Details for Patent: 9,974,773

Which drugs does patent 9,974,773 protect, and when does it expire?

Patent 9,974,773 protects RHOFADE and is included in one NDA.

This patent has six patent family members in six countries.

Summary for Patent: 9,974,773

Title:	Stabilized oxymetazoline formulations and their uses
Abstract:	The present invention provides stabilized cream formulations of oxymetazoline and uses thereof. The present invention also provides a method of treating facial erythema associated with rosacea in a patient in need of such treatment, comprising topically administering once or twice daily to the site of erythema on the face of the patient a pharmaceutical composition comprising 0.5%, 1.0% or 1.5% oxymetazoline or a pharmaceutically acceptable salt thereof as the sole active ingredient.
Inventor(s):	Pramod Sarpotdar, Kevin Warner, Steven Zhang, Gurpreet Ahluwalia, Amy Kuang
Assignee:	Mayne Pharma LLC
Application Number:	US15/429,873
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,974,773
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

US Patent 9,974,773: Claim Scope, Rosacea Exclusivity, Orange Book Status, and Patent Landscape

US Patent 9,974,773 covers once-daily topical treatment of rosacea-associated facial erythema with a pharmaceutical composition containing 1.0% or 1.5% w/w oxymetazoline hydrochloride as the sole active ingredient. Its strongest commercial coverage is directed to the RHOFADE-type 1% oxymetazoline cream formulation. The patent is a method-of-treatment patent, not a broad composition-of-matter patent.

The claims can reach a competing product even if the formulation contains different inactive ingredients, provided the product is used once daily on facial erythema associated with rosacea and contains oxymetazoline hydrochloride at one of the claimed concentrations.

What does US Patent 9,974,773 protect?

The patent protects a treatment regimen with five central limitations:

1. The condition is facial erythema associated with rosacea.
2. The product is administered topically to the facial site of erythema.
3. Administration occurs once daily.
4. The composition contains 1.0% or 1.5% w/w oxymetazoline hydrochloride.
5. Oxymetazoline hydrochloride is the sole active ingredient.

Claim 1 is the governing independent claim. Claims 2 through 7 narrow the scope by specifying dosage forms, cream formulations, excipients, and concentration.

Claim	Subject matter	Practical scope
1	Once-daily topical treatment of rosacea facial erythema using 1.0% or 1.5% oxymetazoline HCl as the sole active	Broadest enforceable method scope
2	Composition in one of numerous dosage forms	Covers creams, gels, lotions, foams, solutions, sprays and other forms
3	Composition is a cream	Commercially important narrowing limitation
4	Cream contains a specified excipient group	Formulation-specific but still open-ended because of “comprising”
5	Approximately 1.0% oxymetazoline HCl formulation	Closely tracks the 1% commercial cream
6	Approximately 1.5% oxymetazoline HCl formulation	Covers the higher-strength formulation
7	Cream with 1.0% oxymetazoline HCl as sole active	Narrow commercial-use claim

The claims use “comprising,” which generally makes them open-ended. A competing formulation can contain additional inactive ingredients and still fall within the claims. The phrase “sole active ingredient,” however, excludes a product containing another pharmacologically active compound.

When does US Patent 9,974,773 expire?

The patent issued on May 22, 2018. Its ordinary US patent term is expected to run until approximately November 2034, subject to any applicable patent-term adjustment, terminal disclaimer, or regulatory patent-term extension reflected in the official USPTO or Orange Book records.[1][2]

Event	Date or status
Patent	US 9,974,773
Issue date	May 22, 2018
Technology	Oxymetazoline HCl topical treatment for rosacea erythema
Expected ordinary expiration	Approximately November 2034
Patent term extension	Must be confirmed from the Orange Book and USPTO records
Patent term adjustment	Must be confirmed from the issued patent record

The relevant commercial date is not necessarily the patent’s ordinary expiration date. FDA-listed patents, pediatric exclusivity, patent-term extension, terminal disclaimers, and litigation-related launch agreements can affect the practical date of generic entry.

What are the limitations of claim 1?

Claim 1 is broad in dosage-form terms but narrow in clinical and dosing terms.

Required disease and anatomical site

The treatment must address “facial erythema associated with rosacea.” A product directed to general vasoconstriction, nasal congestion, non-rosacea flushing, or erythema on another body site would not satisfy this limitation based solely on its indication.

