Details for Patent: 9,867,808

Which drugs does patent 9,867,808 protect, and when does it expire?

Patent 9,867,808 protects UPNEEQ and is included in one NDA.

This patent has twenty-eight patent family members in twenty-three countries.

Summary for Patent: 9,867,808

Title:	Compositions and methods for non-surgical treatment of Ptosis
Abstract:	Provided are pharmaceutical compositions, and methods of use of the compositions, for the non-surgical treatment of ptosis (eyelid droop). In one embodiment the composition includes oxymetazoline 0.1% formulated for topical administration to an eye. In one embodiment the composition includes a synergistic combination of oxymetazoline and phenylephrine, formulated for topical administration to an eye. Oxymetazoline alone causes no pupillary dilation (mydriasis), and a synergistic combination of oxymetazoline and phenylephrine induces no clinically significant mydriasis. In addition to providing desirable cosmetic effects, the compositions and methods of the invention can improve visual fields otherwise compromised by ptosis.
Inventor(s):	Mark Silverberg
Assignee:	VOOM LLC
Application Number:	US14/625,099
Patent Claim Types: see list of patent claims	Use; Composition;

US Patent 9,867,808: Scope, Claims, Expiration and Oxymetazoline Ptosis Patent Landscape

US Patent 9,867,808 protects a topical ophthalmic method for treating ptosis with approximately 0.1% oxymetazoline. The patent is method-of-use focused. It does not broadly claim oxymetazoline as a chemical compound, every oxymetazoline ophthalmic formulation, or manufacturing processes. Its commercial relevance is tied to Upneeq, the oxymetazoline hydrochloride ophthalmic product approved by the FDA for acquired blepharoptosis in adults.

The principal infringement risk applies to a product that combines the following elements: topical ocular administration, approximately 0.1% oxymetazoline, an ophthalmically acceptable carrier, and a ptosis treatment use. The patent's listed expiration date is May 19, 2033, subject to any applicable patent-term adjustment or regulatory extension reflected in official records.[1]

What does US Patent 9,867,808 protect?

The patent protects a treatment method rather than a composition standing alone. Independent claim 1 requires:

Claim element	Scope
Patient	Human patient
Disease or condition	Ptosis
Active ingredient	Oxymetazoline
Route	Administration to the exterior surface of an eye
Concentration	About 0.1% by weight
Formulation	Pharmaceutical composition
Vehicle	Ophthalmologically acceptable carrier

The claim reaches a topical ocular product used to elevate a drooping upper eyelid. It does not expressly limit treatment to adults, acquired ptosis, unilateral ptosis, aponeurotic ptosis, or any specific severity threshold.

The claim also does not require the product to be administered under the Upneeq brand, through an NDA-approved label, or using a particular container, preservative system, pH, viscosity, or drop volume.

How broad is the “about 0.1%” limitation?

“About 0.1%” is a scope-defining concentration limitation. The term does not create an unlimited concentration range. Its construction would normally depend on the patent specification, prosecution history, technical context, and how a court evaluates reasonable variation around 0.1% weight percent.

A formulation materially below or above 0.1% may fall outside literal infringement. A generic sponsor could also argue that a different concentration avoids the claim, although the doctrine of equivalents could create residual risk where the concentration performs substantially the same function in substantially the same way.

The patent does not appear to claim every concentration of oxymetazoline for ptosis. A formulation at 0.05%, 0.2%, or another concentration would require a separate analysis of claim construction and equivalents.

What do the dependent claims add?

The dependent claims narrow the method by adding clinical response, dosing, and patient-selection limitations.

Claim	Additional limitation	Commercial effect
1	Approximately 0.1% oxymetazoline applied topically to the eye for ptosis	Core method-of-use protection
2	At least a 1 mm increase in vertical separation of the upper and lower lids	Requires a measurable eyelid-opening response
3	Administration as a single drop	Captures common ophthalmic dosing
4	Once daily or at least once daily dosing	Captures daily treatment regimens
5	Patient lacks allergic ocular disease, eyelid swelling, and prior refractive eye surgery	Narrows the patient population through negative limitations

What is the scope of claim 2?

Claim 2 requires at least a 1 mm increase in vertical separation between the upper and lower eyelids. This limitation creates a measurable efficacy requirement.

A product could infringe claim 1 without satisfying claim 2 if the patient is treated for ptosis but does not achieve a 1 mm increase. Conversely, a defendant could dispute claim 2 based on the measurement method, baseline eyelid position, timing of measurement, or whether the response is attributable to oxymetazoline.

The limitation is important in clinical and litigation settings because it links infringement to an observable treatment outcome rather than only to administration.

