olaparib - Profile

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 tentative approvals for this compound.

Summary for olaparib

International Patents:	254
US Patents:	12
Tradenames:	1
Applicants:	1
NDAs:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for olaparib

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

Constraining patent/regulatory exclusivity:

8,143,241

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

11,975,001

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.

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.

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	CAPSULE;ORAL	206162-001	Dec 19, 2014		DISCN	Yes	No	8,143,241
Astrazeneca	LYNPARZA	olaparib	CAPSULE;ORAL	206162-001	Dec 19, 2014		DISCN	Yes	No	8,859,562
Astrazeneca	LYNPARZA	olaparib	CAPSULE;ORAL	206162-001	Dec 19, 2014		DISCN	Yes	No	8,247,416			Y

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	8,912,187
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

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
Portugal	1633724
Brazil	PI0920604
Japan	5248513

Supplementary Protection Certificates for olaparib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1633724	15C0022	France		PRODUCT NAME: OLAPARIB,SELS ET SOLVATES DE CELUI-CI; REGISTRATION NO/DATE: EU 1/14/959 20141218
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
1633724	PA2015016	Lithuania		PRODUCT NAME: OLAPARIBUM; REGISTRATION NO/DATE: EU/1/14/959 20141216

Olaparib Investment Scenario and Fundamentals Analysis (Commercial, Competitive, and Patent/Value Protection)

Last updated: April 26, 2026

What is olaparib, and where does it sit in oncology today?

Olaparib (PARP inhibitor) is a core branded oncology asset used across multiple lines in ovarian, breast, pancreatic, and prostate cancers, with its positioning anchored to homologous recombination deficiency (HRD) biology and biomarker-driven use. The drug’s fundamental value is a function of: (1) ongoing label expansion and refined patient selection, (2) competitive intensity in PARP/adjacent DNA damage pathways, (3) uptake and persistence for branded and branded generics, and (4) patent and exclusivity structure across jurisdictions.

How does the revenue profile typically build for a PARP franchise like olaparib?

Olaparib’s market performance generally follows a pattern common to PARP inhibitors:

• Indication breadth drives repeat prescribing cycles (different lines of therapy and tumor types).
• Biomarker selection (HRD and germline/ somatic BRCA status) impacts eligible populations and treatment duration.
• Class competition reallocates share from first-in-class to later entrants and to next-generation PARP inhibitors.

For investment purposes, the key is not just top-line growth, but the durability of share and the slope of net erosion as competition increases and as patent calendars roll.

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Where are the main commercialization levers for olaparib?

What indication areas determine the profit curve?

Olaparib’s commercialization depends on maintaining leadership (or at least strong share) across major, high-volume oncology settings:

• Ovarian cancer (maintenance and subsequent lines)
• Breast cancer (selected HRR mutation populations)
• Pancreatic cancer (HRR mutation enriched settings)
• Prostate cancer (HRR mutation and biomarker-driven populations)

What are the “must-win” practical levers?

• Formulation and dosing convenience: adherence and treatment continuity matter in maintenance settings.
• Biomarker testing availability: HRD/BRCA testing penetration controls addressable volume.
• Real-world persistence: dose management and discontinuation rates affect downstream TRx and duration-based treatment economics.

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How does competition shape olaparib’s fundamentals?

Who are olaparib’s competitive set peers?

Olaparib competes within the PARP inhibitor class and against adjacent DNA repair strategies. Core class competitive pressure comes from other marketed PARP inhibitors with differing efficacy profiles by biomarker and line of therapy, and from strategies that expand beyond PARP monotherapy.

What determines whether olaparib holds share or erodes faster?

A PARP leader like olaparib is most exposed when:

• A competitor demonstrates superior outcomes in broader biomarker populations or more favorable safety enabling longer dosing.
• Payor coverage shifts toward newer agents.
• Treatment sequencing changes (for example, PARP earlier in the pathway or switching strategies after prior PARP exposure).

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What do patent and exclusivity mechanics mean for olaparib’s value?

What is the patent-risk reality for an established olaparib asset?

Olaparib entered mature stages where:

• Composition-of-matter and process patents drive the long tail.
• Second-generation filings and specific formulations/method-of-use can extend monetization where still enforceable.
• Patent term adjustments, pediatric extensions, and regulatory exclusivity can materially change jurisdictional end dates.

From an investment lens, value protection is not a single date. It is the stack of protection events that can keep generics and biosimilars (where relevant) from taking full share.

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How do regulatory exclusivities affect launch calendars for generics?

What exclusivity levers matter in the US and EU?

The practical exclusivity stack for prescription oncology small molecules typically hinges on:

• New Chemical Entity exclusivity (where applicable for the original product)
• Orphan drug designation (where granted)
• Supplementary protection certificates (SPC) in the EU (when patent and regulatory date alignment exists)

These mechanics determine whether generic entrants face delayed market entry or are forced into carve-outs.

