AKEEGA Drug Patent Profile

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

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

This drug has three hundred and fourteen patent family members in fifty-seven 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, 2031. This may change due to patent challenges or generic licensing.

There have been ten 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:	314
US Patents:	13
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AKEEGA

US Patents and Regulatory Information for AKEEGA

AKEEGA is protected by twenty-two US patents and two FDA Regulatory Exclusivities.

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	216793-002	Aug 11, 2023		RX	Yes	Yes			Y	Y
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-002	Aug 11, 2023		RX	Yes	Yes
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-002	Aug 11, 2023		RX	Yes	Yes
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-001	Aug 11, 2023		RX	Yes	No
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-001	Aug 11, 2023		RX	Yes	No
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-002	Aug 11, 2023		RX	Yes	Yes
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-001	Aug 11, 2023		RX	Yes	No

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:

Argentina

Austria

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
Norway	2018016
South Africa	200507097	Phthalazinone derivatives
Lithuania	PA2025528
Japan	2009079056	PHTHALAZINONE DERIVATIVE
Mexico	337421	SALES FARMACEUTICAMENTE ACEPTABLES DE 2-{4-[(3S)-PIPERIDIN-3-IL]FE NIL}-2H-INDAZOL-7-CARBOXAMIDA. (PHARMACEUTICALLY ACCEPTABLE SALTS OF 2-{4-[(3S)-PIPERIDIN-3- YL]PHENYL} -2H-INDAZOLE-7-CARBOXAMIDE.)
Japan	2024150638
Croatia	P20250157

Supplementary Protection Certificates for AKEEGA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3490560	122025000033	Germany		PRODUCT NAME: NIRAPARIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON INSBESONDERE NIRAPARIBTOSYLAT INSBESONDERE NIRAPARIBTOSYLAT-MONOHYDRAT, GEGEBENENFALLS IN KOMBINATION MIT ABIRATERON INSBESONDERE ABIRATERONACETAT.; REGISTRATION NO/DATE: EU/1/23/1722 20230419
0633893	SPC/GB11/063	United Kingdom		PRODUCT NAME: ABIRATERONE AND ACID ADDITION SALTS AND 3-ESTERS THEREOF ESPECIALLY ABIRATERONE ACETATE; REGISTERED: UK EU/1/11/714/001 20110905
3490560	C20250026	Finland
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
2240466	18C1020	France		PRODUCT NAME: LE TOSYLATE DE NIRAPARIB OU L'UN DE SES HYDRATES,EN PARTICULIER LE TOSYLATE DE NIRAPARIB MONOHYDRATE; REGISTRATION NO/DATE: EU/1/17/1235 20171120
2109608	300937	Netherlands		PRODUCT NAME: NIRAPARIB, OF EEN TAUTOMEER DAARVAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET TOSYLAAT OF EEN HYDRAAT, MEER IN HET BIJZONDER HET TOSYLAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/17/1235 20171120
2109608	132018000000263	Italy		PRODUCT NAME: NIRAPARIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, UN SUO STEREOISOMERO O TAUTOMERO, IN PARTICOLARE IL TOSILATO O UN IDRATO, IN PARTICOLARE IL TOSILATO MONOIDRATO(ZEJULA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1235, 20171120

Last updated: April 23, 2026

AKEEGA (Akeega): Investment scenario and fundamentals analysis

What is AKEEGA and what risks drive the investment case?

AKEEGA is the fixed-dose combination of niraparib (PARP inhibitor) plus abiraterone acetate (and prednisone) for metastatic castration-resistant prostate cancer (mCRPC). The investment case hinges on whether payers and clinicians treat AKEEGA as a durable, differentiated standard-of-care option versus branded and generic abiraterone, and whether uptake accelerates beyond the initial label anchor populations.

Key investment drivers and constraints:

• Clinical differentiation depends on label position: AKEEGA’s value is concentrated in the specific indication(s) and line-of-therapy placements where niraparib meaningfully improves outcomes relative to abiraterone-based regimens.
• Competitive pressure is structural: androgen receptor pathway inhibitors (ARPI) and other PARP inhibitors compete on sequencing rules, biomarker coverage, and tolerability.
• Safety and adherence affects net realization: PARP inhibitor class signals drive dose modifications, discontinuations, and pharmacy utilization under real-world constraints.
• Patent and exclusivity maturity determines long-term economics: combination products and component patents can create staggered erosion windows for market protection.

---

What does the market tell you about demand durability?

Demand durability for AKEEGA is a function of:

• How quickly clinicians adopt niraparib-augmented ARPI regimens for mCRPC.
• Biomarker-driven targeting (when applicable) that can cap addressable population.
• Payer requirements that often favor narrower criteria earlier, then broaden if evidence and budget impact support expansion.

Commercial durability signals to track:

• Quarterly prescription counts vs. patient starts (lagging indicator: treatment duration).
• Share of voice in urology/oncology networks where sequencing decisions concentrate.
• Real-world discontinuation rate and dose intensity relative to label expectations, which influences reorder behavior.

---

What are the fundamentals of the drug’s competitive positioning?

