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 sixteen 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 twelve 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:	316
US Patents:	13
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

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 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

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
Australia	2018246214	Niraparib compositions
Australia	2021245223	Niraparib compositions
Brazil	112019020211	composições de niraparib
Canada	3058375	COMPOSITIONS DE NIRAPARIB (NIRAPARIB COMPOSITIONS)
China	110944638	尼拉帕尼组合物 (NIRAPARIB COMPOSITIONS)
Eurasian Patent Organization	201992177	КОМПОЗИЦИИ НА ОСНОВЕ НИРАПАРИБА

Supplementary Protection Certificates for AKEEGA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1633724	C300726	Netherlands		PRODUCT NAME: OLAPARIB, EN ZOUTEN EN; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
1633724	CR 2015 00012	Denmark		PRODUCT NAME: OLAPARIB, OG SALTE OG SOLVATER DERAF; REG. NO/DATE: EU/1/14/959/001 20141216
1633724	C20150012 00136	Estonia		PRODUCT NAME: OLAPARIIB;REG NO/DATE: EU/1/14/959 18.12.2014
1633724	92680	Luxembourg		PRODUCT NAME: OLAPARIB AINSI QUE DES SELS ET DES SOLVATES DE CELUI-CI. FIRST REGISTRATION: 20141218
0633893	11C0055	France		PRODUCT NAME: ABIRATERONE, SES SELS D'ADDITION D'ACIDE ET 3-ESTERS, EN PARTICULIER ACETATE D'ABIRATERONE; REGISTRATION NO/DATE: EU/1/11/714/001 20110905
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

AKEEGA (abiraterone acetate + prednisone) market dynamics and financial trajectory: exclusivity, competitive threats, and revenue outlook

Last updated: July 29, 2026

AKEEGA is a fixed-dose combination of abiraterone acetate plus prednisone cleared for metastatic castration-sensitive prostate cancer (mCSPC) and metastatic castration-resistant prostate cancer (mCRPC). Growth has been driven by mCRPC adoption and expanding mCSPC uptake, but the long-run revenue profile is constrained by impending patent cliffs for abiraterone-based regimens, payer steering toward lower net-cost options, and competition from other next-generation androgen receptor pathway inhibitors. From a patent and regulatory risk standpoint, AKEEGA’s monetization trajectory is largely tied to how quickly biosimilar/biologic risk is irrelevant (none), generic oral small-molecule entrants arrive, and label-specific exclusivity and switching economics persist.

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What is AKEEGA and which indications drive sales?

Featured snippet: AKEEGA (abiraterone acetate + prednisone) is used in prostate cancer across metastatic settings. Sales are primarily linked to mCRPC use, with mCSPC becoming a growth driver as more treatment lines are deployed.

Indication map that matters for commercial demand

mCRPC (metastatic castration-resistant prostate cancer)

• Core population: men progressing on androgen deprivation therapy with metastatic disease.
• Commercial driver: broad prescriber adoption when sequencing and combination strategies favor abiraterone-related regimens.

mCSPC (metastatic castration-sensitive prostate cancer)

• Expansion population: patients treated earlier in the disease course.
• Commercial driver: payer and guideline preference for androgen receptor pathway inhibitor combinations that show survival benefit.

Where “label breadth” influences market share

• AKEEGA’s fixed-dose format reduces pill burden versus some co-administered regimens, which can improve adherence and streamline dispensing.
• The real switching risk is not “treatment effectiveness,” it is net price and formulary placement against generics and competing ARPI products.

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What market dynamics shape AKEEGA demand in the US and Europe?

Featured snippet: AKEEGA’s demand is shaped by payer formulary controls, the economics of oral ARPI competition, and the pace of generic erosion for abiraterone acetate-based therapy.

US payer and distribution dynamics

Key dynamics

• Oral oncology and men’s health formularies increasingly manage via step edits and prior authorization.
• Net price compression is common when multiple AR pathway inhibitors coexist with generic abiraterone acetate availability.

How fixed-dose combinations typically trade

• Fixed-dose combinations can initially outperform generic co-administration in retention if formulary preference favors simplicity.
• Over time, if a generic abiraterone plus prednisone regimen reaches parity or near-parity in total cost, switching accelerates.

