Details for Patent: 11,590,138

Which drugs does patent 11,590,138 protect, and when does it expire?

Patent 11,590,138 protects OPZELURA and is included in one NDA.

This patent has seventeen patent family members in ten countries.

Summary for Patent: 11,590,138

Title:	Topical treatment of vitiligo by a jak inhibitor
Abstract:	The present disclosure relates to topical treatment of vitiligo using ruxolitinib, or a pharmaceutically acceptable salt thereof.
Inventor(s):	Kathleen BUTLER, Jim Lee, Kang Sun, Fiona KUO, Michael Howell
Assignee:	Incyte Corp
Application Number:	US17/860,884
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,590,138
Patent Claim Types: see list of patent claims	Use; Composition;

United States Patent 11,590,138: Scope, Claims, Expiration, and Ruxolitinib Patent Landscape

U.S. Patent No. 11,590,138 protects a specific method of treating nonsegmental vitiligo with 1.5% ruxolitinib cream applied twice daily, without phototherapy. The patent is assigned to Incyte Corporation and is directed to treatment of non-facial body areas, particularly the lower extremities, trunk, and feet. Its strongest commercial claims require measurable repigmentation after 52 weeks, including at least 25% or 50% improvement in the Vitiligo Area Scoring Index, or VASI.

The patent does not broadly cover every use of ruxolitinib for vitiligo. Infringement requires satisfaction of multiple limitations: concentration, topical route, dosing frequency, nonsegmental vitiligo, specified anatomical areas, absence of phototherapy, and, for the narrower claims, treatment duration and VASI outcomes.

What does U.S. Patent 11,590,138 protect?

U.S. Patent 11,590,138 protects treatment methods using topical ruxolitinib at a 1.5% weight-to-weight concentration, administered twice daily to patients with nonsegmental vitiligo.

The independent claims are claims 1 and 15.

Claim	Principal protected subject matter	Key additional limitation
1	Treatment of nonsegmental vitiligo with 1.5% ruxolitinib, applied topically twice daily	Affected area includes lower extremities, trunk, or feet; no phototherapy
15	Same basic treatment method	At least 50% VASI improvement in the specified area after 52 weeks

The claims cover ruxolitinib itself and pharmaceutically acceptable salts on a free-base basis. Claim 2 expressly identifies ruxolitinib phosphate, the active ingredient used in commercial ruxolitinib products.

What are the mandatory elements of claim 1?

A potentially infringing method must include all of the following:

1. A patient with vitiligo.
2. Nonsegmental vitiligo.
3. Topical administration to affected skin.
4. A pharmaceutical composition containing 1.5% w/w ruxolitinib, calculated on a free-base basis.
5. Administration twice per day.
6. An affected area including at least one of:
   • lower extremities;
   • trunk; or
   • feet.
7. No administration of phototherapy as part of the claimed method.

The claim is method-of-treatment subject matter. It generally applies to conduct by a treating physician, healthcare provider, or other party directing or performing the claimed treatment, rather than merely to possession of the product.

How narrow are the anatomical limitations?

The anatomical limitations are material claim restrictions. Claim 1 does not cover treatment directed solely to facial vitiligo unless the treatment also includes the lower extremities, trunk, or feet.

Claims 3, 4, and 5 separately specify the lower extremities, trunk, and feet. These claims create alternative claim positions rather than cumulative requirements.

Claim	Anatomical site
1	One or more of lower extremities, trunk, or feet
3	Lower extremities
4	Trunk
5	Feet
8	Continued treatment until repigmentation in lower extremities
9	Continued treatment until repigmentation in trunk
10	Continued treatment until repigmentation in feet
19	At least 50% VASI improvement in lower extremities
20	At least 50% VASI improvement in trunk
21	At least 50% VASI improvement in feet

The claim language creates potential design-around space for a regimen limited exclusively to facial vitiligo. That strategy would not necessarily avoid other ruxolitinib patents, regulatory restrictions, labeling claims, or contributory-infringement theories.

What treatment duration and efficacy outcomes are claimed?

Claim 7 requires administration for at least 52 weeks. Claim 11 requires at least a 25% improvement in VASI after 52 weeks. Claim 15 independently requires at least a 50% VASI improvement after 52 weeks.

Claims 6 through 11 and claims 15 through 21 therefore protect treatment regimens defined partly by clinical outcome.

Claim group	Duration	Required outcome
Claims 1-5	Not expressly specified	Treatment method with anatomical and dosing limitations
Claims 6-10	Continued until pigmentation increases	Site-specific repigmentation
Claim 7	At least 52 weeks	Increase in pigmentation
Claim 11	At least 52 weeks	At least 25% VASI improvement
Claims 15-21	At least 52 weeks	At least 50% VASI improvement

Outcome-based method claims can be commercially significant but fact-intensive. In an enforcement action, the patent owner would need to establish that the claimed treatment was performed and that the specified clinical outcome occurred or was the treatment objective, depending on the applicable infringement theory and claim construction.