AKEEGA competes along two axes:

1. With ARPI regimens (abiraterone acetate, enzalutamide, etc.) used across mCRPC lines.
2. With other PARP inhibitor strategies (either as monotherapy or combined with hormonal agents, depending on label).

Net effect:

• If AKEEGA is priced at a premium, it must show outcomes that translate into payer willingness-to-pay.
• If AKEEGA’s adoption is limited to narrow subsets, the revenue curve can flatten even without immediate safety setbacks.

---

What is the payer and access reality for an oral combination?

AKEEGA is an oral fixed-dose regimen. Oral oncology adoption still runs into common access constraints:

• Formulary placement: specialty pharmacy channels and prior authorization (PA) requirements control uptake.
• Step therapy and sequencing rules: payers may require documentation of ARPI exposure or resistance status where clinically consistent.
• Reimbursement dynamics: cost-sharing design can affect persistence and adherence, particularly early during uptake.

Investment implication: a model that assumes linear penetration without PA friction will overstate early-year revenue and understate churn.

---

What are the key clinical and safety fundamentals affecting commercial performance?

For PARP inhibitor-based strategies, the commercial KPI set typically includes:

• Adverse event burden leading to dose interruption
• Hematologic toxicities driving monitoring and lab cadence
• Treatment discontinuation rates
• Patient persistence (time-on-therapy)

Investment implication: AKEEGA’s patient journey profile will determine whether sales are “starts-led” or “duration-led.” A starts-led product can still deliver revenues, but it is more exposed to rapid competitive sequencing changes.

---

How does patent and exclusivity timing shape long-range value?

Investment-grade valuation of AKEEGA requires a scenario of:

• Component protection overlap: niraparib and abiraterone have distinct protection landscapes.
• Combination product protection: fixed-dose formulation and method-of-use can extend exclusivity where allowed.
• Regulatory exclusivities and any supplemental protection windows: can delay generic entry even if single-agent protection weakens.

The investment model should treat the protection stack as staggered erosion, not a single cliff.

---

Investment scenario modeling: base, bull, bear

What revenue scenario range fits the adoption and competition structure?

A practical investment scenario framework:

Scenario	Adoption profile	Competition response	What you expect in KPIs
Bear	Limited label uptake; narrow payer coverage early	ARPI incumbents retain share	Lower patient starts, shorter persistence, higher discontinuation
Base	Moderate adoption with payer stabilization	Stronger than historical benchmarks for combo regimens	Starts rise then normalize; persistence improves with experience
Bull	Broadening criteria post-evidence; smoother PA pathways	Incumbents lose share faster	Higher treatment duration, stronger net retention, better dose intensity

Investment implication: the spread between bear and bull should come more from persistence and net pricing than from headline patient starts alone.

---

What cost and margin levers matter most?

For an oncology combination like AKEEGA, margin sensitivity typically concentrates in:

• Specialty pharmacy distribution costs and rebate structures tied to volume and access design.
• Drug substance and formulation cost efficiency (fixed-dose efficiency can be favorable).
• Realization pressure if payers shift to “lowest net cost” contracting under competitive class dynamics.

Investment implication: margin models should apply net price erosion curves tied to competition and coverage change rather than holding gross-to-net constant.

---

What are the key diligence checkpoints for an investor?

Critical diligence points for AKEEGA:

• Utilization data: patient starts, persistence, and discontinuation by line-of-therapy.
• Net pricing: payer-specific WAC-to-net conversion, rebate volatility, and contract renegotiations.
• Safety and tolerability in real-world cohorts: dose modifications and lab monitoring burden.
• Competitive churn: evidence of share movement relative to ARPI and other PARP pathways.
• Pipeline and label expansion exposure: whether AKEEGA’s moat grows via new populations or shrinks due to better alternatives.

---

Key takeaways

• AKEEGA’s investment thesis is adoption-plus-persistence: revenue quality depends on patient duration and net realization after payer friction.
• Competitive pressure is layered: it faces ARPI incumbents and PARP strategies with different sequencing rules and biomarker coverage.
• Valuation is protection-stack driven: long-term value depends on staggered component and combination exclusivity, not a single patent expiration date.
• Real-world safety translates into commercial outcomes: dosing intensity and discontinuation rates directly affect reorder and persistence.

---

FAQs

1) What is AKEEGA’s core therapeutic rationale?

It is a fixed-dose combination that pairs a PARP inhibitor strategy (niraparib) with androgen pathway suppression using abiraterone acetate plus prednisone for mCRPC.

2) What determines whether AKEEGA wins or loses share?

Reimbursement access, sequencing placement by clinicians, and patient persistence driven by tolerability and dose modifications.

3) What KPI best forecasts revenue quality for an oral oncology combination?

Time on therapy (persistence) plus net price realization, not just prescription starts.

4) How does competition typically affect pricing?

Payers often drive net price down once competing regimens secure formulary placement and contracting pressure increases.

5) What is the main long-term risk to value?

Staggered erosion from generic or lower-cost alternatives as component protections and combination exclusivities weaken.

---

References

[1] APA reference entry placeholder.
[2] APA reference entry placeholder.
[3] APA reference entry placeholder.