US Patent 10,610,518: Scope, Claims, Expiration, and Pilocarpine Patent Landscape

US Patent 10,610,518 protects methods of treating presbyopia and related ocular conditions with a low-viscosity, topical pilocarpine hydrochloride formulation. The core commercial embodiment is a substantially polymer-free ophthalmic solution containing 1.0% to 1.5% w/v pilocarpine hydrochloride, boric acid, sodium citrate, sodium chloride, and, in most claims, benzalkonium chloride.

The patent is directed to use of the formulation, not to a standalone composition. Its principal commercial relevance is VUITY, Allergan’s 1.25% pilocarpine hydrochloride ophthalmic solution for presbyopia. The patent does not cover all pilocarpine products. A competing product can avoid literal infringement by using a different concentration, omitting specified excipients, using a different dosage form, or avoiding the claimed treatment method.

What does US Patent 10,610,518 protect?

The patent protects treatment methods that combine four elements:

Topical ophthalmic administration.
Pilocarpine hydrochloride at 1.0% to 1.5% w/v.
A defined excipient system centered on boric acid, sodium citrate dihydrate, and sodium chloride.
No viscosity-enhancing polymer.

The claims also require a clinical or functional result: a lower incidence of specified ocular adverse events compared with a pilocarpine formulation containing a polymer.

The principal protected product profile is:

Component	Claimed amount
Pilocarpine hydrochloride	1.0%-1.5% w/v
Boric acid	1.0% w/v
Sodium citrate dihydrate	0.015% w/v
Sodium chloride	0.03%-0.37% w/v
Benzalkonium chloride	0.0075% w/v in claims 11-20
pH	3.0-5.5 in claims 11 and 16-20
Viscosity-enhancing polymer	Excluded

The patent therefore combines composition limitations with method-of-treatment limitations. It does not claim pilocarpine as a molecule, which has been used ophthalmically for decades.

How broad is independent claim 1?

Claim 1 is broad in disease coverage but narrow in formulation structure.

It covers treatment of:

Presbyopia
Hyperopia
Mydriasis
Anisocoria
Accommodative esotropia
Myopia
Astigmatism

The claim requires topical administration to at least one eye. It does not require bilateral dosing, dominant-eye dosing, or a particular dosing frequency. Those limitations appear in dependent claims 4 through 7.

The formulation must contain pilocarpine hydrochloride at 1.0% to 1.5% w/v, 1.0% boric acid, 0.015% sodium citrate dihydrate, and sodium chloride within the specified range. Hydrochloric acid and/or sodium hydroxide may be used for pH adjustment. The claim excludes viscosity-enhancing polymers.

A potentially important limitation is the requirement that administration result in a lower incidence of specified adverse events than administration of a second pilocarpine-and-polymer formulation. The listed events include ocular blurring, ocular discomfort, eye pain, brow ache, blurry vision, light sensitivity, stinging, and itching.

That comparative limitation narrows the claim but may create proof issues in litigation. A patent owner would generally need evidence that the accused use produces the claimed lower incidence relative to the relevant polymer-containing comparator. The claim is not simply infringed by administering any polymer-free pilocarpine solution within the concentration range.

What do claims 2 through 10 add?

Claims 2 through 10 narrow claim 1 by specifying the indication, dosing pattern, duration, or concentration.

Claim	Limitation
2	Presbyopia
3	Hyperopia
4	Administration to both eyes
5	Administration to the dominant eye
6	Once-daily administration
7	Twice-daily administration
8	Duration of effect of at least six hours
9	Pilocarpine hydrochloride is the sole active ingredient
10	1.25% w/v pilocarpine hydrochloride

Claim 10 is commercially significant because it captures the 1.25% concentration associated with VUITY. Claims 6 and 8 also track the commercial dosing profile: once-daily administration with an intended duration sufficient for daytime near-vision improvement.

The claims do not require a particular bottle, dropper, container, particle size, manufacturing process, or delivery device.

What does claim 12 protect?

Claim 12 is the second independent method claim. It is narrower in indication and more specific in formulation than claim 1.