What patient population is covered by claims 12, 13, 16, and 17?

Claims 12 and 16 narrow the patient population by requiring:

• at least 0.5% facial body surface area affected by vitiligo at baseline;
• at least 3% non-facial body surface area affected at baseline; and
• clinical diagnosis of vitiligo.

Claims 13 and 17 further require that the patient be at least 12 years old.

These limitations align with the FDA-approved patient population for Opzelura in nonsegmental vitiligo. The claims do not cover every patient with vitiligo. They require specified baseline disease burden and clinical diagnosis.

The baseline body-surface-area limitations may be important in litigation because they require medical records, baseline assessments, photographs, VASI calculations, or other evidence documenting the patient’s status before treatment.

What formulation is protected by U.S. Patent 11,590,138?

Claims 14 and 18 require the pharmaceutical composition to be an oil-in-water emulsion that is a cream.

This limitation is consistent with Opzelura, a topical ruxolitinib cream. The patent therefore has stronger relevance to a commercial cream product than to an oral tablet, injectable product, ointment, gel, foam, lotion, or other dosage form that does not satisfy the oil-in-water emulsion limitation.

The formulation claims do not require every excipient in the marketed product. They require the claimed dosage form and emulsion type. A competing product could face separate formulation-patent issues even if it avoided claims 14 and 18 through a different vehicle.

When does U.S. Patent 11,590,138 expire?

The patent issued on February 28, 2023. Its earliest identified priority date is June 8, 2017. On a standard 20-year term calculated from the earliest effective nonprovisional filing date, the expected nominal expiration is June 8, 2037, subject to patent-term adjustment, terminal disclaimers, and any applicable statutory correction.

Event	Date
Earliest identified priority date	June 8, 2017
Patent issuance	February 28, 2023
Expected nominal term end	June 8, 2037
Earliest ordinary generic-entry reference point	June 8, 2037, subject to regulatory and litigation effects

The expiration date should be confirmed against the USPTO patent record and any terminal-disclaimer or patent-term-adjustment data before use in a transaction, freedom-to-operate opinion, or litigation filing. The 2037 date is the principal commercial planning date associated with this patent family.

What is the FDA and Orange Book status of the patent?

Opzelura, containing ruxolitinib phosphate, is FDA-approved as a topical cream. The FDA approved Opzelura for atopic dermatitis in September 2021 and for nonsegmental vitiligo in July 2022. The vitiligo indication covers topical treatment in patients 12 years of age and older with nonsegmental vitiligo.[1]

Ruxolitinib cream is regulated as a small-molecule drug. A future generic applicant would generally use the abbreviated new drug application, or ANDA, pathway rather than the 351(k) biosimilar pathway.

The relevant regulatory issues include:

• whether the patent is listed in the FDA Orange Book for the approved product;
• whether the listed use corresponds to an approved labeling indication;
• whether an ANDA applicant files a Paragraph IV certification;
• whether Incyte brings an action within 45 days of receiving notice;
• whether a 30-month stay applies;
• whether the proposed generic labeling must carve out the patented vitiligo use.

The Orange Book is product-specific. A patent may be relevant to commercial enforcement without covering every approved use of the reference product. Method-of-use listings also may be subject to regulatory scrutiny if the listed claims do not properly correspond to an approved method of use.[2]

Which companies could challenge the Opzelura patent estate?

Potential challengers would normally include generic dermatology manufacturers with the capability to formulate and manufacture topical creams. Publicly relevant challenger categories include large ANDA sponsors and specialty-generic companies targeting dermatology products.

A Paragraph IV challenge to a listed Opzelura patent could trigger patent litigation in federal district court. The challenger could attack the patent on grounds including:

• lack of written description;
• lack of enablement;
• anticipation;
• obviousness;
• indefiniteness;
• improper patent-term or listing issues;
• noninfringement based on a different formulation, indication, patient population, or dosing regimen.

The existence of an ANDA filing would not itself establish that a generic product can launch. Launch timing would depend on the patent certifications, litigation outcome, settlement terms, regulatory approval, pediatric exclusivity, and any other listed patents.

What Paragraph IV risks exist for generic ruxolitinib cream?

A generic applicant seeking approval for nonsegmental vitiligo could face a direct Paragraph IV risk because the proposed label may instruct use within the scope of claims 1 or 15.

