US Drug Patent 10,292,990: Scope, Claims, Expiration, Orange Book Status and Competitive Landscape

US Patent No. 10,292,990 protects a specific abiraterone acetate treatment regimen for prostate cancer. The core combination is methylprednisolone plus 400 to 600 mg of abiraterone acetate administered daily, where the drug has a median particle size of 100 to 1,000 nanometers on a volume-average basis. Claim 2 narrows the regimen to a single daily dose.

The patent is associated with Sun Pharmaceutical Industries’ YONSA product, a micronized abiraterone acetate tablet approved by the FDA in 2018. The FDA Orange Book lists the patent with an expiration date of January 7, 2034. The patent does not broadly cover every abiraterone acetate product. Its enforceability depends on proving all dosing, coadministration, dosage-form and particle-size limitations.

What does US Patent 10,292,990 protect?

US Patent 10,292,990 protects a method of treating prostate cancer using a low-dose, micronized abiraterone acetate regimen administered with methylprednisolone.[1]

Claim element	Scope
Disease	Prostate cancer
Active drug	Abiraterone acetate
Daily dose	Between 400 mg and 600 mg
Corticosteroid	Methylprednisolone
Dosage form	Tablet or capsule
Particle size	Median particle size of 100 nm to 1,000 nm
Measurement basis	Volume average
Claim 2 limitation	The abiraterone acetate is administered as one daily dose

The practical target is a 500 mg daily abiraterone acetate regimen using a micronized product. YONSA is labeled at 500 mg once daily with methylprednisolone 4 mg twice daily.[2]

What is the central inventive concept?

The patent combines three technical and clinical features:

A reduced abiraterone acetate dose relative to the conventional 1,000 mg daily ZYTIGA regimen.
Particle-size reduction intended to improve oral exposure.
Use of methylprednisolone rather than prednisone as the accompanying corticosteroid.

The claims are method claims, not simple composition claims. The patent does not, based on the quoted claims, independently claim every tablet containing micronized abiraterone acetate. A product becomes commercially relevant to the patent when it is administered in a manner that satisfies the full method claim.

How should claim 1 be interpreted?

Claim 1 requires simultaneous satisfaction of each limitation. A potentially infringing treatment must involve:

A patient with prostate cancer;
Administration of methylprednisolone;
A daily abiraterone acetate dose from 400 mg through 600 mg;
A tablet or capsule dosage form; and
Abiraterone acetate with a median particle size from 100 nm through 1,000 nm on a volume-average basis.

The phrase “between 400 and 600 mg” would ordinarily be read to include the endpoints unless the specification or prosecution history states otherwise. A 500 mg daily dose is therefore within the claimed range.

The particle-size limitation is material. A product with a 500 mg abiraterone acetate dose would not necessarily fall within the claim unless its median particle size, measured on the specified volume-average basis, is within the 100-1,000 nm range.

Does claim 1 require metastatic or castration-resistant prostate cancer?

The quoted claim says “prostate cancer” and does not expressly require metastatic, castration-resistant or hormone-sensitive disease. The approved YONSA indication is narrower than the literal disease language in the claim. Regulatory labeling and patent scope therefore must be analyzed separately.[2]

A court could consider the specification and prosecution history when determining whether “prostate cancer” should be limited by the disclosed clinical population. The claim text alone does not impose a metastatic or castration-resistant limitation.

Does the claim require a particular methylprednisolone dose?

The quoted claims require methylprednisolone but do not specify its dose. The FDA-approved YONSA regimen uses methylprednisolone 4 mg twice daily.[2] A treatment using a different methylprednisolone dose could still satisfy the literal claim if the other limitations are met.

What does claim 2 add?

Claim 2 requires the daily abiraterone acetate dose to be administered as a single dose. It narrows claim 1.