The claim does not expressly require treatment of papules, pustules, telangiectasia, ocular rosacea, or other rosacea manifestations. The claimed condition is facial erythema.

Required concentration

The claim covers two concentration endpoints:

• 1.0% w/w oxymetazoline hydrochloride
• 1.5% w/w oxymetazoline hydrochloride

A formulation containing 0.5%, 0.75%, 1.25%, 2.0%, or another concentration would not literally satisfy the concentration limitation of claim 1. A doctrine-of-equivalents analysis could still be relevant in litigation, but it would depend on prosecution history, claim construction, and the technical facts.

Required once-daily administration

The claim expressly requires once-daily administration. A label directing twice-daily or as-needed use may avoid literal infringement of the method claim if the evidence shows that the claimed once-daily regimen is not performed. A once-daily label creates materially higher method-of-use risk.

Actual patient use can also matter. A generic sponsor that markets a product for once-daily treatment of rosacea facial erythema faces a stronger inducement risk than a sponsor that limits its labeling to an unclaimed use, assuming the label and promotional conduct support the claimed method.

Sole active ingredient

The composition must contain oxymetazoline hydrochloride as the sole active ingredient. The claims do not require oxymetazoline to be the only ingredient. Preservatives, emulsifiers, oils, solvents, chelators and stabilizers are permitted because they are inactive excipients.

A combination product containing oxymetazoline plus another active ingredient would likely fall outside claim 1 as written, although other patents could cover the combination.

What formulations are protected by US Patent 9,974,773?

Claim 2 covers a long list of dosage forms, including solutions, gels, lotions, creams, ointments, foams, emulsions, microemulsions, milks, serums, aerosols, sprays, dispersions, microcapsules, vesicles and microparticles.

Claim 3 narrows this universe to creams. Claims 5 and 6 then identify specific formulations containing the following excipient system:

• Methylparaben
• Propylparaben
• Phenoxyethanol
• Sodium citrate dihydrate
• Citric acid
• Disodium edetate
• Butylated hydroxytoluene
• Anhydrous lanolin
• Medium-chain triglycerides
• Diisopropyl adipate
• Oleyl alcohol
• PEG-300
• PEG-6
• PEG-32
• Glycol stearate
• Cetostearyl alcohol
• Ceteareth-6
• Stearyl alcohol
• Ceteareth-25
• Purified water

The 1.0% formulation in claim 5 is the commercially significant version. Claim 6 applies the same general excipient profile to a 1.5% oxymetazoline HCl cream.

The exact excipient claims are narrower than claim 1. A competing manufacturer could attempt to design around claims 4 through 6 by changing the emulsifier system, preservative system, emollients, or other inactive ingredients. Such a change would not avoid claim 1 if the resulting product still satisfies the clinical-use, dosing, concentration and sole-active limitations.

How strong is the patent estate for oxymetazoline rosacea treatment?

US 9,974,773 is strongest as a method-of-use barrier around the approved 1% topical oxymetazoline product. It is less powerful as a formulation barrier because the independent claim does not require the specific RHOFADE excipient system.

Risk area	Strength of US 9,974,773
1% oxymetazoline cream for once-daily rosacea erythema	High
1.5% oxymetazoline cream for the same indication	High, subject to product and use evidence
Non-cream topical formulation	Covered by claim 1 if all core limitations are met
Different inactive ingredients	Usually does not avoid claim 1
Different concentration	Strong literal design-around opportunity
Twice-daily or non-rosacea labeling	Potential design-around, but conduct and actual use matter
Combination with another active	Potentially outside the sole-active limitation
Oral, injectable or non-topical administration	Outside the claimed method
General oxymetazoline composition	Not covered by these claims alone

The patent does not claim oxymetazoline hydrochloride as a chemical compound. It also does not claim every use of oxymetazoline, every topical composition, or every treatment of redness.

What is the FDA and Orange Book status of the protected product?

