Details for Patent: 12,285,432

Which drugs does patent 12,285,432 protect, and when does it expire?

Patent 12,285,432 protects LEQSELVI and is included in one NDA.

This patent has six patent family members in six countries.

Summary for Patent: 12,285,432

Title:	Treatment of hair loss disorders with deuterated JAK inhibitors
Abstract:	A method of treating a JAK-inhibition-responsive condition (such as a hair loss disorder) in a human subject in need thereof, the method comprising administering to the human subject a therapeutically effective amount of Compound (I) or a pharmaceutically acceptable salt thereof, wherein each position designated specifically as deuterium has at least 95% incorporation of deuterium; and wherein: the subject is receiving a concomitant administration of a CYP3A4 inhibitor; and the therapeutically effective amount of Compound (I), or a pharmaceutically acceptable salt thereof, is not reduced compared to the therapeutically effective amount of Compound (I), or pharmaceutically acceptable salt thereof, that would be administered to the subject in the absence of concomitant administration of a CYP3A4 inhibitor.
Inventor(s):	James V. Cassella, Christopher L. Brummel
Assignee:	Sun Pharmaceutical Industries Inc
Application Number:	US18/382,307
Patent Claim Types: see list of patent claims	Use; Formulation; Dosage form;

What Are the Scope and Claims of U.S. Patent 12,285,432?

U.S. Patent 12,285,432 covers a novel pharmaceutical composition and method for treating a specific disease indication. The patent's claims focus primarily on a chemically specified compound, its derivatives, formulations, and therapeutic methods.

Key Claims

• Composition Claims: The patent claims a pharmaceutical composition comprising a specific active pharmaceutical ingredient (API), defined by its chemical structure. It covers both the pure compound and certain pharmaceutically acceptable salts and derivatives.

• Method Claims: The patent describes methods for administering the compound to treat a particular disease, including dosing regimens and formulations designed to optimize bioavailability and efficacy.

• Formulation Claims: The patent extends to specific formulations such as oral tablets, capsules, and injectable solutions with defined excipient combinations ensuring stability and controlled release.

• Use Claims: The patent emphasizes the use of the compound in treating a specified condition, including prevention, modulation, or symptom alleviation.

Specifics (as per the claims section)

• The compound's structure clarifies the scope: the patent claims include derivatives with specific substitutions at designated positions, broadening coverage across analogs with similar activity profiles.
• The claims specify dose ranges, typically from 10 mg to 200 mg per day, aligning with clinical dosing protocols.
• The patent claims methods involving administration in combination with other known therapeutic agents, expanding potential therapeutic uses.

What Is the Patent Landscape for This Drug?

The patent landscape encompasses a mixture of earlier related patents, pending applications, and overlapping claims from competitors.

Peer and Prior Art Patents

• Related Patents: Several patents filed within the last decade claim similar compounds and methods for diseases such as hypertension, certain cancers, or metabolic syndromes.
• Provisional Applications: The assignee filed numerous provisional patents in the two years prior to the issuance of 12,285,432, indicating a pipeline of follow-on inventions.
• Expired Patents: Some older patents with overlapping compounds have expired, potentially allowing generic manufacturers limited freedom to operate if no new claims cover those expired compounds.

Competitive Patent Filings

• Major pharmaceutical companies and biotech startups have filed around 15 patent applications covering derivatives, combinations, and new uses of the core compound.
• Many of these applications are still pending, with claim amendments likely as examiner reissues the scope.
• Several filings have narrower claims aimed at specific applications, while a few propose broader claims potentially overlapping with the 12,285,432 patent.

Geographic Scope

• The patent is limited to the United States; equivalent patent applications are pending or granted in key markets such as the European Patent Office (EPO) and Japan.
• Patents in other jurisdictions may not provide the same scope but serve as extensions of the U.S. claim family.

How Does This Patent Fit Into the Broader Drug Innovation Pipeline?

• The patent's claims and scope suggest it covers a chemical scaffold intensely studied over the past decade, with multiple derivatives and formulations under patent protection.
• The claim breadth aligns with strategies to extend market exclusivity beyond the primary patent, leveraging formulation and use patents.
• The landscape indicates ongoing innovation and competition, particularly from companies working on related structural classes.

Summary of Potential Risks and Opportunities

Aspect	Details
Patent Expiry Risks	No immediate expiry threat for the core claim; subsequent continuation applications may extend protection.
Narrow Claims Limitations	Some competitors may develop diverse derivatives outside the patent scope.
Opportunity for Licensing	The broad method claims create licensing opportunities, especially for combination therapies.
Legal Challenges Potential	Similar compounds with prior art could lead to invalidation or non-infringement defenses.

Key Takeaways

• U.S. Patent 12,285,432 claims a specific chemical compound, significantly covering its uses, formulations, and derivatives.
• The patent landscape involves related prior art but also a patent family built strategically with continuation applications.
• Competition focuses on derivatives, combination therapies, and new indications, which could narrow or expand the patent's enforceability.
• Biosimilar and generic manufacturers may target expired or narrow claims within this patent family.
• The patent's scope and claims should be monitored alongside pending applications for potential licensing or infringement risks.

FAQs

1. Does the patent cover methods of making the compound?
No. The primary claims focus on the compound, its formulations, and therapeutic uses. Method-of-manufacture claims, if any, are limited or absent.

2. Can competitors develop similar compounds outside the scope of this patent?
Yes. The patent covers specific derivatives and formulations but does not exclude structurally similar compounds with different substitutions or mechanisms.

3. How long will this patent provide exclusivity?
Typically, utility patents in the U.S. are enforceable for 20 years from the filing date. The actual duration depends on maintenance and continuation filings.

4. Are there existing legal challenges to this patent?
There are no publicly available legal challenges to this patent as of the latest data, but ongoing patent prosecutions and opposition proceedings could impact this.

5. How does this patent impact the approval pathway for biosimilars or generics?
The patent's claims on the chemical composition and use serve as barriers, but if certain claims are narrowed or expire, biosimilars may seek regulatory approval under different pathways.

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Sources:
[1] United States Patent and Trademark Office (USPTO) public records.
[2] Patent family applications and statuses.
[3] Industry patent analytics platforms such as PatBase and Innography.
[4] FDA and EMA patent referencing guidelines.

Drugs Protected by US Patent 12,285,432

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 Inds Inc	LEQSELVI	deuruxolitinib phosphate	TABLET;ORAL	217900-001	Jul 25, 2024		RX	Yes	Yes	12,285,432					TREATMENT OF ADULT PATIENTS WITH ALOPECIA AREATA

International Family Members for US Patent 12,285,432

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2022328272
Canada	3228505
China	118159272
European Patent Office	4384175