United States Patent 9,744,105: Glycopyrrolate Solution, Hyperhidrosis Wipe, and Patent Landscape

US Patent No. 9,744,105 protects a stabilized topical glycopyrrolate solution and individually packaged wipe designed for hyperhidrosis treatment. Its commercially important coverage centers on a narrow formulation combination: glycopyrrolate or a pharmaceutically acceptable salt, approximately 50:50 to 60:40 ethanol and water, citric acid plus sodium citrate or tromethamine, and a defined pH-stability profile. The patent also claims the wipe dosage form, leakage-resistant pouch, and topical treatment method.

The patent is directly relevant to Qbrexza, the glycopyrronium tosylate cloth marketed for primary axillary hyperhidrosis. The strongest commercial claims are the formulation claims covering approximately 59% ethanol, 39% water, citric acid, sodium citrate, and topical wipes. The patent is not a composition-of-matter patent on glycopyrrolate itself. It is a formulation, delivery-system, and method-of-use patent.

What does US Patent 9,744,105 cover?

US 9,744,105 covers four related subject-matter groups:

A liquid glycopyrrolate formulation.
Specific buffer systems and pH ranges.
A wipe loaded with the formulation and sealed in a leakage-resistant pouch.
Topical administration of the wipe to reduce hyperhidrosis.

The patent's independent claims are claims 1, 20, 22, 23, 25, 26, 28, and 29 as presented in the supplied claim set. Claims 2-19 and 21, 24, and 27 are dependent claims.

Claim group	Subject matter	Commercial significance
Claims 1-19	Glycopyrrolate base solution	Protects formulation architecture
Claims 20-21	Wipe loaded with claim 1 solution	Protects dosage form and substrate
Claim 22	Hyperhidrosis treatment using claim 20 wipe	Protects therapeutic use
Claims 23-24	Wipe loaded with claim 13 formulation	Protects more specific commercial formulation
Claim 25	Treatment using claim 23 wipe	Use claim tied to the specific formulation
Claims 26-27	Wipe loaded with claim 16 formulation	Protects a narrower ethanol/water embodiment
Claim 28	Treatment using claim 26 wipe	Use claim tied to claim 16
Claim 29	"Consisting essentially of" formulation	Narrows permissible additional ingredients while preserving formulation coverage

What formulation is protected by US 9,744,105?

The core formulation requires all of the following:

Required element	Claimed range or limitation
Glycopyrrolate compound	About 0.5% to about 4.0% w/w
Counterion	Pharmaceutically acceptable salt counterion
Ethanol and water	About 50:50 to about 60:40 weight ratio
Buffer acid	Citric acid
Buffer base	Sodium citrate or tromethamine
Total buffer concentration	About 0.2% to about 0.5% w/w
pH	About 3.5 to about 6
Stability	pH maintained for at least nine months at 25°C

The most commercially significant dependent claims narrow this platform to:

pH of approximately 4.0;
pH of 4.0 ± 0.5;
approximately 0.15% citric acid and 0.06% sodium citrate;
ethanol and water at approximately 60:40;
approximately 59% ethanol and 39% water;
ethanol at approximately 53.7% to 57.3% w/w, with water making up the balance;
optional propylene glycol;
optional polyvinylpyrrolidone and a butyl ester of polyvinylmethylether/maleic anhydride copolymer.

The claim language requires the formulation to satisfy compositional and functional limitations together. A product containing glycopyrrolate and ethanol may fall outside the patent if it lacks the claimed citric-acid buffer, falls outside the claimed solvent ratio, or does not meet the stated pH and stability limitations.

Does US 9,744,105 cover glycopyrronium tosylate?

The claims cover a glycopyrrolate compound represented by a chemical formula with a pharmaceutically acceptable counterion. The supplied text does not reproduce the chemical structure image, so the scope must be assessed from the written claim language and the patent specification.

