Details for Patent: 11,034,652

Which drugs does patent 11,034,652 protect, and when does it expire?

Patent 11,034,652 protects SOFDRA and is included in one NDA.

This patent has ninety patent family members in twenty-two countries.

Summary for Patent: 11,034,652

Title:	Formulation for soft anticholinergic analogs
Abstract:	Topical formulations comprising soft glycopyrrolates are useful for treating excessive sweating conditions in subjects, such as humans suffering from hyperhidrosis. Preferably, at least one soft anticholinergic agent is provided in an effective amount or concentration in an anhydrous formulation that can inhibit excessive perspiration resulting from a condition such as hyperhidrosis.
Inventor(s):	Nicholas S. Bodor, John J. Koleng, David Angulo
Assignee:	Bodor Laboratories Inc
Application Number:	US17/099,163
Patent Claim Types: see list of patent claims	Use; Composition;

United States Patent 11,034,652: What Is Claimed, How Broad It Is, and Where It Sits in the Hyperhidrosis Patent Landscape

US 11,034,652 claims an anhydrous topical gel and methods for treating hyperhidrosis using stereochemically defined glycopyrrolate (and selected stereoisomers / mixtures) in a near-anhydrous ethanol gel matrix containing specific excipient classes (hydroxypropyl cellulose plus citric acid plus hexylene glycol). The claims narrow by (i) drug identity and stereochemistry, (ii) drug concentration bands (1% to 20% w/w; plus dependent 2% to 10%), (iii) formulation solvent regime (anhydrous ethanol at least 70% w/w; bounded to 70% to 99.99% w/w in dependent claims), and (iv) performance and administration details in the method claims (>=25% sweat reduction for at least 6 hours; body site list; dosing volume range; multiple- vs unit-dose packaging options).

What is the claim backbone (composition vs method)?

Independent claim 1: Anhydrous topical gel composition

Claim 1 requires an anhydrous topical gel with the following mandatory elements:

• Active compound identity (formula (2))
  A compound where:
  • R = methyl or ethyl
  • The compound has:
  • R stereoisomeric configuration at the 2-position
  • R, S, or RS stereochemical configuration at the 1′ and 3′ positions (including mixtures)
• Solvent system
  • Anhydrous ethanol present as a non-aqueous solvent for the compound
• Gelling / viscosity control
  • Hydroxypropyl cellulose (at least one gelling/viscosity-controlling ingredient comprising it)
• Acid / solubilizer / stabilizer
  • Citric acid
• Humectant / co-solvent
  • Hexylene glycol
• Optional carriers/excipients
  • At least one additional carrier or excipient is optional
• Drug loading
  • The composition comprises about 1% to about 20% w/w of the compound of formula (2)

Composition scope anchor: The gel is essentially an anhydrous ethanol system with a hydroxypropyl cellulose-based gelling structure plus citric acid and hexylene glycol, with stereochemically defined glycopyrrolate-like active.

Dependent claims 2-10: Solvent fraction, drug loading band, container formats, and specific stereoisomers

• Claim 2: ethanol >=70% w/w
• Claim 3: ethanol 70% to 99.99% w/w
• Claim 6: active concentration 2% to 10% w/w
• Claims 7-8: packaging that meters/appplies 0.5 mL to 1.0 mL per application
• Claim 9: active specifically (2R, 3′R) species (named)
• Claim 10: further includes 6% silicone gum blend in dimethicone

These dependent claims create a layered “porch” around claim 1: if you stay within ethanol-dominant, hydroxypropyl cellulose gel, and citric acid/hexylene glycol, you still often fall under dependent constraints if you also match the narrower active-loading and/or formulation add-ons and packaging geometry.

Independent claim 11: Method of treating hyperhidrosis using the claimed gel

Claim 11 ties the formulation to a therapeutic performance outcome and to where and how it is used.