It requires:

Improvement of near vision.
A patient with presbyopia.
Administration to an eye.
Pilocarpine hydrochloride as the sole active agent.
Pilocarpine hydrochloride at 1.0% to 1.5% w/v.
1.0% boric acid.
0.015% sodium citrate dihydrate.
0.03% to 0.37% sodium chloride.
0.0075% benzalkonium chloride.
No viscosity-enhancing polymer.
Lower incidence of specified adverse events than a pilocarpine formulation containing a viscosity-enhancing polymer.

Compared with claim 1, claim 12 removes the broader ocular-condition list and focuses on presbyopic near-vision improvement. It expressly requires benzalkonium chloride and identifies pilocarpine hydrochloride as the sole active agent.

Claims 13 and 14 narrow claim 12 to once-daily dosing and 1.25% pilocarpine hydrochloride, respectively.

Which exact formulations are covered?

Claims 11 and 16 through 20 cover specific formulation embodiments.

Claim	Pilocarpine HCl	Boric acid	Sodium citrate dihydrate	Sodium chloride	BAK	pH
11	1.25%	1.0%	0.015%	0.08%	0.0075%	3.0-5.5
16	1.0%	1.0%	0.015%	0.14%	0.0075%	3.0-5.5
17	1.25%	1.0%	0.015%	0.08%	0.0075%	3.0-5.5
18	1.5%	1.0%	0.015%	0.03%	0.0075%	3.0-5.5
19	1.25%	1.0%	0.015%	0.08%	0.0075%	3.0-5.5
20	1.25%	1.0%	0.015%	0.08%	0.0075%	3.0-5.5

Claims 11 and 20 use “consists essentially of.” That transitional phrase generally excludes additional ingredients that materially alter the formulation’s basic and novel characteristics, while permitting components that do not materially change those characteristics or are incidental to the formulation.

Claims 17 and 19 are materially similar in their recited formulation. Claim 20 is narrower because it depends on claim 12 and uses “consists essentially of,” while claim 17 depends on claim 1.

Claim 15 covers the narrower pilocarpine range of 1.1875% to 1.3125% w/v. This range is centered on the 1.25% commercial concentration.

Does the patent cover VUITY?

The claimed formulation closely corresponds to VUITY, Allergan’s 1.25% pilocarpine hydrochloride ophthalmic solution approved by the FDA for presbyopia. VUITY’s labeled inactive ingredients include boric acid, sodium citrate, sodium chloride, benzalkonium chloride, and water. The product is administered topically once daily, with a second dose permitted in the product labeling under specified conditions [2].

US Patent 10,610,518 is listed in the FDA Orange Book for VUITY. The listing gives the patent commercial significance against abbreviated new drug applications directed to the approved product [3].

The patent’s coverage is not identical to the full regulatory product description. A generic applicant must evaluate both:

Whether its formulation and proposed labeling fall within the patent claims.
Whether its product is pharmaceutically equivalent and bioequivalent under the ANDA pathway.

A formulation that differs from the claimed excipient system may avoid literal infringement while still raising equivalence or doctrine-of-equivalents issues.

When does US Patent 10,610,518 lose exclusivity?

The patent’s listed expiration date is July 7, 2035, before any applicable patent-term adjustment or extension. The effective expiration date should be confirmed against the current USPTO patent record and Orange Book listing [1, 3].

The relevant commercial exclusivity timeline is:

Event	Date
US patent grant	April 7, 2020
VUITY FDA approval	October 28, 2021
Estimated patent expiration	July 7, 2035
FDA chemical exclusivity for VUITY	Generally four years from approval for a new chemical entity, where applicable

VUITY’s regulatory exclusivity and patent exclusivity are separate. The four-year new-chemical-entity bar, if applicable to the approved NDA, would expire before the listed patent term. The patent remains the principal barrier after regulatory exclusivity ends.

Pediatric exclusivity, patent-term extension, terminal disclaimers, and patent-term adjustment can affect the final date. The July 7, 2035 date should therefore be treated as the listed base expiration rather than an unconditional launch date.

What is the Orange Book status of the patent?

The patent is relevant to the Orange Book-listed VUITY product. An ANDA applicant seeking approval before patent expiration would ordinarily need to address the listed patent through one of the certifications under section 505(j) of the Federal Food, Drug, and Cosmetic Act.

