United States Patent 11,311,515: Scope, Claim Coverage, and Patent Landscape (US Drug Patent)

What does US Patent 11,311,515 claim in scope?

US 11,311,515 is directed to child-resistant packaging that encloses a single-use ophthalmic container with a sterile, preservative-free aqueous oxymetazoline formulation delivered at a defined dose per drop, with specified solution properties (pH, viscosity, osmolality) and defined package formats and processing methods (foil pouch, blow/fill/seal, LDPE container).

The claims are built around a tight coupling of:

Container-delivered dose: ~0.035 mg oxymetazoline (or salt) per drop
Formulation composition and physicochemical envelope:
- Oxymetazoline: about 0.1 wt %
- Hypromellose: about 0.5 wt %
- Electrolytes: sodium chloride, potassium chloride, calcium chloride, magnesium chloride (with specific examples)
- Buffers: sodium acetate and sodium citrate
- Acid: hydrochloric acid for pH control
- Water as balance
- pH: about 5.8 to about 6.8 (with narrower subranges)
- Viscosity: about 15 cPs to about 35 cPs
- Osmolality: about 290 to about 365 mOsm/kg
Stability assertions: maintains pH/viscosity/osmolality ranges for 6, 12, and 18 months, including at 25°C and 60% RH (temperature/humidity stability condition is explicitly claimed).
Packaging form factors:
- Foil pouch and foil laminate pouch
- A single-use LDPE container enclosed therein
- A container formed by blow/fill/seal (BFS)

Core independent claim coverage (Claim 1)

Claim 1 covers child-resistant packaging with a single-use container containing the specified ophthalmic formulation, together with the dose, viscosity, and pH constraints.

Dependent claim expansion (Claims 2–29)

The dependent claims narrow or operationalize coverage by specifying:

Packaging material and structure (foil pouch, foil laminate)
Container manufacturing method (blow/fill/seal)
Container polymer (low density polyethylene)
Salt identity (oxymetazoline hydrochloride)
Specific electrolyte/buffer component identities and hydrated forms
Formulation numeric example compositions
Stability durations and storage conditions
Container fill volume and container volume for the foil pouch embodiment (0.3 mL fill; 0.5 mL container volume)

Claim-by-claim coverage map (what is directly covered)

Independent claim anchor

Claim 1: Child-resistant packaging + single-use ophthalmic container + preservative-free aqueous oxymetazoline formulation + physicochemical ranges + dose per drop.

Independent claim anchor (foi pouch variant)

Claim 15: Child-resistant foil pouch + single-use LDPE container + the same core formulation and property envelope + dose per drop. Claim 15 is materially the same core chemistry and specs, but locks in the foil pouch architecture and repeats osmolality, viscosity, pH constraints.

Packaging format and materials (claims 2–3, 16)

Claim	Feature added	Coverage impact
2	Packaging is a foil pouch	Limits Claim 1 to foil pouch architecture
3	Foil pouch is a foil laminate pouch	Further narrows to laminate structure
16	Foil pouch is a foil laminate pouch	Same narrowing for Claim 15

Dose and formulation specs (claims 1, 4, 7, 8, 10–13, 20–23)

Claim(s)	Added requirement	Numeric scope
1	Dose per drop	~0.035 mg oxymetazoline (salt) per drop
4	Osmolality constraint	290–365 mOsm/kg
7	Salt identity	oxymetazoline hydrochloride
8–9	Electrolyte composition example + hydration forms	Example: NaCl 0.64 wt%, KCl 0.075 wt%, CaCl2 0.048 wt%, MgCl2 0.03 wt% (with CaCl2·dihydrate and MgCl2·hexahydrate in claim 9)
10	Hydrated buffer forms	sodium acetate trihydrate + sodium citrate dihydrate
11	Buffer composition example	Na acetate 0.39 wt%, sodium citrate 0.17 wt%
12	pH narrower band	6.3–6.5
13	Stability window	maintains pH/viscosity/osmolality for 6 months
20–23	Repeat example + ranges inside foil pouch claim	mirrors 8–13

Container construction and delivery platform (claims 5–6, 19)

Claim	Added requirement	What it captures
5	Container formed by blow/fill/seal	Captures BFS-compatible LDPE single-use systems
6	Container is low density polyethylene	Polymer-limited to LDPE
19	Container formed by blow/fill/seal	BFS is required in foil pouch embodiment

Fill/volume limitations for foil pouch (claims 17–18)

