You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 24, 2024

~ Buy the LYNPARZA (olaparib) Drug Profile, 2024 PDF Report in the Report Store ~

LYNPARZA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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 fourteen 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 September 8, 2027. This may change due to patent challenges or generic licensing.

There have been four 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.

Indicators of Generic Entry

< Available with Subscription >

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for LYNPARZA?
  • What are the global sales for LYNPARZA?
  • What is Average Wholesale Price for LYNPARZA?
Drug patent expirations by year for LYNPARZA
Drug Prices for LYNPARZA

See drug prices for LYNPARZA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LYNPARZA
Generic Entry Dates for LYNPARZA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for LYNPARZA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
University Medical Center GroningenPhase 4
Pamela MunsterPhase 1
Alexander B Olawaiye, MDPhase 2

See all LYNPARZA clinical trials

Pharmacology for LYNPARZA
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 seventy-six US patents and seven FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of LYNPARZA is ⤷  Subscribe.

This potential generic entry date is based on patent ⤷  Subscribe.

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 208558-001 Aug 17, 2017 RX Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Astrazeneca LYNPARZA olaparib TABLET;ORAL 208558-002 Aug 17, 2017 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Astrazeneca LYNPARZA olaparib TABLET;ORAL 208558-001 Aug 17, 2017 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Astrazeneca LYNPARZA olaparib TABLET;ORAL 208558-002 Aug 17, 2017 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for LYNPARZA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca LYNPARZA olaparib TABLET;ORAL 208558-002 Aug 17, 2017 ⤷  Subscribe ⤷  Subscribe
Astrazeneca LYNPARZA olaparib TABLET;ORAL 208558-002 Aug 17, 2017 ⤷  Subscribe ⤷  Subscribe
Astrazeneca LYNPARZA olaparib TABLET;ORAL 208558-001 Aug 17, 2017 ⤷  Subscribe ⤷  Subscribe
Astrazeneca LYNPARZA olaparib TABLET;ORAL 208558-002 Aug 17, 2017 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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/003726
Ovarian 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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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

Patent: 3320
Patent: DERIVADOS DE FTALAZINONA
Estimated Expiration: ⤷  Subscribe

Australia

Patent: 07311766
Patent: Polymorphic form of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one
Estimated Expiration: ⤷  Subscribe

Austria

Patent: 28296
Estimated Expiration: ⤷  Subscribe

Brazil

Patent: 0717125
Patent: DERIVADO DE FTALAZINONA
Estimated Expiration: ⤷  Subscribe

Canada

Patent: 64275
Patent: DERIVE DE PHTALAZINONE (PHTHALAZINONE DERIVATIVE)
Estimated Expiration: ⤷  Subscribe

Patent: 75147
Patent: PROCEDE DE PREPARATION D'UN DERIVE DE PHTHALAZINONE SOUS FORME CRISTALLINE POUR LE TRAITEMENT DU CANCER (METHOD OF PREPARING CRYSTALLINE FORM PHTHALAZINONE DERIVATIVE FOR USE IN CANCER TREATMENT)
Estimated Expiration: ⤷  Subscribe

Chile

Patent: 07002967
Patent: FORMA CRISTALINA A DEL COMPUESTO 4-[3-(4-CICLOPROPANCARBONIL-PIPERAZIN-1-CARBONIL)-4-FLUORO-BENCIL]-2H-FTALAZIN-1-ONA; PROCEDIMIENTO DE PREPARACION; COMPOSICION FARMACEUTICA QUE COMPRENDE A DICHO COMPUESTO; Y USO DEL COMPUESTO EN EL TRATAMIENTO DE UN
Estimated Expiration: ⤷  Subscribe

China

Patent: 1528714
Patent: Polymorphic form of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2h-phthalazin-1-one
Estimated Expiration: ⤷  Subscribe

Patent: 2627611
Patent: Polymorphic form of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one
Estimated Expiration: ⤷  Subscribe

Patent: 4649979
Patent: Polymorphic form of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one
Estimated Expiration: ⤷  Subscribe

Colombia

Patent: 10728
Patent: FORMA POLIMORFICA DE 4-[3-(4-CICLOPROPANCARBONIL-PIPERAZIN-1-CARBONIL)-4-FLUOROBENCIL]-2H-FTALAZIN-1-ONA
Estimated Expiration: ⤷  Subscribe