Europe procurement realities

• Hospital and national tender pricing can compress branded margins faster than in the US.
• Substitution rules and reference pricing affect “how fast” AKEEGA can be displaced by lower-cost equivalent regimens.

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What financial trajectory has AKEEGA followed since launch?

Featured snippet: AKEEGA’s revenue trajectory reflects ARPI adoption and later payer-driven margin compression as generic abiraterone pressure increases.

Commercial inflection points that typically drive year-over-year revenue

• Uptake in mCRPC after initial launches: formulary adoption, prescriber comfort, and line-of-therapy placement.
• Uptake in mCSPC once evidence supported earlier use: expansion of addressable patient volume.
• Net price pressure from generic abiraterone acetate and competition from other AR pathway inhibitors: this affects revenue even if volume holds up.

Margin and accounting considerations for investors

• Revenue growth can be volume-led while profitability declines from:
  • payer rebates,
  • channel inventory movements,
  • conversion to lower-cost patient share through formulary switching.

(No consolidated financial figures are provided here because the prompt does not include source financials or the company reporting context.)

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How do AKEEGA’s exclusivity and patent expirations affect its revenue cliff timing?

Featured snippet: For AKEEGA, revenue durability is tied to patents covering the combination and dosing regimen and to any regulatory exclusivity around approved products. Generic entry risk rises as those patents expire and as ANDA litigation settles or is resolved.

Where exclusivity typically comes from

1. Product-specific exclusivity (US patent term and regulatory exclusivity, if applicable).
2. Formulation and combination patents for fixed-dose delivery.
3. Method-of-use patents for the approved indications and dosing regimen.

Revenue cliff model (timing logic)

• Early: branded retention supported by label placement, patient adherence, and prescriber inertia.
• Mid: payer steering and competitive rebates tighten.
• Late: patent expirations and Paragraph IV outcomes determine whether generics launch at risk or wait for full expiration.

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What patents protect AKEEGA (abiraterone acetate + prednisone) and how many are enforceable?

Featured snippet: Patent estates for abiraterone-based combinations usually cluster around the active ingredient, dosing/formulation, and method-of-treatment claims. The enforceable subset controlling generic entry is the one listed in relevant jurisdictions and not already surrendered or invalidated.

Claim types that matter for generic switch prevention

• Combination or fixed-dose ratio claims (abiraterone acetate + prednisone in specified dosing schedules).
• Formulation claims (tablet composition, coating, excipients, manufacturing method).
• Use claims for mCRPC and mCSPC dosing paradigms.

Enforceability bottlenecks that decide “real” protection

• Settlement agreements that cap launch date or require redesign.
• Prior art and obviousness challenges that weaken method/formulation claims.
• Prosecution history estoppel or claim narrowing that reduces coverage.

(Specific patent numbers, expiry dates, and assignees are not included here because no patent list or jurisdictional scope was provided in the prompt.)

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What Paragraph IV and ANDA generic entry risks exist for AKEEGA?

Featured snippet: AKEEGA faces generic entry risk from ANDAs targeting abiraterone acetate-based oral regimens. The launch timing depends on which AKEEGA-specific combination/formulation/method patents are asserted and how litigation ends.

Typical ANDA threat mechanics

• ANDA applicants file with certifications against listed patents.
• If they submit Paragraph IV certifications, they can launch “at risk” after a 180-day period or upon court decision/settlement.

Risk severity factors

• Strength of formulation/combination claims.
• Whether the applicant’s proposed label and regimen design avoids claim elements.
• Likelihood of settlement versus final adjudication.

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What patent litigation affects AKEEGA and could delay or accelerate generic launches?

Featured snippet: Litigation outcome patterns determine whether generics launch immediately post-expiration or are delayed by design-arounds, injunctions, or settlement caps.

Litigation paths that shape the financial trajectory

• Case-by-case claim construction that narrows or preserves patent scope.
• Settlement with agreed launch dates or royalty-like payments.
• Final judgment that confirms invalidity or non-infringement, enabling earlier competition.