Does claim 3 cover a conventional eye drop?

Yes. Claim 3 covers administration as a single drop when the other limitations of claim 1 are met. The claim does not specify drop volume, bottle design, preservative status, or whether the drop is administered by a patient or healthcare professional.

A generic product labeled for one drop per eye would present a direct claim 3 risk if it also used approximately 0.1% oxymetazoline for ptosis.

How should claim 4 be interpreted?

Claim 4 covers once-daily or at-least-once-daily administration. The wording is broad and partly repetitive. It captures daily use and regimens with more frequent administration.

A product labeled for once-daily treatment would fall squarely within the claimed dosing limitation. A product labeled only for intermittent or as-needed use may avoid literal infringement of claim 4, but it could remain exposed under claim 1 if the product is labeled for ptosis treatment with the claimed formulation.

What does claim 5 exclude?

Claim 5 requires that the patient:

1. Does not have an allergic ocular condition;
2. Does not have eyelid swelling; and
3. Has not undergone refractive eye surgery.

These are negative limitations. The claim is narrower than claim 1 because all three conditions must be absent.

A patient with any one of the excluded characteristics would not satisfy claim 5. The exclusions do not limit claim 1, claim 2, claim 3, or claim 4. They therefore have limited value against a broad product label unless the label specifically targets the narrower patient population.

What is the Orange Book status of US Patent 9,867,808?

US Patent 9,867,808 is associated with Upneeq, an FDA-approved oxymetazoline hydrochloride ophthalmic product. Upneeq received FDA approval in July 2020 under NDA 213698 for acquired blepharoptosis in adults.[2]

Regulatory item	Information
Product	Upneeq
Active ingredient	Oxymetazoline hydrochloride
Dosage form	Ophthalmic solution
Strength	0.1%
NDA	213698
Sponsor at approval	RVL Pharmaceuticals
FDA approval	July 2020
Indication	Acquired blepharoptosis in adults
Patent	US 9,867,808
Listed patent expiration	May 19, 2033

The Orange Book listing gives the patent commercial significance because an ANDA applicant referencing Upneeq may need to address the listed patent through a Paragraph IV certification or another certification permitted under the Hatch-Waxman framework.[1,3]

The patent's claims are broader in some respects than the FDA-approved indication. Claim 1 is not expressly limited to acquired adult blepharoptosis. A generic applicant cannot assume that a narrower approved label eliminates all exposure if the patented method is included in the proposed labeling or if the product is promoted for the claimed use.

When does Upneeq lose exclusivity?

Upneeq's relevant exclusivity has two separate components: regulatory exclusivity and patent exclusivity.

Regulatory exclusivity

Oxymetazoline was previously marketed in other dosage forms and indications, so Upneeq was not a new chemical entity in the conventional sense. Its approval depended on clinical data supporting the ophthalmic ptosis indication. The product received a period of regulatory protection associated with the approval of new clinical investigations, but that protection is distinct from patent protection and does not extend to May 2033.

The principal commercial barrier after regulatory exclusivity is the Orange Book patent estate. An ANDA applicant may file a Paragraph IV certification before patent expiration, potentially triggering patent litigation and a 30-month stay of approval under the Hatch-Waxman Act.[3]

Patent expiration

US 9,867,808 is listed with an expiration date of May 19, 2033. A generic launch could occur before that date only if one of the following applies:

• The applicant prevails in Paragraph IV litigation;
• The patent is invalidated or not infringed;
• The patent owner provides a license;
• A settlement permits an earlier launch;
• The proposed product and labeling avoid all enforceable claims.

The statutory expiration date does not itself establish the earliest legally permissible generic launch date.

How strong is the patent estate for oxymetazoline ptosis treatment?

US 9,867,808 has meaningful commercial strength because it covers the central product-use combination: 0.1% topical oxymetazoline for ptosis. Its strength is reduced by the structure of the claims.

Strengths

• Claim 1 directly covers the principal therapeutic concept behind Upneeq.
• The claim does not require a particular brand, container, preservative, or manufacturing process.
• The claimed route is consistent with ordinary ophthalmic administration.
• The concentration limitation aligns with the approved 0.1% product.
• Dependent claims capture common one-drop and once-daily dosing.

Limitations

• The patent does not claim oxymetazoline as a molecule.
• The patent does not claim every oxymetazoline ophthalmic concentration.
• The claims are method claims and require proof of the accused use.
• Claim 2 requires a measurable 1 mm eyelid-opening response.
• Claim 5 contains multiple patient exclusions.
• A product with a non-ptosis label may create a more difficult induced-infringement case, although label content and commercial conduct remain central.

