Details for Patent: 10,493,103

Which drugs does patent 10,493,103 protect, and when does it expire?

Patent 10,493,103 protects ESKATA and is included in one NDA.

This patent has nineteen patent family members in sixteen countries.

Summary for Patent: 10,493,103

Title:	Peroxide formulations and methods and applicators for using the same
Abstract:	Embodiments are directed to a stable composition comprising stabilized hydrogen peroxide and 2-propanol and applicators configured to store, dispense, and apply such stable compositions. Such compositions may be used to treat skin conditions such as warts, condyloma accuminatum, molluscum contagiosum, acrochordons, seborrheic keratosis, or a combination thereof. Some embodiments also describe take home compositions, in office compositions, over-the-counter compositions, and kits for the use of such compositions.
Inventor(s):	Stuart D. Shanler, Christopher Powala, Christopher Phillips, Brian BEGER, Charles Rodney Greenaway Evans, Sian Tiong Lim, Marc Barry Brown, Michael A. Botta, Thomas Nagler
Assignee:	Aclaris Therapeutics Inc
Application Number:	US16/159,894
Patent Claim Types: see list of patent claims	Use; Composition; Delivery;

Executive summary US Patent 10,493,103 is directed to a single-use applicator that stores and dispenses a topical hydrogen peroxide composition via a rupturable (frangible) ampoule. The independent scope centers on: (i) hydrogen peroxide concentration (about 25% to about 50% w/w), (ii) 2-propanol (about 1% to about 10% w/w), (iii) a borosilicate-glass frangible ampoule, and (iv) a dispensing architecture that includes an applicator body, a hub forming a seal, a proximal tip, and a filter arranged between the ampoule and the hub to retain shards. Dependent claim coverage expands to optional mixing with additional ingredients and to specific material selections for the ampoule body, filter, and optional debriding element, plus concentration subranges (e.g., about 40% to about 50% w/w peroxide and about 5% w/w 2-propanol). The claim set is structured to capture both “rupture-and-flow” embodiments and pressure-actuated rupture designs, with filtration as a key structural limitation.

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Scope of US Patent 10,493,103 for a frangible-ampoule applicator dispensing hydrogen peroxide + 2-propanol

Claim 1 sets the core boundary conditions. It is a combination claim that requires both the chemical composition and the mechanical dispensing system.

What does claim 1 require?

A. Topical composition (must match ranges)

• Hydrogen peroxide: about 25% w/w to about 50% w/w
• 2-propanol: about 1% w/w to about 10% w/w

B. Applicator architecture (must be present)

• A frangible ampoule containing the composition
• The frangible ampoule is formed from borosilicate glass
• An applicator body with the frangible ampoule arranged inside
• An applicator hub fixedly attached to the applicator body
• A tip fixedly arranged within a central bore at the proximal end of the applicator hub
• A filter arranged between the frangible ampoule and the applicator hub

How broad is the composition scope?

The composition portion is broad in that it covers two major formulation levers:

• Peroxide strength: wide band (25 to 50% w/w)
• Solvent/alcohol additive: wide band (1 to 10% w/w)

That means many hydrogen peroxide antiseptic compositions that include 2-propanol in that range could fall within the chemical subrange, provided the applicator structure also matches.

How broad is the mechanical scope?

The mechanical scope is moderately narrow because it locks several structural elements:

• Borosilicate glass frangible ampoule is explicitly required in claim 1.
• A filter located between the frangible ampoule and the hub is a required structural feature.
• A specific hub-tip geometry is required (“tip fixedly arranged within a central bore at the proximal end of the applicator hub”).
• Claim 1 also requires the fixed attachment and arrangement relationships (hub fixedly attached to body; tip fixedly arranged in hub bore).

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Which claim elements are most likely to control infringement of US 10,493,103?

For claim charts, the most infringement-sensitive limitations are those that are both:

1. structural and
2. clearly required together.