RHOFADE is an oxymetazoline hydrochloride cream approved by FDA for the topical treatment of persistent facial erythema associated with rosacea in adults. The approved product contains 1% oxymetazoline hydrochloride and is administered once daily.[3]

Regulatory item	Status
Product	RHOFADE
Active ingredient	Oxymetazoline hydrochloride
Strength	1% cream
Dosage route	Topical
Approved indication	Persistent facial erythema associated with rosacea
Approved regimen	Once daily
NDA	208552
FDA approval	January 19, 2017
Orange Book relevance	Patent listings and use-code information control ANDA certification analysis

The FDA-approved product aligns closely with claims 1, 3, 5 and 7. The 1.5% formulation in claim 6 is not the approved RHOFADE strength identified in the standard FDA labeling.

An ANDA applicant may need to address listed patents through a Paragraph IV certification, a section viii statement, or another applicable certification pathway under the Hatch-Waxman framework. The precise pathway depends on the Orange Book listing, the approved labeling, and whether the proposed generic label includes the patented rosacea use.[4]

What Paragraph IV challenges and generic entry risks exist?

A generic oxymetazoline applicant faces its greatest risk if its proposed label includes all of the following:

• Topical treatment of rosacea-associated facial erythema
• Once-daily administration
• 1% oxymetazoline hydrochloride
• Oxymetazoline as the only active ingredient

That label would closely reproduce claim 1 and would also create potential exposure under claims 3 and 7 if the product is a cream.

A carve-out strategy may reduce risk if the applicant omits the patented rosacea indication and markets the product only for an unclaimed use. The strategy is commercially difficult if the main market is rosacea facial erythema and if prescribing, promotional activity or product instructions effectively encourage the patented use.

Generic launch scenarios

Scenario	Patent risk	Commercial consequence
Label includes once-daily rosacea treatment	High	Paragraph IV litigation likely if patent is listed and enforceable
Label omits rosacea use under section viii	Lower on paper	Reduced addressable market and inducement risk remains fact-dependent
Product uses 1% oxymetazoline but a non-cream vehicle	Claim 1 risk remains high	Vehicle change alone may not provide freedom to operate
Product uses a concentration outside 1.0% or 1.5%	Lower literal risk	Clinical, regulatory and efficacy barriers may limit value
Product includes another active	Potentially outside claim 1	New safety, efficacy and regulatory requirements
Authorized generic or license	Depends on agreement	Earlier entry may be possible without invalidity ruling

The principal litigation arguments would likely involve anticipation, obviousness, written description, enablement, claim construction, noninfringement and prosecution-history estoppel. The vulnerability of the patent cannot be determined from the issued claims alone. Prior-art analysis would need to focus on earlier oxymetazoline rosacea studies, dosage selection, once-daily treatment, topical vehicles and the claimed excipient combinations.

What patent litigation and settlement agreements affect RHOFADE?

US 9,974,773 itself does not disclose litigation, settlement or licensing terms in the claim text. Those issues must be evaluated through FDA Orange Book records, USPTO Patent Center, federal court dockets and any public settlement filings.

For a business assessment, the relevant questions are:

1. Was the patent listed against NDA 208552?
2. Did an ANDA applicant submit a Paragraph IV certification?
3. Was a Hatch-Waxman action filed within 45 days?
4. Did the litigation trigger a 30-month stay?
5. Was there an authorized generic, license or supply agreement?
6. Does a settlement permit an agreed launch date before patent expiration?
7. Are additional patents listed for the product, formulation or method of use?

A settlement can materially change the effective market-entry date even when the patent remains valid and unexpired. The patent’s nominal expiration date should therefore not be treated as the only generic-entry date.

How does the patent compare with competing rosacea therapies?

The closest commercial comparator is topical brimonidine, marketed as MIRVASO. Brimonidine and oxymetazoline are both topical alpha-adrenergic agonists used to reduce facial erythema, but they have different active ingredients and separate product-specific patent estates.

Product	Active ingredient	Main use	Relationship to US 9,974,773
RHOFADE	Oxymetazoline HCl 1%	Persistent facial erythema of rosacea	Directly aligned with the patent
MIRVASO	Brimonidine tartrate	Persistent facial erythema of rosacea	Not covered by the oxymetazoline claims
Generic oxymetazoline products	Oxymetazoline HCl	Depends on labeling	Direct risk depends on concentration, use and label
Combination products	Oxymetazoline plus another active	Depends on indication	May avoid sole-active limitation but face separate patents

A brimonidine product does not infringe the claims merely because it treats the same disease. The claims are ingredient-specific.

