Details for Patent: 11,123,325

Which drugs does patent 11,123,325 protect, and when does it expire?

Patent 11,123,325 protects SOFDRA and is included in one NDA.

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

Summary for Patent: 11,123,325

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:	US16/319,793
Patent Claim Types: see list of patent claims	Use; Composition;

US Patent 11,123,325: Scope, Claim Construction, Expiration Risk, and Sofpironium Bromide Patent Landscape

US Patent 11,123,325 covers an anhydrous, high-ethanol topical gel containing a specified stereochemical form or mixture of sofpironium bromide-type compounds, isopropyl myristate, and a gelling or viscosity-controlling agent. The broadest protection is concentrated in claim 1. Claims 16 and 17 add method-of-treatment protection for hyperhidrosis, including efficacy, duration, comparator, safety, and anatomical-site limitations.

The patent is commercially relevant to Sofdra, the FDA-approved sofpironium bromide topical gel for primary axillary hyperhidrosis. The strongest practical infringement risk concerns products containing the claimed stereoisomer, at least 70% anhydrous ethanol, isopropyl myristate, and a gel-forming agent.

What drug and formulation does US Patent 11,123,325 protect?

The claims identify the active pharmaceutical ingredient by chemical structure and stereochemistry rather than by the generic name "sofpironium bromide." Claim 10 expressly covers the compound commonly associated with sofpironium bromide:

(2R,3'R) 3-(2-cyclopentyl-2-phenyl-2-hydroxyacetoxy)-1-(ethoxycarbonylmethyl)-1-methylpyrrolidinium bromide.

The claimed product is a topical anhydrous gel for delivery to sweat glands in selected skin areas, including:

• Axillae
• Palms
• Soles
• Groin
• Face

The core formulation requires:

Claim element	Claim 1 requirement
Active ingredient	Specified compound of formula (2), with defined stereochemistry
Solvent	Anhydrous ethanol at least about 70% w/w
Gel structure	At least one gelling or viscosity-controlling ingredient
Penetration or formulation component	Isopropyl myristate
Active concentration	About 1% to about 25% w/w
Physical state	Anhydrous gel
Stability	Greater storage stability than an aqueous-solvent or aqueous-buffer composition
Delivery	Delivery to sweat glands in specified anatomical areas

The claim set is directed to a finished topical dosage form rather than to the active molecule alone, its synthesis, or every use of an anticholinergic agent.

How broad is independent composition claim 1?

Claim 1 is broad in ingredient selection but narrow in its required combination of formulation and use characteristics. A potentially infringing composition must satisfy every material limitation.

Required active-ingredient scope

Claim 1 covers a compound having the claimed formula with:

• An R configuration at the 2 position; and
• An R, S, or RS configuration at the 1' and 3' positions; or
• A mixture of the permitted stereoisomers.

Claim 5 lists specific stereochemical compounds, while claim 10 narrows the invention to the (2R,3'R) compound. The claim therefore reaches both a defined commercial stereoisomer and other stereochemical forms within the Markush language.

A product using a chemically different anticholinergic, such as glycopyrronium tosylate, would not literally satisfy the active-ingredient limitation. A glycopyrronium product could still be relevant to method-of-use or obviousness analysis, but it would not fall within the literal composition scope merely because it treats hyperhidrosis.

Anhydrous ethanol limitation

The formulation must contain anhydrous ethanol at not less than approximately 70% w/w. Dependent claims define two narrower ranges:

• Claim 2: about 70% to about 99.99% w/w
• Claim 3: about 70% to about 85% w/w

The ethanol limitation is commercially important. A formulation using a substantial aqueous phase, a hydroalcoholic vehicle below the claimed threshold, or a nonethanolic solvent system may avoid literal infringement of claim 1.

The claim also states that the ethanol must be sufficient to act as a nonaqueous solvent for the active compound. That language reinforces the requirement that ethanol perform a formulation function, rather than being present only as a minor processing residue or volatile excipient.

Isopropyl myristate limitation

Isopropyl myristate is mandatory under claim 1. This limitation distinguishes the claimed formulation from high-ethanol gels that omit the ester.

Isopropyl myristate may operate as an emollient, penetration-enhancing component, solvent, or skin-delivery aid. The claim does not appear to require a specific concentration. That increases formulation latitude but makes the presence of the ingredient a central product-screening issue.

Gelling-agent limitation

Claim 1 requires at least one gelling or viscosity-controlling ingredient. Claim 11 identifies hydroxypropyl cellulose. Claim 15 further identifies a 6% silicone gum blend in dimethicone.

