United States Patent 10,806,701: Claim Scope, Expiration, Litigation Risk and Glycopyrronium Inhaler Patent Landscape

U.S. Patent No. 10,806,701 protects a narrow pressurized metered-dose inhaler formulation containing glycopyrronium bromide, HFA-134a, ethanol and a defined hydrochloric-acid equivalent. The principal commercial relevance is to solution-type pMDIs and combination inhalers containing formoterol fumarate, beclometasone dipropionate, or related respiratory actives.

The patent does not broadly cover all glycopyrronium inhalers. Infringement of independent claim 1 requires the claimed solvent system, propellant, ethanol, glycopyrronium and hydrochloric-acid parameters to be present in the same composition. The most material design-around options are removal or substantial reduction of ethanol, use of a different propellant, use of a suspension rather than a solution, substitution of a different acid or pH-control system, and alteration of the claimed concentration ranges.

The patent was granted on October 20, 2020. Its nominal patent-term endpoint is December 23, 2035, based on the earliest identified priority date of December 23, 2014. The effective expiration date requires confirmation against the USPTO patent-term-adjustment record. No patent-term extension is apparent from the formulation claims themselves. [1]

What does U.S. Patent 10,806,701 protect?

The patent protects a pharmaceutical composition for a pMDI in which glycopyrronium bromide is dissolved in a hydrofluoroalkane propellant and ethanol, with hydrochloric acid present within a specified equivalent range.

Claim element	Claim 1 requirement
Active ingredient	Glycopyrronium bromide
Physical state	Dissolved
Propellant	HFA-134a
Ethanol	10% to 15% w/w
HFA-134a	85% to 90% w/w
Glycopyrronium bromide	0.015% to 0.04% w/w
Acidity parameter	0.005 to 1.0 μg/μl equivalent of 1M hydrochloric acid
Device context	Pressurized metered-dose inhaler

The claim uses “comprising,” making it open-ended. A composition can contain additional components unless another claim narrows the formulation. Claim 13 creates a narrower version that is free of excipients other than ethanol, HFA-134a and hydrochloric acid.

The composition is not defined solely by the presence of glycopyrronium bromide. A product containing glycopyrronium bromide in HFA-134a but lacking the claimed ethanol and hydrochloric-acid characteristics would not literally satisfy claim 1.

How do the individual claims differ?

Claims 1, 2 and 8: hydrochloric-acid concentration

Claim 1 establishes the broad acidity range: 0.005 to 1.0 μg/μl of 1M hydrochloric-acid equivalent.

Claim 2 narrows the range to 0.18 to 0.32 μg/μl.

Claim 8 recites 0.099 to 0.74 μg/μl. Because claim 8 depends from claim 1, it is a narrower claim than claim 1 even though its acidity range is broader than claim 2.

The ranges overlap:

Claim	HCl equivalent range
Claim 1	0.005-1.0 μg/μl
Claim 2	0.18-0.32 μg/μl
Claim 8	0.099-0.74 μg/μl

An accused formulation within the claim 2 range would also fall within claim 8 and claim 1, assuming the other limitations are met.

The acidity limitation is likely to create analytical disputes. The claim does not simply recite pH. It uses an amount “equivalent to” a specified quantity of 1M hydrochloric acid. In a dispute, the relevant questions would include the assay protocol, sample preparation, solvent composition, titration endpoint, batch variability and whether the measurement is performed on the bulk formulation or after dilution.

Claims 3 through 5: combination products

Claim 3 covers the composition of claim 1 when it also contains one or more active ingredients selected from:

beta-2 agonists;
corticosteroids;
antimuscarinic agents; and
phosphodiesterase IV inhibitors.

Claim 4 specifically identifies formoterol fumarate. Claim 5 specifically identifies beclometasone dipropionate.

These claims are relevant to dual and triple respiratory products. Claim 4 can reach a glycopyrronium/formoterol formulation if all claim 1 excipient and concentration limitations are present. Claim 5 can reach a glycopyrronium/beclometasone formulation on the same basis.

Neither claim 4 nor claim 5, standing alone, establishes protection for every glycopyrronium/formoterol or glycopyrronium/beclometasone product. The formulation must still meet the parent claim 1 limitations.

Claims 6 and 9: inhaler and valve protection

Claim 6 covers a pMDI containing the claimed composition.

Claim 9 narrows the device to a metering valve capable of delivering approximately 63 μl per actuation. The term “about” creates tolerance around the nominal valve volume, but the scope will depend on the relevant claim-construction standard and measurement method.

