LYNPARZA Drug Patent Profile

Which patents cover Lynparza, and what generic alternatives are available?

Lynparza is a drug marketed by Astrazeneca and is included in two NDAs. There are twelve patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in LYNPARZA is olaparib. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the olaparib profile page.

DrugPatentWatch^® Generic Entry Outlook for Lynparza

Lynparza was eligible for patent challenges on December 19, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 12, 2027. This may change due to patent challenges or generic licensing.

There have been twelve patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are three tentative approvals for the generic drug (olaparib), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for LYNPARZA

International Patents:	254
US Patents:	12
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	153
Patent Applications:	4,756
Drug Prices:	Drug price information for LYNPARZA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LYNPARZA
What excipients (inactive ingredients) are in LYNPARZA?	LYNPARZA excipients list
DailyMed Link:	LYNPARZA at DailyMed

See drug prices for LYNPARZA

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

NDA:

206162

Dosage:

CAPSULE;ORAL

NDA:

208558

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 LYNPARZA

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

Sponsor	Phase
University Medical Center Groningen	Phase 4
Pamela Munster	Phase 1
Alexander B Olawaiye, MD	Phase 2

See all LYNPARZA clinical trials

Pharmacology for LYNPARZA

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

Paragraph IV (Patent) Challenges for LYNPARZA

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 LYNPARZA

LYNPARZA is protected by sixty US patents and three FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Expired US Patents for LYNPARZA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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 LYNPARZA

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 LYNPARZA

When does loss-of-exclusivity occur for LYNPARZA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cuba

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Finland

Honduras

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

New Zealand

Nicaragua

Norway

Peru

Poland

Portugal

Saudi Arabia

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering LYNPARZA around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	496034
Australia	2001295789
Australia	9578901
Brazil	0115062
Canada	2423279	DERIVES DE PHTALAZINONE (PHTHALAZINONE DERIVATIVES)

Supplementary Protection Certificates for LYNPARZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1633724	C300726	Netherlands		PRODUCT NAME: OLAPARIB, EN ZOUTEN EN; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
1633724	CR 2015 00012	Denmark		PRODUCT NAME: OLAPARIB, OG SALTE OG SOLVATER DERAF; REG. NO/DATE: EU/1/14/959/001 20141216
1633724	C20150012 00136	Estonia		PRODUCT NAME: OLAPARIIB;REG NO/DATE: EU/1/14/959 18.12.2014
1633724	92680	Luxembourg		PRODUCT NAME: OLAPARIB AINSI QUE DES SELS ET DES SOLVATES DE CELUI-CI. FIRST REGISTRATION: 20141218
1633724	PA2015016	Lithuania		PRODUCT NAME: OLAPARIBUM; REGISTRATION NO/DATE: EU/1/14/959 20141216

LYNPARZA (olaparib) Market Dynamics and Financial Trajectory (Sales, Growth Drivers, Competition, and Exclusivity Risk)

Last updated: July 30, 2026

Executive summary: LYNPARZA is the commercial face of AstraZeneca’s PARP-inhibitor franchise, with sustained franchise expansion driven by label broadening across ovarian cancer and continued penetration into earlier lines via combinations. The near-term growth profile is shaped by (1) ongoing uptake in metastatic castration-resistant prostate cancer (mCRPC) with abiraterone, (2) expansion across breast cancer risk groups via biomarker-defined indications, and (3) competitive pressure from rival PARP inhibitors and sequencing strategies. The exclusivity calendar for olaparib is governed by a mix of biologically oriented formulation/device, method-of-use, and combination patents plus regulatory exclusivities, creating a multi-layered barrier to generic and biosimilar substitution (generics are expected rather than biosimilars). Financial trajectory is tied to net price, patient mix by line of therapy, and the pace of combination adoption, offset by patent-expiration-driven entry risk over time.

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What is the current sales trajectory for LYNPARZA (olaparib) and how has revenue evolved by indication?

Featured answer: LYNPARZA’s revenue trajectory has followed label expansion and combination adoption, with growth anchored in ovarian cancer (gBRCA and HRR-mutated populations) and later extended into prostate cancer and breast cancer settings through stratified, biomarker-led prescribing.

Indication mix: where LYNPARZA revenue is most exposed

Commercially, LYNPARZA’s major demand pools align to:

• Ovarian cancer (maintenance and treatment settings, heavily biomarker-driven)
• mCRPC (combination with abiraterone in biomarker-defined populations, where payer coverage and sequencing matter)
• Breast cancer (HRR mutations, earlier lines in some geographies depending on regulator label and guideline uptake)

Pricing and reimbursement dynamics that drive net revenue

Net sales are sensitive to:

• WAC-to-net erosion from rebates and contracting
• Indication-by-indication access changes (formularies, prior authorization, step edits)
• Geographic pricing differences tied to health technology assessment outcomes
• Patient assistance and buy-and-bill variations (where applicable through oncology channel norms)

Competitive substitution effect on uptake

PARP competition typically does not cause immediate wholesale loss, but it changes:

• First-line PARP selection (if payer policy prefers one agent)
• Switching patterns after progression
• Combination sequencing (who gets used with which partner and in which line)

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Which companies sell competing PARP inhibitors to LYNPARZA and how does the competitive landscape affect market share?

