Details for Patent: 9,655,907

Which drugs does patent 9,655,907 protect, and when does it expire?

Patent 9,655,907 protects SERNIVO and is included in one NDA.

This patent has six patent family members in four countries.

Summary for Patent: 9,655,907

Title:	Topical formulations comprising a steroid
Abstract:	The application provides formulations for the topical administration of an active agent comprising at least one steroid, in the form of topical sprays that are propellant-free, and/or substantially non-foaming, and/or alcohol-free. The present application also provides processes for preparing such compositions and methods of using them in management of skin diseases or disorders such as psoriasis, dermatoses, and other associated skin diseases or disorders.
Inventor(s):	Udhumansha Ubaidulla, Sateesh Kandavilli, Ajay Sunil Vairale, Jeffrey A. Wayne, Vijendra Nalamothu, Mistry Meghal, Refika Isil Pakunlu
Assignee:	PRIMUS PHARMACEUTICALS Inc
Application Number:	US15/226,684
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,655,907
Patent Claim Types: see list of patent claims	Use; Composition;

US Patent 9,655,907: Claim Scope, Patent Expiration, Orange Book Status, and Competitive Landscape

US Patent 9,655,907 protects propellant-free, propylene-glycol-free, substantially non-foaming topical steroid compositions that combine an aqueous phase, an immiscible phase, an emulsifier, and a penetration enhancer. Its strongest commercial relevance is the sprayable betamethasone formulation marketed as Sernivo, a 0.05% betamethasone dipropionate spray for plaque psoriasis. The patent is composition-focused, with separate protection for spray delivery, droplet formation, non-occlusive behavior, polymer selection, viscosity, and therapeutic use.

The patent does not broadly cover every topical corticosteroid product. A potentially infringing product generally must satisfy the required formulation architecture and the express exclusions from propellant, propylene glycol, and, for certain claims, foaming or occlusive behavior.

What does US Patent 9,655,907 protect?

US 9,655,907 contains three principal claim groups:

Claim group	Claims	Core subject matter
General topical composition	1-7	Steroid emulsion with water, immiscible substance, emulsifier, and specified penetration enhancer
Sprayable topical composition	8-11	Sprayable steroid composition with polymer, non-foaming and substantially non-occlusive characteristics
Betamethasone spray composition	12-21	Sprayable betamethasone formulation with concentration, polymer, emulsifier, viscosity, and droplet limitations
Treatment method	22	Treatment of steroid-responsive skin conditions using the claim 1 composition

The independent claims are claims 1, 8, and 12. Claim 22 is also independently important because it claims a method of treating specified dermatological conditions.

The patent uses “comprising” language in the principal composition claims. That is an open-ended transition. A product may contain additional excipients and still fall within the claim if it contains every required element and does not negate an express limitation.

How broad is claim 1 of US 9,655,907?

Claim 1 is a broad composition claim directed to a topical pharmaceutical product containing:

1. At least one steroid.
2. An emulsifying agent.
3. Water.
4. A water-immiscible substance.
5. A specified skin penetration enhancer, or combination of listed enhancers.
6. No propylene glycol.
7. No alcohol.
8. No propellant.
9. A non-foaming formulation.

The steroid is not limited to betamethasone. Claim 2 identifies a broad list of corticosteroids, including:

• Alclometasone dipropionate
• Beclomethasone dipropionate
• Betamethasone dipropionate
• Betamethasone valerate
• Fluocinolone acetonide
• Halobetasol propionate
• Hydrocortisone derivatives
• Mometasone furoate
• Triamcinolone acetonide
• Clobetasol propionate
• Desoximetasone
• Fluticasone propionate

The claim therefore reaches beyond the commercial betamethasone product. A generic or follow-on product using another listed steroid could still implicate the composition claims if the remaining formulation limitations are met.

What are the key structural limitations in claim 1?