The principal risk factors are:

Risk factor	Relevance
1.5% ruxolitinib concentration	Directly matches the central claim limitation
Twice-daily dosing	Directly matches claims 1 and 15
Nonsegmental vitiligo indication	Directly matches the claims
Lower-extremity, trunk, or foot treatment	Directly matches the anatomical limitations
52-week treatment duration	Relevant to claims 7 and 11
VASI improvement claims	Relevant to claims 11 and 15
Oil-in-water cream	Relevant to claims 14 and 18
No phototherapy	Relevant to claims 1 and 15

A label carve-out could theoretically remove the patented vitiligo use while retaining an unpatented indication, such as atopic dermatitis. That approach would depend on the Orange Book listing, FDA labeling rules, the wording of the proposed label, and whether the remaining label still induces infringement.

A generic entering with only an atopic dermatitis indication may face less direct exposure under this patent, but it could remain exposed to other Opzelura patents covering composition, formulation, manufacturing, or atopic dermatitis treatment.

How does this patent compare with earlier ruxolitinib patents?

The ruxolitinib patent estate has several layers:

Estate layer	Typical subject matter	Commercial relevance
Compound patents	Ruxolitinib molecule and salts	Broad active-ingredient protection
Oral-use patents	Myelofibrosis, polycythemia vera, and related uses	More relevant to Jakafi/Jakavi
Topical formulation patents	Cream composition, emulsion, excipients, delivery	Relevant to Opzelura product design
Atopic dermatitis patents	Topical ruxolitinib for inflammatory skin disease	Protects the first Opzelura indication
Vitiligo method patents	Nonsegmental vitiligo, body sites, duration, VASI outcomes	Directly relevant to the patent analyzed here
Manufacturing patents	Synthesis, purification, and formulation processes	Can create supply-chain barriers

U.S. Patent 11,590,138 is a late-stage, indication-specific patent. It does not replace earlier composition or formulation patents. Instead, it adds use-based protection around the clinical deployment of ruxolitinib cream for nonsegmental vitiligo.

A generic company may therefore need to clear multiple patent categories. Avoiding one method-of-use claim does not eliminate exposure under a formulation or manufacturing patent.

How strong is the patent estate for nonsegmental vitiligo?

The patent has meaningful commercial strength because its central limitations track the approved product and approved use:

• 1.5% topical ruxolitinib;
• twice-daily administration;
• nonsegmental vitiligo;
• age 12 years and older in narrower claims;
• oil-in-water cream;
• treatment of non-facial body areas;
• measurable repigmentation after extended treatment.

Its principal vulnerabilities are claim narrowness and dependence on clinical facts. A challenger could focus on whether:

• the claimed anatomical sites are essential to the approved treatment;
• the specification adequately supports the full range of VASI and body-site outcomes;
• the 25% and 50% VASI limitations were predictable from the prior art;
• the exclusion of phototherapy provides a patentable distinction;
• the claim adequately enables treatment across all covered sites and patient subgroups;
• a generic label would actually instruct the claimed conduct.

The 50% VASI claims are narrower than claim 1 but may be more difficult to invalidate if supported by clinical trial data. They may also be more difficult to enforce because the outcome must be documented.

What litigation or settlement issues affect this patent?

A complete current litigation determination requires review of USPTO Patent Center, PACER, district-court dockets, the Federal Circuit docket, and FDA Orange Book updates. The claim language alone does not establish whether an ANDA challenge has been filed or whether a settlement exists.

The principal litigation scenarios are:

1. A Paragraph IV ANDA challenge directed to the vitiligo indication.
2. A declaratory-judgment action by a generic applicant.
3. An infringement action by Incyte following Paragraph IV notice.
4. A settlement providing a licensed entry date before patent expiration.
5. A skinny-label launch limited to atopic dermatitis.
6. A post-launch suit based on induced infringement or use of the generic for vitiligo.
7. Inter partes review or post-grant proceedings challenging validity.

No biosimilar litigation pathway applies because ruxolitinib is a chemically synthesized small molecule, not a biologic.

What are the generic launch scenarios?

Scenario	Likely commercial effect
Patent upheld after Paragraph IV litigation	Generic vitiligo entry delayed until settlement date or patent expiry
Patent invalidated	Earlier unrestricted entry may become possible, subject to other patents
Noninfringement ruling	Generic may launch if no other blocking patents remain
Skinny-label approval	Entry for non-vitiligo indications while vitiligo use remains restricted
Settlement with licensed entry	Entry occurs on contractually defined date, often before expiry
Formulation redesign	May avoid claims 14 and 18 but not necessarily claims 1 or 15
Alternative dosing or concentration	May avoid literal infringement but may create clinical and regulatory disadvantages

The largest practical barrier is likely the combination of this indication patent with other formulation and product patents. A generic company would need a complete patent-clearance strategy rather than a single-patent analysis.

What licensing deals affect ruxolitinib?

