Details for Patent: 11,285,134

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Which drugs does patent 11,285,134 protect, and when does it expire?

Patent 11,285,134 protects VUITY and is included in one NDA.

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

Summary for Patent: 11,285,134

Title:	Presbyopia treatments
Abstract:	Described herein are methods and compositions for the treatment of ocular conditions and for the improvement of vision parameters using pharmaceutically acceptable ophthalmic pilocarpine formulations. A nonlimiting example of an ocular condition that may be treated with the methods and compositions disclosed herein is presbyopia.
Inventor(s):	Michael R. Robinson, Mohammed DIBAS, Jaya Giyanani, Anuradha Gore, Sungwook Lee, Haixia Liu, Aileen Morgan, Jihao Zhou
Assignee:	Allergan Inc
Application Number:	US16/791,039
Patent Claim Types: see list of patent claims	Use; Composition;

US Patent 11,285,134: Claim Scope, Expiration, Orange Book Status and Presbyopia Patent Landscape

US Patent 11,285,134 protects specified dosing regimens for a 1.25% pilocarpine hydrochloride ophthalmic solution used to treat presbyopia. The patent is directed to method-of-use protection rather than a broad composition claim. Its strongest commercial relevance is to VUITY, AbbVie’s pilocarpine hydrochloride ophthalmic solution approved by the FDA for presbyopia.

The claims require a narrow combination of concentration, excipients, pH, viscosity, dosing frequency, visual-acuity outcomes and comparison against a pilocarpine formulation containing 0.5% or less pilocarpine hydrochloride. The patent’s stated expiration date is June 11, 2039, subject to any applicable patent-term adjustment or terminal disclaimer recorded by the USPTO.[1]

What does US Patent 11,285,134 cover?

US 11,285,134 covers topical treatment of presbyopia with one drop of an ophthalmic composition containing 1.25% w/v pilocarpine hydrochloride. The independent claims are divided into four groups:

Claims	Dosing frequency	Transition	Core subject
1	Once daily	Comprising	1.25% pilocarpine composition and visual-acuity superiority
10	Once daily	Consisting of	Same formulation and outcome limitations
19	Twice daily	Comprising	Same formulation and visual-acuity superiority
28	Twice daily	Consisting of	Same formulation and outcome limitations

The specified formulation contains:

Component	Concentration
Pilocarpine hydrochloride	1.25% w/v
Boric acid	1.0% w/v
Sodium citrate dihydrate	0.015% w/v
Sodium chloride	0.08% w/v
Benzalkonium chloride	0.0075% w/v
Water	Balance
pH	3.0 to 5.5
Viscosity	1 centipoise

Pilocarpine hydrochloride must be the sole active ingredient. The claims therefore do not cover a multi-active ophthalmic product containing another pharmacologically active compound, such as brimonidine, phenylephrine or another miotic, unless that product can still satisfy the “sole active ingredient” limitation.

How many independent inventions are claimed?

The patent effectively claims two treatment frequencies and two claim-transition formats.

The once-daily claims are claims 1 and 10. The twice-daily claims are claims 19 and 28. Claims 1 and 19 use “comprising,” which generally leaves room for additional unrecited ingredients if all express limitations are met. Claims 10 and 28 use “consisting of,” which creates a materially narrower formulation scope because the composition is limited to the recited components.

The four independent claims also require the treatment to produce:

1. Greater improvement in near visual acuity;
2. No reduction in distance visual acuity; and
3. A better result than a comparator composition containing the same listed ingredients but 0.5% w/v or less pilocarpine hydrochloride.

This comparative limitation is central to both infringement analysis and validity analysis.

What are the dependent claims directed to?

Claims 2 through 9, 11 through 18, 20 through 27, and 29 through 36 add visual-testing conditions and duration-of-effect requirements.

Visual-acuity endpoints

The dependent claims cover improvement from baseline under the following conditions:

• Mesopic, high-contrast near vision;
• Photopic, high-contrast near vision;
• Mesopic, high-contrast distance vision;
• Photopic, high-contrast intermediate vision;
• Mesopic, high-contrast intermediate vision.

