AKEEGA Drug Patent Profile

Which patents cover Akeega, and when can generic versions of Akeega launch?

Akeega is a drug marketed by Janssen Biotech and is included in one NDA. There are eleven patents protecting this drug.

This drug has two hundred and ninety-one patent family members in fifty-five countries.

The generic ingredient in AKEEGA is abiraterone acetate; niraparib tosylate. There are twenty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the abiraterone acetate; niraparib tosylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Akeega

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 AKEEGA

International Patents:	291
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for AKEEGA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AKEEGA
What excipients (inactive ingredients) are in AKEEGA?	AKEEGA excipients list
DailyMed Link:	AKEEGA at DailyMed

See drug prices for AKEEGA

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

Constraining patent/regulatory exclusivity:

11,091,459

NDA:

216793

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.

Pharmacology for AKEEGA

Drug Class	Cytochrome P450 17A1 Inhibitor Poly(ADP-Ribose) Polymerase Inhibitor
Mechanism of Action	Cytochrome P450 17A1 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors Poly(ADP-Ribose) Polymerase Inhibitors

US Patents and Regulatory Information for AKEEGA

AKEEGA is protected by eleven US patents and one FDA Regulatory Exclusivity.

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
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-001	Aug 11, 2023		RX	Yes	No	11,992,486
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-002	Aug 11, 2023		RX	Yes	Yes	8,859,562
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-002	Aug 11, 2023		RX	Yes	Yes

International Patents for AKEEGA

When does loss-of-exclusivity occur for AKEEGA?

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 AKEEGA around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2336120	Combinaisons contenant indazoles à substitution amide utilisés comme inhibiteurs de la poly(ADP-ribose)polymérase (PARP) (Combinations containing amide substituted indazoles as poly(adp-ribose)polymerase (parp) inhibitors)
Norway	2015008
Spain	2362214

Supplementary Protection Certificates for AKEEGA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2240466	C201830027	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	132018000000301	Italy		PRODUCT NAME: NIRAPARIB TOSILATO O UN SUO IDRATO, IN PARTICOLARE IL TOSILATO MONOIDRATO(ZEJULA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1235, 20171120
2109608	18/2018	Austria		PRODUCT NAME: NIRAPARIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ, STEREOISOMER ODER TAUTOMER DAVON, INSBESONDERE DAS TOSYLAT ODER EIN HYDRAT, INSBESONDERE DAS TOSYLAT-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/17/1235 (MITTEILUNG) 20171120

Market Dynamics and Financial Trajectory for AKEEGA

Introduction to AKEEGA

AKEEGA, a dual-action tablet combining niraparib (a PARP inhibitor) and abiraterone acetate (a hormone therapy), has been approved for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in patients with BRCA1/2 mutations. This approval marks a significant development in the treatment landscape for prostate cancer, but it also comes with specific market and financial implications.

Approval and Regulatory Landscape

The FDA approval of AKEEGA is based on the Phase 3 MAGNITUDE study, which demonstrated a 47% reduction in the risk of radiographic progression-free survival (rPFS) in BRCA-positive patients compared to abiraterone acetate plus prednisone or prednisolone (AAP) alone[3][4].

• Narrow Label: The FDA approved AKEEGA only for patients with BRCA mutations, similar to the approvals for other PARP inhibitors like Lynparza and Talzenna. This narrow label limits the potential market size[4].

Market Competition

AKEEGA enters a competitive market dominated by other PARP inhibitors:

• Lynparza and Talzenna: These drugs, developed by AstraZeneca/Merck and Pfizer, respectively, have also received approvals for similar indications. The competition is intense, with each drug vying for a share of the limited market defined by BRCA-positive patients[1][4].

Sales Projections and Market Potential

Despite its innovative dual-action mechanism, AKEEGA's sales are expected to be modest due to several factors:

• Limited Patient Population: The drug is approved for only about 10% to 15% of prostate cancer patients who have BRCA mutations, significantly limiting its market potential[4].
• Global Sales Forecast: According to GlobalData, while the combined annual sales of Zejula and Zytiga are projected to reach $2.5 billion by 2029, only a small subset of these sales will be attributed to AKEEGA. Most sales will come from the individual drugs' sales in other indications[1].