Incyte developed and commercialized ruxolitinib and has maintained significant rights to the product. Novartis commercializes ruxolitinib under the Jakavi brand outside the United States under arrangements involving Incyte. Those arrangements primarily concern systemic ruxolitinib indications and do not necessarily transfer U.S. rights to Opzelura or to this vitiligo patent.

The relevant U.S. rights for Opzelura remain principally associated with Incyte. Any license, co-commercialization agreement, or authorized generic arrangement would need to be verified from the applicable transaction documents and regulatory filings.

What is the commercial exposure from this patent?

Opzelura is commercially important because it is a branded, nonsteroidal topical treatment with FDA-approved uses in atopic dermatitis and nonsegmental vitiligo. The patent is most relevant to revenue generated from the vitiligo indication and from prescriptions used on covered non-facial areas.

The patent’s commercial value is constrained by three factors:

• the claims do not cover every vitiligo regimen;
• enforcement depends on physician instructions and patient treatment records;
• other patents may expire earlier or later and may independently block generic entry.

The patent has greater strategic value as part of the wider Opzelura estate than as a standalone right. Its 2037 nominal term may support settlement leverage, licensing negotiations, and delayed generic entry, but the actual exclusivity period will depend on validity, listing status, litigation, and settlement terms.

Key Takeaways

• U.S. Patent 11,590,138 is an Incyte patent directed to topical ruxolitinib treatment of nonsegmental vitiligo.
• The core regimen is 1.5% ruxolitinib cream applied twice daily.
• The affected area must include the lower extremities, trunk, or feet.
• The claimed method excludes phototherapy.
• Claims 11 and 15 require VASI improvement after 52 weeks, with thresholds of 25% and 50%, respectively.
• Claims 12, 13, 16, and 17 narrow the population by baseline disease burden, clinical diagnosis, and age.
• Claims 14 and 18 require an oil-in-water cream.
• The expected nominal expiration date is June 8, 2037, subject to USPTO term adjustments and disclaimers.
• Generic applicants would face ANDA and Paragraph IV issues, not biosimilar litigation.
• A generic may pursue a skinny label for atopic dermatitis, but the commercial value of that strategy depends on the remaining Opzelura patent estate.
• The patent is strongest when combined with formulation, composition, and other method-of-use patents covering Opzelura.

FAQs About U.S. Patent 11,590,138

Does the patent cover ruxolitinib tablets for vitiligo?

No. The claims require topical administration to affected skin. Oral ruxolitinib products do not literally satisfy the topical cream limitations.

Does treating facial vitiligo alone infringe the patent?

A regimen limited exclusively to facial vitiligo would not satisfy the express requirement that the affected area include the lower extremities, trunk, or feet. Other patents or infringement theories could remain relevant.

Can a generic use a different cream base?

Possibly. A different vehicle could avoid claims 14 and 18, but it may still fall within broader method claims if it contains 1.5% ruxolitinib and is used twice daily for the claimed vitiligo population and body sites.

Is phototherapy required for the claimed treatment?

No. The claims expressly state that the method does not comprise administering phototherapy. A regimen that includes phototherapy may create a noninfringement argument under the claim language, but the issue would depend on claim construction and the precise treatment protocol.

Does the patent block all nonsegmental vitiligo treatments?

No. It targets a defined ruxolitinib regimen. Nonsegmental vitiligo treatments using other active ingredients, different dosage forms, different concentrations, different dosing schedules, or different treatment methods may fall outside its claims, although separate patents and regulatory restrictions may apply.

References

1. U.S. Food and Drug Administration. (2022). Opzelura (ruxolitinib) cream prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215309s002lbl.pdf

2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/

3. United States Patent and Trademark Office. (2023). U.S. Patent No. 11,590,138, methods of treating vitiligo. https://patents.google.com/patent/US11590138B2/en

4. United States Patent and Trademark Office. (2024). Patent Center. https://patentcenter.uspto.gov/

5. Incyte Corporation. (2024). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. https://investor.incyte.com/financial-information/sec-filings

Drugs Protected by US Patent 11,590,138

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Incyte Corp	OPZELURA	ruxolitinib phosphate	CREAM;TOPICAL	215309-001	Sep 21, 2021		RX	Yes	Yes						FOR THE TOPICAL TREATMENT OF NONSEGMENTAL VITILIGO IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER, IN THE ABSENCE OF PHOTOTHERAPY, WHEREIN THE VITILIGO AFFECTS AT LEAST ONE OF THE LOWER EXTREMITIES, TRUNK, AND FEET OF THE PATIENT

International Family Members for US Patent 11,590,138

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2020290995
Australia	2026200410
Canada	3150975
Canada	3195357
China	116261447
European Patent Office	3982971
European Patent Office	4213800