The claim does not appear limited to hydroxypropyl cellulose. A different polymer or rheology modifier could satisfy the broader functional category if it performs the claimed viscosity-control function. Claims 11 and 15 provide narrower species protection but do not exhaust the scope of claim 1.

What formulations are protected by the dependent claims?

The dependent claims create several formulation and presentation fallbacks.

Claim	Protected feature
2	70% to 99.99% w/w anhydrous ethanol
3	70% to 85% w/w anhydrous ethanol
4	At least one additional carrier or excipient
5	Listed stereoisomeric compounds
6	1% to 20% w/v or w/w active
7	2% to 10% w/v or w/w active
8	Multidose container delivering 0.5 mL to 1.0 mL per application
9	Single- or unit-dose container delivering 0.5 mL to 1.0 mL
10	Specific (2R,3'R) compound
11	Hydroxypropyl cellulose
12	Citric acid
13	Hexylene glycol
14	Dimethicone or cyclomethicone
15	6% silicone gum blend in dimethicone

Claims 6 and 7 are unusual because they use "w/v or w/w." That language expands the claimed concentration expression but can create construction and enablement issues if the specification does not consistently support both measurement bases.

A commercial product does not need to include every dependent feature. It may infringe claim 1 without infringing claims 11 through 15. Conversely, a formulation that falls outside claim 1 cannot be brought back within the patent solely by using a listed excipient.

Does the patent cover Sofdra and sofpironium bromide gel?

The claim set is closely aligned with sofpironium bromide gel products. FDA approved Sofdra, sofpironium bromide gel 12.45%, for treatment of primary axillary hyperhidrosis in adults and children aged 9 years and older in June 2024 (FDA, 2024a).

The commercial product concentration is 12.45%, which is within:

• Claim 1's approximately 1% to 25% w/w range;
• Claim 6's approximately 1% to 20% concentration range; and
• Claim 7's approximately 2% to 10% range only if the applicable active concentration is measured differently or the marketed formulation does not match the narrower numerical limitation.

The commercial formulation must be compared against the approved product's complete qualitative and quantitative composition. The supplied claims alone establish a strong structural overlap with a sofpironium bromide anhydrous gel, but they do not establish that every marketed product satisfies each limitation, including the exact ethanol and isopropyl myristate concentrations.

What do method claims 16 and 17 cover?

Claims 16 and 17 cover methods of treating hyperhidrosis by administering the claim 1 composition. They require more than merely applying a sofpironium bromide gel.

The claimed treatment must involve:

1. A subject with hyperhidrosis.
2. Topical administration to a specified anatomical area.
3. Delivery to sweat glands.
4. At least 25% reduction in sweat production.
5. The reduction lasting at least six hours.
6. Efficacy substantially equivalent to the same concentration of glycopyrrolate.
7. An improved safety profile compared with topical glycopyrrolate.

Claim 16 adds administration before bedtime. Claim 17 does not include that timing requirement.

Method-claim enforcement issues

The performance limitations create proof requirements. A patent holder seeking to enforce claims 16 or 17 would need to establish that the accused method satisfies the reduction, duration, comparator, and safety limitations. Product labeling, clinical protocols, promotional materials, physician instructions, and actual use could be relevant.

The phrase "substantially equivalent" may require a fact-intensive comparison. "Improved safety profile" also raises claim-construction questions, including which adverse events are compared, the statistical threshold, and whether the comparison must be established in a controlled clinical study.

These limitations can narrow enforcement relative to a pure composition claim. They can also create validity exposure under definiteness, written description, enablement, and lack-of-antecedent-basis theories, depending on the patent specification and prosecution history.

When does US Patent 11,123,325 lose exclusivity?

The patent issued on September 21, 2021. Patent expiration is determined by the applicable 20-year term measured from the earliest effective nonprovisional or international application filing date, subject to patent-term adjustment, patent-term extension, terminal disclaimers, and regulatory patent-term extension under 35 U.S.C. §§ 154 and 156.

The issue date alone does not establish the expiration date. The claim text supplied does not include the priority chain or certificate data needed to calculate a legally operative expiration date.

The FDA regulatory exclusivity timeline is separate from patent exclusivity. Sofdra received FDA approval in June 2024. If the product received five-year new chemical entity exclusivity, that period would generally block submission of a standard ANDA until June 2029, subject to statutory exceptions and the precise FDA exclusivity designation. FDA approval timing does not itself determine patent expiration.

What is the Orange Book status of the product?

Sofdra is an FDA-approved small-molecule drug product, so generic competition would ordinarily proceed through the ANDA pathway rather than a biosimilar pathway. Orange Book relevance depends on whether the patent holder submitted the patent for listing and whether FDA accepted it as a patent claiming the drug substance, drug product, or approved method of use.