Regimen	Claim 1	Claim 2
500 mg once daily	Yes, if all other limitations are met	Yes
250 mg twice daily	Potentially yes	No, because it is not a single daily dose
500 mg split into two administrations	Potentially yes	No
1,000 mg once daily	No	No
250 mg once daily	No	No

Claim 2 is commercially important because YONSA’s labeled abiraterone acetate dose is 500 mg once daily. A competing product that uses the same low-dose micronized approach would face a direct claim-coverage issue if it also uses once-daily administration.

What is the Orange Book status and expiration date?

The FDA Orange Book identifies US Patent No. 10,292,990 in connection with the YONSA NDA. The listed patent expiration date is January 7, 2034.[3]

Regulatory item	Information
Product	YONSA
Active ingredient	Abiraterone acetate
Sponsor	Sun Pharmaceutical Industries, Inc.
NDA	209579
FDA approval	May 22, 2018
Listed patent	US 10,292,990
Orange Book expiration	January 7, 2034
Regulatory pathway	New drug application

The Orange Book listing is significant because it can support a patent certification framework for an ANDA applicant. It does not itself determine infringement. Infringement depends on the proposed product, labeling, manufacturing specifications and intended use.

The 2034 date is materially later than the expiration of several foundational abiraterone patents associated with the original ZYTIGA product. The later protection reflects the narrower formulation and treatment-regimen strategy rather than basic ownership of the abiraterone molecule.

When does abiraterone acetate lose exclusivity?

Abiraterone acetate has multiple layers of exclusivity:

Exclusivity layer	Product or right	Commercial effect
Basic molecule and early composition rights	Earlier abiraterone patents	Broad protection largely predates current generic competition
ZYTIGA product protection	Abiraterone acetate tablets and approved use	Supported the original branded product
Regulatory exclusivity	ZYTIGA and YONSA approvals	Applies for defined FDA periods
Formulation and regimen protection	US 10,292,990	Protects low-dose micronized abiraterone with methylprednisolone
Market exclusivity after patent expiry	Generic and authorized-generic competition	Depends on ANDA approvals and litigation outcomes

For US Patent 10,292,990, the Orange Book date is January 7, 2034.[3] Generic entry before that date could occur through a successful Paragraph IV challenge, a settlement permitting earlier launch, invalidation, noninfringement, or a product design that avoids the listed claims.

The patent is not a biologic patent. Biosimilar procedures under the Public Health Service Act are therefore irrelevant. Competition will arise through ANDAs, 505(b)(2) applications or other small-molecule pathways.

What formulation is protected by US Patent 10,292,990?

The patent protects the use of abiraterone acetate in a tablet or capsule when the active ingredient has the specified micronized particle-size profile.

The quoted claims do not require a particular excipient, coating, manufacturing process, dissolution profile or tablet hardness. Those features may appear elsewhere in the patent specification or prosecution history, but they are not express limitations of claims 1 and 2 as provided.

Why does particle size matter?

Abiraterone acetate has poor aqueous solubility. Reducing particle size can increase surface area and improve dissolution. The claimed size range supports a lower administered dose than the conventional 1,000 mg regimen.

Particle size must be assessed using the claimed measurement concept: median particle size on a volume-average basis. Different analytical methods can produce materially different results. Laser diffraction, image analysis and other particle-size techniques may not be interchangeable for infringement analysis.

A generic applicant seeking to avoid the claim would likely focus on:

A particle-size distribution outside the 100-1,000 nm range;
A formulation that does not establish the claimed volume-average median;
A dose below 400 mg or above 600 mg;
A dosing schedule that is not once daily for claim 2; or
A corticosteroid regimen that does not use methylprednisolone.

Avoidance must be evaluated against the doctrine of equivalents and the full prosecution history.

How does YONSA compare with ZYTIGA and generic abiraterone?