Claim	Requirement	Numbers
17	Fill of container	~0.3 mL
18	Volume of container	~0.5 mL

Stability and storage conditions (claims 13, 23, 24–29)

Claim	Time/conditions	Coverage trigger
13	Maintains pH/viscosity/osmolality for 6 months	Core stability requirement in Claim 1 family
23	Same stability for 6 months in Claim 15 family	Core stability requirement in foil pouch family
24	12 months	dependent on Claim 13
25	18 months	dependent on Claim 13
26	25°C and 60% RH (no explicit duration in the claim text shown)	dependent on Claim 13; adds condition
27	12 months (foil pouch)	dependent on Claim 23
28	18 months (foil pouch)	dependent on Claim 23
29	25°C and 60% RH (foil pouch)	dependent on Claim 23

Where the claim structure creates enforceable “design around” pressure

The patent forces competitors to avoid not only the molecule and the ophthalmic context, but also the combination of: 1) child-resistant packaging architecture (foil pouch/laminate or general child-resistant packaging),
2) single-use container (LDPE in Claim 15 family, BFS method across families),
3) preservative-free oxymetazoline aqueous formulation,
4) drop delivery dose ~0.035 mg, and
5) tight physicochemical ranges for pH, viscosity, osmolality, plus stability durations/conditions.

A competitor that changes any one of these may exit a particular claim, but the risk is claim-set overlap: the dependent claims attach different narrowing features to the same core composition and product attributes.

What does the claim set practically cover (product form, not only chemical formulation)?

Packaging and container ecosystem

The claims are not limited to a formulation “in bulk.” They require:

Child-resistant packaging
A single-use container enclosed within it
The container’s manufacturing method (BFS) and often its polymer (LDPE)
An explicit foil pouch embodiment with explicit container volumes (0.3 mL fill; 0.5 mL container)

Formulation envelope is defined by measurable parameters

The independent and dependent claims use specific measurable ranges:

pH 5.8–6.8 (or narrower 6.3–6.5 in claim 12)
viscosity 15–35 cPs
osmolality 290–365 mOsm/kg

These are typically testable endpoints that can make infringement more “spec-driven” than “ingredient-driven.”

How broad is the coverage: claim taxonomy

Broadest (within the provided text)

Claim 1 is the broadest because it covers child-resistant packaging with a single-use container containing the formulation with the full parameter envelope and dose per drop, without limiting the packaging specifically to foil or limiting polymer to LDPE (though BFS and LDPE appear in dependent claims).

Medium breadth

Claim 15 is a major independent that is less broad than Claim 1 because it locks in:
- foil pouch architecture
- LDPE container
- explicit inclusion of osmolality, viscosity, pH ranges
- dose per drop and same formulation constraints

Most constrained

Dependent claims that add:
- specific hydrated forms for calcium chloride, magnesium chloride, sodium acetate, sodium citrate
- explicit buffer and electrolyte example numbers
- specific fill/container volumes
- extended stability durations and 25°C/60% RH conditions

These provide narrower footholds but strengthen enforceability against products that follow the same formulation example and commercial packaging build.

Patent landscape for oxymetazoline ophthalmic products and child-resistant single-dose delivery

The provided prompt includes claim language for US 11,311,515 but does not include bibliographic data (assignee, filing date, priority date), prosecution history, or citations to other patents. Without those, a complete legal landscape cannot be produced.

Accordingly, the only landscape conclusions that can be stated from the claim text alone are structural: the patent sits at the intersection of (i) oxymetazoline aqueous ophthalmic dosing, (ii) preservative-free formulation chemistry with viscosity and osmolality targets, and (iii) child-resistant packaging and single-use containerization, with a foil pouch and BFS LDPE pathway explicitly claimed.

Where infringement risk concentrates (practical reading of the claim set)

Highest risk to products that match the “drop dose + formulation envelope + packaging architecture”

A product that is:

oxymetazoline ophthalmic,
preservative-free,
single-use,
dispenses approximately 0.035 mg per drop,
targets pH ~5.8–6.8, viscosity 15–35 cPs, osmolality 290–365 mOsm/kg,
is enclosed in child-resistant packaging and (for Claim 15 family) a foil laminate pouch with BFS LDPE container, will align tightly with Claims 1 and 15 and their dependent stability/variant claims.

Secondary risk to products that only partially match the “platform” but match the chemistry envelope

If a competitor uses a different child-resistant enclosure or container material, it may avoid some dependent claims (e.g., LDPE requirement in claim 6/15 family, foil pouch requirements in claims 2–3 and 16), but Claim 1 still anchors to the core formulation plus dose plus pH/viscosity envelope. Products must ensure that any altered element is not captured by remaining dependent claim dependencies.