Featured answer: LYNPARZA competes in the PARP inhibitor class, where rivals include brands such as niraparib (Zejula), rucaparib (Rubraca), talazoparib (TALZENNA), and combination strategies. The competitive outcome is less about molecule-level substitution and more about label coverage, biomarker constraints, dosing practicality, and payer coverage.

How competitors typically win or lose

Key levers:

• Label breadth by biomarker (gBRCA vs somatic BRCA vs broader HRR)
• Maintenance vs treatment positioning
• Payer-friendly dosing schedules and formulary placement
• Evidence fit to local guideline sequences
• Combination portfolio strength for specific partners (e.g., androgen axis, chemotherapy backbone, immunotherapy where supported)

Competitive dynamics by oncology segment

• Ovarian cancer: PARP dominance persists, with competition concentrated around maintenance strategies and biomarker subgroups.
• mCRPC: Uptake is driven by combination evidence and payer comfort with biomarker-defined eligibility.
• Breast cancer: Access depends on HRR mutation definitions, prior therapy criteria, and guideline uptake.

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When does LYNPARZA lose exclusivity and what is the generic entry risk timeline?

Featured answer: LYNPARZA’s exclusivity endgame is structured by patent term expirations that vary by claim type (active ingredient, polymorph, formulation, method-of-use, and combination) plus regulatory exclusivity (application- and market-specific). Generic entry risk depends on whether ANDA filers can design around formulation and method-of-use claims and whether Paragraph IV litigation blocks approval.

What determines the launch timing for generic olaparib

Generic risk timing is driven by:

• Active ingredient patent expirations (composition-of-matter or equivalent)
• Formulation patents (drug product composition, polymorph, release profile, stability)
• Use patents (biomarker-defined regimens and combinations)
• Regulatory exclusivities tied to first approvals and new indication approvals

Practical entry scenario

In practice, generic entry is typically segmented:

1. Early entry in markets where method-of-use claims are narrow or design-around is feasible
2. Later entry where combination/use coverage is broad or where litigation/settlements delay approval
3. Loss of market share before final exclusivity expiry as payer preferences shift and competing PARP inhibitors gain formulary position

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What patents protect LYNPARZA (olaparib) and which patent families matter for market exclusivity?

Featured answer: LYNPARZA’s enforceable estate usually spans composition claims covering olaparib, plus layered product and method-of-use families that protect specific dose forms, stability/polymorph traits, and regimen-level claims. For generic ANDA risk, the most relevant are method-of-use and formulation claims tied to marketed dosing regimens and biomarker-defined indications.

Patent estate segmentation (what typically drives litigation and ANDA design-around)

• Composition of matter: olaparib and close chemical derivatives
• Formulation and polymorph: specific solid-state forms, excipient blends, or release/stability specifications
• Dosing regimen: specific daily dosing schedules and cycle structures
• Combination regimens: co-administration claims with partner agents
• Biomarker-defined use: HRR mutation and BRCA-defined patient selection criteria

How to interpret “how many patents cover” in real-world barriers

For generic filers, “how many patents” matters less than:

• Whether claims are listed in Orange Book for the relevant NDA/BLA
• Claim scope overlap with the generic’s intended labeling
• Whether patents are method-of-use (more design-around constrained) versus product claims

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What is the Orange Book status of LYNPARZA (olaparib) and how does it shape Paragraph IV challenges?

Featured answer: The Orange Book listing drives ANDA Paragraph IV strategy because it identifies which patents are listed for each marketed NDA strength and dosage form. For LYNPARZA, the effective barrier is typically dominated by a subset of listed patents that correspond to formulation and method-of-use claims aligned to the label.

Orange Book mechanics relevant to ANDA filers

• ANDA applicants file with certifications against each listed patent (I, II, III, IV).
• Paragraph IV challenges target patents for which the applicant asserts invalidity or non-infringement.
• Litigation can trigger statutory approval stays depending on outcome and timing.

Why Orange Book claims affect commercial trajectory

Even without final court outcomes, Paragraph IV challenges can:

• Trigger settlement agreements with delayed generic launches
• Force label carve-outs that reduce generic adoption
• Create payer confusion and delayed switching due to perceived risk

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How many Paragraph IV challenges and patent suits affect LYNPARZA generic entry?

Featured answer: LYNPARZA has faced the typical PARP inhibitor pattern: Paragraph IV filings and associated litigation that can delay ANDA approvals, especially where Orange Book-listed patents include method-of-use or formulation claims. The practical outcome for market dynamics is a delayed or partial generic presence rather than immediate broad substitution.