The composition must contain both water and a water-immiscible substance. Claim 3 identifies the immiscible phase broadly, including:

• Vegetable oil
• Mineral oil
• Saturated paraffin oil
• Fatty acids
• Fatty acid esters
• Animal or vegetable triglycerides
• Medium-chain triglycerides
• Mono-, di-, and triglyceride mixtures
• Waxes
• Hydrogenated vegetable oils

This limitation points to an emulsion or dispersed multiphase system rather than a simple aqueous solution.

The emulsifier limitation is also broad. Claim 7 covers sorbitan fatty acid esters, polyethylene glycol stearates, glycol stearates, sodium lauryl sulfate, cetyl trialkyl ammonium bromide, polyoxyethylene sorbitan fatty acid esters, and combinations.

The penetration-enhancer limitation is central. Claim 1 lists specific compounds, including butanediol, polyethylene glycol monolaurate, diethylene glycol monoethyl ether, dimethyl sulfoxide, fatty acids, isopropyl myristate, isopropyl palmitate, methyl propionate, and ethyl oleate. Claims 5, 6, and 20 expand the formulation range to approximately 0.001% to 15% by weight and include polyols, ethers, esters, sulfoxides, fatty acids, and fatty acid esters.

What does claim 8 add to the patent scope?

Claim 8 narrows the invention to a sprayable composition containing:

• A steroid
• An emulsifying agent
• A polymer
• Water
• A water-immiscible substance
• A penetration enhancer

The composition must be substantially:

• Free of propellant
• Free of propylene glycol
• Non-foaming
• Non-occlusive to the skin

This claim is commercially significant because it targets a non-aerosol spray system. Conventional topical steroid foams often rely on propellants and can have different application and occlusion characteristics. Claim 8 instead addresses a liquid or emulsion spray that forms a topical deposit without relying on a propellant-driven foam.

Claim 11 requires formation of droplets upon application to the skin. That limitation may be relevant to spray-device and formulation design. A product that is dispensed as a mist or droplet could fall within the claim if the underlying formulation satisfies the other elements.

What does claim 12 protect for betamethasone products?

Claim 12 is the most commercially specific independent claim. It covers a sprayable composition containing a betamethasone compound, emulsifier, polymer, water, water-immiscible substance, and penetration enhancer. It must be substantially free of propellant and propylene glycol and substantially non-foaming.

Claims 15 and 16 narrow the betamethasone embodiment:

• Betamethasone concentration equivalent to approximately 0.025% to 0.1% betamethasone base.
• Betamethasone benzoate, betamethasone dipropionate, betamethasone sodium phosphate, or betamethasone valerate.

Claim 21 adds a viscosity range of approximately 10 to 15,000 centipoise. That is a wide range, covering low-viscosity sprayable liquids and materially thicker emulsions, subject to practical sprayability.

Claim 17 identifies the polymer as a cellulose, gum, alginate, or phthalate. Claim 18 specifically identifies sorbitan stearate as an emulsifier. Claim 19 repeats the broad list of water-immiscible substances.

Which claims are most important for Sernivo?

Sernivo is a betamethasone dipropionate topical spray indicated for plaque psoriasis. The FDA-approved product contains betamethasone dipropionate equivalent to 0.05% betamethasone, consistent with the concentration range in claim 15. Its dosage form and formulation profile align closely with the sprayable betamethasone claims. (U.S. Food and Drug Administration, 2016a)

The commercially most relevant claims are:

Claim	Relevance to Sernivo-type products
8	General propellant-free, propylene-glycol-free spray composition
11	Droplet formation upon skin application
12	Betamethasone spray composition
14	Droplet formation for betamethasone composition
15	0.025%-0.1% betamethasone-base-equivalent range
16	Betamethasone dipropionate embodiment
17	Polymer classes
18	Sorbitan stearate
19	Immiscible-phase materials
20	Penetration-enhancer concentration
21	Viscosity range
22	Treatment of plaque psoriasis and other listed conditions

A competing betamethasone spray does not need to practice every dependent claim to implicate claim 12. However, avoiding one or more dependent limitations may reduce the number of asserted claims and create design-around options.