The claim set does not expressly include every possible combination of photopic or mesopic testing with near, intermediate and distance acuity. The claimed endpoints are specifically enumerated.

Duration of effect

The dependent claims require either:

• A duration of effect of at least two hours; or
• A duration of effect of at least six hours.

The six-hour claims are commercially more significant because they align more closely with once-daily use and the product-label positioning for extended functional benefit. A product or regimen that produces an improvement lasting less than two hours would not satisfy claims 8, 9, 17, 18, 26, 27, 35 or 36, although it could still potentially fall within an independent claim if all other limitations are met.

What formulation limitations matter most?

The formulation limitations create several potential design-around points.

Pilocarpine concentration

The claims require 1.25% w/v pilocarpine hydrochloride. A formulation containing 1.0%, 1.5% or another concentration would not literally satisfy the express 1.25% limitation. Infringement under the doctrine of equivalents would depend on the magnitude of the concentration difference and the prosecution history.

The comparator limitation also requires comparison against a formulation containing 0.5% or less pilocarpine hydrochloride. That language ties the claimed benefit to a low-dose comparator and may create proof issues where the accused product has not been directly tested against the required comparator.

Excipients

The listed excipients are not incidental. The claims identify specific quantities of boric acid, sodium citrate dihydrate, sodium chloride and benzalkonium chloride. A formulation with materially different concentrations may avoid literal infringement even if its clinical effect is similar.

Claims 1 and 19 use “comprising.” Those claims may tolerate additional excipients, depending on the construction of the full claim and the “sole active ingredient” limitation. Claims 10 and 28 use “consisting of,” making them substantially narrower.

pH

The claimed pH range is 3.0 to 5.5. A formulation with a pH above 5.5 or below 3.0 falls outside the literal range. The pH must be measured using a defined and reproducible analytical method because pH can vary with storage, temperature and measurement conditions.

Viscosity

The claims require viscosity of 1 centipoise. This is a particularly restrictive limitation. A product with a viscosity of 1.2 or 1.5 centipoise may present a noninfringement position, subject to claim construction and measurement tolerances.

The patent does not appear to claim a broad viscosity range in the supplied claim language. The exact test method, temperature, shear conditions and instrument parameters may become important in litigation.

Benzalkonium chloride

The claim requires 0.0075% w/v benzalkonium chloride. This preservative concentration is relevant to both formulation matching and regulatory substitution. A preservative-free product or one using a different preservative may avoid the literal formulation limitations, although it would not necessarily avoid other patents in the family or related patent families.

How strong is the patent estate for VUITY?

The patent is strong against a product that copies all of the following characteristics:

• 1.25% pilocarpine hydrochloride;
• The listed excipient system;
• pH between 3.0 and 5.5;
• Approximately 1 centipoise viscosity;
• Once-daily or twice-daily topical administration;
• Presbyopia indication;
• The claimed near-vision improvement without distance-vision reduction; and
• The required comparison against a 0.5% or lower pilocarpine formulation.

Its scope is narrower against products that change concentration, formulation, dosing frequency or preservative system. The patent is also vulnerable to factual disputes over whether the claimed visual-acuity improvement and comparative result are limitations that must be proven in each patient or can be established through clinical testing of the accused product.

The claims are method claims. A manufacturer’s sale of a formulation may not, by itself, establish direct performance of every treatment step. However, labeling, prescribing instructions, promotional materials, clinical study protocols and product composition can support induced-infringement allegations where the product is marketed for the claimed regimen.

When does US Patent 11,285,134 expire?

The patent’s expected base expiration is June 11, 2039, based on the earliest relevant nonprovisional priority date reported for the patent family.[1] The term may be affected by:

• Patent-term adjustment;
• A terminal disclaimer;
• Any correction recorded by the USPTO; or
• A later determination regarding the relevant priority chain.

The patent is therefore positioned to provide protection well beyond the FDA’s regulatory exclusivity period for VUITY.