Glycopyrronium tosylate, also called glycopyrrolate tosylate in certain product contexts, is the active ingredient in Qbrexza. FDA labeling identifies Qbrexza as a 2.4% glycopyrronium tosylate topical cloth for primary axillary hyperhidrosis.[1]

The practical scope is likely directed to glycopyrrolate salts used in topical solution form, including the commercial tosylate form, provided the compound falls within the claimed structural formula and the formulation satisfies the other limitations. The patent does not broadly claim every glycopyrrolate product regardless of dosage form or excipient system.

How strong are the independent formulation claims?

Claim 1

Claim 1 is a combination claim. It requires:

the specified glycopyrrolate compound;
0.5%-4.0% concentration;
ethanol and water in the claimed ratio;
citric acid plus sodium citrate or tromethamine;
the claimed buffer concentration;
pH of approximately 3.5-6;
pH maintenance for at least nine months at 25°C.

The claim has meaningful commercial breadth because it covers a range of active concentration, solvent ratio, buffer concentration, and pH. Its principal limitation is that all variables must operate together. A competing product using a different acid, a different buffer base, a nonaqueous vehicle, or a materially different solvent ratio could avoid literal infringement.

The nine-month stability limitation creates a potential proof issue. An accused product need not necessarily have nine months of actual market stability data if the formulation inherently satisfies the limitation. In litigation, the patentee would likely rely on formulation testing, accelerated stability data, batch records, and expert analysis.

Claim 29

Claim 29 uses "consisting essentially of," rather than "comprising." That language generally permits additional ingredients that do not materially affect the basic and novel characteristics of the claimed solution. The claim is therefore narrower than claim 1 with respect to additional excipients.

For a generic or competing product, claim 29 may create a design-around route through an excipient system that materially changes the formulation's stability, delivery, evaporation, skin feel, or other claimed characteristics. The legal outcome would depend on claim construction and technical evidence.

Claims 2-19

The dependent claims reduce uncertainty around specific commercial implementations but also narrow the infringement test. Claims 10-13 are especially important because they recite the approximate commercial formulation:

0.15% citric acid;
0.06% sodium citrate;
approximately 60:40 ethanol-to-water ratio;
approximately 59% ethanol and 39% water.

Claims 17 and 18 add polymer systems. These claims may protect film formation, skin residence, wipe loading, or delivery characteristics, but they do not appear necessary to practice the basic formulation claims.

What wipe and packaging features are protected?

Claims 20, 23, and 26 require an individually packaged wipe loaded with the claimed solution and contained in a pouch resistant to leakage.

The wipe claims cover broad substrate categories, including:

nonwoven material;
paper;
woven material;
knitted material;
tufted material;
stitched-bonded material;
wet-milled felted material.

The claims do not appear limited to one specific commercial wipe substrate. The packaging limitation is significant. A bulk bottle, pump, tube, spray, or unsealed pad may avoid the wipe claims even if it contains a formulation within claim 1.

The claims also create a separation between formulation infringement and finished-product infringement:

A liquid solution can infringe claims 1-19 or 29 without being supplied on a wipe.
A wipe product can infringe claims 20-28 if the loaded solution falls within the relevant formulation claim.
A different delivery system may avoid the wipe claims while still implicating the formulation claims.

What method-of-use protection does US 9,744,105 provide?

Claims 22, 25, and 28 cover topical administration of the claimed wipe to an area of the body to reduce hyperhidrosis. The claims are not limited expressly to axillary hyperhidrosis in the supplied text. Their language refers to treatment of hyperhidrosis in a mammal.

The method claims require the wipe to be removed from its pouch and topically administered. A product supplied for another indication, or a product administered through a different dosage form, may present a different infringement analysis.

The method claims may be relevant to a 505(b)(2) applicant or a generic applicant whose labeling directs use of a claimed wipe for hyperhidrosis. Under the Hatch-Waxman framework, a method-of-use patent can support a Paragraph IV challenge even when the applicant does not seek approval for every patented use.

How does the patent map to Qbrexza?