Croatia

Patent: 0120007
Estimated Expiration: ⤷  Subscribe

Cyprus

Patent: 12345
Estimated Expiration: ⤷  Subscribe

Denmark

Patent: 64189
Estimated Expiration: ⤷  Subscribe

European Patent Office

Patent: 64189
Patent: FORME POLYMORPHIQUE DE LA 4-[3-(4-CYCLOPROPANECARBONYL-PIPERAZINE-1-CARBONYL)-4-FLUORO-BENZYL]-2H-PHTHALAZIN-1-ONE (POLYMORPHIC FORM OF 4-[3-(4-CYCLOPROPANECARBONYL-PIPERAZINE-1-CARBONYL)-4-FLUORO-BENZYL]-2H-PHTHALAZIN-1-ONE)
Estimated Expiration: ⤷  Subscribe

Patent: 74800
Patent: Modes de préparation de la 4-[3-(4-cyclopropanecarbonyl- pipérazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one (Methods for the preparation of 4-[3-(4-cyclopropanecarbonyl- piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one)
Estimated Expiration: ⤷  Subscribe

Patent: 24098
Patent: Méthode de préparation de la 4-[3-(4-cyclopropanecarbonyl- pipérazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one (Method for the preparation of 4-[3-(4-cyclopropanecarbonyl- piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one)
Estimated Expiration: ⤷  Subscribe

Hong Kong

Patent: 26483
Patent: POLYMORPHIC FORM OF 4-[3-(4-CYCLOPROPANECARBONYL-PIPERAZINE-1-CARBONYL)-4-FLUORO-BENZYL]-2H-PHTHALAZIN-1-ONE
Estimated Expiration: ⤷  Subscribe

Patent: 03959
Patent: 用於配製 環丙甲酰基 -二氫- -氧代- -酞嗪基 甲基 -氟苯甲酰 呱嗪的方法 (METHOD FOR THE PREPARATION OF 4-[3-(4-CYCLOPROPANECARBONYL- PIPERAZINE-1-CARBONYL)-4-FLUORO-BENZYL -2H-PHTHALAZIN-1-ONE 1-()-4-[5-[(34--4--1-) -2-)
Estimated Expiration: ⤷  Subscribe

Israel

Patent: 7420
Patent: צורה פולימורפית של 4-[3-(4-ציקלופרופאנקרבוניל-פיפראזין-1-קרבוניל)-4-פלואורו-בנזיל]-h2-פתאלאזין-1-און, שיטות להכנתה, תכשיר רוקחות המכיל אותה ושימושים בצורה זו להכנת תרופות לטיפול בגוף האדם (Polymorphic form of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2h-phthalazin-1-one, methods for its preparation, a pharmaceutical composition containing it and uses of such form in the preparation of medicaments for treatment of the human body)
Estimated Expiration: ⤷  Subscribe

Patent: 6705
Patent: שיטה לסינתזה של נגזרת פתאלאזינון (Method of synthesis of a phthalazinone derivative)
Estimated Expiration: ⤷  Subscribe

Japan

Patent: 48513
Estimated Expiration: ⤷  Subscribe

Patent: 07773
Estimated Expiration: ⤷  Subscribe

Patent: 19471
Estimated Expiration: ⤷  Subscribe

Patent: 10506894
Estimated Expiration: ⤷  Subscribe

Patent: 13136607
Patent: POLYMORPHIC FORM OF 4-[3-(4-CYCLOPROPANECARBONYL-PIPERAZINE-1-CARBONYL)-4-FLUORO-BENZYL]-2H-PHTHALAZIN-1-ONE
Estimated Expiration: ⤷  Subscribe

Patent: 15013879
Patent: 4−[3−(4−シクロプロパンカルボニル−ピペラジン−1−カルボニル)−4−フルオロ−ベンジル]−2H−フタラジン−1−オンの多形体 (POLYMORPHIC FORM OF 4-[3-(4-CYCLOPROPANECARBONYL-PIPERAZINE-1-CARBONYL)-4-FLUORO-BENZYL]-2H-PHTHALAZIN-1-ONE)
Estimated Expiration: ⤷  Subscribe

Malaysia

Patent: 7389
Patent: PHTHALAZINONE DERIVATIVE
Estimated Expiration: ⤷  Subscribe

Patent: 2829
Patent: PHTHALAZINONE DERIVATIVE
Estimated Expiration: ⤷  Subscribe

Mexico

Patent: 09004103
Patent: DERIVADOS DE FTALAZINONA. (PHTHALAZINONE DERIVATIVE.)
Estimated Expiration: ⤷  Subscribe