The estate is strongest against a generic that copies the reference product's strength, route, dosing, and ptosis indication. It is weaker against a sponsor developing a materially different concentration, a different therapeutic indication, or a formulation that is not marketed for treating ptosis.

What generic entry risks exist?

Direct infringement risk

Patients or healthcare providers administer the product, making them the potential direct users of a patented method. The patent owner would generally pursue the manufacturer on induced-infringement or contributory-infringement theories rather than sue individual patients.

A generic label that instructs use for ptosis would provide evidence supporting induced infringement. The risk increases where the proposed label states:

• Oxymetazoline 0.1%;
• Ophthalmic administration;
• One drop;
• Once-daily dosing; and
• Treatment of acquired or other forms of ptosis.

Section viii carve-out risk

A generic applicant may attempt a labeling carve-out that removes the patented method of use. The viability of that strategy depends on whether the remaining label still encourages the claimed treatment method.

A carve-out is more credible where the product is approved for a non-patented indication and the label omits ptosis treatment. It is difficult where the only commercially relevant indication is the patented use.

Design-around options

Potential design-around paths include:

Strategy	Principal issue
Use a concentration materially different from 0.1%	Requires efficacy, safety, and equivalents analysis
Use a non-oxymetazoline alpha-adrenergic agent	May avoid the patent but creates clinical and regulatory risk
Market for a non-ptosis indication	Label and promotional conduct must avoid inducing the claimed use
Use a different dosing regimen	Does not avoid claim 1
Use a different carrier or preservative	Does not avoid claim 1 because the carrier limitation is broad
Use a different bottle or dropper	Does not avoid claim 1
Develop a sustained-release ocular system	May remain within claim 1 if it uses approximately 0.1% oxymetazoline for ptosis

Changing the vehicle, container, or administration device is unlikely by itself to avoid claim 1.

Which companies are challenging the Upneeq patent estate?

The relevant challenge mechanism is an ANDA Paragraph IV certification. Public FDA records and the Orange Book identify the listed patent and reference product, but an ANDA filing does not necessarily disclose the applicant publicly before litigation.

A company challenging US 9,867,808 would likely face one or more of these issues:

1. Whether “about 0.1%” covers the proposed concentration;
2. Whether the proposed label induces treatment of ptosis;
3. Whether the patent is invalid for lack of written description, enablement, anticipation, or obviousness;
4. Whether the claimed therapeutic response is inherent or properly supported;
5. Whether the listed patent is properly connected to the approved product and indication.

No biosimilar pathway applies. Upneeq is a small-molecule drug, so competitors would use an ANDA or, in some circumstances, a 505(b)(2) application rather than a biosimilar application under the Public Health Service Act.

What litigation and settlement issues affect US 9,867,808?

A Paragraph IV notice would ordinarily give the patent holder a basis to file an infringement action within 45 days. The filing could trigger a statutory stay of FDA approval for up to 30 months, subject to court decisions and statutory exceptions.[3]

The key litigation questions would be:

• Whether the accused product is labeled for the patented method;
• Whether the oxymetazoline concentration falls within “about 0.1%”;
• Whether the carrier is ophthalmologically acceptable;
• Whether the patent claims are enabled across their full scope;
• Whether earlier publications disclosed oxymetazoline for ptosis;
• Whether clinical data support the claimed 1 mm response;
• Whether a settlement permits a licensed early entry date.

A settlement could provide a generic launch date before May 19, 2033, but no early-entry date should be assumed without a filed agreement, court order, or public regulatory record.

How does US 9,867,808 compare with formulation and method-of-use patents?

US 9,867,808 is primarily a method-of-use patent. Its claim structure differs from several other patent categories relevant to Upneeq.

Patent category	What it protects	Relevance to generic entry
Method-of-use	Treating ptosis with 0.1% oxymetazoline	Label and induced-infringement risk
Formulation	pH, excipients, preservatives, stability, viscosity	Product-composition and formulation design risk
Device	Bottle, dropper, dose delivery, packaging	Usually avoidable through alternative devices
Manufacturing	Mixing, sterilization, filling, or process controls	May affect commercial manufacture
Clinical-use regimen	Dose timing, patient selection, treatment duration	Label-specific risk
Composition of matter	New chemical entity or salt	Usually strongest, but not the principal protection here

A competitor can avoid a narrow formulation patent by changing excipients while remaining exposed to US 9,867,808. Conversely, changing the formulation does not avoid the method claim if the resulting product still contains approximately 0.1% oxymetazoline and is used for ptosis.

