List of Excipients in Branded Drug QLOSI

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Orasis Pharmaceuticals Inc	QLOSI	pilocarpine hydrochloride	83661-018	EDETATE DISODIUM
Orasis Pharmaceuticals Inc	QLOSI	pilocarpine hydrochloride	83661-018	HYALURONATE SODIUM
Orasis Pharmaceuticals Inc	QLOSI	pilocarpine hydrochloride	83661-018	HYDROCHLORIC ACID
Orasis Pharmaceuticals Inc	QLOSI	pilocarpine hydrochloride	83661-018	HYPROMELLOSE 2910

QLOSI Excipient Strategy, Patent Position, and Commercial Opportunities

Last updated: October 19, 2026

QLOSI is a preservative-free, low-dose pilocarpine hydrochloride ophthalmic solution approved by the FDA for the treatment of presbyopia in adults. Its commercial differentiation depends on more than the active ingredient. The formulation uses a simple aqueous excipient system, but pH control, osmolality, ocular tolerability, preservative avoidance, unit-dose packaging, and manufacturing consistency create potential barriers for competing products.

QLOSI was approved on October 17, 2023, under NDA 216836. The product is marketed by Orasis Pharmaceuticals. Its principal commercial risks are competition from Vuity, future pilocarpine products, compounded preparations, and alternative presbyopia therapies. Its principal formulation opportunities are preservative-free delivery, improved comfort, longer stability, lower manufacturing cost, and alternative unit-dose or multidose packaging.

What is QLOSI and how is it formulated?

QLOSI contains pilocarpine hydrochloride 0.4% in an ophthalmic solution. The product is administered as one drop in each eye twice daily, approximately six hours apart, according to the FDA-approved labeling.[1]

The formulation uses a relatively conventional aqueous ophthalmic platform:

Component	Function
Pilocarpine hydrochloride	Active pharmaceutical ingredient
Boric acid	Buffering and tonicity contribution
Sodium citrate dihydrate	Buffering and pH control
Sodium chloride	Tonicity adjustment
Hydrochloric acid and sodium hydroxide	Final pH adjustment
Water for injection	Vehicle

QLOSI is supplied as a preservative-free, single-use ophthalmic solution. The absence of preservatives is commercially relevant because chronic ophthalmic exposure to preservatives, particularly benzalkonium chloride, can contribute to ocular-surface irritation and tear-film disruption.

The product’s formulation strategy is based on lowering pilocarpine concentration while retaining a clinically useful miotic effect. QLOSI uses 0.4% pilocarpine, compared with the 1.25% concentration used in Vuity. The lower concentration is intended to reduce dose-related adverse effects associated with pilocarpine, including headache, dim vision, accommodative spasm, and difficulty seeing in low light.[1,2]

What excipients protect QLOSI’s commercial position?

The individual excipients are generally well known and are unlikely to provide strong standalone protection. The commercial value lies in the combination, concentration, pH range, osmolality, preservative-free presentation, packaging configuration, and manufacturing controls.

pH and buffer system

Pilocarpine is chemically sensitive in aqueous environments. The boric acid and citrate system provides buffering while allowing the manufacturer to control ocular tolerability and product stability. Excessive acidity or alkalinity can cause stinging, tearing, and poor patient adherence.

A competing product could use a different buffer, but it would need to demonstrate:

• Acceptable ocular comfort
• Chemical stability through shelf life
• Consistent pilocarpine assay and impurity profile
• Comparable pH and osmolality
• Compatibility with the container closure
• Preservative-free microbiological control

Buffer substitution may therefore create a regulatory burden even where it does not create a patent issue.

Preservative-free design

Preservative-free delivery is one of QLOSI’s most important commercial attributes. It supports use in patients with dry eye, ocular-surface sensitivity, or repeated dosing requirements.

The design shifts the control strategy from chemical preservation to:

• Sterile manufacturing
• Container-closure integrity
• Low-bioburden processing
• Single-use packaging
• Controlled filling and sealing
• Validated in-use disposal instructions

This creates opportunities for contract manufacturers with sterile ophthalmic filling capacity. It also raises manufacturing costs compared with multidose preserved products.