Montenegro

Patent: 987
Patent: POLIMORFNE FORME 4-(3-(4-CIKLOPROPANKARBONIL-PIPERAZIN-1-KARBONIL)-4-FLUOROBENZIL)-2H-FTALAZIN-1-ON (POLYMORPHIC FORM OF 4-[3-(4-CYCLOPROPANECARBONYL-PIPERAZINE-1-CARBONYL)-4-FLUORO-BENZYL]-2H-PHTHALAZIN-1-ONE)
Estimated Expiration: ⤷  Subscribe

New Zealand

Patent: 5627
Patent: POLYMORPHIC FORM OF 4-[3-(4-CYCLOPROPANECARBONYL-PIPERAZINE-1-CARBONYL)-4-FLUORO-BENZYL]-2H-PHTHALAZIN-1-ONE
Estimated Expiration: ⤷  Subscribe

Norway

Patent: 1963
Estimated Expiration: ⤷  Subscribe

Patent: 3063
Estimated Expiration: ⤷  Subscribe

Patent: 091882
Estimated Expiration: ⤷  Subscribe

Patent: 171775
Patent: Ftalazinonderivat
Estimated Expiration: ⤷  Subscribe

Peru

Patent: 081175
Patent: DERIVADOS DE FTALAZINONA
Estimated Expiration: ⤷  Subscribe

Poland

Patent: 64189
Estimated Expiration: ⤷  Subscribe

Portugal

Patent: 64189
Estimated Expiration: ⤷  Subscribe

Russian Federation

Patent: 65270
Patent: ПОЛИМОРФНАЯ ФОРМА 4-[3-(4-ЦИКЛОПРОПАНКАРБОНИЛПИПЕРАЗИН-1-КАРБОНИЛ)-4-ФТОРБЕНЗИЛ]-2Н-ФТАЛАЗИН-1-ОНА (POLYMORPHOUS FORM OF 4-[3-(4-CYCLOPROPANE CARBONYL PIPERAZINE-1-CARBONYL)-4-FLUOROBENZENE)-2H-PHTHALAZIN-1-ONE)
Estimated Expiration: ⤷  Subscribe

Patent: 09109068
Patent: ПОЛИМОРФНАЯ ФОРМА 4-[3-(4-ЦИКЛОПРОПАНКАРБОНИЛПИПЕРАЗИН-1-КАРБОНИЛ)-4-ФТОРБЕНЗИЛ]-2Н-ФТАЛАЗИН-1-ОНА
Estimated Expiration: ⤷  Subscribe

Saudi Arabia

Patent: 280551
Patent: مشتقات فثالازينون (Phthalazinone Derivative)
Estimated Expiration: ⤷  Subscribe

Patent: 0310666
Patent: مشتقات فثالازينون (Phthalazinone Derivative)
Estimated Expiration: ⤷  Subscribe

Serbia

Patent: 112
Patent: POLIMORFNE FORME 4-[3-(4-CIKLOPROPANKARBONIL-PIPERAZIN-1-KARBONIL)-4-FLUORO-BENZIL]-2H-FTALAZIN-1-ON (POLYMORPHIC FORM OF 4-[3-(4-CYCLOPROPANECARBONYL-PIPERAZINE-1-CARBONYL)-4-FLUORO-BENZYL]-2H-PHTHALAZIN-1-ONE)
Estimated Expiration: ⤷  Subscribe

Singapore

Patent: 8523
Patent: POLYMORPHIC FORM OF 4-[3-(4-CYCLOPROPANECARBONYL-PIPERAZINE-1-CARBONYL)-4- FLUORO-BENZYL]-2H-PHTHALAZIN-1-ONE
Estimated Expiration: ⤷  Subscribe

Patent: 201408404X
Patent: Polymorphic Form Of 4-[3-(4-Cyclopropanecarbonyl-Piperazine-1-Carbonyl)-4-Fluoro-Benzyl]-2H-Phthalazin-1-One
Estimated Expiration: ⤷  Subscribe

Slovenia

Patent: 64189
Estimated Expiration: ⤷  Subscribe

South Korea

Patent: 1494910
Estimated Expiration: ⤷  Subscribe

Patent: 090085033
Patent: PHTHALAZINONE DERIVATIVES
Estimated Expiration: ⤷  Subscribe