The key Orange Book categories are:

• Drug-substance patents
• Drug-product or formulation patents
• Method-of-use patents

US 11,123,325 is principally a formulation and method patent based on the supplied claims. It does not claim the active pharmaceutical ingredient in isolation. Its commercial value therefore depends on whether the approved product embodies the claimed formulation and whether the relevant claims are listed for the approved use.

A current Orange Book listing determination cannot be derived from the claim text. FDA's active Orange Book database and the sponsor's patent submissions control the regulatory listing analysis (FDA, 2024b).

How would a generic manufacturer challenge this patent?

A generic applicant seeking approval for a product that could implicate a listed patent could use one of four principal approaches:

Strategy	Commercial effect
Paragraph III certification	Approval delayed until patent expiration
Paragraph IV certification	Applicant alleges the patent is invalid, unenforceable, or not infringed
Carve-out or section viii statement	Omit a patented method of use where FDA permits
Formulation redesign	Avoid one or more required composition elements

A Paragraph IV challenge would likely focus on:

• Whether the claimed combination of sofpironium bromide, high anhydrous ethanol, isopropyl myristate, and a gelling agent was obvious.
• Whether the specification adequately supports the full stereochemical and concentration scope.
• Whether the stability limitation is sufficiently definite and technically measurable.
• Whether the method claims adequately define "substantially equivalent" efficacy and "improved safety profile."
• Whether the claimed anatomical delivery limitation adds a patentable technical distinction.
• Whether the claims are enabled across the full active concentration and excipient ranges.

A generic applicant could also pursue a formulation that uses the same active ingredient but changes the solvent system, omits isopropyl myristate, substitutes a different delivery vehicle, or uses a different concentration outside the asserted range.

Which companies are challenging the patent?

The supplied information does not identify a Paragraph IV filer, ANDA applicant, district-court complaint, or patent settlement involving US 11,123,325. No challenger or settlement should be treated as established from the claims alone.

The likely competitive set includes manufacturers evaluating generic sofpironium bromide gel, but a potential competitor is not the same as a filed Paragraph IV challenger. A definitive litigation assessment requires the FDA Orange Book, FDA Paragraph IV notices where publicly available, PACER, and district-court dockets.

How does this patent compare with Qbrexza and other hyperhidrosis therapies?

Product or therapy	Active or mechanism	Dosage form	Relevance to US 11,123,325
Sofdra	Sofpironium bromide	Topical gel	Direct commercial overlap
Qbrexza	Glycopyrronium tosylate	Topical cloth	Different active and dosage form
Drysol	Aluminum chloride	Topical solution	Different mechanism and formulation
Oral oxybutynin	Oxybutynin	Systemic tablet	Different active and route
Botulinum toxin	Botulinum toxin type A	Injection	Different biologic and route
Device therapies	Thermal or energy-based sweat-gland treatment	Procedure	No composition overlap

Qbrexza is the closest branded therapeutic comparator because it is also a topical anticholinergic treatment for primary axillary hyperhidrosis. Its active ingredient, glycopyrronium tosylate, is chemically different from sofpironium bromide. A Qbrexza product would not literally infringe the active-ingredient limitation of claim 1.

The method claims are more commercially sensitive because both products target hyperhidrosis. Even so, method-of-use overlap does not eliminate the requirement that the administered composition be the claim 1 composition.

Is there biosimilar risk?

There is no biosimilar pathway risk for sofpironium bromide. Sofpironium bromide is a small-molecule active ingredient, not a biologic. Competitive products would generally be evaluated under the ANDA pathway or, for a materially different product, a full NDA pathway.

The principal risks are therefore:

• ANDA entry after regulatory exclusivity;
• Paragraph IV patent litigation;
• Non-infringing formulation redesign;
• Off-label or alternative topical anticholinergic competition;
• Clinical differentiation by dosing convenience, tolerability, or treatment site.

How strong is the patent estate?

Based on the supplied claims, US 11,123,325 has meaningful commercial strength in three areas.

Strongest protection

The strongest practical protection is the combination of:

• The sofpironium bromide-type active;
• At least 70% anhydrous ethanol;
• Isopropyl myristate;
• A gelling or viscosity-controlling agent;
• A topical anhydrous gel.

That combination may make a direct copy of the commercial formulation difficult to market without a license or successful validity challenge.

Moderate protection

The stereochemical Markush language provides breadth, but its value depends on the written description and prosecution record. If the specification supports only a limited number of stereoisomers, broader coverage could face written-description or enablement attacks.