Milestone	Date or period
Earliest reported priority date	June 11, 2018
Patent application publication	2021
Patent grant	March 29, 2022
Expected base expiration	June 11, 2039
FDA approval of VUITY	October 28, 2021
FDA exclusivity category	Non-NCE product; 3-year exclusivity framework generally applicable to qualifying new clinical investigations
Potential six-month pediatric extension	Not established from the supplied record

Pilocarpine is an old active ingredient, so VUITY did not receive the five-year new chemical entity exclusivity normally associated with a new molecular entity. The relevant regulatory exclusivity analysis is therefore separate from the patent term.

What is the FDA and Orange Book status of VUITY?

The FDA approved VUITY, pilocarpine hydrochloride ophthalmic solution 1.25%, on October 28, 2021, for the treatment of presbyopia in adults.[2] The product is marketed by AbbVie following its acquisition of Allergan.

The FDA-approved product contains the same core active ingredient and excipient profile recited in the patent claims. The FDA label specifies topical ocular administration and a once-daily dosing regimen.[3]

The Orange Book analysis is important because an approved drug’s listed patents can trigger Paragraph IV certification litigation. VUITY’s relevant patent listings have included method-of-use and formulation-related protection associated with pilocarpine ophthalmic treatment. The precise listing status, use codes and delisting status should be checked against the current FDA Orange Book entry for the NDA, because Orange Book listings can change through corrections, patent-term updates, delisting requests and litigation outcomes.[4]

What Paragraph IV challenges affect VUITY?

A generic applicant seeking approval before listed patent expiration may file an Abbreviated New Drug Application with a Paragraph IV certification asserting that the relevant patent is invalid, unenforceable or not infringed.

A Paragraph IV challenge to a method-of-use patent would likely focus on:

• Whether the generic label induces the patented presbyopia treatment;
• Whether the product is indicated for the claimed dosing frequency;
• Whether the formulation has the claimed pH and viscosity;
• Whether the clinical outcome limitations are inherent or must be demonstrated;
• Whether the claims are indefinite because of “greater improvement” and “without reduction” language;
• Whether the comparative limitations are adequately supported by the specification;
• Whether the claims are obvious over earlier pilocarpine ophthalmic formulations and presbyopia studies; and
• Whether the patent properly claims a new clinical use of an old active ingredient.

A generic applicant may also pursue a section viii statement carving out the patented method from its labeling. That strategy becomes more difficult if the approved product’s commercial use is substantially concentrated in the patented presbyopia indication.

No specific settled Paragraph IV case involving US 11,285,134 should be treated as established without confirmation from the current FDA Orange Book, USPTO records and PACER docket history.

What validity issues are most likely to arise?

Obviousness

The principal validity risk is obviousness. Pilocarpine was an established miotic used in ophthalmology before VUITY. A challenger could combine prior-art disclosures relating to:

• Pilocarpine concentrations;
• Presbyopia treatment;
• Pupil-size reduction;
• Near-vision improvement;
• Ocular formulation excipients;
• Once-daily or repeated dosing; and
• Clinical testing under photopic and mesopic conditions.

The patentee’s counterposition would rely on the specific 1.25% concentration, formulation, dosing regimen and claimed visual-acuity profile, including improvement in near vision without loss of distance vision.

Written description and enablement

The claims cover several clinical environments and durations. A challenger could argue that the specification does not adequately support the full breadth of every claimed endpoint, particularly the six-hour duration claims and both once-daily and twice-daily regimens.

The patentee would point to clinical data, formulation examples and disclosure linking the 1.25% concentration to the claimed visual outcomes.

Indefiniteness

The terms “greater improvement,” “without reduction,” “improvement from baseline” and “duration of effect” may create claim-construction disputes. The relevant questions include:

• What statistical threshold establishes “greater improvement”?
• What qualifies as a reduction in distance visual acuity?
• Which time points are used?
• Must the result occur in every treated patient or in a statistically significant population?
• How is a six-hour duration measured?
• What clinical instrument and testing protocol define the endpoint?

