Details for Patent: 8,263,580

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Which drugs does patent 8,263,580 protect, and when does it expire?

Patent 8,263,580 protects SORILUX and is included in one NDA.

This patent has twenty-six patent family members in twelve countries.

Summary for Patent: 8,263,580

Title:	Vitamin formulation
Abstract:	A pharmaceutical aerosol foam composition, comprising: an effective amount of a pharmaceutically active ingredient, wherein said pharmaceutically active ingredient is a vitamin or analogue thereof; an occlusive agent; an aqueous solvent; an organic cosolvent; wherein the pharmaceutically active ingredient is insoluble in both water and the occlusive agent; and the occlusive agent being present in an amount sufficient to form an occlusive layer on the skin, in use. In a second embodiment, an oil-in water emulsion having a vitamin, an occlusive agent; an aqueous solvent; and an organic cosolvent, wherein the occlusive agent is present in an amount sufficient to form an occlusive layer on the skin.
Inventor(s):	Richard Buchta, Robert James Houlden, Rose Ye, Maria Graziella Larm, Leon LOUPENOK
Assignee:	Stiefel West Coast LLC
Application Number:	US11/420,700
Patent Claim Types: see list of patent claims	Use; Composition;

US Patent 8,263,580: Scope, Claims, Expiration, Orange Book Status, and Generic Risk

US Patent 8,263,580 protects a calcipotriene-containing topical oil-in-water aerosol emulsion that forms a foam after release from a pressurized container. Its broadest commercial relevance is the 0.005% calcipotriene foam product Sorilux. The patent focuses on the composition architecture, not merely the active ingredient: a water-solubilized vitamin D analogue, an oil phase containing an occlusive agent and stabilizer, an emulsifier, a water-soluble solvent, and aerosol delivery as foam.

The patent issued on September 11, 2012, from a Foamix-related patent family. Its claims cover calcipotriene and other vitamin D analogues, multiple emulsifier systems, antioxidant stabilizers, solvent choices, concentration ranges, pH ranges, propellants, and psoriasis treatment methods. The base patent term is tied to the family’s 2005 international filing and is therefore in the 2025 period, subject to any applicable patent-term adjustment or terminal-disclaimer information recorded by the USPTO.[1]

What does US Patent 8,263,580 protect?

The independent claims protect three overlapping categories:

Claim group	Principal protected subject matter	Commercial relevance
Claims 1-24	Broad topical oil-in-water aerosol emulsion containing a vitamin D compound	Platform composition
Claim 25	Psoriasis treatment using the claimed composition	Method-of-use coverage
Claims 27-43	Composition with vitamin E or a vitamin E analogue as stabilizer	Antioxidant-stabilized formulation
Claims 44-67	More specific calcipotriene formulation with defined solvent, emulsifier, and occlusive-agent ranges	Closest claim set to calcipotriene foam products
Claim 68	Psoriasis treatment using claim 44	Method-of-use coverage
Claims 69-70	Expanded stabilizer group, including vitamin E derivatives, beta-carotene, coenzyme Q10, lutein, tocotrienols, soy isoflavones, S-adenosylmethionine, and BHT	Formulation-development alternatives

The patent does not claim every calcipotriene topical product. A product must satisfy the required combination of active ingredient, phase structure, excipients, solvent, and aerosol-foam delivery limitations.

How broad is claim 1?

Claim 1 is broad in chemical selection but narrow in dosage-form architecture. It requires all of the following:

1. A topical oil-in-water emulsion.
2. A water phase containing water and a vitamin D compound or analogue.
3. The vitamin D compound solubilized in the water phase.
4. An oil phase containing an occlusive agent and stabilizer.
5. An emulsifier.
6. A water-soluble organic solvent.
7. Aerosol delivery from a pressurized container.
8. Foam formation upon release.

The vitamin D analogue list includes calcidiol, calcitriol, calcipotriene, paricalcitol, 22-oxacalcitriol, dihydrotachysterol, calciferol, and combinations.