Likely “control points” for infringement

1. Borosilicate-glass frangible ampoule
   • If a competitor uses a non-borosilicate frangible ampoule material, claim 1 may be avoided, though other claims may capture alternatives (see claim 12).
2. Filter between ampoule and hub
   • Omitting a filter or placing it outside the claimed location (“between the frangible ampoule and the applicator hub”) is a straightforward non-infringement lever.
3. Topical composition ranges
   • Running peroxide outside 25% to 50% w/w or 2-propanol outside 1% to 10% w/w is a direct design-around lever.

Common design-around strategies implied by the claim set

• Use a different alcohol (remove or replace 2-propanol) or adjust 2-propanol below 1% or above 10% w/w.
• Use peroxide below 25% or above 50% w/w.
• Use a frangible ampoule that is not borosilicate glass if targeting claim 1.
• Use a frangible ampoule filtration strategy that does not include a filter arranged between the ampoule and the hub.

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What formulations are covered by US 10,493,103: hydrogen peroxide and 2-propanol concentration limits?

The patent claims a composition-defined drug product within a delivery system.

Independent claim composition band

• Hydrogen peroxide: about 25% to about 50% w/w
• 2-propanol: about 1% to about 10% w/w

Dependent claim subranges that narrow commercial copycats

• Claim 8: 25% to 50% w/w hydrogen peroxide and 1% to 5% w/w 2-propanol.
• Claim 16: about 40% to about 50% w/w hydrogen peroxide.
• Claim 17: about 5% w/w 2-propanol.

These subranges matter because competitors may attempt to match the delivery system but choose formulation values outside the tighter dependent claim windows. If they remain within claim 1’s wider bands, they still risk claim 1 capture even if they avoid claim 8/16/17.

Optional additional ingredients

Claim 2 and claim 18 expand scope to embodiments where:

• the composition is released from the frangible ampoule responsive to rupture, and
• it is mixed in the applicator body with an additional ingredient prior to administration.

This matters in practice because it covers multi-component on-device mixing rather than a single premixed composition.

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What patent claim language protects the “rupture, filtration, and flow-out” dispensing pathway?

Claims 3, 6, 7, 19 define the functional flow and structural filtration requirements.

Claim 3: release and flow path through components

Requires:

• rupture of frangible ampoule
• composition released from ampoule
• flows through applicator body, filter, and out through tip

This is a pathway limitation. A competitor could try to route flow differently (e.g., filter in a different location or separate flow channel) to avoid matching the flow narrative required by the claim.

Claim 6: filter purpose and performance

The filter is configured:

• to prevent shards of ruptured frangible ampoule from passing through
• while allowing topical composition to flow

That ties the filtration element to shard retention. A filter with different function (or no shard retention design intent) still must satisfy the claim configuration and function described.

Claim 7: filter materials list

Filter can be formed from at least one of:

• polypropylene
• high-density polyethylene
• low-density polyethylene
• polyethylene
• polystyrene
• ceramic material
• foam material
• sand
• diatomaceous earth
• paper fibers

This is a broad materials coverage clause that reduces design-around leverage via material substitution alone.

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How does claim 4 (“pressure area”) affect exclusivity vs. self-actuating rupture designs?

Claim 4 adds:

• a pressure area on an outer surface of the applicator body
• indicating the portion to apply pressure to rupture the frangible ampoule

Claim 20 repeats this in the claim 11 family. This is a user-action/geometry limitation.

Practical effect

• If a competitor uses a different activation mechanism (e.g., twist-to-break, lever mechanism, internal piercing, spring-actuated breaker) and does not include the claimed “pressure area” indicating where to apply pressure, it may avoid these specific dependent claims.
• Claim 1 and claim 11 do not require the pressure area; so activation mechanism can still infringe independent claims if rupture is otherwise achieved.

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What does US 10,493,103 claim about applicator materials and hermetic sealing?

Applicator body materials (claims 5 and 13)

Claim 5 requires applicator body formed from at least one of:

• polypropylene
• high-density polyethylene
• low-density polyethylene
• polyvinyl chloride
• polyethylene
• combination thereof

Claim 13 lists overlapping options and similar coverage.

