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 fourteen 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.

Summary for olaparib

International Patents:	254
US Patents:	14
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	140
Clinical Trials:	381
Patent Applications:	1,473
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
Lee Ocuin, MD	Phase 2
University of Alabama at Birmingham	Phase 2
University Medical Center Groningen	Phase 4

See all olaparib clinical trials

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	208558-002	Aug 17, 2017		RX	Yes	Yes
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017		RX	Yes	No
Astrazeneca	LYNPARZA	olaparib	CAPSULE;ORAL	206162-001	Dec 19, 2014		DISCN	Yes	No				Y
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
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 olaparib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017
Astrazeneca	LYNPARZA	olaparib	CAPSULE;ORAL	206162-001	Dec 19, 2014
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017

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/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 olaparib

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2465270	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)
Russian Federation	2009109068	ПОЛИМОРФНАЯ ФОРМА 4-[3-(4-ЦИКЛОПРОПАНКАРБОНИЛПИПЕРАЗИН-1-КАРБОНИЛ)-4-ФТОРБЕНЗИЛ]-2Н-ФТАЛАЗИН-1-ОНА
Israel	197420	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)
Saudi Arabia	07280551	مشتقات فثالازينون (Phthalazinone Derivative)
South Africa	200605340	DNA damage repair inhibitors for treatment of cancer
South Korea	20060066067	TRICYCLIC PARP INHIBITORS
Cuba	24032	UNA FORMULACIÓN FARMACÉUTICA QUE COMPRENDE 4-[3-(4-CICLOPROPANOCARBONIL-PIPERAZINA-1-CARBONIL)-4-FLUOROBENCIL]-2h-FTALAZIN-1-ONA EN DISPERSIÓN SÓLIDA CON COPOVIDONA

Supplementary Protection Certificates for olaparib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2346495	300956	Netherlands		PRODUCT NAME: AMORF OLAPARIB OF EEN ZOUT OF SOLVAAT DAARVAN, IN EEN VASTE DISPERSIE; REGISTRATION NO/DATE: EU1/14/959 20180515
1633724	C01633724/01	Switzerland		PRODUCT NAME: OLAPARIB; REGISTRATION NO/DATE: SWISSMEDIC 65160 14.01.2016
1633724	92680	Luxembourg		PRODUCT NAME: OLAPARIB AINSI QUE DES SELS ET DES SOLVATES DE CELUI-CI. FIRST REGISTRATION: 20141218
1633724	C 2015 011	Romania		PRODUCT NAME: OLAPARIB; NATIONAL AUTHORISATION NUMBER: EU/1/14/959/001; DATE OF NATIONAL AUTHORISATION: 20141216; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/959/001; DATE OF FIRST AUTHORISATION IN EEA: 20141216
1633724	122015000025	Germany		PRODUCT NAME: OLAPARIB, SOWIE SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
2346495	PA2018014	Lithuania		PRODUCT NAME: AMORFINIS OLAPARIBAS ARBA JO DRUSKA ARBA SOLVATAS KIETOJE DISPERSIJOJE; REGISTRATION NO/DATE: EU/1/14/959 20180508
1633724	PA2015016	Lithuania		PRODUCT NAME: OLAPARIBUM; REGISTRATION NO/DATE: EU/1/14/959 20141216

Olaparib Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Olaparib

Introduction to Olaparib

Olaparib, a groundbreaking drug in the class of PARP (Poly (ADP-ribose) polymerase) inhibitors, has revolutionized the treatment of various cancers, particularly those associated with BRCA1 and BRCA2 gene mutations. Here, we delve into the market dynamics and financial trajectory of olaparib, highlighting its current status, growth drivers, and future projections.

Market Size and Growth Projections

The global olaparib API market is poised for significant growth. As of 2024, the market is estimated to be valued at approximately US$ 1.07 billion and is projected to expand to US$ 4.41 billion by 2034, driven by a compelling Compound Annual Growth Rate (CAGR) of 15.3%[1].

Key Drivers of Market Growth

Several factors are driving the growth of the olaparib market:

Increasing Prevalence of Cancer

The rising incidence of breast, ovarian, prostate, and pancreatic cancers is a major driver. According to the National Cancer Institute, the number of new cancer cases per year is expected to rise to over 30 million by 2040 worldwide[4].