Core method elements:

• Topical administration to an anatomic area

• Condition: hyperhidrosis

• Performance: compared to untreated baseline:

  • sweat production reduced by at least 25% for at least 6 hours

• Comparator equivalence and safety:

  • sweat reduction is “substantially equivalent” to a composition with the same concentration of glycopyrrolate
  • with an improved safety profile compared to topical glycopyrrolate

• Composition ingredients are the same as claim 1, including:

  • stereochemically specified compound (formula (2))
  • anhydrous ethanol as solvent
  • hydroxypropyl cellulose
  • citric acid
  • hexylene glycol
  • 1% to 20% w/w active

• Administration sites (explicit list):

  • hand palm area, foot plantar area, groin area, axilla area, and facial area

• Administration volume and packaging options are also recited via dependent claims (12-20) (below).

Dependent claims 12-20: Method narrowing to ethanol fraction, drug loading band, dosing containers, and specific stereoisomers/add-ons

• Claim 12: ethanol >=70% w/w
• Claim 13: ethanol 70% to 99.99% w/w
• Claim 16: active concentration 2% to 10% w/w
• Claims 17-18: metered single/multiple dose containers delivering 0.5 mL to 1.0 mL
• Claim 19: specific stereoisomer (2R, 3′R) species
• Claim 20: further includes 6% silicone gum blend in dimethicone

How broad are the claims in practice (what you can design around)?

1) Active ingredient and stereochemical gate is the tightest boundary

Claim 1 does not claim “any glycopyrrolate.” It claims a stereochemically constrained compound class:

• R at 2-position is fixed as R
• 1′ and 3′ positions accept R, S, or RS, including mixtures
• R group is methyl or ethyl

This is broader than a single stereoisomer because it allows multiple configurations at 1′ and 3′ (and mixtures), but narrower than “glycopyrrolate generally.” The explicit dependent claim 5 enumerates multiple species consistent with those stereochemical constraints.

Implication for landscape: most product concepts that use “glycopyrrolate” without matching this stereo pattern are not automatically captured by claim 1. If a generic or competitor uses a different stereochemical form or different substitution at the “R” positions, it can fall outside.

2) Ethanol dominance plus anhydrous structure is a second major boundary

Claim 1 requires an anhydrous gel with anhydrous ethanol as non-aqueous solvent, but not necessarily ethanol at very high fractions in the independent claim. Dependent claims then narrow:

• ethanol >=70% w/w (claim 2)
• ethanol 70% to 99.99% w/w (claim 3)

Design-around levers (conceptual): using a substantially different solvent regime (water-containing gels, different alcohol blends that do not meet “anhydrous ethanol” requirement, or ethanol not meeting >=70% w/w when trying to land on dependent claims) is a potential non-infringing route if performance can still be matched.

3) Gel architecture is specific but not overly detailed

At the excipient level, claim 1 fixes these ingredients:

• Hydroxypropyl cellulose (gelling/viscosity controlling)
• Citric acid
• Hexylene glycol

It does not specify the grade of hydroxypropyl cellulose, its concentration, or exact citric acid/hexylene glycol ranges. That leaves some formulation latitude on excipient levels, so long as these are present and function within the anhydrous ethanol gel.

4) Drug loading band sets a wide but bounded active concentration

Claim 1 allows ~1% to ~20% w/w. Dependent claim 6 tightens to ~2% to ~10%.

This creates two practical “therapeutic product” windows:

• Formulations at 1% to <2% can still be within claim 1 but not claim 6.
• Formulations at >10% and up to 20% can hit claim 1 but miss claim 6.
• If competitors choose dosing strategies that require lower or higher loading, they may avoid the narrower dependent bands (but not claim 1).

5) Method claim includes a performance outcome and site list

The method claim 11 includes:

• A defined clinical effect magnitude (>=25% sweat reduction)
• Defined duration (>=6 hours)
• A site list (palms, soles, groin, axillae, face)
• A performance “equivalence” statement relative to glycopyrrolate at same concentration plus an improved safety profile

These features can be used both by the patentee (to argue direct infringement via labeled/claimed method) and by challengers (depending on how evidence is framed at enforcement).