These limitations may narrow enforcement but can also create indefiniteness arguments if the patent does not provide objective boundaries.

Double patenting and priority

The family may contain related patents directed to the composition, dosing regimen, clinical use or treatment outcomes. A challenger would review the family for:

• Overlapping method claims;
• Terminal disclaimers;
• Continuation and divisional relationships;
• Patent-term-adjustment effects; and
• Whether the same disclosure supports multiple overlapping claim sets.

Which companies are challenging or competing with VUITY?

VUITY is the principal FDA-approved pharmacologic prescription treatment specifically indicated for presbyopia in the United States. Competitive development has included products based on different miotics, combination therapies and alternative delivery systems.

Company	Program or approach	Competitive relevance
AbbVie/Allergan	VUITY, pilocarpine hydrochloride 1.25%	Approved US presbyopia product
Orasis Pharmaceuticals	CSF-1, aceclidine-based ophthalmic approach	Alternative miotic mechanism and formulation strategy
Visus Therapeutics	Brimochol and related programs	Combination of brimonidine and carbachol in development
Eyenovia	Microdose ophthalmic delivery platforms and presbyopia programs	Delivery-system differentiation
Glaukos and other ophthalmic companies	Presbyopia devices, implants or procedural products	Non-pharmacologic competition

These products may avoid literal infringement of US 11,285,134 because they use different active ingredients, concentrations or delivery technologies. They may still face other patents directed to presbyopia treatment, miotic therapy, formulations or delivery devices.

What generic launch scenarios exist?

Scenario 1: Launch after patent expiration

A generic manufacturer could launch a 1.25% pilocarpine product after expiration of the relevant listed patents, subject to FDA approval and any remaining regulatory exclusivity.

Scenario 2: Paragraph IV launch

A challenger could file Paragraph IV certifications and litigate noninfringement or invalidity. The commercial launch date would depend on litigation timing, any 30-month stay, settlement terms and the generic’s eligibility for 180-day exclusivity.

Scenario 3: Label carve-out

A generic could attempt to omit the patented presbyopia use from its labeling. This approach would depend on whether the remaining label is commercially viable and whether the product’s marketing or physician-directed use still supports induced infringement.

Scenario 4: Formulation design-around

A competitor could alter:

• Pilocarpine concentration;
• Preservative system;
• pH;
• Viscosity;
• Dosing schedule;
• Excipients; or
• Active ingredient.

This approach may reduce infringement exposure but would require separate FDA development and clinical support.

What is the commercial exposure?

AbbVie does not generally report VUITY revenue as a separately disclosed major product line in its public annual reporting. The product’s commercial exposure is therefore best assessed through prescription volume, payer coverage, market share and ophthalmology-channel data rather than a standalone revenue figure.[5]

The patent’s business value is tied to the absence of a direct FDA-approved generic substitute and to the cost of reproducing the claimed clinical profile. A formulation design-around may avoid this patent but still require clinical evidence showing adequate near-vision improvement without unacceptable distance-vision effects.

What licensing or settlement deals are publicly relevant?

No licensing agreement or Paragraph IV settlement specific to US 11,285,134 is established in the supplied record. AbbVie’s ownership and commercialization of VUITY derive from its Allergan ophthalmology portfolio, rather than from a publicly identified third-party license for the specific claimed method.

Any settlement involving a generic challenger would require review of the FDA’s settlement-reporting materials, court docket, patent listing and agreement terms. A settlement could include a licensed entry date, authorized generic provisions, supply arrangements or restrictions on the generic label.

How does US 11,285,134 compare with a conventional pilocarpine patent?