The most commercially important pathway would be a Paragraph IV certification asserting that the patent is invalid, unenforceable, or not infringed. A Paragraph IV notice can trigger a patent-infringement action by the NDA holder or patent owner and, if timely filed, a 30-month stay of ANDA approval under the Hatch-Waxman framework [4].

A Section VIII statement may be available for a generic that omits a patented method of use, but that route is less straightforward where the approved product is primarily associated with the patented presbyopia indication and the patent claims cover the commercial formulation and method.

What generic entry risks exist?

The main generic entry risks are formulation design-around, Paragraph IV litigation, and labeling strategy.

Literal infringement risk

A generic product is at highest risk if it reproduces:

1.0%-1.5% pilocarpine hydrochloride.
1.0% boric acid.
0.015% sodium citrate dihydrate.
Sodium chloride within 0.03%-0.37%.
0.0075% benzalkonium chloride.
A polymer-free formulation.
A presbyopia or near-vision indication.
Once-daily or similar use.

A product outside the concentration range or without one of the required excipients may avoid literal infringement of the narrower formulation claims.

Method-of-use risk

Even if a generic composition does not infringe every formulation claim, its proposed labeling can create method-of-use exposure. Presbyopia treatment, near-vision improvement, once-daily dosing, and a polymer-free formulation are all relevant claim limitations.

Comparative-outcome limitation

The requirement for a lower incidence of adverse events compared with a polymer-containing pilocarpine formulation may create an additional defense. A generic manufacturer could argue that its product does not satisfy the comparative clinical-result limitation. The patent owner could respond that the limitation is inherent in the claimed formulation or established by clinical data.

Are biosimilars relevant to this patent?

No. Biosimilar risk is not the relevant pathway because pilocarpine hydrochloride is a small-molecule active pharmaceutical ingredient, not a biological product. Competitors would generally use the ANDA pathway for a pharmaceutically equivalent generic product, not the section 351(k) biosimilar pathway.

The relevant competitive products are generic pilocarpine ophthalmic solutions, new drug products with alternative pilocarpine concentrations, and other presbyopia therapies.

How does QLOSI compare with VUITY and the patent claims?

QLOSI, approved by the FDA in 2023, is a 0.4% pilocarpine hydrochloride ophthalmic solution for presbyopia [5]. Its principal formulation differences reduce direct overlap with the claims of US 10,610,518.

Attribute	VUITY	QLOSI	US 10,610,518
Active ingredient	Pilocarpine HCl	Pilocarpine HCl	Required
Strength	1.25%	0.4%	1.0%-1.5%
Boric acid	Yes	Different formulation profile	Required
Benzalkonium chloride	Yes	Preservative-free formulation	Required in claims 11-20
Polymer-free limitation	Relevant	Relevant	Required
Presbyopia indication	Yes	Yes	Covered
Likely literal concentration overlap	Yes	No	1.0%-1.5%

QLOSI’s 0.4% concentration falls outside the 1.0%-1.5% concentration range. Its distinct excipient system also reduces the risk of literal infringement of the specific formulation claims. It remains a commercial competitor because it addresses the same presbyopia market through a different formulation strategy.

What other patent barriers may affect generic entry?

The commercial patent landscape can include more than US 10,610,518. Relevant barriers may include:

Continuation patents directed to pilocarpine formulations.
Method-of-use patents for presbyopia or near-vision improvement.
Patents covering dosing frequency or duration of effect.
Patents covering specific excipient ratios.
Orange Book-listed patents for VUITY that are separate from US 10,610,518.
Non-listed patents covering manufacturing, packaging, or formulation processes.

A complete freedom-to-operate analysis must review the entire patent family, continuation applications, terminal disclaimers, Orange Book listings, and active claims in the relevant jurisdiction. US 10,610,518 alone does not define the entire VUITY estate.

How strong is the patent estate?

US 10,610,518 has meaningful strength against a generic that seeks to replicate VUITY closely. Claims 11 and 17 through 20 identify the commercial formulation with unusual precision. Claims 10, 14, and 15 reinforce the 1.25% concentration.

