Details for Patent: 11,690,827

Which drugs does patent 11,690,827 protect, and when does it expire?

Patent 11,690,827 protects XDEMVY and is included in one NDA.

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

Summary for Patent: 11,690,827

Title:	Methods for treating ocular Demodex using lotilaner formulations
Abstract:	Disclosed herein are methods for treating or preventing ophthalmic and dermatologic conditions in a patient, including ocular surface conditions such as blepharitis. The methods can include topically administering directly to an ocular surface of one or more eyes of a patient in need of treatment thereof an effective amount of an isoxazoline parasiticide, formamidine parasiticide, or other active ingredient, formulated into an ophthalmic composition, the ophthalmic composition further comprising a pharmaceutically acceptable vehicle. Compositions are also disclosed.
Inventor(s):	Bobak Robert Azamian, Douglas Michael Ackermann, Shawn D. Hickok, Joseph G. Vehige
Assignee:	Tarsus Pharmaceuticals Inc
Application Number:	US17/873,548
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

US Drug Patent 11,690,827: Lotilaner Eye Drops, Ocular Demodicosis Claims, and Generic Entry Risk

US Patent No. 11,690,827 protects the use of topical lotilaner eye drops to treat Demodex-associated blepharitis, eyelid-margin redness, and Demodex mite infestation. The patent does not claim lotilaner as a molecule or broadly claim every lotilaner formulation. Its commercial value is concentrated in method-of-treatment claims covering a human patient, an ophthalmic eye-drop composition, ocular or periocular administration, and specified concentration, volume, and dosing schedules.[1]

The patent is assigned to Tarsus Pharmaceuticals and underpins the commercial protection for XDEMVY, lotilaner ophthalmic solution 0.25%, approved by the FDA in July 2023 for Demodex blepharitis.[2] The principal generic-entry risk is an ANDA applicant proposing a lotilaner product with a Paragraph IV certification against the patent. A product that uses a different active ingredient, a non-ophthalmic dosage form, or a non-Demodex indication would not directly practice the issued claims.

What does US Patent 11,690,827 cover?

The patent covers three related treatment categories:

Claim group	Independent claim	Protected use	Core administration requirement
Demodex blepharitis	Claim 1	Treating blepharitis caused by Demodex mites	Lotilaner ophthalmic composition in eye-drop form, administered directly to an ocular surface
Eyelid-margin redness	Claim 8	Treating eyelid-margin redness caused by Demodex mites	Lotilaner ophthalmic eye drops administered to the eye, eyelids, or eyelashes
Demodex eradication	Claim 15	Eradicating Demodex mites	Lotilaner ophthalmic eye drops administered directly to an ocular surface

The independent claims require all of the following:

1. A human patient in need of treatment.
2. A Demodex-related disease condition or mite-eradication objective.
3. Topical administration.
4. Lotilaner in the ophthalmic composition.
5. A pharmaceutically acceptable vehicle.
6. An eye-drop dosage form.
7. Administration to an ocular or periocular site specified in the relevant claim.

The claims are method claims. They do not independently claim:

• the lotilaner chemical compound;
• lotilaner veterinary products;
• a lotilaner composition without a treatment step;
• every treatment of blepharitis;
• every treatment of ocular inflammation;
• oral lotilaner;
• a non-Demodex use of lotilaner;
• a formulation used only on skin outside the claimed ocular or eyelid sites.

How broad are the independent claims in Patent 11,690,827?

Claim 1 is the principal blepharitis claim. It does not require castor oil, a specific lotilaner concentration, or a specified dosing frequency. Those limitations appear in dependent claims 3, 5, 6, and 7.

Claim 8 is broader in administration location than claim 1 because it reaches administration to one or more of the eye, eyelids, or eyelashes. It also requires treatment of eyelid-margin redness caused by Demodex mites.

Claim 15 targets eradication rather than a named clinical symptom. The claim requires topical administration directly to an ocular surface, which makes it narrower in administration location than claim 8 but potentially important for products marketed with an eradication or mite-elimination objective.

The phrase “effective amount” is functional. A product can infringe if the administered amount is effective for the claimed treatment, even when the claim does not specify the exact dose. Claims 3, 10, and 16 narrow the scope to 0.15% to 0.40% lotilaner by weight, a range that includes XDEMVY’s 0.25% strength.[2]

What formulations are protected by US Patent 11,690,827?

The patent protects use of an ophthalmic composition containing lotilaner and a pharmaceutically acceptable vehicle in eye-drop form. Claim 5, and the corresponding claims 12 and 18, require castor oil.