Expanding Indications

Olaparib's use is no longer limited to ovarian cancer; it has been approved for breast, prostate, and pancreatic cancers, significantly broadening its market potential[1].

Personalized Medicine

The growing adoption of personalized medicine worldwide is boosting demand for targeted therapies like olaparib, which is particularly effective in patients with BRCA mutations[1].

Combination Therapies

Research into combination therapies involving olaparib, such as with immunotherapy, is expanding its therapeutic applications and patient pool[4].

Regional Market Outlook

North America

North America leads the global market, holding approximately 37% of the market share in 2024. This dominance is attributed to the region's strong healthcare systems and high adoption rates of advanced cancer treatments[1].

Emerging Markets

Regions like Asia and Latin America are expected to grow significantly due to increasing healthcare expenditure and the expansion of pharmaceutical services into these areas[1].

Segmentation by Indication

Ovarian Cancer

The ovarian cancer segment is projected to account for a substantial 48.2% of the market in 2024, due to olaparib's proven efficacy in treating ovarian cancer with BRCA mutations[1].

Other Cancer Types

Segments for breast, prostate, and pancreatic cancers are also growing, driven by regulatory approvals and positive clinical trial results[1].

Financial Performance and Revenue Streams

Revenue Growth

The total revenue from olaparib API is expected to see a significant increase, driven by its expanding applications and growing demand. By 2034, the market is projected to reach US$ 4.41 billion[1].

Contract Manufacturing Organizations (CMOs)

CMOs are expected to play a crucial role, with the CMO segment projected to reach US$ 2.61 billion by 2034[1].

Challenges and Restraints

Side Effects

Despite its efficacy, olaparib is associated with side effects, which can hinder market growth. Managing and mitigating these side effects through research and development is crucial[1].

Production Costs

The higher production costs of olaparib API can also act as a restraint. However, advancements in manufacturing and the introduction of generics post-patent expiry are helping to address this issue[1].

Competitive Landscape

Key Players

Companies like AstraZeneca, which markets olaparib under the brand name Lynparza, are significant players in this market. AstraZeneca's strong financial performance, including an 18% increase in total revenue in the first half of 2024, underscores the market's potential[2].

Market Consolidation

The market is witnessing consolidation activities such as new manufacturing facilities, capacity expansions, mergers, and acquisitions. These activities are expected to enhance market potential and distribution networks[1].

Future Outlook

The future of olaparib looks promising, driven by:

Advancements in Research and Development

Significant investments in research and clinical trials are expected to expand olaparib's therapeutic applications and improve its safety profile[1].

Regulatory Approvals

Continued regulatory approvals for new indications and combination therapies will further boost the market[1].

Growing Affordability

The entry of generics into the market post-patent expiry has made olaparib more affordable, particularly in price-sensitive developing nations[4].

Key Takeaways

• The olaparib API market is projected to grow from US$ 1.07 billion in 2024 to US$ 4.41 billion by 2034, driven by a CAGR of 15.3%.
• North America leads the market with a 37% share due to strong healthcare systems and high adoption rates.
• Ovarian cancer remains the largest segment, but other cancer types are gaining traction.
• Combination therapies and personalized medicine are key growth drivers.
• Side effects and production costs are significant challenges that need to be addressed.

FAQs

Q: What is the current market size of the olaparib API market? A: The olaparib API market is estimated to be valued at approximately US$ 1.07 billion in 2024[1].

Q: What is the projected growth rate of the olaparib API market? A: The market is expected to grow at a CAGR of 15.3% from 2024 to 2034[1].

Q: Which region holds the largest market share for olaparib API? A: North America holds approximately 37% of the global market share in 2024[1].

Q: What are the primary indications for olaparib? A: Olaparib is primarily used for ovarian, breast, prostate, and pancreatic cancers, especially in patients with BRCA mutations[1].

Q: What are the main challenges facing the olaparib API market? A: The main challenges include side effects associated with olaparib and the higher production costs of the API[1].

Cited Sources

1. Fact.MR: Olaparib API Market Size & Share | Industry Statistics 2034.
2. AstraZeneca: H1 and Q2 2024 results Strong underlying growth supports FY 2024 guidance upgrade.
3. GlobeNewswire: Latest Global PARP Inhibitors Market Size/Share Worth USD 23.5 Billion by 2032 at a 12.1% CAGR.
4. Coherent Market Insights: PARP Inhibitor Market - Share, Size and Industry Analysis.