ZEJULA Drug Patent Profile

When do Zejula patents expire, and what generic alternatives are available?

Zejula is a drug marketed by Glaxosmithkline and is included in two NDAs. There are eight patents protecting this drug.

This drug has two hundred and eighty-three patent family members in fifty-five countries.

The generic ingredient in ZEJULA is niraparib tosylate. One supplier is listed for this compound. Additional details are available on the niraparib tosylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Zejula

Zejula was eligible for patent challenges on March 27, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 27, 2038. 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

Summary for ZEJULA

International Patents:	283
US Patents:	8
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	60
Drug Prices:	Drug price information for ZEJULA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZEJULA
What excipients (inactive ingredients) are in ZEJULA?	ZEJULA excipients list
DailyMed Link:	ZEJULA at DailyMed

See drug prices for ZEJULA

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

Constraining patent/regulatory exclusivity:

11,091,459

NDA:

208447

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

11,091,459

NDA:

214876

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 ZEJULA

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

Sponsor	Phase
Zenith Epigenetics	Phase 1
Haider Mahdi	Phase 1
Institute of Cancer Research, United Kingdom	Phase 2

See all ZEJULA clinical trials

Pharmacology for ZEJULA

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

US Patents and Regulatory Information for ZEJULA

ZEJULA is protected by nine US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 11,091,459.

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
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-003	Apr 26, 2023		RX	Yes	Yes	11,673,877		Y
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-002	Apr 26, 2023		RX	Yes	No	8,436,185			Y
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-003	Apr 26, 2023		RX	Yes	Yes	8,859,562
Glaxosmithkline	ZEJULA	niraparib tosylate	CAPSULE;ORAL	208447-001	Mar 27, 2017		DISCN	Yes	No	8,071,579
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-001	Apr 26, 2023		RX	Yes	No	11,730,725		Y
Glaxosmithkline	ZEJULA	niraparib tosylate	CAPSULE;ORAL	208447-001	Mar 27, 2017		DISCN	Yes	No	8,436,185			Y
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-003	Apr 26, 2023		RX	Yes	Yes	11,730,725		Y

International Patents for ZEJULA

When does loss-of-exclusivity occur for ZEJULA?

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

Australia

Brazil

Canada

China

Eurasian Patent Organization

European Patent Office

Israel

Japan

Mexico

Singapore

South Korea

Taiwan

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 ZEJULA around the world.

Country	Patent Number	Title	Estimated Expiration
Portugal	1684736
South Korea	20200014736	니라파립 조성물
World Intellectual Property Organization (WIPO)	2004080976
Japan	7269227
Japan	2012087135	THERAPEUTIC COMPOUND
Hong Kong	1094006	USE OF RNAI INHIBITING PARP ACTIVTIY FOR THE MANUFACTURE OF A MEDICAMENT FOR THE TREATMENT OF CANCER
Germany	602004032537

Supplementary Protection Certificates for ZEJULA

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
2240466	2018/020	Ireland		PRODUCT NAME: NIRAPARIB TOSYLATE OR A HYDRATE THEREOF, ESPECIALLY THE TOSYLATE MONOHYDRATE; REGISTRATION NO/DATE: EU/1/17/1235 20171116
2109608	18C1019	France		PRODUCT NAME: NIRAPARIB OU L'UN DE SES SELS,STEREOISOMERES OU TAUTOMERES PHARMACEUTIQUEMENT ACCEPTABLES EN PARTICULIER LE TOSYLATE OU HYDRATE DE TOSYLATE,PLUS PARTICULIEREMENT LE TOSYLATE DE NIRAPARIB MONOHYDRATE; REGISTRATION NO/DATE: EU/1/17/1235 20171120
2240466	300938	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
2109608	CR 2018 00017	Denmark		PRODUCT NAME: NIRAPARIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, STEREOISOMER OR TAUTOMER THEREOF, PARTICULARLY THE TOSYLATE OR A HYDRATE, ESPECIALLY THE TOSYLATE MONOHYDRATE; REG. NO/DATE: EU/1/17/1235 20171120
2109608	C201830023	Spain		PRODUCT NAME: NIRAPARIB; NATIONAL AUTHORISATION NUMBER: EU/1/17/1235; DATE OF AUTHORISATION: 20171116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1235; DATE OF FIRST AUTHORISATION IN EEA: 20171116
2240466	122018000052	Germany		PRODUCT NAME: NIRAPARIBTOSYLAT, EINSCHLIESSLICH NIRAPARIBTOSYLATMONOHYDRAT; REGISTRATION NO/DATE: EU/1/17/1235 20171116

Market Dynamics and Financial Trajectory for ZEJULA

Introduction to ZEJULA

ZEJULA, also known as niraparib, is a PARP (poly (ADP-ribose) polymerase) inhibitor developed by Tesaro, Inc., now part of GlaxoSmithKline (GSK) following an acquisition in 2019. This drug has been approved for the treatment of various types of ovarian cancer, including recurrent ovarian cancer.

Market Launch and Initial Reception

ZEJULA was launched in the U.S. in 2017, marking a significant milestone for Tesaro. The launch was highly successful, with over 1,500 patient starts in the second quarter of 2017 and more than a thousand prescribers since its launch. The drug generated $25.9 million in sales during the second quarter, accounting for 88% of Tesaro's total revenues at the time[1].