This is broad for polymer selection. It makes it harder to avoid infringement by selecting a different plastic from among the enumerated set. If a competitor uses a materially distinct category outside the listed polymers, it may help with dependent claim avoidance but still risks independent claims if the independent claim does not specify body material.

Hermetic seal (claims 9 and 21)

Claims add:

• applicator hub forms a hermetic seal with the applicator body

If a design leaks or uses a non-hermetic interface, it may avoid those dependent claims. Again, independent claims still matter.

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Does the patent cover borosilicate-only ampoules or alternative ampoule materials?

Claim 1: borosilicate glass required

The independent claim 1 explicitly requires borosilicate glass for the frangible ampoule.

Claim 12: broader ampoule material set

In the claim 11 family, claim 12 expands frangible ampoule materials to at least one of:

• glass
• plastic
• borosilicate glass
• Type 1 borosilicate glass
• tinted glass

That means the patent estate is not strictly borosilicate-only across all claims. A competitor using a different glass type, tinted glass, or even plastic frangible ampoule could still map into the claim 11/12 set if the rest of the structural requirements align.

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How many distinct claim “families” exist in the provided claim set?

The claims appear in two parallel tracks:

• Claims 1 to 10: with claim 1 having borosilicate-glass-specific frangible ampoule.
• Claims 11 to 21: with claim 11 reciting the same architecture but without the “borosilicate glass” limitation in the base language, and with dependent claim 12 providing a broader ampoule material list.

Functionally, claim 11 mirrors claim 1’s apparatus structure, while dependent claims 12–21 vary specific constraints (ampoule material, body material, filter properties, concentration subranges, pressure area, hermetic seal, additional ingredients mixing, and optional debriding element via claim 10’s inclusion in the first family).

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What is the scope around “debriding element” coverage?

Claim 10 adds:

• further comprising a debriding element arranged on an exterior portion of the applicator.

If the topical composition is used for wound care or debridement (and the product is designed with an external debrider), claim 10 is relevant. A competitor could avoid claim 10 by removing any debriding feature on the exterior.

But claim 10 is dependent. Independent claims 1 and 11 would still potentially capture a debriding-free applicator if the composition and dispensing system match.

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Claim-by-claim claim map (tight structural/compositional interpretation)

Claim	Adds / narrows	Key infringement touchpoints
1	Independent apparatus + composition; borosilicate frangible ampoule	Peroxide (25-50%), 2-propanol (1-10%), borosilicate frangible ampoule, filter between ampoule and hub
2	Additional ingredient mixing in body after rupture	Multi-component mixing in applicator body prior to administration
3	Release and flow path through body + filter + tip	Flow routing includes filter and exit through tip
4	Pressure area to indicate where to apply pressure	Activation interface with labeled pressure zone
5	Applicator body material list	Uses polymers listed for body
6	Filter configured to retain ampoule shards	Shard-retaining filter function
7	Filter materials list	Filter made from enumerated material classes
8	Composition subrange: peroxide (25-50%) + 2-propanol (1-5%)	Tightens 2-propanol band
9	Hermetic seal hub-to-body	Sealing property
10	External debriding element	External debrider hardware presence
11	Independent apparatus (no explicit borosilicate constraint in base) + composition	Same composition + apparatus without borosilicate requirement in base
12	Ampoule materials expanded (incl. plastic, tinted glass, Type 1 borosilicate)	Ampoule material becomes non-exclusive
13	Applicator body material list	Same polymer family
14	Filter shard prevention	Same functional filter constraint
15	Filter materials list	Same broad materials
16	Composition subrange: peroxide 40-50%	Tight peroxide band
17	Composition subrange: 2-propanol 5%	Single-point-ish 2-propanol value
18	Additional ingredient mixing in body	Same mixing concept as claim 2
19	Release and flow through body + filter + tip	Same flow-path constraint as claim 3
20	Pressure area	Same activation feature as claim 4
21	Hermetic seal hub-to-body	Same sealing property

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What does this patent likely exclude: outside-the-scope products and “near misses”?