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What is the investment scenario: base case, bull case, and bear case?

This framing ties fundamentals to measurable drivers: share, price (net), and persistence.

Base case

• Maintains meaningful share in HRD/BRCA-positive ovarian and HRR-mutant pancreatic and prostate settings.
• Net erosion occurs in segments where competitors hold pricing or formulary advantages.
• Brand remains resilient as payors balance cost against clinical differentiation in biomarker-defined use.

Bull case

• Favorable label interpretation and stronger real-world persistence (dose continuity, reduced discontinuations).
• Competitive position improves in a higher proportion of eligible patients through testing and guideline alignment.
• Regulatory or patent events slow genericization or preserve protected indications longer.

Bear case

• Accelerated class competition shifts treatment toward a competitor with stronger outcomes or better tolerability in key populations.
• Net price declines outpace TRx growth.
• Patent challenge outcomes reduce protection windows, enabling earlier and broader generic entry.

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What financial fundamentals should an investor underwrite for olaparib?

Underwriting framework (what moves the needle)

The investment view should be anchored in three components:

Fundamental driver	What to measure	Why it changes value
Share in biomarker-defined indications	TRx mix by HRD/BRCA and line	Determines eligible volume and persistence
Net pricing and reimbursement	Net ASP trends and formulary tier position	Drives gross-to-net and margin durability
Time-to-erosion vs patent calendar	Jurisdictional exclusivity and patent stack status	Sets horizon for margin protection and generic threat

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Is there evidence of multi-year durability for olaparib?

PARP inhibitors have shown durability when they maintain:

• strong test-driven patient selection,
• optimized dosing protocols,
• and retained competitive differentiation in major maintenance and HRR mutation segments.

For an investment scenario, durability is tested by whether competitors displace olaparib in the highest-volume cohorts, not by whether olaparib posts incremental sales growth in isolation.

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Key valuation sensitivities for olaparib investors

What sensitivities most affect downside protection?

• Speed of generic penetration in the US and EU for each protected indication
• Formulary tightening and payer steerage toward preferred PARPs
• Sequencing changes that reduce share in maintenance lines
• Safety/tolerability differentiation that alters real-world dosing intensity

What sensitivities most affect upside?

• Broader biomarker access that expands the treated pool
• Evidence-driven new combinations or earlier-line adoption that increases duration on drug
• Sustained pricing discipline and reduced net erosion

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Competitive strategy implications

What does “winning” look like in a PARP crowded market?

• Hold share where the clinical and biomarker fit is strongest.
• Protect prescribing through guideline alignment and payer contracting.
• Focus lifecycle strategy on persistence and tolerability, where it materially changes treatment duration.

What does it mean if share compresses?

If competitor agents gain share in the highest-volume segments, olaparib’s growth must come from either:

• deeper penetration within current indications, or
• new protected indications, or
• combination strategies that extend treatment time without steep increases in discontinuation.

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Key Takeaways

• Olaparib is a mature PARP leader whose fundamentals rest on biomarker-defined penetration, persistence, and net pricing durability across ovarian, breast, pancreatic, and prostate settings.
• Competitive intensity is the primary operating risk; share erosion and payer steerage can compress margins even if absolute TRx stays stable.
• Value protection is a patent/exclusivity stack problem, not a single date, with jurisdictional mechanics determining the slope of net erosion and generic threat timing.
• Investment scenarios hinge on time-to-erosion vs share durability, with underwriting focused on TRx mix by biomarker and line, net ASP trends, and the protection horizon by indication and geography.

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FAQs

1. What determines olaparib’s commercial resilience?
   Share in biomarker-defined patient populations, net pricing discipline, and persistence due to tolerability and dosing continuity.

2. Why does competition matter more than headline sales growth?
   In mature oncology markets, revenue can decline through faster net price erosion and formulary changes even if gross TRx is stable.

3. How should investors underwrite patent risk for olaparib?
   By mapping the jurisdictional protection stack (composition-of-matter, method-of-use, formulation, and regulatory exclusivity/SPC where applicable) by indication.

4. What is the most important payer dynamic for PARP inhibitors?
   Coverage and tiering decisions that steer use toward preferred agents, affecting net ASP and treated duration.

5. What would signal a bull case for olaparib?
   Improved real-world persistence and retained share in high-volume maintenance and HRR-mutant settings, paired with protection timelines that delay broader generic entry.

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References

[1] European Medicines Agency (EMA). Olaparib EPAR (product information and assessment history). European public assessment reports.
[2] U.S. Food and Drug Administration (FDA). Lynparza (olaparib) prescribing information and label history. FDA label database.
[3] World Health Organization. ATC classification for olaparib (L01XX46) and therapeutic context. WHO ATC/DDD index.