Qbrexza is a topical cloth containing 2.4% glycopyrronium tosylate. The FDA-approved product is supplied as individually packaged cloths for once-daily topical use in primary axillary hyperhidrosis.[1]

The supplied claims align with the central product architecture:

Qbrexza product characteristic	Relationship to US 9,744,105
Glycopyrronium tosylate active ingredient	Consistent with glycopyrrolate salt subject matter
Approximately 2.4% active ingredient	Within the 0.5%-4.0% claimed range
Ethanol/water vehicle	Consistent with the claimed hydroalcoholic solution
Citric acid and sodium citrate	Consistent with claims 1, 7, and 10
Approximately pH 4 formulation	Consistent with claims 2, 3, 8, and 9
Individually packaged cloth	Consistent with claims 20, 23, and 26
Hyperhidrosis indication	Consistent with claims 22, 25, and 28

This alignment makes the patent commercially relevant to the marketed cloth. It does not by itself establish infringement because the final analysis depends on the exact approved formulation, product specifications, claim construction, and any applicable prosecution-history limitations.

What is the Orange Book status of US 9,744,105?

US 9,744,105 has been associated with Qbrexza patent protection and is relevant to the FDA Orange Book listing framework. Orange Book listings identify patents submitted by an NDA holder as covering an approved drug or an approved method of use.[2]

The principal regulatory implications are:

an ANDA applicant may need to make a Paragraph IV certification if it seeks approval before patent expiration;
FDA approval may be delayed by a timely patent-infringement action under the 30-month stay provisions;
a use-code limitation may permit a generic applicant to use a section viii statement for nonpatented indications, where legally and regulatorily available;
formulation and dosage-form claims may still create separate litigation exposure even if a use patent is carved out.

Because the patent claims a wipe and topical hyperhidrosis treatment, the product's dosage form and labeling are central to any Orange Book and Hatch-Waxman analysis. A patent listing does not determine ultimate validity or infringement.

When does US Patent 9,744,105 lose exclusivity?

The patent was issued on September 26, 2017.[3] Its effective expiration is determined by the 20-year term from the earliest effective nonprovisional filing date, subject to patent-term adjustment, terminal disclaimers, and any applicable extension.

Public drug-patent databases commonly identify an expiration date in February 2034 for US 9,744,105. The precise enforceable date should be taken from the USPTO patent record and any later certificate affecting term. Patent expiration and FDA regulatory exclusivity are separate concepts.

Exclusivity element	Approximate timing
Patent grant	September 26, 2017
Expected patent expiration	February 2034
Qbrexza FDA approval	August 2018
New chemical entity exclusivity	Generally four years from approval for ANDA submission purposes
New drug exclusivity period	Generally five years, subject to statutory exceptions
Pediatric exclusivity	Depends on FDA approval of qualifying pediatric studies and any six-month extension

FDA approved Qbrexza in August 2018 for primary axillary hyperhidrosis.[1] The product's FDA regulatory exclusivity does not extend to 2034. The later date is driven primarily by patent protection.

Are there Paragraph IV challenges to Qbrexza?

The supplied information does not establish a specific Paragraph IV filing, ANDA applicant, district-court complaint, or settlement involving US 9,744,105. No named challenger should be treated as confirmed solely from the claim text.

A Paragraph IV challenger would likely attack the patent through one or more of the following theories:

Lack of written description for the full ranges and salt species.
Lack of enablement across all solvent, buffer, pH, and stability combinations.
Obviousness based on known glycopyrrolate topical formulations, hydroalcoholic vehicles, citrate buffers, and wipe delivery systems.
Indefiniteness involving "about," "sufficient to maintain," and degradation thresholds.
Failure to meet the claimed stability limitation.
Noninfringement through a different counterion, buffer, solvent ratio, concentration, or dosage form.

A generic applicant could also pursue a design-around using a different buffer, different alcohol concentration, a liquid bottle rather than a wipe, or a formulation outside the claimed stability and pH parameters.

What generic launch scenarios exist?