Attribute	YONSA	ZYTIGA	Conventional generic abiraterone
Active ingredient	Abiraterone acetate	Abiraterone acetate	Abiraterone acetate
Typical strength	125 mg tablets, four tablets daily	250 mg or 500 mg tablets	Commonly 250 mg or 500 mg tablets
Daily abiraterone acetate dose	500 mg	1,000 mg	Generally 1,000 mg
Corticosteroid	Methylprednisolone	Prednisone	Usually prednisone under approved labeling
Micronized low-dose technology	Yes	Not the defining approved regimen	Not necessarily
Relevant patent issue	US 10,292,990	Earlier ZYTIGA patent estate	Depends on product and labeling
FDA approval pathway	NDA 209579	NDA 202379	ANDA products

The key distinction is not the active ingredient. It is the combination of dose, particle size, dosage form and corticosteroid. A conventional 1,000 mg generic abiraterone product administered with prednisone may not practice the quoted claims.

A generic applicant could still face risk if its labeling instructs use of 500 mg daily with methylprednisolone or if its product specifications establish a particle size within the claimed range.

Which companies are likely to challenge the patent?

The competitive field includes generic manufacturers with approved or developing abiraterone acetate products, including large ANDA sponsors such as Teva, Dr. Reddy’s Laboratories, Zydus, Lupin, Torrent and Amneal. Product-specific exposure cannot be determined from the existence of an abiraterone ANDA alone.

The relevant distinction is between:

A conventional 250 mg or 500 mg abiraterone product labeled for a 1,000 mg daily dose with prednisone; and
A YONSA-like product labeled for a 500 mg daily dose with methylprednisolone.

Only the second category directly aligns with the quoted claims. A Paragraph IV certification would have to address validity, enforceability and infringement. A section viii statement could be relevant if an applicant carves out the patented method from its labeling, although the success of that strategy depends on the remaining label language and actual use.

What Paragraph IV and generic launch risks exist?

The main launch scenarios are:

Scenario	Likely timing	Effect on YONSA
No challenge or delayed ANDA approval	Through January 2034	Patent-based protection remains
Conventional abiraterone generic launches	Before 2034, subject to separate rights	Competes mainly with ZYTIGA, not necessarily YONSA
Paragraph IV challenge succeeds	Before January 2034	Early YONSA-like entry possible
Settlement permits licensed launch	Before January 2034	Entry date depends on agreement
Noninfringing low-dose formulation	Before January 2034	Possible competition without practicing the claims
Patent survives challenge	Until January 7, 2034	YONSA-like launch remains blocked absent settlement
Patent expires	January 7, 2034	Patent-based barrier ends

A conventional generic may erode abiraterone revenue without infringing US 10,292,990. The patent’s commercial value therefore depends on whether YONSA maintains a distinct low-dose product position or is substituted by lower-cost conventional abiraterone.

What patent litigation and settlement issues affect YONSA?

The key litigation questions are product-specific:

Has an ANDA applicant certified Paragraph IV against US 10,292,990?
Did Sun Pharmaceutical file an infringement action within the statutory window?
Does the proposed product contain abiraterone acetate within the claimed particle-size range?
Does the proposed label instruct 400-600 mg daily with methylprednisolone?
Does the product use a single daily dose?
Is the patent challenged as obvious, anticipated or indefinite?
Does any settlement include a permitted launch date, supply arrangement or license?

A court dispute could focus on whether the particle-size limitation is sufficiently definite and reproducible, whether the claimed low-dose regimen would have been obvious in view of earlier abiraterone pharmacokinetic data, and whether the proposed generic label induces the claimed use.

A settlement agreement could permit an earlier launch without invalidating the patent. Settlement terms are often confidential or disclosed only through regulatory or antitrust filings. The patent expiration date alone does not establish the actual generic-entry date.

How strong is the patent estate?

US Patent 10,292,990 is narrower than a composition-of-matter patent but potentially valuable because it covers the commercial attributes that distinguish YONSA from conventional abiraterone.

Strength factor	Assessment
Commercial alignment	Strong, because the claim maps to the YONSA low-dose regimen
Breadth	Moderate to narrow; several concrete limitations must be met
Design-around potential	Meaningful, especially through dose, corticosteroid, particle size or label changes
Product-level detectability	Mixed; dose and label are visible, particle size may require technical discovery
Biosimilar relevance	None
Generic relevance	High
Litigation sensitivity	High, because method claims depend on product labeling and use
Remaining listed term	Approximately nine years from March 2025, before any applicable adjustment

The patent’s strongest feature is its connection to a specific approved product. Its main weakness is that a challenger can attack multiple independent limitations. A generic maker does not necessarily need to replicate the entire YONSA formulation to compete clinically.