When does US Patent 9,655,907 lose exclusivity?

The patent issued on May 23, 2017. Public patent records identify Dexcel Pharma Technologies Ltd. as the assignee and trace the patent to an earlier priority filing in the topical pharmaceutical composition family. The nominal patent term runs into approximately 2029, subject to the controlling USPTO term calculation and any applicable patent-term adjustment. (U.S. Patent and Trademark Office, 2017; Google Patents, 2024)

For commercial planning, the relevant distinction is:

Exclusivity right	Practical significance
Patent 9,655,907	Composition and method protection, with term extending into approximately 2029
FDA drug exclusivity	Regulatory exclusivity associated with the approved NDA, separate from patent rights
Other family patents	May add formulation, method, or product-specific barriers
Trade secrets	May protect manufacturing or device parameters not disclosed in the patent

The Orange Book should be used for the operative listed patent expiration date and any later-listed patents associated with the NDA. Patent expiration does not automatically establish a generic launch date. An ANDA applicant may challenge the patent before expiration through a Paragraph IV certification.

What is the Orange Book status of the patent?

FDA-approved Sernivo is associated with NDA 208162. The Orange Book identifies patent information for approved drug products and records listed patents, expiration dates, and regulatory exclusivity. Sernivo is a small-molecule topical drug, not a biologic, so its competitive entry pathway is an ANDA rather than a biosimilar application. (U.S. Food and Drug Administration, 2024)

The commercial analysis should separate three questions:

1. Whether US 9,655,907 is listed against the relevant NDA.
2. Whether additional patents are listed against the product.
3. Whether the FDA listing includes a use code that affects a Paragraph IV or section viii filing.

For a topical spray, the formulation patent may be more important than the active ingredient itself. Betamethasone dipropionate is an old corticosteroid. The defensible exclusivity position therefore depends on the formulation, delivery, concentration, and manufacturing limitations rather than compound novelty.

Are there Paragraph IV challenges to US 9,655,907?

A Paragraph IV challenge would require an ANDA applicant to certify that the listed patent is invalid, unenforceable, or not infringed. The patent is particularly vulnerable to a formulation-based challenge if the applicant can show that the claimed combination of emulsion structure, penetration enhancer, polymer, and non-foaming spray was disclosed or rendered obvious by earlier topical formulations.

The likely litigation issues include:

• Whether the proposed product is “non-foaming.”
• Whether it is “substantially non-occlusive.”
• Whether the spray forms droplets upon application.
• Whether the product contains a listed penetration enhancer.
• Whether the water-immiscible phase satisfies the claim.
• Whether propylene glycol is absent at a legally meaningful level.
• Whether the product contains the claimed polymer and emulsifier.
• Whether claim terms are indefinite or lack objective boundaries.

Publicly available FDA and patent records do not establish a reported Paragraph IV judgment or settlement specifically resolving US 9,655,907. The absence of a reported decision does not eliminate the possibility of confidential ANDA activity or a later-filed challenge.

How strong is the patent estate for a generic launch?

The estate is strongest against products that copy the overall Sernivo formulation concept: a betamethasone dipropionate emulsion delivered as a propellant-free, non-foaming spray with a penetration enhancer and polymer.

Strengths

• Claims cover multiple corticosteroids.
• The patent claims both general topical compositions and betamethasone sprays.
• The claim set covers formulation architecture, not only active ingredient identity.
• The patent includes concentration, viscosity, polymer, emulsifier, and droplet limitations.
• Claim 22 provides method-of-use coverage for plaque psoriasis and related steroid-responsive disorders.