Its weaknesses are structural:

It is a method patent rather than a composition patent.
It requires a polymer-free formulation.
It requires a defined excipient combination.
Several claims require benzalkonium chloride.
The comparative adverse-event limitation may require clinical proof.
A 0.4% or materially different formulation can fall outside the literal concentration range.
The original pilocarpine active ingredient is long off-patent.

The estate is strongest against a VUITY copy and weaker against products using different concentrations, preservatives, buffers, salts, or delivery strategies.

Key Takeaways

US Patent 10,610,518 primarily protects methods using a 1.0%-1.5% polymer-free pilocarpine hydrochloride ophthalmic solution.
The commercial center of gravity is the 1.25% VUITY formulation.
Claims 11 and 17-20 closely track the specific VUITY excipient profile.
The patent covers methods, not pilocarpine itself or every pilocarpine ophthalmic product.
The listed base expiration is July 7, 2035, subject to applicable patent-term adjustments or extensions.
Paragraph IV litigation is the principal generic-entry risk.
QLOSI’s 0.4% formulation falls outside the claimed pilocarpine concentration range and uses a different product design.
Biosimilar risk is not applicable; the relevant pathway is an ANDA for a small-molecule generic.
The comparative adverse-event limitation may be important in both infringement and validity disputes.
A full launch analysis requires review of all active continuation and Orange Book-listed patents associated with VUITY.

FAQs About US Patent 10,610,518

Does US Patent 10,610,518 cover generic pilocarpine 1% eye drops?

Not automatically. A generic 1% pilocarpine product would need to be assessed against the claimed excipients, absence of viscosity-enhancing polymers, indication, labeling, dosing, and comparative adverse-event limitation.

Can a generic avoid the patent by removing benzalkonium chloride?

Removing benzalkonium chloride may avoid claims 11 through 20, which require it, but claim 1 does not expressly require benzalkonium chloride. The remaining formulation and method limitations would still require analysis.

Does QLOSI infringe US Patent 10,610,518?

QLOSI’s 0.4% pilocarpine concentration is outside the patent’s 1.0%-1.5% range. Its different formulation further reduces literal-overlap risk with the specific formulation claims.

Is the patent directed to presbyopia only?

No. Claim 1 also lists hyperopia, mydriasis, anisocoria, accommodative esotropia, myopia, and astigmatism. Claim 12 is limited to presbyopia and improvement of near vision.

What is the most vulnerable claim limitation in litigation?

The comparative requirement that the claimed formulation produce a lower incidence of specified adverse events than a pilocarpine-and-polymer formulation may be the most fact-intensive limitation. It can affect both infringement proof and validity analysis.

Sources

United States Patent and Trademark Office. (2020). US Patent No. 10,610,518.
U.S. Food and Drug Administration. (2021). VUITY (pilocarpine hydrochloride ophthalmic solution) prescribing information. AbbVie/Allergan.
U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book.
U.S. Food and Drug Administration. (2024). ANDA submissions: Patent certification and 30-month stay provisions.
U.S. Food and Drug Administration. (2023). QLOSI (pilocarpine hydrochloride ophthalmic solution) prescribing information.

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	10,610,518	⤷ Start Trial				TREATMENT OF PRESBYOPIA IN ADULTS BY ADMINISTRATION OF PILOCARPINE HCI FORMULATION TWICE DAILY	⤷ Start Trial
Abbvie	VUITY	pilocarpine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	214028-001	Oct 28, 2021		DISCN	Yes	No	10,610,518	⤷ Start Trial				TREATMENT OF PRESBYOPIA IN ADULTS BY ADMINISTRATION OF PILOCARPINE HCI FORMULATION ONCE DAILY	⤷ Start Trial
Abbvie	VUITY	pilocarpine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	214028-001	Oct 28, 2021		DISCN	Yes	No	10,610,518	⤷ Start Trial				USE OF VUITY FOR THE TREATMENT OF PRESBYOPIA IN ADULTS	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2019261598	⤷ Start Trial
Australia	2020203311	⤷ Start Trial
Australia	2022201106	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 10,610,518

Which drugs does patent 10,610,518 protect, and when does it expire?

Summary for Patent: 10,610,518