The packaging claims are narrower and easier to design around. A competitor could use a different container, dose volume, or metering system while preserving the active and formulation.

Weaker or more litigation-sensitive protection

Claims 16 and 17 contain subjective or comparative limitations. Their enforcement may require clinical or pharmacodynamic evidence. The safety and efficacy language could narrow the claims but also create validity and proof issues.

The patent is therefore best characterized as a focused product-formulation patent with supplementary use and packaging claims, rather than a complete platform estate covering every sofpironium bromide product.

What licensing and commercialization issues matter?

Sofdra commercialization has involved the developer, rights holders, and commercial partners associated with the sofpironium bromide program. The patent holder, NDA holder, and commercial licensee may not be the same entity. Patent ownership, FDA sponsorship, and U.S. commercialization rights should be reviewed separately.

A diligence review should compare:

• Patent assignment records;
• Exclusive-license scope;
• NDA ownership;
• Orange Book listing entity;
• Royalty and milestone rights;
• Territory and field-of-use restrictions;
• Change-of-control provisions;
• Patent enforcement obligations.

The claims suggest that licensing value is concentrated in the U.S. topical hyperhidrosis market, especially for axillary treatment. Broader value would depend on whether the same formulation is approved or commercialized for palmar, plantar, facial, groin, or other hyperhidrosis indications.

Key Takeaways

• US Patent 11,123,325 principally protects an anhydrous high-ethanol topical gel containing a sofpironium bromide-type compound, isopropyl myristate, and a gelling agent.
• Claim 1 is the central composition claim and requires the elements to be present together.
• Claim 10 directly targets the (2R,3'R) stereoisomer associated with sofpironium bromide.
• Claims 16 and 17 add treatment protection but require proof of sweat reduction, six-hour duration, glycopyrrolate-comparable efficacy, and improved safety.
• Qbrexza does not literally satisfy the active-ingredient limitation because it contains glycopyrronium tosylate rather than sofpironium bromide.
• Generic competition would generally use the ANDA pathway, with Paragraph IV litigation as the principal patent challenge mechanism.
• The patent's exact expiration date cannot be calculated from the supplied claim text because the priority chain and term-adjustment data are not included.
• The most credible design-around routes are changing the solvent system, omitting isopropyl myristate, using a non-gelling vehicle, or altering the active concentration outside the asserted ranges.
• No Paragraph IV challenger or settlement is established by the supplied information.
• The patent does not create biosimilar risk because sofpironium bromide is a small molecule.

FAQs

Does US Patent 11,123,325 claim sofpironium bromide itself?

No. The patent claims compositions and treatment methods containing specified compounds. Claim 10 covers the specific stereoisomer associated with sofpironium bromide, but the supplied claims do not claim the active compound in isolation.

Can a generic avoid the patent by replacing anhydrous ethanol with propylene glycol?

Potentially, if the replacement removes the requirement for at least about 70% w/w anhydrous ethanol and the resulting product does not satisfy the claim under an equivalent theory. The complete formulation and prosecution history would control.

Does a product without isopropyl myristate infringe claim 1?

A product that genuinely omits isopropyl myristate would not literally satisfy claim 1 because isopropyl myristate is a required element. Equivalence arguments could still be asserted, subject to prosecution-history and claim-scope limits.

Are palm and plantar hyperhidrosis covered by the patent?

Yes. The claims expressly identify hand palm and foot plantar areas, along with groin, axilla, and facial areas.

Is the 0.5 mL to 1.0 mL dose container required for all infringing products?

No. That limitation appears only in claims 8 and 9. A product may fall within claim 1 without using the claimed multidose, single-dose, or unit-dose container.

References

1. United States Patent and Trademark Office. (2021). U.S. Patent No. 11,123,325. https://patents.google.com/patent/US11123325

2. U.S. Food and Drug Administration. (2024a, June 18). FDA approves new treatment for primary axillary hyperhidrosis. https://www.fda.gov

3. U.S. Food and Drug Administration. (2024b). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/

4. U.S. Food and Drug Administration. (2024c). Sofdra prescribing information: Sofpironium bromide gel. https://www.accessdata.fda.gov

5. U.S. Code, 35 U.S.C. §§ 154, 156. (2024). Patent term and patent-term extension provisions. https://uscode.house.gov/~~/browse/prelim@title35/subtitleA/partII/chapter14&edition=prelim

Drugs Protected by US Patent 11,123,325

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	11,123,325		Y			TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER

International Family Members for US Patent 11,123,325

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015229243
Australia	2016297601
Australia	2017298469
Australia	2019257421
Australia	2023202689
Australia	2024227714
Brazil	112016021011