Tonicity control

Sodium chloride helps bring the formulation closer to physiologic tonicity. Tonicity is not merely a comfort variable. It affects drop retention, reflex tearing, and effective ocular exposure.

A competing formulation that changes sodium chloride concentration or replaces it with another tonicity agent could face a narrow operating window. A product that is too hypotonic or hypertonic may generate more discomfort and washout.

Unit-dose packaging

QLOSI’s single-use format reduces contamination risk and supports preservative-free delivery. Packaging is a major part of the product strategy because the formulation itself is simple.

Potential packaging platforms include:

Packaging platform	Commercial advantage	Main limitation
Blow-fill-seal unit-dose vial	Integrated sterile manufacture and low component count	High equipment and validation requirements
Conventional plastic unit-dose vial	Established supply chain	More component handling and packaging complexity
Multidose preservative-free bottle	Better convenience and lower packaging waste	Requires validated multidose contamination control
Ophthalmic dispenser with filter or one-way valve	Preservative-free multidose use	Higher device cost and combination-product complexity

Unit-dose packaging can support patent claims directed to the container, dose volume, delivery method, or preservative-free system. It also creates potential design-around routes for competitors.

What patents protect QLOSI?

QLOSI’s relevant protection is expected to center on formulation, ophthalmic use, concentration, dosing, and delivery rather than on pilocarpine itself. Pilocarpine is an old active ingredient and cannot support broad composition-of-matter exclusivity for QLOSI.

The likely protection categories are:

1. Pilocarpine ophthalmic formulations at selected concentrations.
2. Presbyopia treatment using low-concentration pilocarpine.
3. Preservative-free aqueous compositions.
4. Buffer and pH combinations.
5. Unit-dose delivery systems.
6. Treatment schedules, including twice-daily administration.
7. Manufacturing and stability characteristics.

Orange Book status

QLOSI’s FDA exclusivity and patent position should be evaluated through the product’s Orange Book record and FDA approval documents. FDA approval alone does not establish the scope of enforceable patent protection. The critical questions are whether patents are listed, which claims cover the approved product, and whether any patent claims are directed to the formulation rather than only to a method of use.[3]

A generic applicant seeking approval before listed patent expiry could file a Paragraph IV certification. If Orasis sued within 45 days, the filing could trigger a 30-month stay under the Hatch-Waxman framework, subject to statutory exceptions and litigation outcomes.[4]

Patent strength

QLOSI’s estate is likely stronger against an exact-copy formulation than against a different pilocarpine formulation. Patent strength can be divided as follows:

Protection type	Relative strength	Reason
Pilocarpine active ingredient	Low	Long-established compound
0.4% ophthalmic concentration	Moderate	May be avoided through concentration changes
Specific buffer and pH system	Moderate	Can be designed around with alternative excipients
Preservative-free presentation	Moderate	Commercially important but potentially broad or narrow depending on claims
Method of treating presbyopia	Moderate to strong	May create use-based litigation against labeled generic indications
Unit-dose packaging	Moderate	Dependent on claim scope and device implementation
Manufacturing process	Moderate	Can create process barriers but may not block all competitors

When does QLOSI lose exclusivity?

QLOSI’s regulatory exclusivity depends on the approval pathway and FDA-recognized exclusivity period. Because pilocarpine is an established active ingredient, QLOSI is not expected to receive five-year new chemical entity exclusivity.

The relevant regulatory milestones are:

Event	Date or period
FDA approval	October 17, 2023
NDA	216836
Expected 505(b)(2) framework	Established active ingredient and new formulation/use
Potential three-year exclusivity endpoint	October 17, 2026
Patent expiry	Depends on listed patents and any patent-term adjustment or extension
Earliest practical generic entry	Controlled by exclusivity, listed patents, litigation, and settlement terms

The three-year exclusivity period would block approval of a competing application that relies on QLOSI’s approval for the same conditions of approval, but it would not necessarily prevent an independently supported application. Patent expiry may extend beyond regulatory exclusivity and will be the more important barrier if formulation or method patents are listed.