Formulation limitation	Claims	Commercial significance
Lotilaner plus pharmaceutically acceptable vehicle	1, 8, 15	Broad formulation requirement in each independent claim
Lotilaner as sole active ingredient	2	Protects monotherapy formulations
0.15% to 0.40% lotilaner	3, 10, 16	Captures the 0.25% XDEMVY strength
Castor oil	5, 12, 18	Protects a specific vehicle component
Eye-drop form	1, 8, 15	Excludes products delivered only as ointments, gels, tablets, or non-drop devices

The castor-oil claims are narrower than the independent claims. A competing product may avoid those claims by using another vehicle, but it would still face the broader claims if it contains lotilaner, is an eye drop, and is used for a claimed Demodex condition.

A formulation change alone may not avoid infringement. A generic lotilaner eye drop using a different excipient could still fall within claims 1, 8, or 15. A different concentration could avoid claims 3, 10, and 16 while leaving the independent claims potentially applicable.

What dosing regimens are protected?

Claims 6, 7, 13, 14, 19, and 20 create regimen-specific protection.

Regimen	Claims	Limitation
At least once daily for at least about four weeks	6, 13, 19	25 to 50 microliters per administration
At least twice daily for at least about six weeks	7, 14, 20	25 to 50 microliters per administration

The dosing claims require both a volume range and a treatment duration. The twice-daily regimen is narrower than the once-daily regimen because it includes the frequency and six-week duration.

The dosing limitations may have commercial importance if a generic sponsor labels its product with the same dosing instructions as XDEMVY. FDA-approved labeling commonly creates a direct infringement pathway for method claims when the label instructs physicians or patients to perform the claimed steps.[3]

How does the closed-eye administration claim affect infringement?

Claim 9 requires that the patient’s eyes be closed when the composition is administered. The claim states that this permits contact with Meibomian-gland orifices and the outside of the eyelid margins.

This limitation is important for two reasons:

• It creates a targeted claim for delivery to the eyelid-margin and Meibomian-gland region.
• It may be avoided if a competing label instructs administration only by placing drops on the open ocular surface and does not direct closed-eye application.

A product can still face claims 1, 8, or 15 even if it avoids claim 9. Claim 9 does not limit the independent claims; it narrows claim 8.

What is the FDA and Orange Book status of lotilaner ophthalmic solution?

XDEMVY is lotilaner ophthalmic solution 0.25%, marketed by Tarsus Pharmaceuticals under NDA 217603. The FDA approved it on July 25, 2023, for the treatment of Demodex blepharitis.[2]

Regulatory item	Status
Product	XDEMVY, lotilaner ophthalmic solution 0.25%
Active ingredient	Lotilaner
Dosage form	Ophthalmic solution
Approved indication	Demodex blepharitis
NDA holder	Tarsus Pharmaceuticals
FDA approval	July 25, 2023
Regulatory pathway	Full NDA approval
Human drug exclusivity	Five-year new chemical entity exclusivity is expected to run through July 25, 2028
Orange Book relevance	Patent listings can block approval or create certification and litigation obligations for an ANDA

The relevant patent listing for XDEMVY should be assessed against the current FDA Orange Book entry and subsequent FDA supplements. Patent listings can change through continuation patents, corrections, delistings, or additional patent issuances.

The patent’s practical protection extends beyond FDA exclusivity. NCE exclusivity limits certain abbreviated applications during the exclusivity period, while the patent can remain enforceable after 2028.

When does US Patent 11,690,827 expire?

The patent issued on June 27, 2023. Its earliest claimed priority is in December 2018, producing a nominal patent-term endpoint in December 2039 under the standard 20-year term framework.[1]

Milestone	Date
Earliest claimed priority	December 2018
Patent issued	June 27, 2023
Nominal term endpoint	December 2039
XDEMVY FDA approval	July 25, 2023
Expected NCE exclusivity endpoint	July 25, 2028

The patent-term endpoint is separate from FDA regulatory exclusivity. Patent-term adjustment, patent-term extension, terminal disclaimers, and continuation-family rights can affect the operative protection period. The issued patent itself is the controlling document for claim scope, while the USPTO patent-term record controls the final statutory expiration calculation.

How strong is the patent estate for XDEMVY?

The ’827 patent has strong product-label relevance because its claims track the commercial product and approved indication:

• lotilaner is the active ingredient;
• XDEMVY is an ophthalmic eye drop;
• the marketed concentration is 0.25%;
• the indication is Demodex blepharitis;
• the treatment is topical and ocular.

Its strength is narrower against design-around products. The patent does not prevent all Demodex therapies. A competitor could pursue:

• ivermectin;
• tea tree oil derivatives;
• metronidazole;
• another acaricide;
• an oral or non-ophthalmic therapy;
• a formulation that does not contain lotilaner;
• a different indication not tied to Demodex;
• a non-drop delivery system.

