coverage is fragmented by dosage.

What dosage forms drive patent landscape complexity for generic entry?

Olaparib’s franchise includes multiple strengths and a tablet formulation; patent coverage commonly differs across:

• Composition-of-matter vs formulation/solid-state patents
• Specific capsule/tablet manufacturing parameters
• Method-of-treatment claims tied to biomarker-defined populations

Because generic products must be bioequivalent and approved for specific strengths, the enforceable patent map at the strength and formulation level determines launch risk.

What patents protect olaparib and how strong is the patent estate?

Olaparib’s patent estate includes a mix of core compound protection, crystalline or formulation-specific claims, and method-of-use claims tied to therapeutic indications. For business decisions, the practical question is not total patent count but which claims remain enforceable at the intended generic entry timeframe.

How to interpret “patent estate strength” for olaparib

Strong estates share several traits:

• Multiple independent claim sets that survive invalidity challenges.
• Active prosecution of improvements that extend enforcement coverage (e.g., formulations or new combinations).
• Jurisdictional breadth that discourages early localized market erosion.

Weak estates show:

• Reliance on a narrow set of claims with easy design-around paths.
• Patent cliffs that align for all dosage forms.
• Settlement patterns that enable predictable, earlier generic entry.

What patent litigation affects olaparib’s generic launch timelines?

Olaparib faces class-level generic scrutiny typical for high-value oncology assets. Patent litigation typically influences launch through:

• 30-month stay from Paragraph IV filings.
• Injunctions tied to likelihood of infringement and irreparable harm standards.
• Settlement agreements that fix future launch design and timing.

How settlements change the financial trajectory

Settlements often convert litigation uncertainty into:

• Defined authorized or non-authorized generic launch windows.
• Revenue compression curves that begin at predictable dates.
• Reduced at-risk launch probability for challengers not included in agreements.

What is the FDA regulatory status of olaparib and how does it affect commercialization?

Olaparib’s FDA status includes approvals across multiple oncology settings and line-of-therapy constructs. Commercially, the critical drivers are:

• Label breadth tied to biomarker selection.
• Continued evidence generation supporting expansion.
• Pathway decisions for supplements and combination indications.

What FDA milestones matter for investor and payer planning?

• Label expansion dates for new indications or combinations.
• Postmarketing commitments that shape confidence in durability and safety.
• Updates to dosing guidance that influence real-world persistence.

How does olaparib revenue compare with other PARP inhibitors?

Within PARP inhibition, revenue comparisons depend on:

• The width of label coverage (monotherapy vs combinations, early relapse vs later-line).
• Strength of biomarker penetration and payer coverage for HRD testing.
• Impact of safety/tolerability on dose continuity.

Olaparib’s relative position is generally supported by its established oncology footprint and broad combination strategy portfolio. However, PARP competition can shift share when competitors gain label advantages in earlier lines or demonstrate improved tolerability, which affects clinician switching.

What are the financial sensitivities for olaparib: pricing, uptake, and reimbursement?

Olaparib’s financial trajectory is sensitive to:

• Net pricing after rebates and contracting.
• Usage management through prior authorization and step therapy.
• Reimbursement policies tied to biomarker testing.
• Costs and administrative complexity of combination regimens.

What pricing and reimbursement pressures typically emerge for mature oncology brands?

• Indications or biomarker subgroups may face tighter reimbursement as competing therapies enter.
• Payer negotiations increasingly require outcomes or cost-effectiveness evidence.
• Competition pushes managed-entry agreements and price-volume contracts.

What commercialization risks exist for olaparib from competition and mechanism crossover?

Beyond PARP competitors, longer-run risk exists from:

• Emerging DNA damage response therapies that overlap with PARP biomarker-defined populations.
• Changes in sequencing that place PARP inhibitors earlier or later depending on trial results and guideline consensus.
• Resistance patterns that reduce response rates, increasing discontinuation.

How do resistance and safety profiles impact market dynamics?

• Dose interruptions and discontinuations affect treated-patient counts and effective market size.
• Resistance can shift clinicians away from olaparib in later-line settings, impacting long-duration revenue.

How do manufacturing and IP constraints affect olaparib generic erosion?

Generic erosion risk for a small molecule depends on both IP and practical manufacturability:

• Patent barriers can force generics into design-around strategies.
• Manufacturing reproducibility for tablet properties and release profiles can affect launch feasibility.
• Bioequivalence requirements and regulatory quality systems can delay entry.

Even where patents are cleared, operational and regulatory execution determines the speed of competitive supply.

Key patent and market timeline checkpoints for olaparib’s financial outlook

Because exact Orange Book listing counts and expiration dates are jurisdiction- and dosage-form-specific, decision timelines should track three checkpoint types:

1. Patent term expiration checkpoints tied to the last enforceable listed patent for each strength.
2. Exclusivity end checkpoints tied to statutory exclusivity coverage.
3. Litigation-to-settlement checkpoints that fix effective launch dates even if theoretical patent cliffs are earlier.

Key Takeaways

• Olaparib’s financial trajectory is driven by label expansion, combination adoption, and persistence in biomarker-defined oncology populations.
• Competitive dynamics are shaped by earlier-line penetration by PARP rivals and switching based on regimen tolerability and payer coverage.
• Generic erosion risk is controlled by strength- and formulation-specific patent coverage, Paragraph IV litigation outcomes, and any settlement-enforced launch windows.
• The near-to-mid term outlook hinges on sequencing decisions in ovarian, breast, prostate, and pancreatic indications and on whether payer contracting tightens as PARP competition intensifies.

FAQs

1. Which olaparib indications have the highest near-term sensitivity to PARP inhibitor competition?
2. How do Paragraph IV settlement agreements typically impact olaparib’s effective generic launch timing?
3. What Orange Book patent categories (compound, formulation, method-of-use) most often block generics for olaparib?
4. How does biomarker testing coverage (BRCA/HRD) influence olaparib addressable market forecasts?
5. What factors most affect olaparib real-world persistence and net revenue across treated patients?

References (APA)

1. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
2. AstraZeneca. (n.d.). Lynparza (olaparib) prescribing information. AstraZeneca.
3. U.S. Food and Drug Administration. (n.d.). Drug approvals and labels for Lynparza (olaparib). FDA.