What generic entry risks exist for QLOSI?

The principal generic pathway is an ANDA referencing the approved product, although a 505(b)(2) application may be relevant for products with meaningful formulation or delivery differences.

A generic competitor would need to address:

• Active ingredient identity
• Strength and dosage form
• Sterility
• Particulate matter
• pH and osmolality
• Impurity profile
• Container-closure integrity
• Delivered drop volume
• Microbiological quality
• Labeling and proposed indications
• Patent certifications

Paragraph IV challenge risk

A Paragraph IV challenge could target patents covering:

• The 0.4% strength
• Preservative-free composition
• Buffer system
• Use in presbyopia
• Dosing frequency
• Unit-dose packaging

The strongest challenge would likely argue that the asserted claims are obvious in view of prior pilocarpine ophthalmic products, known presbyopia treatment, and conventional buffer systems. Orasis would counter that the selected low concentration, tolerability profile, dosing regimen, and clinical performance were not predictable from older high-concentration pilocarpine products.

An ANDA applicant could also pursue a section viii statement and omit a patented method of use from its labeling. That strategy would be more difficult if the claimed use is inseparable from the approved label or if the product is promoted for the patented indication.

What commercial opportunities exist in QLOSI excipients?

The largest opportunity is not a new active ingredient. It is an improved delivery platform that preserves pilocarpine efficacy while reducing tolerability and manufacturing costs.

Preservative-free multidose products

A multidose preservative-free bottle could improve convenience and reduce packaging waste. It would compete directly with single-use QLOSI by reducing the number of vials handled per month.

Commercial hurdles include:

• Tip contamination control
• Repeated-use stability
• Dose uniformity
• Device reliability
• Extractables and leachables
• Human-factors performance

Alternative buffer systems

Potential development programs could evaluate phosphate, citrate, borate, or proprietary buffering systems. The objective would be to improve stability or comfort without increasing ocular irritation.

Any alternative buffer would require comparative development work covering:

• Pilocarpine degradation
• Related substances
• pH drift
• Drop comfort
• Sterility maintenance
• Container interaction
• Long-term and accelerated stability

Improved drop-volume control

A smaller and more consistent drop could reduce systemic absorption, improve bottle longevity, and reduce ocular overflow. This is a device and formulation opportunity rather than a simple excipient substitution.

The commercial value is highest if the delivery system can maintain consistent dosing across patients with reduced dexterity or visual impairment, the same population that uses presbyopia products.

Dry-eye compatible excipient systems

Patients with presbyopia frequently use artificial tears or have ocular-surface disease. Formulations that reduce sting, minimize tear-film disruption, and avoid preservatives may obtain a commercial advantage even when the active ingredient is unchanged.

Potential excipient programs could focus on:

• Lower-irritancy buffering
• Controlled osmolality
• Reduced surfactant burden
• Improved wetting
• Compatibility with concurrent lubricating drops

How does QLOSI compare with Vuity?

Attribute	QLOSI	Vuity
Active ingredient	Pilocarpine hydrochloride	Pilocarpine hydrochloride
Concentration	0.4%	1.25%
Sponsor	Orasis Pharmaceuticals	AbbVie/Allergan
FDA approval	2023	2021
Presbyopia indication	Yes	Yes
Preservative-free positioning	Central product attribute	Product-specific formulation and packaging
Dosing	Twice daily	Once daily
Key differentiation	Lower concentration and preservative-free unit-dose strategy	Earlier market entry and once-daily dosing
Main risk	New-market adoption and reimbursement	Adverse effects and duration limitations

Vuity has the first-mover advantage and a larger corporate commercial platform. QLOSI competes through lower pilocarpine exposure, preservative-free delivery, and twice-daily control. The two products create a reference market for low-dose miotic presbyopia therapy and may establish prior art relevant to future patent disputes.

What is the FDA regulatory status of QLOSI?

QLOSI is FDA-approved for adults with presbyopia. It is a prescription ophthalmic product and is not a biologic. Biosimilar competition is therefore irrelevant. Competition will arise through generic, 505(b)(2), reformulated, compounded, or alternative presbyopia products.