Claim 9 creates a device-level infringement route. A product could infringe claim 6 even if the valve limitation of claim 9 is absent. Conversely, a 63 μl valve does not create infringement if the formulation does not satisfy claim 1.

Claim 7: kit-of-parts protection

Claim 7 covers a kit containing:

the glycopyrronium composition; and
one or more additional active ingredients for separate, sequential or simultaneous administration.

The additional ingredients must fall within the therapeutic classes in claim 3. This claim is broader in product configuration than a single-canister combination claim because it covers separate administration arrangements.

Claim 10: racemic glycopyrronium bromide

Claim 10 identifies the racemic mixture:

“(3S,2′R),(3R,2′S)-3-[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide.”

This limitation matters because glycopyrronium products may be described by different stereochemical, salt or nonproprietary naming conventions. Claim 10 narrows the scope to the specified racemic form. It does not necessarily exclude infringement under claim 1 if another glycopyrronium bromide form is used, provided claim 1’s broader chemical limitation covers that form.

Claims 11 and 12: water content

Claim 11 requires water below 0.5% w/w. Claim 12 narrows that range to 0.005% to 0.5% w/w.

These claims give the patent additional coverage over low-water formulations. A formulation with no intentionally added water could still contain residual water and may fall within claim 11, depending on the measured concentration and claim interpretation.

How strong is the patent estate for glycopyrronium pMDI formulations?

The patent is technically narrow but commercially relevant. Its strength depends on whether a competing product uses the same solution architecture.

Strengths

The claims combine several limitations that are likely to be selected together in a commercial formulation:

glycopyrronium bromide;
HFA-134a;
ethanol at 10% to 15% w/w;
a low drug concentration;
hydrochloric-acid adjustment; and
pMDI delivery.

A commercial product designed around this formulation window may have difficulty avoiding the patent without changing the solvent system or formulation performance.

Claim 13 is particularly restrictive but can be valuable if the marketed formulation contains only the claimed excipients. Claims 6 and 9 extend the protection from the bulk formulation to the inhaler and valve configuration.

Weaknesses and design-around routes

The principal weakness is the number of cumulative limitations. A competitor may seek to avoid infringement by:

Design-around	Likely effect
Use HFA-227ea or another propellant	Avoids literal HFA-134a limitation
Use a suspension rather than a solution	Challenges the “dissolved” limitation
Use ethanol below 10% or above 15%	Avoids claim 1 concentration range
Use a different acid or buffer	Challenges hydrochloric-acid limitation
Alter glycopyrronium concentration outside 0.015%-0.04%	Avoids claim 1
Add another excipient	Avoids claim 13, but not necessarily claim 1
Use a different valve volume	Avoids claim 9, but not claims 1 or 6
Use a dry-powder inhaler or nebulizer	Avoids the pMDI context

The patent is therefore stronger against a close formulation copy than against a product developed using a materially different delivery platform.

What patent expiration date applies to U.S. Patent 10,806,701?

The relevant nominal term is approximately 20 years from the earliest effective nonprovisional filing or priority date, subject to patent-term adjustment.

Event	Date
Earliest identified priority date	December 23, 2014
U.S. patent grant	October 20, 2020
Nominal 20-year endpoint	December 23, 2035
Potential adjustment	USPTO PTA may move the effective date later

A patent expiration calculation should use the USPTO Patent Term Adjustment field rather than the grant date. Regulatory exclusivity is separate from patent term. A formulation patent can remain enforceable after FDA marketing exclusivity has expired, and FDA exclusivity can delay approval even where no blocking patent remains. [2]

What is the Orange Book status of U.S. Patent 10,806,701?

The Orange Book lists patents submitted by sponsors for approved drug products. A patent number is not automatically an Orange Book patent merely because it covers a pharmaceutical formulation. Listing depends on sponsor submission, FDA review of the listing category and linkage to a specific approved NDA. [3]

The principal U.S. glycopyrrolate pMDI products include:

Product	Active ingredients	Sponsor	FDA dosage form
Bevespi Aerosphere	Glycopyrrolate/formoterol fumarate	AstraZeneca	HFA pMDI
Breztri Aerosphere	Budesonide/glycopyrrolate/formoterol fumarate	AstraZeneca	HFA pMDI
Lonhala Magnair	Glycopyrrolate	Sunovion	Nebulized solution
Seebri Neohaler	Glycopyrrolate	Novartis	Dry-powder inhaler

Bevespi and Breztri are the most relevant commercial comparators because they use glycopyrrolate in HFA-based metered-dose inhalers. Their approved labels identify the active ingredients and device systems, but the label alone does not establish that their exact formulations fall within every limitation of Patent 10,806,701. [4, 5]

An Orange Book listing would materially increase ANDA litigation risk. An unlisted formulation patent can still support conventional patent litigation, but it would not automatically create a Paragraph IV certification requirement for an ANDA.