The key claim-construction issue is that the limitations operate cumulatively. A competing product containing calcipotriene may avoid claim 1 if it is:

• a non-aerosol cream, ointment, gel, lotion, or solution;
• a water-in-oil rather than oil-in-water emulsion;
• formulated without a water-soluble organic solvent;
• formulated with calcipotriene dissolved only in the oil phase;
• packaged as a pump or tube product rather than a pressurized foam;
• missing the claimed oil-phase occlusive agent and stabilizer combination.

A product that uses the same active ingredient but a materially different delivery system would not automatically infringe.

What formulations are protected by the calcipotriene claims?

Claims 44-67 provide the most commercially focused protection. Claim 44 requires:

• calcipotriene;
• a concentration of approximately 0.005% to approximately 10.0% by weight;
• initial solubilization in a water-soluble organic solvent;
• subsequent solubilization into the water phase;
• an oil phase containing an occlusive agent and stabilizer;
• emulsifier at approximately 2.0% to approximately 5.0% by weight;
• occlusive agent at approximately 1% to approximately 10% by weight;
• aerosol emulsion that becomes foam from a pressurized container.

The claim covers the commercially important 0.005% calcipotriene concentration. It also covers much higher concentrations up to 10%, although those concentrations may have limited relevance to an approved psoriasis product.

Claim limitations with the greatest enforcement significance

Limitation	Scope
Calcipotriene	Specifically recited in claims 2, 28, and 44
Water-soluble solvent	Propylene glycol and multiple glycols, PEGs, ethers, ethyl acetate, propylene carbonate, and N-methylpyrrolidone
Occlusive agent	Mineral oil, grease, petrolatum, fatty acids, animal or vegetable fats, and water-insoluble polymers
Stabilizer	Vitamin E and derivatives, plus antioxidants listed in claims 69-70
Emulsifier	Surfactants, fatty alcohols, fatty acids, fatty-acid salts, and defined blends
Emulsifier concentration	Approximately 2%-5% in claims 5, 18, and 44
Occlusive-agent concentration	Approximately 1%-10% in claims 17, 30, and 44
Water content	Up to 90%; claims 8 and 53 specify approximately 70%-90%
HLB value	Approximately 9-14 under claims 41 and 65
Aerosol propellant	Hydrocarbons, chlorofluorocarbons, dimethyl ether, hydrofluorocarbons, or mixtures
Therapeutic use	Treatment of psoriasis in a mammal

The formulation claims are therefore strongest against a follow-on product that copies the same foam technology and excipient architecture. They are weaker against a conventional non-foam calcipotriene product.

How do dependent claims narrow the patent?

The dependent claims create several enforcement pathways rather than one single formulation requirement.

Solvent pathway

Claims 3-4, 33-35, and 49-51 cover the use of a water-soluble organic solvent to pre-solubilize the vitamin D compound. Propylene glycol is the most commercially relevant option. The claims also list PEG 200, PEG 300, PEG 400, PEG 800, ethylene glycol, butylene glycol, polyols, ethylene glycol monoethyl ether, diethylene glycol monoethyl ether, ethyl acetate, propylene carbonate, and N-methylpyrrolidone.

A generic sponsor would need to assess both the identity of the solvent and whether the active is first solubilized in that solvent before incorporation into the water phase.

Emulsifier pathway

Claims 9-14, 31-32, and 54-57 cover broad emulsifier classes and narrower mixtures. A particularly relevant combination is:

• a C14-C22 alcohol, including cetyl alcohol or stearyl alcohol; and
• a polyoxyethylene fatty alcohol ether.

Claims 43 and 67 separately cover sorbitan monostearate with polysorbate 60. Claims 41-42 and 65-66 provide functional and chemical alternatives based on HLB value and nonionic surfactant classes.

Because the patent contains overlapping emulsifier definitions, changing one surfactant may not avoid all claims. A design-around analysis must map the actual formulation against each independent and dependent claim.