FDA regulatory risk is concentrated in:

• Demonstrating comparable clinical performance for low-dose alternatives
• Preserving sterile delivery without preservatives
• Supporting long-term stability
• Establishing device performance
• Avoiding label restrictions from method-of-use patents
• Managing ocular and systemic pilocarpine adverse effects

What licensing and partnership opportunities exist?

QLOSI creates licensing opportunities in four areas:

1. Preservative-free ophthalmic filling and packaging.
2. Multidose sterile dispensing technology.
3. Low-irritancy excipient platforms.
4. Regional commercialization of prescription presbyopia products.

The most valuable partnership targets are companies with validated sterile ophthalmic manufacturing, proprietary multidose containers, or established optometry and ophthalmology sales channels.

No major public licensing transaction is required to commercialize an improved pilocarpine formulation, but a partner with device and sterile-manufacturing expertise could reduce development time and capital requirements.

What revenue exposure does QLOSI create?

QLOSI’s revenue potential depends on market expansion rather than replacement of a large established generic market. Presbyopia is widespread, but prescription conversion depends on:

• Patient willingness to use daily drops
• Duration of functional benefit
• Adverse-event tolerance
• Insurance coverage
• Retail price
• Competition from reading glasses, contact lenses, surgery, and over-the-counter products
• Physician prescribing behavior

The lack of publicly disclosed QLOSI revenue data limits product-level valuation. The commercial thesis is strongest if QLOSI expands the prescription presbyopia category and captures patients who cannot tolerate higher-concentration pilocarpine products.

Key Takeaways

• QLOSI is a 0.4% pilocarpine hydrochloride ophthalmic solution approved in 2023 for adult presbyopia.
• Its excipient strategy uses a conventional borate-citrate aqueous system with sodium chloride, pH adjustment, and water for injection.
• Preservative-free single-use packaging is a major commercial and manufacturing differentiator.
• The active ingredient is old, so protection depends on formulation, method-of-use, concentration, packaging, and manufacturing claims.
• The likely regulatory exclusivity period is shorter than five years because pilocarpine is an established active ingredient.
• A generic challenger could use Paragraph IV certifications against listed formulation or method patents.
• The most attractive commercial opportunities are preservative-free multidose delivery, improved drop-volume control, lower-irritancy buffers, and sterile ophthalmic manufacturing partnerships.
• QLOSI competes primarily with Vuity, generic pilocarpine products, compounded preparations, and nonpharmaceutical presbyopia solutions.
• Biosimilar risk does not apply because QLOSI is a small-molecule ophthalmic drug.

FAQs

Is QLOSI preservative-free?

Yes. QLOSI is supplied as a preservative-free ophthalmic solution in single-use packaging.

Can a generic use different excipients from QLOSI?

Potentially. A generic must still demonstrate pharmaceutical equivalence, bioequivalence or applicable equivalence, sterility, stability, and compliance with relevant patent certifications. Different excipients may create formulation or regulatory differences that require additional support.

Does QLOSI have new chemical entity exclusivity?

No. Pilocarpine is an established active ingredient. QLOSI’s protection is expected to depend on formulation, method-of-use, regulatory exclusivity, and listed patents rather than new chemical entity exclusivity.

Is QLOSI a biologic eligible for biosimilar competition?

No. QLOSI is a small-molecule ophthalmic drug. Potential competitors would use generic, 505(b)(2), or other small-molecule pathways.

What is the strongest commercial design-around for QLOSI?

A preservative-free multidose bottle with controlled drop volume is the clearest design-around opportunity. It could improve convenience and reduce packaging waste while avoiding an exact copy of QLOSI’s single-use presentation.

References

1. U.S. Food and Drug Administration. (2023). QLOSI (pilocarpine hydrochloride ophthalmic solution) 0.4% prescribing information. Orasis Pharmaceuticals.

2. U.S. Food and Drug Administration. (2021). VUITY (pilocarpine hydrochloride ophthalmic solution) 1.25% prescribing information. AbbVie Inc.

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. Orange Book.

4. U.S. Congress. (1984). Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585.