What manufacturing and geographic barriers remain?

The patent has US territorial scope. It does not automatically prevent manufacture, sale or use outside the United States. Foreign counterparts, national-phase patents and local regulatory exclusivities must be reviewed separately.

Manufacturing a different cream vehicle may avoid the narrow formulation claims but will not necessarily avoid the independent method claim. The practical freedom-to-operate analysis must examine:

• Concentration control and assay tolerance
• Oxymetazoline salt form
• Topical dosage form
• Indication and labeling
• Dosing instructions
• Active-ingredient combinations
• Promotional materials
• Manufacturing and process patents
• Foreign counterpart patents
• Regulatory exclusivity and Orange Book listings

The manufacturing process itself is not claimed in the seven claims provided. A process patent, if separately issued, could create an additional barrier even when the finished product avoids claims 4 through 6.

Key Takeaways

• US 9,974,773 is a method-of-treatment patent for once-daily topical oxymetazoline HCl treatment of rosacea-associated facial erythema.
• Claim 1 is the central barrier and covers both 1.0% and 1.5% oxymetazoline HCl when it is the sole active ingredient.
• The patent is not limited to creams in its broadest claim.
• Claims 5 and 7 closely target the 1% oxymetazoline cream used commercially by RHOFADE.
• Changing inactive ingredients may avoid the narrow formulation claims but generally will not avoid claim 1.
• Concentration, dosing frequency, indication, route and sole-active status are the principal design-around variables.
• RHOFADE received FDA approval in 2017 for once-daily treatment of persistent facial erythema associated with rosacea.
• The patent issued in 2018 and is expected to expire around November 2034, subject to the official term calculation and any applicable adjustment.
• Generic risk is highest for a 1% oxymetazoline cream labeled for once-daily rosacea treatment.
• Brimonidine products are competitive therapies but are not covered by these oxymetazoline-specific claims.

FAQs About US Patent 9,974,773

Does US 9,974,773 cover all oxymetazoline products?

No. It covers specified topical treatment methods involving 1.0% or 1.5% w/w oxymetazoline hydrochloride, once-daily treatment, rosacea-associated facial erythema and oxymetazoline as the sole active ingredient.

Can a generic avoid the patent by changing the cream base?

Not necessarily. A changed cream base may avoid claims directed to the listed excipients, but claim 1 does not require that particular vehicle.

Does the patent cover oxymetazoline for nasal congestion?

No. The claims are directed to facial erythema associated with rosacea and do not cover nasal administration or nasal congestion treatment.

Is the 1.5% formulation FDA-approved as RHOFADE?

The standard approved RHOFADE product is a 1% oxymetazoline hydrochloride cream. The 1.5% formulation appears in claim 6 but is not the standard FDA-approved RHOFADE strength.

Can a company sell oxymetazoline without infringing the patent?

Potentially, depending on concentration, indication, dosing instructions, dosage form, active ingredients, labeling and promotional conduct. A product that reproduces the claimed once-daily rosacea use at 1% or 1.5% presents the highest risk.

References

1. U.S. Patent and Trademark Office. (2018). U.S. Patent No. 9,974,773, methods of treating facial erythema.
2. U.S. Patent and Trademark Office. (n.d.). Patent term adjustment and patent term information, U.S. Patent No. 9,974,773.
3. U.S. Food and Drug Administration. (2017). RHOFADE (oxymetazoline hydrochloride) cream, 1%: Prescribing information. Allergan USA, Inc.
4. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations, Orange Book.
5. U.S. Code, 35 U.S.C. §§ 154, 271, 355.

Drugs Protected by US Patent 9,974,773

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	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552-001	Jan 18, 2017	AB	RX	Yes	Yes						ONCE DAILY TOPICAL TREATMENT OF PERSISTENT FACIAL ERYTHEMA ASSOCIATED WITH ROSACEA IN ADULTS WITH 1% OXYMETAZOLINE HYDROCHLORIDE CREAM

International Family Members for US Patent 9,974,773

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015274532
Canada	2951725
European Patent Office	3154517
Spain	2796871
Mexico	2016016400
World Intellectual Property Organization (WIPO)	2015191917