Market Share and Competition

In the competitive PARP inhibitor market, ZEJULA quickly gained a substantial market share. Just ten weeks after its launch, ZEJULA was treating around 60% of the monthly PARP inhibitor-treated recurrent ovarian cancer patients in the U.S. The remaining 40% was split between Clovis Oncology's Rubraca (rucaparib) and AstraZeneca's Lynparza (olaparib)[1].

Clinical and Cost Advantages

ZEJULA's success can be attributed to its strong clinical data and cost advantages. The drug has a broad indication for maintenance treatment in recurrent ovarian cancer and offers once-daily dosing, which is a significant advantage. Additionally, while ZEJULA is priced higher than its competitors at the highest dose, many patients reduce their dose to 200 mg or 100 mg, which lowers the cost significantly[1].

Global Expansion

Beyond the U.S., ZEJULA has been expanding its reach globally. Tesaro had licensed ZEJULA to Takeda for markets in Japan, Australia, Russia, South Korea, and Taiwan. The company was also awaiting marketing approval in the EU and had enrolled over 200 patients in the European expanded access program across nine countries[1].

Financial Performance

Early Financials

In the second quarter of 2017, ZEJULA generated $25.9 million in sales, a promising start for the drug. This revenue was a significant portion of Tesaro's total revenues for the quarter[1].

Recent Financials

By 2022, ZEJULA had continued to show strong financial growth. Zai Lab, which has rights to ZEJULA in certain regions, reported that product revenues for ZEJULA increased by 55.2% year-over-year, reaching $145.2 million for the full year 2022. This growth contributed to Zai Lab's total revenue of $215.0 million, a 49.0% increase year-over-year[2][5].

Market Growth Projections

The global PARP inhibitors market, in which ZEJULA is a key player, is projected to grow significantly. The market size was valued at USD 3,425.2 million in 2023 and is expected to reach USD 10,317.3 million by 2031, growing at a CAGR of around 8.0% from 2024 to 2030. ZEJULA is anticipated to register the fastest CAGR during this period due to rising cases of ovarian and fallopian tube cancers and its efficacy in delaying cancer progression[3][4].

Clinical Trials and Future Indications

ZEJULA is currently under evaluation in various clinical trials, including the Phase 3 PRIMA trial, which is examining its use in first-line ovarian cancer with progression-free survival as the primary endpoint. These ongoing trials are expected to further expand its indications and solidify its position in the market[1].

Strategic Collaborations and Acquisitions

The acquisition of Tesaro by GlaxoSmithKline in 2019 has been a pivotal factor in ZEJULA's market dynamics. This acquisition allowed GSK to gain marketing rights for ZEJULA, enhancing its ovarian cancer portfolio. Such strategic collaborations and acquisitions are expected to continue driving the growth of the PARP inhibitors market[4].

Challenges and Considerations

Despite its strong market performance, the high cost of PARP inhibitors, including ZEJULA, remains a challenge. The cost of research and development activities contributes to the high pricing of these drugs, which can affect market growth. However, the clinical benefits and cost advantages of ZEJULA have helped mitigate some of these concerns[1][4].

Conclusion

ZEJULA has established itself as a leading PARP inhibitor in the treatment of ovarian cancer, with a strong market launch, significant market share, and robust financial growth. Its clinical advantages, cost benefits, and ongoing clinical trials position it for continued success in the expanding PARP inhibitors market.

Key Takeaways

• Rapid Market Adoption: ZEJULA quickly gained a substantial market share in the U.S. PARP inhibitor market.
• Clinical Advantages: The drug offers once-daily dosing and broad indications for maintenance treatment in recurrent ovarian cancer.
• Financial Growth: ZEJULA has shown significant year-over-year revenue growth, contributing to the overall revenue of its distributors.
• Global Expansion: The drug is licensed in various regions and is awaiting marketing approvals in new markets.
• Market Projections: ZEJULA is expected to register the fastest CAGR in the PARP inhibitors market from 2024 to 2030.
• Ongoing Trials: Clinical trials, such as the Phase 3 PRIMA trial, are expected to expand its indications further.

FAQs

Q: What is ZEJULA used for?

ZEJULA (niraparib) is used for the treatment of various types of ovarian cancer, including recurrent ovarian cancer.

Q: How did ZEJULA perform in its initial launch?

ZEJULA had a successful launch in the U.S. in 2017, with over 1,500 patient starts in the second quarter and generating $25.9 million in sales.

Q: What is the market share of ZEJULA in the PARP inhibitor market?

Just ten weeks after its launch, ZEJULA was treating around 60% of the monthly PARP inhibitor-treated recurrent ovarian cancer patients in the U.S.

Q: What are the cost advantages of ZEJULA?

While ZEJULA is priced higher at the highest dose, many patients reduce their dose to 200 mg or 100 mg, which lowers the cost significantly.

Q: What are the future growth projections for ZEJULA?

ZEJULA is expected to register the fastest CAGR in the PARP inhibitors market from 2024 to 2030, driven by rising cases of ovarian and fallopian tube cancers and its efficacy in delaying cancer progression.

Sources

1. BioPharma Dive: "Tesaro's Zejula quickly gaining in PARP market"
2. Zai Lab: "Zai Lab Announces Full-Year 2022 Financial Results and Recent Corporate Updates"
3. Grand View Research: "Blockbuster Oncology Brands Market | Industry Report, 2030"
4. InsightAce Analytic: "PARP Inhibitors Market Size, Share, Growth and Forecast to 2031"
5. Zai Lab: "Zai Lab Announces Full-Year 2022 Financial Results and Recent Corporate Updates"