Stabilizer pathway

Claims 5 and 27-28 emphasize vitamin E or a vitamin E analogue. Claims 69 and 70 expand the list to other antioxidants and stabilizers. This creates potential claim coverage even where a competitor replaces vitamin E with another listed stabilizer.

Foam and packaging pathway

The aerosol limitation is central. The emulsion must be a foam when released from a pressurized container. A product that is merely an emulsion, or that is dispensed through a nonpressurized package, may fall outside the aerosol-specific claims.

The patent also recites hydrocarbon, dimethyl ether, hydrofluorocarbon, and mixed propellant systems. Propellant selection alone is not enough to establish infringement because the composition must also satisfy the phase, solvent, active, emulsifier, and stabilizer limitations.

What is the relationship between US 8,263,580 and Sorilux?

Sorilux is calcipotriene foam, 0.005%, approved by the FDA for the topical treatment of plaque psoriasis in patients 12 years of age and older. The product’s aerosol foam dosage form and calcipotriene concentration correspond closely to the subject matter of US 8,263,580.[2]

Product characteristic	Sorilux relevance	Patent relationship
Active ingredient	Calcipotriene	Expressly covered
Strength	0.005%	Expressly within claim 44
Dosage form	Topical foam	Central aerosol limitation
Disease	Plaque psoriasis	Claims 25 and 68
Manufacturer history	Foamix-developed product; commercial rights later associated with VYNE-related entities	Patent-family and product history
Regulatory pathway	FDA NDA	Small-molecule drug, not biologic

The patent should not be treated as a complete list of all intellectual-property rights covering Sorilux. Regulatory products may have multiple Orange Book patents, formulation patents, method-of-use patents, manufacturing rights, trademarks, and contractual rights. The relevant question for generic entry is the combination of all listed, unexpired patents and regulatory exclusivities, not this patent alone.

What is the Orange Book status of US 8,263,580?

US 8,263,580 has been associated with the Sorilux regulatory patent estate and should be evaluated against the FDA’s current Orange Book entry for the product and NDA 022554.[3] The Orange Book controls the FDA’s statutory patent-listing and certification framework, but it does not itself determine whether a patent claim is valid or infringed.

The principal regulatory implications are:

• an ANDA applicant may be required to submit a Paragraph IV certification if it seeks approval before expiration of a listed patent;
• the patent holder may bring a Hatch-Waxman infringement action within 45 days of receiving a proper Paragraph IV notice;
• a timely infringement suit may trigger a 30-month FDA approval stay, subject to statutory exceptions and court rulings;
• a first ANDA applicant with a qualifying Paragraph IV certification may receive 180 days of generic exclusivity under the FDCA framework.

The listing date and current status must be checked in the live Orange Book because FDA patent listings, delistings, expiration dates, and regulatory-status changes can change over time. The patent’s base term is in the 2025 period based on the underlying family chronology, but the operative expiration date may reflect patent-term adjustment, disclaimer, or other USPTO-recorded term information.[1,3]

When does US 8,263,580 lose exclusivity?

The patent’s international filing date was in 2005, and the United States patent issued in 2012. Under the 20-year patent-term rule, the base term is generally calculated from the earliest effective nonprovisional or international filing date, not from the issue date.[4]

The practical timeline is:

Event	Date or period
International patent-family filing	2005
US patent issuance	September 11, 2012
Base 20-year patent term	2025 period
Potential adjustment	Depends on USPTO PTA/PTE and terminal-disclaimer records
FDA generic-entry analysis	Must use the current Orange Book and USPTO term data

FDA approval exclusivity is separate from patent protection. Sorilux received FDA approval in 2010. Any Hatch-Waxman exclusivity associated with the original NDA would have run independently from the patent term and would not extend the patent.[2,3]

What Paragraph IV challenges and litigation affect the patent?

A Paragraph IV challenge is the principal generic-entry mechanism for a listed small-molecule product patent. The applicant asserts that the patent is invalid, unenforceable, or will not be infringed by the proposed product.