Likely outside claim scope

• Hydrogen peroxide formulations without 2-propanol in the claimed range.
• Products that do not use a rupturable frangible ampoule.
• Products that use filtration but do not place a filter “between the frangible ampoule and the applicator hub.”
• Products that meet composition ranges but use an ampoule type not covered by the relevant claim family (e.g., claim 1 borosilicate requirement vs claim 11’s broader options).

Likely “high risk” near matches

• Any single-use applicator where a user presses to rupture a frangible ampoule containing hydrogen peroxide + 2-propanol and the liquid exits through a tip after passing a shard-retaining filter.
• Multi-component on-device mixing designs where hydrogen peroxide/2-propanol composition ruptures and then blends with an added ingredient in the applicator body.

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Patent landscape and freedom-to-operate: what matters for enforcement, licensing, or design-around

What the provided claim set indicates about enforceability posture

• The patent is structurally specific in delivery (frangible ampoule + shard filter + hub-tip geometry).
• The chemical composition is also range-defined (peroxide 25-50%, 2-propanol 1-10%).

That combination increases enforceability likelihood against close competitors who replicate both the formulation range and the dispensing mechanism. It also provides clear design-around levers: adjust composition out of range, change ampoule material (for claim 1), or change filter placement/function.

What to expect in competitive IP blocking

In real product development, IP friction is usually driven by:

• the mechanical breaking/rupture-and-dispense architecture (ampoule, filter/shard retention, hub seal, tip bore), and
• antiseptic composition ranges (high-strength hydrogen peroxide with 2-propanol).

This patent is likely to become a focal point in:

• product redesign for adjacent peroxide strengths,
• substitute alcohol selection, and
• mechanical routing changes to avoid the “filter between ampoule and hub” arrangement.

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Key Takeaways

• US 10,493,103 protects a topical hydrogen peroxide + 2-propanol formulation when packaged in a specific rupture-dispense applicator system.
• The highest-risk infringement elements are: the composition bands (peroxide 25-50% w/w; 2-propanol 1-10% w/w), a rupturable frangible ampoule, and a filter arranged between ampoule and hub to prevent shard passage.
• Claim 1 is borosilicate-glass specific for the frangible ampoule, while the parallel claim set anchored at claim 11 broadens ampoule material options via dependent claim 12.
• Dependent claims add practical product features that matter in enforcement detail: pressure-activation pressure area, hermetic seal, optional debriding element, optional on-device mixing with additional ingredients, and narrowed concentration subranges.

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FAQs

1. What design changes avoid claim 1’s frangible ampoule limitation?
   Use a frangible ampoule that is not borosilicate glass, or ensure the product maps to the broader claim set only if all other elements align.

2. If a product uses a filter, does it need to be between the ampoule and the hub to infringe?
   Based on claims 1/11 and the flow-path language, the filter must be arranged between the frangible ampoule and the applicator hub and participate in the claimed flow path to tip.

3. Can a competitor avoid by changing hydrogen peroxide concentration only?
   Yes, moving peroxide below about 25% w/w or above about 50% w/w avoids the claimed composition range at the independent-claim level.

4. How does 2-propanol concentration drive patent risk?
   Staying within about 1% to about 10% w/w 2-propanol creates composition overlap with independent claims; choosing values outside that band can reduce claim coverage.

5. Do dependent claims on pressure area and debriding element provide additional infringement leverage?
   They add feature-specific scope. Avoiding those features can help with dependent-claim-only theories, but independent-claim coverage may still remain if the core rupture-filter-hub-tip and composition elements match.

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References

1. United States Patent 10,493,103 (claims provided in prompt).

Drugs Protected by US Patent 10,493,103

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Aclaris	ESKATA	hydrogen peroxide	SOLUTION;TOPICAL	209305-001	Dec 14, 2017		DISCN	Yes	No			Y

International Family Members for US Patent 10,493,103

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015249841
Brazil	112016024630
Canada	2946568
China	106659643
Denmark	3134061
European Patent Office	3134061
Spain	2828711