Financial Trajectory

The financial trajectory for AKEEGA is influenced by several key factors:

• Revenue Contribution: Given the narrow label and competitive landscape, AKEEGA is not expected to contribute significantly to Johnson & Johnson's overall revenue. The majority of the revenue will come from other marketed indications of Zejula and Zytiga[1].
• Growth Projections: Johnson & Johnson's overall growth strategy is driven by a robust pipeline of novel therapies and product expansions. However, AKEEGA's contribution to this growth will be marginal compared to other pipeline assets[2].

Challenges and Opportunities

• Safety and Efficacy Concerns: The FDA's narrow approval is partly due to concerns about safety and efficacy in the broader population. This limits the drug's market potential and necessitates careful patient selection[4].
• Innovative Mechanism: Despite the challenges, AKEEGA's dual-action mechanism offers a unique treatment option. This innovation could attract a loyal patient base and healthcare providers looking for targeted therapies[3].

Patient Eligibility and Testing

For patients to be eligible for AKEEGA, they must undergo an FDA-approved genetic test to confirm BRCA mutations. This requirement further narrows the potential patient pool but ensures that the drug is used in the most appropriate cases[4].

Side Effects and Patient Retention

Clinical trials have identified common serious side effects such as pain, fatigue, constipation, high blood pressure, and nausea. About 15% of patients left the study due to adverse reactions, which could impact patient retention and adherence to the treatment[4].

Global Market Impact

• European Approval: AKEEGA received a more limited clearance in Europe compared to what J&J had sought, further indicating the cautious regulatory approach to PARP inhibitors in prostate cancer[4].
• Global Prostate Cancer Landscape: Prostate cancer is a significant health issue, especially in Europe where it is the most common cancer in men. AKEEGA's approval, though limited, contributes to the evolving treatment options for this patient population[5].

Conclusion

AKEEGA's market dynamics are characterized by a narrow approval label, intense competition, and limited sales projections. While it offers a unique dual-action mechanism, its financial trajectory is expected to be modest within Johnson & Johnson's broader portfolio.

Key Takeaways

• Narrow Approval Label: AKEEGA is approved only for BRCA-positive mCRPC patients.
• Competitive Market: AKEEGA competes with other PARP inhibitors like Lynparza and Talzenna.
• Limited Sales Projections: Sales are expected to be modest due to the limited patient population.
• Unique Mechanism: The dual-action tablet offers a targeted treatment option.
• Regulatory Challenges: Safety and efficacy concerns have led to narrow approvals.

FAQs

1. What is AKEEGA, and how is it different from other PARP inhibitors?

   • AKEEGA is a dual-action tablet combining niraparib (a PARP inhibitor) and abiraterone acetate (a hormone therapy), making it unique compared to other PARP inhibitors like Lynparza and Talzenna.

2. Who is eligible for AKEEGA treatment?

   • Patients with metastatic castration-resistant prostate cancer (mCRPC) and confirmed BRCA1/2 mutations are eligible for AKEEGA treatment.

3. What are the common side effects of AKEEGA?

   • Common serious side effects include pain, fatigue, constipation, high blood pressure, and nausea.

4. How does AKEEGA's approval impact the prostate cancer treatment landscape?

   • AKEEGA offers a new targeted treatment option for BRCA-positive mCRPC patients, contributing to the evolving treatment approaches for prostate cancer.

5. What are the sales projections for AKEEGA?

   • Sales projections for AKEEGA are modest due to the narrow approval label and limited patient population, with most sales coming from other indications of Zejula and Zytiga.

Cited Sources

1. Biopharma Reporter - J&J's Akeega FDA approval to heat up PARP battle[1].
2. Johnson & Johnson Innovative Medicine Presentation - Cautionary Note on Forward-Looking Statements[2].
3. Janssen Canada - Health Canada Authorizes AKEEGA TM (niraparib and abiraterone acetate) Dual Action Tablets[3].
4. Biopharma Dive - J&J joins PARP rivals with narrow FDA clearance in prostate cancer[4].
5. Janssen Pharmaceutical Companies - Janssen Marks First Approval Worldwide for AKEEGA® (Niraparib and Abiraterone Acetate) Dual Action Tablet[5].