The estate is stronger against a generic lotilaner eye drop than against a competing Demodex product using another active ingredient.

Claim-strength assessment

Issue	Assessment
Product read-through	High for a 0.25% lotilaner eye drop
Composition protection	Limited because the patent is directed to treatment methods
Indication protection	Strong for Demodex blepharitis and related claimed outcomes
Dose-range protection	Strong where the product uses 0.15% to 0.40% lotilaner
Vehicle protection	Narrower for castor oil
Design-around exposure	Moderate to high for alternative actives or dosage forms
Label-based infringement risk	High for an ANDA label copying XDEMVY instructions
Biosimilar relevance	None, because lotilaner is a small molecule rather than a biologic

What Paragraph IV challenges could affect XDEMVY?

An ANDA applicant seeking approval for a lotilaner ophthalmic solution could certify under Paragraph IV that the listed patent is invalid, unenforceable, or not infringed.[4] A Paragraph IV notice would allow Tarsus to bring a patent-infringement action within 45 days, triggering an FDA approval stay of up to 30 months, subject to statutory exceptions and litigation developments.

Potential Paragraph IV positions include:

1. Non-infringement based on a label that omits Demodex treatment.
2. Non-infringement based on a dosage form other than eye drops.
3. Non-infringement based on a concentration outside the dependent-claim range.
4. Invalidity based on anticipation or obviousness.
5. Written-description or enablement challenges to the method claims.
6. Indefiniteness challenges to terms such as “effective amount,” “about,” and “caused by Demodex mites.”
7. A carve-out strategy that removes patented treatment instructions from the proposed labeling.

A label carve-out may be difficult if the generic’s commercial purpose is to treat Demodex blepharitis. The FDA indication, product labeling, promotional materials, and physician instructions would be relevant to induced-infringement analysis.

What prior art and validity issues matter?

The molecule lotilaner was known before the ’827 patent. Veterinary products and earlier isoxazoline patents establish prior disclosure of lotilaner as an acaricidal compound. That prior art does not automatically anticipate the claimed ophthalmic methods because the patent requires a particular human ocular treatment context.

The most relevant validity questions are:

Anticipation

A single reference would need to disclose the claimed combination, including lotilaner, an ophthalmic eye-drop composition, topical ocular or periocular administration, and treatment of the claimed Demodex condition. A reference showing lotilaner for veterinary ectoparasites would generally lack the full human ophthalmic method.

Obviousness

An obviousness challenge could combine:

• prior lotilaner acaricidal activity;
• known Demodex involvement in blepharitis;
• known ocular formulations;
• known topical administration practices;
• clinical or laboratory evidence supporting ocular tolerability.

The patentee would rely on the specific clinical use, ocular delivery, formulation selection, and treatment results to defend the claims.

Enablement and written description

The claims cover a range of lotilaner concentrations, administration locations, volumes, frequencies, and treatment durations. The specification’s examples, formulation data, toxicology, pharmacokinetics, and clinical results would be central to any challenge under current enablement and written-description standards.

Which companies are challenging or competing with XDEMVY?

The commercial competitive field has two segments.

Direct lotilaner competition

No FDA-approved competing human lotilaner ophthalmic product was identified at the time of XDEMVY approval. A future ANDA applicant would present the most direct patent challenge.

Non-lotilaner Demodex treatments

Competing approaches include off-label topical ivermectin, metronidazole-based therapy, tea tree oil preparations, lid hygiene products, thermal treatments, and mechanical lash or lid-margin procedures. These products may compete clinically without practicing the ’827 claims because they use different active ingredients or treatment modalities.

The patent therefore creates a product-specific barrier rather than a complete market monopoly over Demodex blepharitis.

Are biosimilar risks relevant to Patent 11,690,827?

No. Lotilaner is a synthetic small-molecule active ingredient. The relevant competitive pathway is an ANDA under section 505(j), not a biosimilar application under section 351(k).[5]

The key regulatory and patent mechanisms are:

• ANDA approval;
• Paragraph IV certification;
• 30-month litigation stay;
• labeling carve-out;
• patent listing and Orange Book certification;
• potential authorized-generic or settlement arrangements.

What licensing deals affect lotilaner rights?

Lotilaner was developed within the animal-health sector and commercialized in veterinary products. Tarsus obtained rights to develop lotilaner for human ophthalmic use through a licensing arrangement with Elanco Animal Health.[6] The commercial allocation of rights matters because it separates veterinary and human fields of use.

The ’827 patent is directed to human ophthalmic treatment. Veterinary lotilaner products, including oral or non-ocular formulations, do not inherently practice its claims. A license covering the human ophthalmic field can support Tarsus’s commercial position even where third parties control background compound or veterinary formulation patents.