For US 8,263,580, the relevant litigation questions are:

1. Whether the patent remains listed for the relevant NDA.
2. Whether the proposed generic is an aerosol oil-in-water foam.
3. Whether its calcipotriene is first solubilized in a claimed water-soluble solvent.
4. Whether its excipient system satisfies an independent or dependent claim.
5. Whether the patent remains unexpired when FDA approval is sought.
6. Whether a court has entered a claim-construction, invalidity, or settlement judgment.

The claim set creates multiple possible invalidity and noninfringement arguments. Potential invalidity issues would include anticipation, obviousness, written description, enablement, indefiniteness, and patent-term defects. Potential noninfringement arguments would focus on phase structure, active solubilization location, emulsifier concentration, stabilizer identity, or the absence of a pressurized foam system.

No reliable conclusion about a current Paragraph IV defendant, settlement, or final judgment should be drawn from the patent document alone. Those matters require the current FDA litigation record, PACER filings, and USPTO status data.

Are biosimilar risks relevant to this patent?

No. Sorilux is a small-molecule drug, not a biologic. The relevant competitive pathway is an ANDA for a generic drug, not a biosimilar application under the Public Health Service Act.

A follow-on applicant would generally need to address:

• pharmaceutical equivalence;
• bioequivalence;
• the same active ingredient and strength;
• the same or therapeutically equivalent dosage form;
• labeling requirements;
• Orange Book patent certifications.

The principal technical barrier is formulation and device equivalence. Calcipotriene itself is not difficult to identify, but reproducing a stable aerosol oil-in-water foam with the required active distribution, spray performance, rheology, microbial quality, and container compatibility can be more demanding than developing a conventional cream or ointment.

How strong is the patent estate for calcipotriene foam?

US 8,263,580 is strongest when the accused product closely follows the patented formulation model. Its strength comes from layered claim coverage:

• broad vitamin D analogue claims;
• calcipotriene-specific claims;
• solvent-specific claims;
• vitamin E and antioxidant claims;
• emulsifier and HLB claims;
• concentration ranges;
• aerosol propellant claims;
• psoriasis treatment claims.

Its principal weaknesses are structural. The claims require a specific dosage-form and phase architecture. A competitor may attempt to avoid infringement by using a non-aerosol product, a different emulsion type, a different solubilization sequence, or a formulation that does not contain the claimed oil-phase stabilizer and occlusive-agent combination.

The patent also contains broad numerical ranges. Such ranges may face prior-art and obviousness challenges if earlier references disclose overlapping concentrations, conventional excipients, or aerosol emulsions containing vitamin D analogues.

What generic launch scenarios exist?

Launch after patent expiration

This is the lowest-risk scenario if no other unexpired Orange Book patents or regulatory barriers remain. Approval timing would still depend on ANDA review, inspection, labeling, manufacturing readiness, and any 180-day exclusivity block.

Paragraph IV launch after litigation

A generic sponsor may launch before final patent expiration after prevailing in litigation, securing a covenant not to sue, or reaching a settlement that permits an agreed launch date. A launch carries potential damages exposure if the patent is later upheld.

At-risk launch

An ANDA applicant may launch before final resolution of patent disputes. This can accelerate market entry but exposes the sponsor to lost profits, reasonable royalty, treble damages for willful infringement in appropriate cases, and injunctive risk.

Noninfringing formulation launch

A sponsor could pursue a different calcipotriene dosage form, such as a cream, ointment, gel, or non-aerosol formulation. That strategy may avoid this patent but would not necessarily produce an ANDA referencing Sorilux if the dosage form and formulation differ materially.

How does this patent compare with conventional calcipotriene patents?

Issue	US 8,263,580	Conventional calcipotriene composition patent
Primary subject	Aerosol oil-in-water foam	Cream, ointment, gel, or solution
Active scope	Vitamin D analogues, with calcipotriene emphasis	Often calcipotriene-specific
Key technical limitation	Foam from pressurized container	Vehicle, particle size, stability, or delivery
Solubilization	Water-soluble solvent and water-phase placement	May use oil-phase or suspension technology
Commercial target	Calcipotriene foam	Traditional topical calcipotriene products
Generic design-around	Change package, emulsion type, or solvent sequence	Change vehicle or active dispersion system

What manufacturing and IP barriers remain after expiration?