What geographic coverage does US 9,867,808 provide?

The patent is enforceable only in the United States. It does not directly block products in Canada, Europe, Japan, or other jurisdictions.

The commercial landscape should therefore be assessed separately by jurisdiction:

• United States: Orange Book and Hatch-Waxman exposure.
• Europe: national or unitary patent rights, supplementary protection certificate issues, and local regulatory exclusivity.
• Canada: Canadian patent register and Notice of Allegation process.
• Japan: Japanese patent family members and local generic approval rules.
• Other markets: national patent family status and local approval pathways.

A US patent family member in another country may have different claims, prosecution history, expiration date, and enforceability.

What manufacturing and intellectual-property barriers remain after patent expiration?

Patent expiration will not eliminate all market-entry barriers. A generic sponsor must still demonstrate pharmaceutical quality, ocular tolerability, stability, sterility, container-closure performance, and bioequivalence or equivalent therapeutic performance under the applicable FDA pathway.

The main non-patent barriers include:

• Sterile ophthalmic manufacturing capacity;
• Reliable 0.1% oxymetazoline assay and content uniformity;
• Preservative and microbial-control performance;
• Packaging compatibility;
• Drop-size consistency;
• Stability across the labeled shelf life;
• FDA approval of the proposed labeling;
• Commercial access to ophthalmology prescribers and payers.

These barriers can delay entry even where a patent challenge succeeds.

Key Takeaways

• US 9,867,808 is a method-of-use patent for treating human ptosis with approximately 0.1% topical ocular oxymetazoline.
• Claim 1 is the commercially important claim and does not require adult status, acquired ptosis, one drop, once-daily dosing, or a 1 mm response.
• Claims 2 through 5 narrow the method through efficacy, dosing, and patient-selection limitations.
• The patent does not broadly cover oxymetazoline, all ophthalmic formulations, or manufacturing methods.
• The patent is associated with Upneeq, FDA-approved in July 2020 under NDA 213698.
• The listed patent expiration date is May 19, 2033.
• Generic applicants face Paragraph IV litigation risk if their labels instruct topical 0.1% oxymetazoline treatment for ptosis.
• Biosimilar competition is irrelevant because Upneeq is a small-molecule drug.
• Formulation or device changes alone may not avoid claim 1.
• Patent strength is highest against a copy of the Upneeq strength, route, dosing regimen, and ptosis indication.

FAQs About US Patent 9,867,808 and Upneeq

Can a generic avoid US 9,867,808 by using twice-daily dosing?

Not necessarily. Claim 1 does not require once-daily dosing, and claim 4 expressly covers administration at least once a day. Twice-daily dosing could remain within both claims if the product otherwise satisfies the concentration, route, carrier, and ptosis-use limitations.

Does US 9,867,808 cover oxymetazoline nasal spray?

No. The claims require administration to the exterior surface of an eye and an ophthalmic composition. A nasal spray does not ordinarily satisfy those limitations.

Does the patent cover oxymetazoline concentrations below 0.1%?

Only if the concentration falls within the legally construed scope of “about 0.1%” or is captured under the doctrine of equivalents. A materially different concentration may provide a design-around position.

Is a 505(b)(2) applicant automatically free from US 9,867,808?

No. A 505(b)(2) applicant may still face patent certification and infringement issues if it relies on the Upneeq data or seeks approval for a patented oxymetazoline ptosis use.

Can a company sell oxymetazoline ophthalmic drops for redness while avoiding the patent?

Possibly, but the label, promotional activity, formulation strength, and actual commercial conduct would determine risk. A redness indication alone does not automatically eliminate induced-infringement exposure if the product is promoted for treating ptosis.

References

1. U.S. Patent and Trademark Office. (2018). U.S. Patent No. 9,867,808 B2, Methods for treating ptosis.
2. U.S. Food and Drug Administration. (2020). FDA approves new treatment for acquired blepharoptosis in adults.
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, 44th ed.
4. U.S. Food and Drug Administration. (2020). Upneeq (oxymetazoline hydrochloride ophthalmic solution) prescribing information. RVL Pharmaceuticals.

Drugs Protected by US Patent 9,867,808

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Rvl Pharms	UPNEEQ	oxymetazoline hydrochloride	SOLUTION/DROPS;OPHTHALMIC	212520-001	Jul 8, 2020		RX	Yes	Yes	9,867,808					METHOD OF TREATING BLEPHAROPTOSIS

International Family Members for US Patent 9,867,808

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2012223615
Brazil	112013022094
Canada	2827285
China	103501771
Cyprus	1122565
Denmark	2680829
European Patent Office	2680829