What are the explicit formula(2) embodiments covered?

Claim 5 enumerates specific stereoisomeric embodiments of formula (2). The independent claim 1 already covers mixtures, but claim 5 provides a concrete, easily readable claim set for freedom-to-operate (FTO) screens.

Claim 5-listed stereoisomers / variants (as written):

1. (2R,3′R) … -1-(ethoxycarbonylmethyl)-1-methylpyrrolidinium bromide
2. (2R,3′S) … -1-(ethoxycarbonylmethyl)-1-methylpyrrolidinium bromide
3. (2R,1′R,3′S) … -1-(ethoxycarbonylmethyl)-1-methylpyrrolidinium bromide
4. (2R,1′S,3′S) … -1-(ethoxycarbonylmethyl)-1-methylpyrrolidinium bromide
5. (2R,1′R,3′R) … -1-(ethoxycarbonylmethyl)-1-methylpyrrolidinium bromide
6. (2R,1′S,3′R) … -1-(ethoxycarbonylmethyl)-1-methylpyrrolidinium bromide
7. (2R,3′R) … -1-methyl-1-methoxycarbonylmethylpyrrolidinium bromide
8. (2R,3′S) … -1-methyl-1-methoxycarbonylmethylpyrrolidinium bromide
9. (2R,1′R,3′R) … -1-methyl-1-methoxycarbonylmethylpyrrolidinium bromide
10. (2R,1′R,3′S) … -1-methyl-1-methoxycarbonylmethylpyrrolidinium bromide
11. (2R,1′S,3′R) … -1-methyl-1-methoxycarbonylmethylpyrrolidinium bromide
12. (2R,1′S,3′S) … -1-methyl-1-methoxycarbonylmethylpyrrolidinium bromide

(“…” indicates the shared core naming as provided in the claim text, including “3-(2-cyclopentyl-2-phenyl-2-hydroxyacetoxy)” and the stereochemical framework.)

Claim 9 and Claim 19 each lock in a single member of the group: (2R, 3′R).

Packaging and dosing: what volumes are claimed?

Claims 7-8 and 17-18 cover container-driven dosing:

• Multiple-dose container that meters 0.5 mL to 1.0 mL per application
• Single/unit-dose container delivering 0.5 mL to 1.0 mL per application

This matters for product design and for enforcement posture because it ties infringement to a metered use pattern rather than just “formulation exists.” If a product uses materially smaller or larger delivered volumes, it may fall outside the dependent method constraints even if the composition overlaps.

Silicone gum blend add-on is explicitly claimed

Claim 10 and claim 20 add a specific excipient feature:

• 6% silicone gum blend in dimethicone

This is a formulation-specific dependent limitation. If a competitor uses a different film-former or silicone excipient level (or no silicone gum blend in dimethicone), it may avoid those dependent claims while still falling under the independent claim if the core ingredients and boundaries match.

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Patent Landscape Positioning (U.S. context) and How to Read Competitive Risk

The information supplied contains only the text of the claims for US 11,034,652. It does not include:

• filing dates, priority dates, prosecution history, assignee, related patent family members, claim charts, or cited documents,
• which prevents an evidence-based mapping of overlapping patents and expiration timelines without adding unsupported assumptions.

Within that constraint, the landscape interpretation is limited to scope-based competitive risk.

What competitive products are most at risk based on claim structure?

High risk (most likely to read on the patent)

Products that combine all of the following:

1. Topical anhydrous ethanol gel
2. Hydroxypropyl cellulose gel matrix
3. Citric acid + hexylene glycol
4. Active glycopyrrolate stereoisomer(s) matching the claim’s stereochemical constraints (formula (2) with R = methyl/ethyl at the specified position and 2-position fixed as R)
5. Active concentration within 1% to 20% w/w (or within 2% to 10% w/w for the narrower dependent claim sets)
6. For method claims, use in hyperhidrosis at the listed sites with >=25% sweat reduction for >=6 hours and the claimed dosing volumes (via packaging-dependent claims)

Medium risk (may infringe independent but not dependent)

• Products that match formulation but differ in:
  • ethanol fraction (for dependent claims 2-3 and 12-13)
  • active concentration outside 2% to 10% (claim 6 / 16)
  • delivered volume outside 0.5 mL to 1.0 mL (claims 7-8 / 17-18)
  • silicone gum blend inclusion (claims 10 / 20)

They can still face exposure under independent claims 1 and 11 if all core elements are present.