When does glycopyrronium pMDI exclusivity end?

For this patent, the principal date is the nominal December 2035 patent-term endpoint, subject to USPTO adjustment.

Commercial exclusivity can end earlier or later depending on the product:

Exclusivity type	Relevance
New chemical entity exclusivity	Generally five years for an eligible new active moiety
New clinical investigation exclusivity	May provide three years for qualifying changes
Orphan-drug exclusivity	Seven years for an approved orphan indication
Patent term	Controlled by the patent’s statutory term and PTA/PTE
Orange Book linkage	Determines whether an ANDA must address listed patents

Glycopyrronium bromide has been marketed in multiple dosage forms and combinations. The applicable FDA exclusivity period is product-specific and cannot be inferred from Patent 10,806,701 alone.

Which companies are challenging the glycopyrronium pMDI market?

The competitive landscape is divided between HFA pMDIs, dry-powder inhalers and nebulized products.

AstraZeneca

AstraZeneca has the strongest direct U.S. commercial position in glycopyrronium HFA pMDIs through Bevespi Aerosphere and Breztri Aerosphere. Breztri combines an inhaled corticosteroid, a long-acting muscarinic antagonist and a long-acting beta-2 agonist.

Novartis

Novartis markets glycopycopyrrolate through dry-powder technology rather than the HFA-134a solution architecture relevant to Patent 10,806,701. The device and formulation platform create a substantial noninfringement distinction.

Sunovion

Sunovion’s Lonhala Magnair uses nebulized delivery. It competes in the same long-acting muscarinic antagonist market but does not directly target the patented pMDI formulation.

Chiesi

The claim combination of glycopyrronium, formoterol and beclometasone is closely aligned with Chiesi’s extrafine triple-therapy platform outside the United States. Chiesi’s Trimbow product uses beclometasone dipropionate, formoterol fumarate and glycopyrronium bromide in a pMDI presentation in certain markets. The commercial relationship between any marketed product and Patent 10,806,701 must be established through the patent family, regulatory filings and product composition records. [1, 6]

What Paragraph IV challenges and litigation risks exist?

A Paragraph IV challenge is relevant only where a generic applicant files an ANDA referencing an approved product and identifies a listed patent as invalid, unenforceable or not infringed under the Hatch-Waxman framework. [7]

The risk profile is:

Scenario	Risk assessment
Same glycopyrronium/HFA-134a/ethanol solution	High literal-infringement risk
Same formulation with changed acidity	Depends on assay and claim construction
HFA-134a suspension formulation	Lower risk on “dissolved” limitation
Different HFA propellant	Strong noninfringement position
Dry-powder glycopyrronium	Outside the pMDI claims
Nebulized glycopyrrolate	Outside the pMDI claims
Combination product with formoterol	Claim 4 risk if claim 1 is met
Combination product with beclometasone	Claim 5 risk if claim 1 is met

Potential litigation issues include:

whether glycopyrronium is fully dissolved at commercial temperature and pressure;
whether HCl is present in the claimed equivalent amount;
whether concentration is measured before or after filling;
whether “about 63 μl” covers the accused valve;
whether the patent adequately describes the full numerical ranges;
whether the claims are enabled across all combinations of ingredients; and
whether any asserted claims are subject to prosecution-history estoppel.

No Paragraph IV strategy can be evaluated from the patent text alone. The decisive evidence would be the ANDA product’s formulation, valve specification and analytical data.

What manufacturing and intellectual-property barriers affect market entry?

The main manufacturing barrier is the need to maintain a stable solution containing a quaternary ammonium antimuscarinic salt in a volatile HFA-ethanol system. Formulation changes can affect:

solubility and precipitation;
valve compatibility;
delivered dose uniformity;
plume geometry;
aerodynamic particle-size distribution;
container closure integrity;
extractables and leachables;
moisture ingress; and
chemical stability.

The patent’s hydrochloric-acid limitation may be tied to formulation stability, but a competitor can potentially preserve product performance through a different acidification or buffering strategy. That creates a technical design-around question rather than a simple substitution exercise.

The broader patent landscape may include separate families for:

active-ingredient salts and stereoisomers;
HFA solution formulations;
ethanol and acid stabilization;
extrafine particle generation;
metering valves;
canister coatings;
combination therapy;
manufacturing and filling processes; and
therapeutic methods for COPD and asthma.