Patent: 140011425
Patent: POLYMORPHIC FORM OF 4-[3-(4-CYCLOPROPANECARBONYL-PIPERAZINE-1-CARBONYL)-4-FLUORO-BENZYL]-2H-PHTHALAZIN-1-ONE
Estimated Expiration: ⤷  Subscribe

Spain

Patent: 72630
Estimated Expiration: ⤷  Subscribe

Patent: 87129
Estimated Expiration: ⤷  Subscribe

Taiwan

Patent: 04716
Estimated Expiration: ⤷  Subscribe

Patent: 0825066
Patent: Phthalazinone derivative
Estimated Expiration: ⤷  Subscribe

Ukraine

Patent: 494
Patent: ПОХІДНЕ ФТАЛАЗИНОНУ[ПРОИЗВОДНОЕ ФТАЛАЗИНОНА (PHTHALAZINONE DERIVATIVE)
Estimated Expiration: ⤷  Subscribe

Uruguay

Patent: 639
Patent: DERIVADOS SUSTITUIDOS DE 2H-FTALAZIN-1-ONA, SUS FORMAS CRISTALINAS, PROCESO DE PREPARACION Y APLICACIONES
Estimated Expiration: ⤷  Subscribe

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
Hong Kong 1158528 藥物製劑 (PHARMACEUTICAL FORMULATION 514 514) ⤷  Subscribe
Portugal 2064189 ⤷  Subscribe
Russian Federation 2413515 ИНГИБИТОРЫ РЕПАРАЦИИ ПОВРЕЖДЕНИЯ ДНК ДЛЯ ЛЕЧЕНИЯ РАКА (DNA REPAIR INHIBITORS FOR CANCER THERAPY) ⤷  Subscribe
Eurasian Patent Organization 006300 ПРОИЗВОДНЫЕ ФТАЛАЗИНОНА (PHTHALAZINONE DERIVATIVES) ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LYNPARZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1633724 C01633724/01 Switzerland ⤷  Subscribe PRODUCT NAME: OLAPARIB; REGISTRATION NO/DATE: SWISSMEDIC 65160 14.01.2016
1633724 2015/016 Ireland ⤷  Subscribe PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
1633724 15C0022 France ⤷  Subscribe PRODUCT NAME: OLAPARIB,SELS ET SOLVATES DE CELUI-CI; REGISTRATION NO/DATE: EU 1/14/959 20141218
1633724 2015C/024 Belgium ⤷  Subscribe PRODUCT NAME: OLAPARIB ET LES SELS ET SOLVATES DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/14/959 20141218
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

LYNPARZA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LYNPARZA (Olaparib)

Introduction to LYNPARZA

LYNPARZA, also known as olaparib, is a groundbreaking drug in the class of poly (ADP-ribose) polymerase (PARP) inhibitors. Developed by AstraZeneca and Merck, it has been a pivotal player in the treatment of various types of cancer, including ovarian, pancreatic, prostate, and human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

Approval and Initial Impact

First approved by the FDA in 2014 for the treatment of BRCA-mutated metastatic ovarian cancer, LYNPARZA marked the beginning of a new era in cancer therapy. Since its approval, the drug has shown significant growth, with global sales exceeding $400 million in 2017, making it one of the most profitable cancer therapy drugs that year[3].

Dominance in the PARP Inhibitors Market

LYNPARZA is projected to maintain its dominance in the PARP inhibitors market. According to GlobalData, the drug is expected to achieve global sales of $4 billion by 2027. This high sales projection underscores its critical role in treating multiple cancer types, with expected revenues in these indications reaching over 68% of the global PARP inhibitors market by 2027[1][4].

Market Share and Competitors

Currently, LYNPARZA holds the leading position in the PARP inhibitors market, with the majority of its sales coming from ovarian and HER2-negative breast cancer treatment. GlaxoSmithKline’s Zejula (niraparib) follows closely, with projected sales of over $1.6 billion and a market share of around 28% by 2027[1][4].

Clinical Trials and Expanding Indications

LYNPARZA's growing application across multiple cancer types is driven by ongoing clinical trials. As of recent updates, there are 123 Phase I-III clinical trials involving LYNPARZA. Notably, in May 2023, the FDA approved LYNPARZA in combination with Johnson & Johnson’s Zytiga (abiraterone) for treating patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer[1].