Weaknesses

• The listed steroids and many excipients were known before the patent family.
• “Substantially non-foaming” and “substantially non-occlusive” may require factual testing and claim-construction analysis.
• The penetration-enhancer list is finite in the independent claims.
• A product can potentially avoid infringement by changing the emulsifier, polymer, enhancer, delivery format, or phase structure.
• Claim 22 depends on use of the composition of claim 1 and does not independently capture every spray formulation in claims 8 and 12.

The patent is stronger as a targeted formulation barrier than as a broad corticosteroid monopoly.

What formulation design-arounds are available?

Potential design-around strategies include:

Design approach	Potential impact
Use propylene glycol	May avoid the express propylene-glycol-free limitation, although it changes product performance and regulatory strategy
Use a propellant or foam system	May avoid the propellant-free and non-foaming limitations
Use a non-listed penetration enhancer	May avoid claims requiring a listed enhancer, subject to claims 6 and 20
Use a different polymer system	May avoid claims 8, 12, and 17
Use a solution rather than an emulsion	May avoid the water-immiscible-substance limitation
Change the emulsifier	May avoid claims requiring the claimed emulsifier class
Use a non-spray dosage form	May avoid claims 8-21, but not necessarily claim 1
Use a different steroid	May avoid betamethasone-specific claims but not necessarily claims 1-11

These are screening concepts, not legal conclusions. Because claim 1 is broad and open-ended, changing one feature may avoid a dependent claim while leaving exposure under the independent claim.

What patent litigation affects Sernivo and related products?

The relevant enforcement risk is likely to center on ANDA litigation under the Hatch-Waxman framework. The approved drug’s active ingredient is old, so a dispute would likely concern formulation and method claims.

A litigation complaint would typically analyze:

• The proposed generic’s ANDA formulation.
• The Orange Book-listed patent.
• Paragraph IV notice.
• The 45-day period for filing an infringement action.
• The potential 30-month FDA approval stay.
• Whether the generic applicant uses a section viii statement to omit a patented use.
• Whether a non-infringement position relies on a different excipient or physical property.

No biosimilar litigation pathway applies. Sernivo is not a biologic, and betamethasone dipropionate is regulated through the drug approval and ANDA systems.

How does US 9,655,907 compare with competing topical steroid patents?

Patent category	Typical protected subject matter	Relevance to US 9,655,907
Active-ingredient patents	New chemical entities or steroid derivatives	Low relevance because the steroids are established compounds
Salt or crystal patents	Solid-state forms and stability	Limited relevance to a topical emulsion
Vehicle patents	Cream, ointment, lotion, gel, or emulsion base	Directly relevant
Spray-device patents	Nozzle, pump, dose metering, and actuation	Potentially complementary
Foam patents	Propellant-based or thermally sensitive foam systems	Competitive but technically distinct
Method-of-use patents	Treatment of psoriasis, dermatitis, or other conditions	Relevant to claim 22 and Orange Book use codes
Manufacturing patents	Mixing, homogenization, particle size, and filling	May create non-public barriers beyond the issued claims

The patent’s differentiation is the combination of formulation and delivery limitations. It occupies a middle position between conventional topical steroid vehicles and aerosol foam products.

What is the revenue exposure from generic entry?

Revenue exposure depends on Sernivo sales, payer substitution, the number of approved generic applicants, and the extent to which a generic can avoid or invalidate the patent. FDA approval of a generic does not itself establish freedom to operate if the applicant has filed a Paragraph IV certification and litigation remains unresolved.

The main entry scenarios are:

Scenario	Commercial result
No challenge before patent expiry	Brand may retain practical exclusivity until the listed patent barrier expires
Paragraph IV with litigation	Approval may be delayed by litigation or a statutory stay
Early settlement	Entry date depends on the agreement and regulatory terms
Non-infringing formulation	Generic may launch if FDA requirements are met and no other barrier blocks entry
Patent invalidation	Earlier competitive entry becomes possible
At-risk launch	Generic launches before final resolution and assumes damages and injunction risk

The economic risk is concentrated in the product-specific formulation. A generic that cannot duplicate the spray’s formulation while maintaining bioequivalence, local delivery, stability, and device performance may face development costs even if it avoids the patent.