Full-label ANDA launch

A full-label ANDA would face the greatest risk if its product reproduced the Qbrexza formulation and cloth presentation. Claims 1, 10-13, 20, 23, and 26 could become the principal asserted claims.

Carved-out-label launch

A section viii strategy would have limited value if the patented use is the same indication sought by the applicant. It could become relevant only if the applicant seeks approval for noncovered uses and FDA permits the corresponding labeling carve-out.

Non-wipe topical solution

A bottle, pump, spray, or other liquid dosage form could avoid claims 20-28. It would still need to avoid or challenge the formulation claims if it uses the claimed glycopyrrolate, ethanol/water, citrate buffer, pH, and stability combination.

Alternative buffer

Replacing sodium citrate or tromethamine with another buffer is a relatively direct design-around of claim 1, assuming the alternative does not fall within the claim under an equivalence theory and the resulting product remains acceptable from a stability and regulatory perspective.

Alternative solvent system

A formulation outside the 50:50 to 60:40 ethanol/water range may avoid literal infringement. This approach could affect evaporation, skin tolerability, active solubility, wipe loading, drying time, and product performance.

Which technical features create the main IP barriers?

The patent's main technical barrier is the integration of several formulation variables rather than any single excipient.

Hydroalcoholic vehicle

The ethanol/water ratio supports active solubilization, drying, skin delivery, and wipe impregnation. A competing formulation must balance these functions while avoiding the claimed range.

Citrate buffering

Citric acid with sodium citrate or tromethamine provides the central claimed pH-control system. A replacement buffer may require new stability, irritation, compatibility, and packaging studies.

Stability performance

The claims require pH maintenance for at least nine months at 25°C and, in dependent claims, low degradation over specified storage periods. Stability data can create a practical barrier even when a design-around is technically available.

Wipe and pouch system

The wipe must retain and deliver the liquid formulation, while the pouch must resist leakage. Packaging selection can affect solvent loss, seal integrity, active recovery, microbial control, and shelf life. These factors may create separate trade-secret or know-how barriers not fully captured by the patent claims.

What other patents may protect Qbrexza?

Qbrexza's patent estate may include continuation or related patents covering formulation details, wipe construction, packaging, manufacturing, or methods of treatment. Patent-family analysis should distinguish:

granted patents from abandoned applications;
live claims from canceled claims;
Orange Book-listed patents from unlisted patents;
patents with formulation claims from patents with method-of-use claims;
US rights from foreign-family rights.

US 9,744,105 is the central patent addressed here. The supplied claim set does not identify related patent numbers, continuation applications, terminal disclaimers, assignment history, or later-issued family members. A complete family-level landscape cannot be stated from the claim text alone.

How does US 9,744,105 compare with competing antiperspirant products?

Product category	Active ingredient	Delivery form	Relationship to US 9,744,105
Qbrexza	Glycopyrronium tosylate	Individually packaged cloth	Closest commercial product
Aluminum chloride products	Aluminum chloride	Solution, roll-on, or pad	Different active and generally outside glycopyrrolate claims
Oral glycopyrrolate	Glycopyrrolate	Tablet or oral liquid	Different route and dosage form
Botulinum toxin products	Botulinum toxin	Injection	Different active and delivery system
Other topical anticholinergics	Varies	Cream, gel, solution, or wipe	Risk depends on active, formulation, and delivery architecture

The patent is most relevant to products that combine topical glycopyrrolate with a hydroalcoholic citrate-buffered solution and wipe presentation. It is less relevant to unrelated hyperhidrosis therapies.

What is the revenue exposure from this patent?

The patent's revenue exposure is concentrated in Qbrexza sales and any future products using the same formulation or wipe technology. FDA-approved product revenue, however, cannot be inferred from the patent alone. Public company filings, license agreements, and product-level sales disclosures are required to quantify exposure.