(No case caption, docket, or decision data is included due to missing source litigation records in the prompt.)

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What is the Orange Book status of AKEEGA (and what does it imply for generic timing)?

Featured snippet: Orange Book listings for AKEEGA determine which patents can be challenged through ANDA Paragraph IV. The remaining patents and their expiration dates define the generic “wait” versus “challenge now” calculus.

What to look for in the Orange Book (commercially)

• Patent expiration dates (including pediatric adjustments where applicable).
• Claim scope categories (drug substance, drug product, method of use).
• Whether patents are “listed but easy to design around” versus “listed and broad.”

(Orange Book listing content is not reproduced here because no Orange Book dataset was provided.)

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How does AKEEGA compare with competing abiraterone and ARPI brands on market dynamics?

Featured snippet: In prostate metastatic cancer, AKEEGA competes against other oral AR pathway inhibitors and, for abiraterone, against generic abiraterone acetate regimens. Competitive advantage shifts with net price, guideline placement, and patient-level convenience.

Competitive set categories

• Other branded AR pathway inhibitors (marketed as next-generation or differentiated regimens).
• Generic abiraterone acetate plus prednisone co-administration.
• Treatment sequencing alternatives (chemo-first or other pathway drugs) that can shift volume away.

Competitive advantage metrics that drive switching

• Formulary placement and prior authorization ease.
• Total cost of regimen, including prednisone procurement and dispensing.
• Evidence alignment with treatment line and patient profile.

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What manufacturing and IP barriers protect AKEEGA from rapid substitution?

Featured snippet: The fastest generic erosion typically comes from small-molecule substitutability unless formulation and method claims are blocking. For fixed-dose combinations, tablet formulation and manufacturing method claims can slow down “true” substitution.

Barriers by claim type

• Formulation: excipient system and manufacturing steps can increase development time and bioequivalence risk.
• Method-of-use: may delay label parity if entry applicant avoids asserted dosing/indication elements.
• Combination ratio: fixed-dose ratio claims can restrict label switching even if active ingredient generics exist.

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What commercial risks matter most for investors holding AKEEGA exposure?

Featured snippet: The highest commercial risks are net price compression from generic abiraterone, formulation switching to lower-cost equivalent regimens, and payer restrictions that limit eligible prescribers.

Principal downside scenarios

1. Generic abiraterone acetate + prednisone substitution accelerates once relevant patents lapse or are invalidated/settled.
2. Net price resets as competitors bundle rebates and capture preference on formularies.
3. Line-of-therapy displacement as other ARPI or sequencing standards gain share.

Principal upside scenarios

1. mCSPC volume outperformance if clinical guideline adoption remains broad and payer coverage persists.
2. Retention from fixed-dose convenience and adherence benefits if formulary managers treat fixed-dose combinations as distinct.
3. Delayed generic entry from enforceable combination/formulation patents and litigation outcomes.

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Key takeaways

• AKEEGA’s market growth is tied to metastatic prostate cancer penetration across mCRPC and mCSPC, with commercial power driven by guideline placement and payer access.
• The long-run financial trajectory is constrained by generic abiraterone acetate erosion dynamics and ARPI competition, which pressure net price even when volumes remain stable.
• Revenue cliff timing depends on Orange Book-listed patent estates that cover combination, formulation, and method-of-use elements, plus how Paragraph IV challenges and settlements resolve.
• Competitive switching is primarily an economics and access story: total regimen cost, formulary status, and treatment sequencing matter more than brand differentiation once equivalent regimens exist.

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FAQs

1. When do AKEEGA’s key listed patents expire and how does that map to generic launch windows?
2. Which AKEEGA-specific patents are most likely to be asserted in an ANDA Paragraph IV challenge?
3. Does AKEEGA fixed-dose convenience slow payer switching versus generic abiraterone acetate plus prednisone?
4. How do mCSPC guideline changes shift AKEEGA’s addressable market versus mCRPC-focused demand?
5. What settlement structures in abiraterone-related patent disputes most often delay generic launches?

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References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. United States.
2. FDA. Drug Approval Package for AKEEGA (abiraterone acetate and prednisone). United States.