Issue	US 11,285,134	Conventional pilocarpine composition patent
Claim type	Method of treatment	Composition or formulation
Active ingredient	1.25% pilocarpine hydrochloride	May cover broader concentration range
Clinical result	Expressly required	Usually not required
Dosing	Once daily or twice daily	May be unrestricted
Comparator	0.5% or less pilocarpine formulation	Usually absent
Formulation	Precisely specified	May cover broader excipient classes
Enforcement	Requires use of claimed regimen and outcome	Can focus on product composition
Design-around potential	Relatively high through formulation or regimen changes	Depends on breadth of composition claims

Key Takeaways

• US 11,285,134 is a narrow but commercially relevant method-of-use patent associated with 1.25% pilocarpine hydrochloride treatment for presbyopia.
• The claims require a specific formulation, pH range, viscosity, dosing frequency and visual-acuity outcome.
• Claims 1 and 19 use “comprising”; claims 10 and 28 use the narrower “consisting of” format.
• The patent covers once-daily and twice-daily regimens.
• Dependent claims add photopic or mesopic visual testing and two-hour or six-hour duration requirements.
• The expected base expiration is June 11, 2039.
• VUITY received FDA approval on October 28, 2021, but pilocarpine is not a new chemical entity, so patent protection is more important than five-year NCE exclusivity.
• The main invalidity issues are obviousness, written description, enablement and indefiniteness of the comparative clinical-outcome limitations.
• A generic applicant may pursue Paragraph IV litigation, a section viii carve-out, or a formulation design-around.
• Alternative presbyopia programs using aceclidine, carbachol, brimonidine or novel delivery systems are less likely to infringe this patent literally.

FAQs

Does US 11,285,134 cover all pilocarpine treatments for presbyopia?

No. It requires 1.25% w/v pilocarpine hydrochloride, specified excipients, pH, viscosity, dosing and clinical outcomes. Other pilocarpine concentrations or formulations may fall outside the literal claims.

Can a preservative-free pilocarpine product avoid this patent?

Potentially. The claims recite 0.0075% w/v benzalkonium chloride. A preservative-free formulation would not literally satisfy that limitation, although other patents or the doctrine of equivalents could remain relevant.

Does twice-daily use infringe the patent?

Twice-daily administration is expressly covered by claims 19 and 28, provided the formulation and clinical-outcome limitations are also met.

Are the six-hour claims required for infringement?

No. The independent claims do not require the two-hour or six-hour duration limitations. Those requirements apply only to the dependent claims directed to duration of effect.

Could an aceclidine product infringe US 11,285,134?

A product using aceclidine instead of pilocarpine hydrochloride would generally fail the requirement that the composition contain 1.25% pilocarpine hydrochloride as the sole active ingredient. It could, however, face separate patents directed to presbyopia treatment or ophthalmic formulations.

References

1. United States Patent and Trademark Office. (2022). US Patent No. 11,285,134, methods of treating presbyopia. USPTO Patent Center. https://patentcenter.uspto.gov/
2. U.S. Food and Drug Administration. (2021, October 28). FDA approves first eye drop to improve near vision in adults with age-related blurry vision. https://www.fda.gov/
3. U.S. Food and Drug Administration. (2021). VUITY prescribing information: Pilocarpine hydrochloride ophthalmic solution, 1.25%. https://www.accessdata.fda.gov/
4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/
5. AbbVie Inc. (2024). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. https://investors.abbvie.com/

Drugs Protected by US Patent 11,285,134

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Abbvie	VUITY	pilocarpine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	214028-001	Oct 28, 2021		DISCN	Yes	No	11,285,134					TREATMENT OF PRESBYOPIA IN ADULTS BY ADMINISTRATION OF PILOCARPINE HCI FORMULATION ONCE DAILY
Abbvie	VUITY	pilocarpine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	214028-001	Oct 28, 2021		DISCN	Yes	No	11,285,134					TREATMENT OF PRESBYOPIA IN ADULTS BY ADMINISTRATION OF PILOCARPINE HCI FORMULATION TWICE DAILY
Abbvie	VUITY	pilocarpine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	214028-001	Oct 28, 2021		DISCN	Yes	No	11,285,134					USE OF VUITY FOR THE TREATMENT OF PRESBYOPIA IN ADULTS

International Family Members for US Patent 11,285,134

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2019261598
Australia	2020203311
Australia	2022201106
Brazil	112020021845
Canada	3074618
Canada	3162141