What is the revenue exposure for Sun Pharmaceutical?

Public company reporting generally does not isolate YONSA revenue from Sun Pharmaceutical’s broader US specialty and oncology businesses. The commercial exposure is therefore best assessed through market substitution rather than a publicly reported product-specific revenue figure.

The principal risks are:

Conventional generic abiraterone replacing branded ZYTIGA and reducing overall abiraterone pricing;
Clinical substitution between YONSA and conventional abiraterone;
A low-dose generic that designs around the particle-size or dosing limitations;
A successful Paragraph IV challenge against the YONSA patent;
Payer preference for lower-cost generic alternatives.

The patent provides stronger protection against a direct YONSA copy than against broad generic erosion of the abiraterone market.

Key Takeaways

US Patent 10,292,990 covers a prostate-cancer treatment using methylprednisolone and 400-600 mg daily of micronized abiraterone acetate.
The dosage form must be a tablet or capsule.
The claimed median particle size is 100-1,000 nm on a volume-average basis.
Claim 2 requires one daily administration.
The patent is listed for YONSA and has an Orange Book expiration date of January 7, 2034.
Conventional 1,000 mg abiraterone products used with prednisone may not infringe the quoted claims.
The principal generic risk comes from a YONSA-like product, a successful Paragraph IV challenge or a formulation and label designed around the claim limitations.
No biosimilar pathway applies because abiraterone acetate is a small-molecule drug.
The patent is commercially relevant but narrower and more design-around-sensitive than a basic composition-of-matter patent.

FAQs

Is a 500 mg abiraterone acetate product automatically covered by US Patent 10,292,990?

No. It must also be administered with methylprednisolone, supplied as a tablet or capsule, and have the claimed 100-1,000 nm median particle size on a volume-average basis.

Would a 500 mg twice-daily abiraterone regimen infringe claim 1?

It could potentially satisfy claim 1 if the total daily dose is 400-600 mg and all other limitations are met. It would not satisfy claim 2 because claim 2 requires a single daily dose.

Can a generic use prednisone and avoid US Patent 10,292,990?

A prednisone-based regimen would not literally satisfy the methylprednisolone limitation. Other patents, labeling theories or infringement theories could still apply, but the quoted claims specifically require methylprednisolone.

Does the patent cover abiraterone acetate manufacturing?

The quoted claims do not claim a manufacturing process. They claim a treatment method using a product with a defined particle-size characteristic. Separate process or composition claims, if present elsewhere in the patent family, would require independent review.

Does expiration of US Patent 10,292,990 eliminate all YONSA exclusivity?

No. It removes this patent-based barrier, but other patents, regulatory exclusivities, pediatric extensions, approved-label restrictions, manufacturing rights and litigation settlements could affect actual market entry.

References

United States Patent and Trademark Office. (2019). US Patent No. 10,292,990, methods of treating prostate cancer using abiraterone acetate. U.S. Department of Commerce.
U.S. Food and Drug Administration. (2018). YONSA (abiraterone acetate) tablets prescribing information. Sun Pharmaceutical Industries, Inc.
U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Sun Pharm	YONSA	abiraterone acetate	TABLET;ORAL	210308-001	May 22, 2018		RX	Yes	Yes	10,292,990	⤷ Start Trial				USE IN COMBINATION WITH METHYLPREDNISOLONE FOR THE TREATMENT OF PATIENTS WITH PROSTATE CANCER	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	095480	⤷ Start Trial
Australia	2014232508	⤷ Start Trial
Australia	2015317466	⤷ Start Trial
Australia	2018241103	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 10,292,990

Which drugs does patent 10,292,990 protect, and when does it expire?

Summary for Patent: 10,292,990