Litigation outcomes that matter commercially

• “Win” outcomes for patent holders often convert uncertainty into exclusivity certainty.
• Settlement agreements typically define:
  • a date of permitted approval
  • and sometimes labeling limitations or marketing “carve-outs.”
• “Design-around” acceptance can lead to earlier launches at reduced brand erosion pace.

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What settlement agreements or licensing deals shaped LYNPARZA’s competitive timeline?

Featured answer: Where patent litigation resolves via settlement, it usually structures a launch date and can include labeling constraints. These agreements are the mechanism by which brand continuity persists despite Paragraph IV filings.

Business impact of settlements

Settlements affect:

• Brand retention by preventing early market substitution
• Payer contracting timing
• Generic manufacturer capacity planning
• AstraZeneca’s lifecycle strategy (new indications, line-of-therapy expansions)

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How does LYNPARZA financial performance compare with other PARP inhibitors like Zejula, Rubraca, and TALZENNA?

Featured answer: LYNPARZA’s relative performance depends on label breadth and combination positioning, while PARP rivals compete through differentiation in indication scope, patient selection, and payer-friendly adoption. LYNPARZA’s commercial traction tends to track the breadth of oncology segments where it holds preferred biomarker-defined access.

Comparison dimensions used by investors and payers

• Indication coverage across ovarian, breast, and prostate
• Maintenance vs combination treatment breadth
• Biomarker specificity and eligibility friction
• Dose administration convenience and discontinuation rates
• Real-world patient persistence (adherence and discontinuation drivers)

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What regulatory milestones and FDA pathway decisions most influenced LYNPARZA market uptake?

Featured answer: LYNPARZA’s market adoption is influenced by FDA approvals tied to biomarker-defined populations, plus supplemental approvals that extend its use into earlier lines and combinations. Regulatory pathway acceleration can speed competitive positioning, particularly when combination labels come first in the local oncology guideline ladder.

FDA approval cadence that tends to move revenue

• Initial approvals establish the foundational market.
• Supplemental approvals expand:
  • maintenance and combination settings
  • biomarker subsets eligible for therapy
• Each label expansion typically shifts the eligible population, changes physician adoption speed, and supports payer reimbursement expansion.

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What formulation and manufacturing/IP barriers protect LYNPARZA from generic substitution?

Featured answer: The barrier profile is usually strongest where formulation and method-of-use patents overlap with practical formulation and label design choices for ANDA products. For oral oncology drugs, product stability, solid-state form, and release characteristics can be the highest-friction areas.

Typical manufacturing/IP constraint areas

• Specific solid-state forms and polymorph control
• Excipients and manufacturing parameters affecting dissolution and bioavailability
• Stability and shelf-life claims tied to marketed product performance
• Combination dosing regimen limitations that constrain generic labeling

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What generic entry scenarios could materially pressure LYNPARZA net sales?

Featured answer: Sales pressure would intensify under scenarios where generic approval aligns with:

1. broad label coverage (least constrained by method-of-use carve-outs), and
2. payer willingness to substitute for the brand, often triggered by meaningful price discounts and formulary updates.

High-risk scenarios for brand erosion

• ANDA approval without meaningful labeling carve-outs
• Multiple market entrants increasing pricing pressure in dominant geographies
• Payer step therapy favoring lower-cost alternatives within PARP class
• Switching policies that allow post-progression substitution

Lower-risk scenarios

• Generic approval with limited indication carve-outs
• Ongoing litigation delays that keep substitution minimal
• Ongoing brand advantage in combination sequencing and biomarker coverage

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Key Takeaways

• LYNPARZA’s financial trajectory is driven by label breadth and combination adoption more than by standalone molecule competition.
• Competitive risk is class-based: payer preference, biomarker eligibility friction, and sequencing strategies with other PARP inhibitors determine market share shifts.
• Generic entry risk is structured by Orange Book-listed patents spanning formulation and method-of-use claims; practical substitution depends on litigation outcomes and labeling scope.
• The most material net sales pressure occurs when generic approval coincides with broad label availability and rapid payer formulary switching.

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FAQs

1. How do biomarker eligibility rules (gBRCA vs HRR mutations) affect LYNPARZA utilization and payer coverage?
2. Which LYNPARZA indications are most sensitive to PARP inhibitor sequencing decisions in ovarian and prostate oncology?
3. What role do formulation-specific patents play in delaying ANDA approvals for oral PARP inhibitors like olaparib?
4. How do Paragraph IV litigation and settlement dates typically translate into brand erosion timing for cancer oral drugs?
5. What metrics best predict LYNPARZA net sales changes in oncology real-world settings (persistence, switching, and time on therapy)?

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References (APA)

No sources were cited in the response.

DrugChatter Q&A for LYNPARZA

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