Tables: exact numeric anchors in the claims (as given)

Formulation components and numeric ranges in Claims 1 and 15

Component	Claimed amount / range
Oxymetazoline (or salt)	about 0.1 wt%
Hypromellose	about 0.5 wt%
Electrolytes	sodium chloride, potassium chloride, calcium chloride, magnesium chloride (general in claim 1; specific example in claim 8/20)
Buffers	sodium acetate and sodium citrate
pH adjuster	hydrochloric acid
Water	balance

Example electrolyte and buffer compositions (Claims 8, 11, 20, 22)

Example	Sodium chloride	Potassium chloride	Calcium chloride	Magnesium chloride	Sodium acetate	Sodium citrate
Claim 8 / 20	0.64 wt%	0.075 wt%	0.048 wt%	0.03 wt%	N/A	N/A
Claim 11 / 22	N/A	N/A	N/A	N/A	0.39 wt%	0.17 wt%

Hydration-state specifications (Claims 9, 10; 21 repeats in foil family)

Calcium chloride: calcium chloride dihydrate
Magnesium chloride: magnesium chloride hexahydrate
Sodium acetate: sodium acetate trihydrate
Sodium citrate: sodium citrate dihydrate

Product parameter ranges

Parameter	Claimed range
pH	about 5.8 to 6.8 (narrower: 6.3 to 6.5 in claim 12)
Viscosity	about 15 to 35 cPs
Osmolality	about 290 to 365 mOsm/kg
Dose per drop	about 0.035 mg oxymetazoline (salt) per drop

Packaging build specifications in foil pouch embodiment

Parameter	Claimed value
Container fill	about 0.3 mL (claim 17)
Container volume	about 0.5 mL (claim 18)

Stability durations and conditions

Claim	Maintenance period / condition
Claim 13 / 23	6 months
Claims 24 and 27	12 months
Claims 25 and 28	18 months
Claims 26 and 29	Maintains ranges at 25°C and 60% RH

Key Takeaways

US 11,311,515 protects a single-use, preservative-free oxymetazoline ophthalmic formulation defined by dose per drop (~0.035 mg) and measurable physicochemical targets (pH 5.8–6.8, viscosity 15–35 cPs, osmolality 290–365 mOsm/kg) plus stability (6/12/18 months and 25°C/60% RH).
Enforcement leverage is amplified by product-format constraints: child-resistant packaging, single-use container, and in the foil embodiment: foil laminate pouch + BFS LDPE container, with explicit fill and container volumes.
The dependent claims add tight “variant” hooks (hydrated salts, narrower pH band 6.3–6.5, explicit electrolyte and buffer numbers), which increases risk for competitors that follow the same formulation example and packaging build.

FAQs

1) Does US 11,311,515 claim a specific oxymetazoline concentration?
Yes. It requires about 0.1 wt% oxymetazoline (or a pharmaceutically acceptable salt) in the preservative-free aqueous ophthalmic formulation.

2) What physicochemical ranges must the ophthalmic formulation meet?
It must have pH about 5.8–6.8, viscosity about 15–35 cPs, and osmolality about 290–365 mOsm/kg.

3) Is the patent limited to preservative-free products?
Yes. The formulation is explicitly sterile, preservative-free.

4) Is the delivered dose tied to a “per drop” specification?
Yes. The container delivers about 0.035 mg oxymetazoline per drop (or a pharmaceutically acceptable salt).

5) What packaging formats are explicitly claimed?
Child-resistant packaging is claimed generally, with specific embodiments for a foil pouch and foil laminate pouch, and in the foil embodiment the container is a single-use LDPE container formed by blow/fill/seal, with ~0.3 mL fill and ~0.5 mL container volume.

References

[1] United States Patent Application/Patent publication: US 11,311,515 (claim text as provided in prompt).

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	11,311,515	⤷ Start Trial	Y				⤷ 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	2020268329	⤷ Start Trial
Brazil	112021022404	⤷ Start Trial
Canada	3139443	⤷ Start Trial
Chile	2021002918	⤷ Start Trial
China	111888326	⤷ Start Trial
China	117045596	⤷ Start Trial
Colombia	2021015265	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 11,311,515

Which drugs does patent 11,311,515 protect, and when does it expire?

Summary for Patent: 11,311,515