Lower risk (likely avoid both independent and dependent claims)

• Formulations that materially change:
  • solvent system (e.g., water-containing gels or non-anhydrous ethanol regimes)
  • excipient package (lack of hydroxypropyl cellulose, citric acid, hexylene glycol)
  • active stereochemistry (non-matching stereoisomer identity)
  • dosing/administration method outside claimed sites or performance window

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Claim Strength and Enforcement Leverage: What Matters Most for R&D and Legal Strategy

Where enforcement is easiest

• Claims are drafted with ingredient-level specificity (anhydrous ethanol, hydroxypropyl cellulose, citric acid, hexylene glycol) and active stereochemical identity.
• Method claim 11 uses a quantified endpoint (>=25% reduction for >=6 hours) and a site list, supporting label-based or protocol-based infringement theories.

Where uncertainty tends to arise

• Dependent claims add constraints (ethanol % ranges, active loading 2% to 10%, dosing volume 0.5-1.0 mL, silicone gum blend). Competitors can sometimes tailor these to reduce overlap with narrower claim sets while leaving independent claim exposure intact.
• The most meaningful design-around is the active stereoisomer choice and the solvent/anhydrous architecture.

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Key Takeaways

• US 11,034,652 protects an anhydrous topical ethanol gel for hyperhidrosis using stereochemically defined glycopyrrolate derivatives (formula (2)), with fixed excipient requirements: hydroxypropyl cellulose, citric acid, hexylene glycol.
• The composition claim covers 1% to 20% w/w active and requires anhydrous ethanol as solvent; dependent claims lock ethanol >=70% w/w and optionally narrow to 2% to 10% active.
• The method claim 11 requires >=25% sweat reduction for at least 6 hours versus baseline and specifies treated anatomic areas (palms, soles, groin, axillae, face), tied to the same gel composition.
• Dependent method and formulation claims add metered dose volume (0.5-1.0 mL) and a specific excipient option: 6% silicone gum blend in dimethicone.
• Based on scope alone, the highest infringement risk sits with products that match the stereochemistry + anhydrous ethanol gel excipient package + concentration bands, with method exposure increasing when marketed/used within the site list, dosing volume range, and performance window.

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FAQs

1. Does US 11,034,652 claim all glycopyrrolate formulations for hyperhidrosis?
   No. It claims an anhydrous topical gel using a specific stereochemically defined compound (formula (2)) with R= methyl or ethyl and stereochemical constraints at the 2-position and 1′/3′ positions.

2. What excipients are required in the composition claim?
   The claim requires anhydrous ethanol, hydroxypropyl cellulose, citric acid, and hexylene glycol (plus optional additional carriers/excipients).

3. What ethanol concentration is required?
   Claim 1 requires ethanol to act as a solvent; dependent claims specify ethanol >=70% w/w and 70% to 99.99% w/w.

4. What dosing volumes are claimed?
   Dependent claims cover metered/unit dosing of 0.5 mL to 1.0 mL per application.

5. What performance criterion is required for the method claim?
   The method claim requires sweat production reduction of at least 25% for at least 6 hours versus untreated baseline.

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References

1. US Patent 11,034,652. Claims 1-20 (as provided in the prompt).

Drugs Protected by US Patent 11,034,652

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Botanix Sb	SOFDRA	sofpironium bromide	GEL, METERED;TOPICAL	217347-001	Jun 18, 2024		RX	Yes	Yes			Y			TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER

International Family Members for US Patent 11,034,652

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015229243
Australia	2016297601
Australia	2017298469
Australia	2019257421