Patent 10,806,701 is most important as a formulation and device patent. It should not be treated as the complete patent estate for a glycopyrronium product.

How does Patent 10,806,701 compare with dry-powder and nebulized glycopyrronium patents?

Technology	Relationship to Patent 10,806,701	Main IP focus
HFA pMDI solution	Directly relevant	Solvent, acid, concentration and valve
HFA pMDI suspension	Potentially outside “dissolved” limitation	Particle engineering and suspension stability
Dry-powder inhaler	Generally outside the claims	Carrier, particle size and device
Nebulized solution	Outside the pMDI claims	Nebulizer compatibility and unit-dose formulation
Triple HFA pMDI	High relevance if formulation matches	Combination composition and device

The patent has limited relevance to dry-powder and nebulized products even when those products contain the same active ingredient. Its commercial value is concentrated in pMDI products using the specified HFA-134a and ethanol formulation architecture.

Key Takeaways

Patent 10,806,701 is a formulation patent focused on glycopyrronium bromide dissolved in HFA-134a and ethanol.
Claim 1 requires all of the principal numerical limitations to be met in the same composition.
Claims 4 and 5 create specific relevance for formoterol fumarate and beclometasone dipropionate combinations.
Claim 6 covers an inhaler containing the formulation, while claim 9 adds an approximately 63 μl metering-valve limitation.
Claims 11 and 12 address low-water formulations; claim 13 covers an excipient-limited composition.
The nominal patent-term endpoint is December 23, 2035, subject to USPTO patent-term adjustment.
The strongest design-arounds are a different propellant, a suspension instead of a solution, a different acidification system, or a non-pMDI delivery platform.
Bevespi Aerosphere and Breztri Aerosphere are the most relevant U.S. commercial comparators because they use glycopyrrolate HFA pMDI technology.
Orange Book relevance depends on linkage to a specific approved NDA and sponsor listing, not merely on the patent’s formulation subject matter.
A Paragraph IV challenge would turn primarily on the accused product’s solvent system, acid equivalent, drug concentration, water content and device configuration.

FAQs

Does Patent 10,806,701 cover all glycopyrrolate inhalers?

No. Its claims are directed to a specific HFA-134a and ethanol pMDI composition. Dry-powder and nebulized glycopyrrolate products generally fall outside the claimed delivery system.

Can a competitor avoid the patent by adding another excipient?

Adding an excipient can avoid claim 13, which requires the composition to be free of other excipients. It does not necessarily avoid claim 1, because claim 1 uses the open-ended term “comprising.”

Does a formulation with no added hydrochloric acid avoid infringement?

Not necessarily. The claim uses an equivalent hydrochloric-acid parameter. Residual acidity or an acid introduced through another component could become relevant if the claimed equivalent range is met.

Is glycopyrrolate the same active ingredient as glycopyrronium bromide?

Glycopyrrolate is commonly used as the nonproprietary name for the glycopyrronium cation, often supplied as glycopyrronium bromide. The exact salt and stereochemical form remain relevant to claim interpretation.

Could a biosimilar challenge Patent 10,806,701?

No. Glycopyrronium bromide is a small-molecule active ingredient, so the principal abbreviated pathway is an ANDA or, in some circumstances, a 505(b)(2) application rather than a biosimilar application under the biologics pathway.

References

United States Patent and Trademark Office. (2020). U.S. Patent No. 10,806,701, pharmaceutical composition for use in a pressurized metered dose inhaler.
United States Code, 35 U.S.C. §§ 154, 156, 271.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
U.S. Food and Drug Administration. (2024). Bevespi Aerosphere prescribing information.
U.S. Food and Drug Administration. (2024). Breztri Aerosphere prescribing information.
European Medicines Agency. (2024). Trimbow product information.
United States Code, 21 U.S.C. § 355(j).

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Chiesi	TRIMBOW	beclomethasone dipropionate; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	219622-001	May 14, 2026		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y				⤷ Start Trial
Chiesi	TRIMBOW	beclomethasone dipropionate; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	219622-002	May 14, 2026		RX	Yes	Yes	⤷ Start Trial	⤷ 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	2010334858	⤷ Start Trial
Australia	2016234894	⤷ Start Trial
Brazil	112012015336	⤷ Start Trial
Canada	2785317	⤷ Start Trial
Chile	2012001668	⤷ Start Trial
China	102665680	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 10,806,701

Which drugs does patent 10,806,701 protect, and when does it expire?

Summary for Patent: 10,806,701