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 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.

There is one tentative approval 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:	139
Clinical Trials:	153
Patent Applications:	740
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

Constraining patent/regulatory exclusivity:

8,247,416

NDA:

206162

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

7,449,464

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 five FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 7,449,464.

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	11,975,001		Y
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017		RX	Yes	Yes	12,178,816		Y
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017		RX	Yes	No	8,475,842		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	11,970,530
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017		RX	Yes	Yes
Astrazeneca	LYNPARZA	olaparib	CAPSULE;ORAL	206162-001	Dec 19, 2014		DISCN	Yes	No	8,143,241

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

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

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

Austria

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

European Patent Office

Hong Kong

Israel

Japan

Malaysia

Mexico

Montenegro

New Zealand

Norway

Peru

Poland

Portugal

Russian Federation

Saudi Arabia

Serbia

Singapore

Slovenia

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
China	1905864	DNA damage repair inhibitors for treatment of cancer
Hong Kong	1158528	藥物製劑 (PHARMACEUTICAL FORMULATION 514 514)
Norway	20031498
Japan	2012087135	THERAPEUTIC COMPOUND
South Africa	201103333	PHARMACEUTICAL FORMULATION 514
European Patent Office	1633724	DERIVES DE PHTALAZINONE (PHTHALAZINONE DERIVATIVES)
Cuba	20110080	FORMULACIÓN FARMACÉUTICA 514

Supplementary Protection Certificates for LYNPARZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1633724	PA2015016,C1633724	Lithuania		PRODUCT NAME: OLAPARIBAS IR JO DRUSKOS IR SOLVATAI; REGISTRATION NO/DATE: EU/1/14/959 20141216
1633724	C20150012 00136	Estonia		PRODUCT NAME: OLAPARIIB;REG NO/DATE: EU/1/14/959 18.12.2014
1633724	PA2015016	Lithuania		PRODUCT NAME: OLAPARIBUM; REGISTRATION NO/DATE: EU/1/14/959 20141216
1633724	C01633724/01	Switzerland		PRODUCT NAME: OLAPARIB; REGISTRATION NO/DATE: SWISSMEDIC 65160 14.01.2016
1633724	C300726	Netherlands		PRODUCT NAME: OLAPARIB, EN ZOUTEN EN; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
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	2015/016	Ireland		PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REGISTRATION NO/DATE: EU/1/14/959/001 20141216

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

Last updated: 2024-12-16