What patent litigation and settlement issues should investors monitor?

The key litigation events would be:

• a Paragraph IV notice against the ’827 patent;
• a Delaware or other federal district court infringement action;
• an inter partes review petition at the Patent Trial and Appeal Board;
• a motion for a preliminary injunction;
• a settlement providing a delayed generic entry date;
• an authorized-generic agreement;
• additional Orange Book-listed continuation patents.

A settlement could preserve market exclusivity beyond the nominal NCE period without requiring the patent to survive final judgment. The economic value would depend on the agreed entry date, generic volume limits, authorized-generic rights, and treatment of later-issued continuation patents.

What generic launch scenarios exist for XDEMVY?

Scenario	Likely timing	Commercial effect
No successful challenge	After patent expiration or negotiated entry	XDEMVY retains protected market
Paragraph IV challenge defeated	After litigation and any applicable stay	Delayed generic entry
Paragraph IV settlement	Contract-specific	Entry date may precede patent expiration
Label carve-out	Potentially after regulatory exclusivity barriers end	Generic may enter only for non-patented uses
Successful invalidity or non-infringement case	Potentially before 2039	High erosion risk
Alternative-active product	Independent of ’827 patent	Competitive pressure without direct lotilaner infringement

The highest-risk scenario for Tarsus is approval of a 0.25% lotilaner eye drop with a label that directs treatment of Demodex blepharitis and reproduces the XDEMVY dosing instructions. That product would closely track claims 1, 3, 6, and potentially 7.

Key Takeaways

• US Patent 11,690,827 is a human-treatment patent for lotilaner ophthalmic eye drops.
• Claims 1, 8, and 15 cover Demodex blepharitis, eyelid-margin redness, and Demodex mite eradication.
• Claims 3, 10, and 16 cover 0.15% to 0.40% lotilaner, including XDEMVY’s 0.25% strength.
• Castor oil and specific dosing schedules are protected only in dependent claims.
• The patent does not broadly cover all Demodex treatments or all lotilaner products.
• XDEMVY received FDA approval on July 25, 2023, with expected five-year NCE exclusivity through July 25, 2028.
• The patent has a nominal term endpoint in December 2039 under the standard term calculation.
• Generic risk centers on an ANDA with a Paragraph IV certification or a label carve-out.
• Biosimilar regulation does not apply.
• Alternative-active Demodex products can compete without directly infringing the ’827 claims.

FAQs About US Patent 11,690,827 and XDEMVY

Does Patent 11,690,827 cover all lotilaner eye drops?

No. It covers lotilaner eye drops when used in the claimed human Demodex treatment methods. A lotilaner eye drop used for a non-Demodex indication may fall outside the claims.

Does changing castor oil avoid the patent?

Not necessarily. Removing castor oil may avoid claims 5, 12, and 18, but the broader independent claims do not require castor oil.

Can an ivermectin product infringe Patent 11,690,827?

An ivermectin product would not satisfy the lotilaner limitation. It would not directly infringe these claims solely by treating Demodex blepharitis.

Is XDEMVY protected by a composition-of-matter patent?

The ’827 patent is directed to methods of treatment. It does not, based on the supplied claims, claim lotilaner as a compound or broadly claim the ophthalmic composition independently of treatment.

Could a generic launch before 2039?

Yes, a generic could enter earlier through successful invalidity or non-infringement litigation, a settlement, a valid label carve-out, or an authorized-generic arrangement. FDA exclusivity and patent rights are separate barriers.

References

1. United States Patent and Trademark Office. (2023). U.S. Patent No. 11,690,827, methods for treating ocular demodicosis.
2. U.S. Food and Drug Administration. (2023, July 25). FDA approves first treatment for Demodex blepharitis.
3. U.S. Food and Drug Administration. (2023). XDEMVY (lotilaner ophthalmic solution) prescribing information.
4. U.S. Food and Drug Administration. (n.d.). ANDA approvals: Patent certifications and 30-month stays.
5. U.S. Food and Drug Administration. (n.d.). Abbreviated new drug application and biosimilar approval pathways.
6. Tarsus Pharmaceuticals, Inc. (2024). Annual report on Form 10-K.

Drugs Protected by US Patent 11,690,827

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Tarsus	XDEMVY	lotilaner	SOLUTION/DROPS;OPHTHALMIC	217603-001	Jul 24, 2023		RX	Yes	Yes	11,690,827					TREATMENT OF DEMODEX BLEPHARITIS VIA TOPICAL ADMINISTRATION TO AN OCULAR SURFACE

International Family Members for US Patent 11,690,827

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2018385766
Australia	2023200843
Australia	2025204628
Brazil	112020012018
Canada	3085787
China	111655241