Patent expiration does not eliminate technical barriers. A follow-on manufacturer must reproduce:

• aerosol valve and actuator performance;
• foam density and collapse behavior;
• active uniformity throughout the canister;
• emulsion stability;
• preservative and microbial-control performance;
• compatibility between formulation, propellant, valve, and container;
• scale-up mixing and filling conditions;
• stability under long-term and accelerated storage.

Manufacturing know-how may remain protected by trade secrets even after the patent expires. That protection does not block independent development, but it can increase development time and batch-failure risk.

Key Takeaways

• US 8,263,580 is a formulation and delivery patent for vitamin D analogue aerosol foams.
• Calcipotriene at 0.005% falls squarely within the principal calcipotriene claim set.
• The most important limitations are the oil-in-water emulsion, water-phase solubilization, water-soluble solvent, oil-phase occlusive agent and stabilizer, emulsifier, and pressurized foam delivery.
• Claims 44-67 are the most commercially relevant claims for a Sorilux-type product.
• The patent is not a universal calcipotriene patent. Conventional creams, ointments, gels, and non-aerosol products may avoid its central limitations.
• The base patent term is in the 2025 period, subject to the USPTO-recorded term and any applicable adjustment or disclaimer.
• Generic competition is governed by ANDA and Paragraph IV procedures, not biosimilar law.
• A complete launch analysis must account for every current Orange Book patent associated with the relevant NDA, not US 8,263,580 in isolation.

FAQs

Is calcipotriene cream automatically blocked by US 8,263,580?

No. The patent requires an aerosol oil-in-water emulsion that forms foam from a pressurized container. A conventional cream may fall outside the claims, although separate patents may apply.

Does changing propellant avoid infringement?

Not necessarily. The claims cover several propellant classes and mixtures. Changing propellant avoids infringement only if the resulting product no longer satisfies all limitations of the asserted claim.

Does claim 44 cover calcipotriene concentrations above 0.005%?

Yes. Claim 44 recites approximately 0.005% to approximately 10.0% by weight, subject to the other claim limitations.

Is a vitamin E-free calcipotriene foam outside the patent?

Not automatically. Some claims specifically require vitamin E or its analogue, while claims 69 and 70 identify broader stabilizer alternatives. The complete formulation must be mapped against each asserted claim.

Can a generic sponsor avoid this patent by using a pump dispenser?

Potentially, because the claims require an aerosol emulsion that becomes foam when released from a pressurized container. The sponsor would still need to evaluate other patents, regulatory requirements, and infringement under any broader related patent claims.

References

1. United States Patent and Trademark Office. (2012). US Patent No. 8,263,580 B2, topical oil-in-water emulsion compositions.
2. U.S. Food and Drug Administration. (2010). Sorilux (calcipotriene) foam, 0.005%, prescribing information, NDA 022554.
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
4. United States Code. 35 U.S.C. §§ 154, 156, 271(e)(2).

Drugs Protected by US Patent 8,263,580

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Mayne Pharma	SORILUX	calcipotriene	AEROSOL, FOAM;TOPICAL	022563-001	Oct 6, 2010		RX	Yes	Yes	8,263,580		Y			USE OF A CALCIPOTRIENE CONTAINING FOAM FOR THE TREATMENT OF PSORIASIS
Mayne Pharma	SORILUX	calcipotriene	AEROSOL, FOAM;TOPICAL	022563-001	Oct 6, 2010		RX	Yes	Yes	8,263,580		Y			USE OF CALCIPOTRIENE FOAM FOR THE TOPICAL TREATMENT OF PLAQUE PSORIASIS IN PATIENTS AGED 4 YEARS AND OLDER

International Family Members for US Patent 8,263,580

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	381315
Australia	2006253913
Australia	6069299
Australia	760153
Brazil	9913154
Canada	2333869