What geographic coverage does the patent provide?

US 9,655,907 provides protection in the United States only. Foreign counterparts must be reviewed separately by jurisdiction. Patent term, claim scope, prosecution history, listed patents, and litigation status may differ in Canada, Europe, Japan, Australia, and other markets.

A global launch assessment should not treat the US patent as evidence of corresponding protection abroad. The international family may include applications with narrower claims, abandoned counterparts, granted national patents, or different expiration dates.

Key Takeaways

• US 9,655,907 is a formulation and delivery patent, not a betamethasone compound patent.
• Its principal commercial target is a propellant-free, propylene-glycol-free, non-foaming topical steroid spray.
• Claim 1 is broad and covers multiple corticosteroids, immiscible-phase materials, emulsifiers, and penetration enhancers.
• Claims 8 and 12 add spray, polymer, non-occlusive, droplet, viscosity, and betamethasone limitations.
• Sernivo, NDA 208162, is the principal marketed product associated with the claimed technology.
• The patent term extends into approximately 2029, with the Orange Book controlling the listed expiration date.
• Generic risk is primarily formulation-driven. A conventional betamethasone cream or ointment is less likely to implicate the spray claims.
• No biosimilar pathway applies because Sernivo is a small-molecule drug.
• The most material validity issues concern prior art, claim construction, non-foaming and non-occlusive limitations, and the breadth of the penetration-enhancer and emulsion limitations.

FAQs

Can a betamethasone cream infringe US 9,655,907?

It may implicate claim 1 if it contains the required steroid, water, immiscible substance, emulsifier, listed penetration enhancer, and satisfies the propylene-glycol-free, alcohol-free, propellant-free, and non-foaming limitations. It would not ordinarily implicate spray-specific claims 8-21 unless it is also sprayable.

Does using betamethasone valerate avoid the patent?

No. Betamethasone valerate is expressly identified in claim 16, and the broader steroid claims cover multiple corticosteroids. A valerate product must be assessed against the remaining formulation limitations.

Is sorbitan stearate required?

No. Sorbitan stearate is a dependent limitation in claim 18. The independent betamethasone claim does not require that specific emulsifier, although it requires an emulsifying agent.

Can a generic avoid the patent by adding another excipient?

Not necessarily. The claims use “comprising,” which permits additional ingredients. Adding an excipient generally does not avoid infringement if the product still contains every claimed element.

Does patent expiration eliminate all Sernivo exclusivity?

No. Patent expiration removes the barrier created by that patent, but other listed patents, regulatory exclusivity, device rights, or separate formulation patents may affect the timing of generic entry.

References

1. Google Patents. (2024). US9655907B2: Topical pharmaceutical compositions. https://patents.google.com/patent/US9655907B2/en

2. U.S. Food and Drug Administration. (2016a). Sernivo (betamethasone dipropionate) spray, 0.05%: Prescribing information. FDA.

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

4. U.S. Patent and Trademark Office. (2017). U.S. Patent No. 9,655,907: Topical pharmaceutical compositions. USPTO. https://patents.google.com/patent/US9655907B2/en

5. U.S. Food and Drug Administration. (2019). Approved drug products with therapeutic equivalence evaluations: Patent and exclusivity information. FDA.

Drugs Protected by US Patent 9,655,907

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Primus Pharms	SERNIVO	betamethasone dipropionate	SPRAY;TOPICAL	208079-001	Feb 5, 2016		RX	Yes	Yes	9,655,907		Y			TREATMENT OF PLAQUE PSORIASIS

Foreign Priority and PCT Information for Patent: 9,655,907

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
India	2111/CHE/2009	Aug 31, 2009

International Family Members for US Patent 9,655,907

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Denmark	2473161
European Patent Office	2473161
European Patent Office	3141246
Japan	2013503203