The commercial risk increases where:

the approved product closely matches claims 10-13;
the wipe and pouch are necessary parts of the marketed product;
the patent is listed in the Orange Book;
no substitutable formulation has completed regulatory development;
the sponsor has additional related patents or confidential manufacturing know-how.

The risk decreases where a competitor can obtain approval for a non-wipe formulation, use a different buffer system, or establish noninfringing stability and delivery characteristics.

What licensing and ownership issues affect the patent?

Patent ownership, exclusive licensing, and commercialization rights should be traced through USPTO assignment records and the relevant corporate disclosures. Qbrexza was developed by Dermira and later became part of Almirall's dermatology portfolio through Almirall's acquisition of Dermira.[4]

The commercial party marketing Qbrexza may not be identical to the original patent assignee. Assignment, exclusive license, merger, and acquisition records affect:

standing to sue;
control of Orange Book submissions;
rights to enforce the patent;
obligations under settlement agreements;
royalty or milestone economics.

The patent number alone does not establish the current owner or all contractual rights.

Key Takeaways

US 9,744,105 is a formulation and drug-delivery patent, not a basic glycopyrrolate composition patent.
Its core claim requires glycopyrrolate, 50:50-60:40 ethanol/water, citric acid plus sodium citrate or tromethamine, a defined buffer concentration, and pH stability.
Claims 10-13 closely track the commercially important Qbrexza formulation.
Claims 20-28 extend protection to individually packaged wipes, leakage-resistant pouches, and topical hyperhidrosis treatment.
Claim 29 is narrower because it uses "consisting essentially of."
Qbrexza's 2.4% glycopyrronium tosylate cloth is the principal commercial product implicated by the patent.
The expected patent expiration is in February 2034, subject to the official USPTO term record and any later term adjustment.
A generic challenger would likely focus on obviousness, enablement, written description, stability limitations, and design-around formulations.
A non-wipe product may avoid the wipe claims but can still implicate the formulation claims.
The supplied claim text does not establish a specific Paragraph IV challenger, patent litigation outcome, settlement, or complete related-family landscape.

FAQs

Is US 9,744,105 a patent on glycopyrrolate itself?

No. It claims particular glycopyrrolate formulations, wipes, packaging, and hyperhidrosis treatment methods. Glycopyrrolate as an active pharmaceutical ingredient predates this patent.

Does a glycopyrrolate cream infringe US 9,744,105?

Not necessarily. A cream may avoid the claimed ethanol/water solution and wipe limitations. Infringement would depend on whether the cream meets the specific formulation elements and whether any relevant patent claims outside the supplied set apply.

Can a generic use a different salt of glycopyrrolate?

Potentially. The claims cover a glycopyrrolate compound with a pharmaceutically acceptable counterion, so the exact chemical formula and scope of the salt limitation matter. A different salt is not automatically outside the patent.

Does changing citric acid to another acid avoid the patent?

It would likely avoid literal infringement of claims requiring citric acid, assuming the substitute does not satisfy the claim under an equivalence theory. The regulatory and formulation consequences would require separate evaluation.

Does patent expiration automatically permit immediate Qbrexza generic marketing?

No. FDA approval requirements, ANDA review, other listed or unlisted patents, regulatory exclusivity, litigation outcomes, and commercial manufacturing readiness can affect launch timing.

References

U.S. Food and Drug Administration. (2018). Qbrexza (glycopyrronium) cloth, 2.4% prescribing information.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
United States Patent and Trademark Office. (2017). U.S. Patent No. 9,744,105, glycopyrrolate formulations and methods of use.
Almirall, S.A. (2020). Annual report and corporate disclosures concerning the acquisition of Dermira, Inc.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Journey	QBREXZA	glycopyrronium tosylate	CLOTH;TOPICAL	210361-001	Jun 28, 2018		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y			TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER	⤷ 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	2008314628	⤷ Start Trial
Australia	2014203072	⤷ Start Trial
Canada	2702830	⤷ Start Trial
European Patent Office	2200550	⤷ Start Trial
European Patent Office	3415127	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Summary for Patent: 9,744,105