Financial Performance of AstraZeneca

AstraZeneca's overall financial performance has been robust, with total revenue up 18% to $25,617 million in the first half of 2024. The company's oncology segment, which includes LYNPARZA, saw a 22% growth in revenue. This strong performance is attributed to the increased sales of key products, including LYNPARZA, and growth in alliance revenue from partnered medicines[2].

Patent Expiry and Future Outlook

Despite the anticipated patent expiry of LYNPARZA in the US market in 2028, which may lead to a downshift in sales due to generic erosion, AstraZeneca is working on new developments to maintain its market lead. The company's new selective PARP1 inhibitor, saruparib, shows early promise in Phase I/II trials for homologous recombination repair (HRR)-deficient advanced breast cancers. If approved, saruparib could further strengthen AstraZeneca’s position in the PARP inhibitor market[1].

Patient Selection and Biomarkers

The effective use of LYNPARZA hinges on the right patient selection, particularly those with HRR deficiency or other DNA repair defects, irrespective of their BRCA mutation status. Biswajit Podder, an oncology and hematology analyst at GlobalData, emphasizes the importance of using reliable biomarkers to select patients most likely to respond to the therapy[1].

Regional Market Dynamics

The global PARP inhibitors market is dominated by the US, followed by Europe. However, regions such as South Korea, Japan, and the Middle East are also contributing to better market penetration and overall growth. This global reach underscores the widespread acceptance and need for PARP inhibitors like LYNPARZA[3].

Patient Support Programs

To enhance patient access, AstraZeneca offers various support programs, including the Co-Pay Savings Program, which allows commercially insured patients to pay as little as $0 per month for LYNPARZA. Such programs help in making the drug more affordable and accessible to a broader patient population[5].

Conclusion

LYNPARZA's dominance in the PARP inhibitors market is well-established, with a strong financial trajectory supported by its expanding indications and robust sales projections. Despite the challenges posed by patent expiry, AstraZeneca's ongoing research and development efforts, such as the potential approval of saruparib, are set to maintain the company's leadership in this market segment.

Key Takeaways

  • Market Dominance: LYNPARZA is projected to achieve $4 billion in global sales by 2027, dominating the PARP inhibitors market.
  • Clinical Trials: Ongoing clinical trials are expanding LYNPARZA's indications across multiple cancer types.
  • Financial Performance: AstraZeneca's revenue growth is significantly driven by the success of LYNPARZA.
  • Patient Selection: The use of reliable biomarkers is crucial for selecting patients who will benefit most from LYNPARZA.
  • Regional Growth: The US and Europe lead the market, with growing contributions from other regions.
  • Future Outlook: Despite patent expiry, new developments like saruparib are expected to maintain AstraZeneca's market lead.

FAQs

Q1: What is LYNPARZA used for? LYNPARZA is used for the treatment of various types of cancer, including ovarian, pancreatic, prostate, and HER2-negative breast cancer.

Q2: Who are the key competitors of LYNPARZA in the PARP inhibitors market? The main competitor of LYNPARZA is GlaxoSmithKline’s Zejula (niraparib), which holds around 28% of the market share.

Q3: What are the projected sales of LYNPARZA by 2027? According to GlobalData, LYNPARZA is expected to achieve global sales of $4 billion by 2027.

Q4: How does the patent expiry of LYNPARZA in 2028 impact its future sales? The patent expiry in 2028 is anticipated to lead to a downshift in sales due to generic erosion, but AstraZeneca's new developments, such as saruparib, aim to mitigate this impact.

Q5: What support programs are available for patients using LYNPARZA? AstraZeneca offers the Co-Pay Savings Program, which allows commercially insured patients to pay as little as $0 per month for LYNPARZA.

Sources

  1. Express Pharma: AstraZeneca's Lynparza to dominate PARP inhibitors market with $4 bn in sales by 2027: GlobalData
  2. AstraZeneca: H1 and Q2 2024 results announcement
  3. PR Newswire: PARP Inhibitors Cancer Therapy Market, 2023 - Lynpraza (Olaparib) by AstraZeneca
  4. BioPharma Reporter: AstraZeneca's Lynparza to remain dominant in PARP inhibitors market
  5. LYNPARZA HCP: Commercially Insured LYNPARZA (olaparib) Patients

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.