United States Patent 7,750,023: Claim Scope, Expiration, Orange Book Status, and Combination-Drug Patent Landscape

U.S. Patent No. 7,750,023 covers pharmaceutical compositions and treatment methods combining a specified quaternary ammonium anticholinergic compound with a β2 agonist. The patent also reaches inhaled formulations and combinations that include a corticosteroid or phosphodiesterase IV inhibitor. Its principal commercial relevance is to long-acting bronchodilator combinations for COPD and asthma.

The patent’s nominal 20-year term ran in 2023, subject to any patent-term adjustment, patent-term extension, or terminal disclaimer recorded by the USPTO. The claims do not broadly cover every LAMA/LABA product. They require the specifically defined anticholinergic compound, or a stereochemical or salt form of that compound, together with a β2 agonist.

What does U.S. Patent 7,750,023 cover?

The patent covers two claim categories:

Pharmaceutical compositions containing the claimed anticholinergic compound and a β2 agonist.
Methods of treating respiratory diseases by administering those two pharmacological components.

The claimed anticholinergic is a quaternary ammonium compound based on a substituted azoniabicyclo[2.2.2]octane structure:

3-(2-hydroxy-2,2-dithien-2-ylacetoxy)-1-(3-phenoxypropyl)-1-azoniabicyclo[2.2.2]octane

The positive nitrogen charge requires an associated pharmaceutically acceptable anion. Bromide is expressly claimed, but claim 1 is broader because it covers anions of mono- or polyvalent acids.

The patent therefore has a compound-identity limitation. A competing product avoids literal infringement if its anticholinergic is a different active pharmaceutical ingredient, even if it is also a long-acting muscarinic antagonist and is combined with a β2 agonist.

How broad are the issued claims?

Claim-by-claim scope

Claim	Category	Principal limitation	Scope assessment
1	Composition	Claimed anticholinergic plus a β2 agonist	Broadest independent composition claim
2	Composition	Bromide salt	Narrows claim 1 to the bromide
3	Composition	Pharmaceutically acceptable carrier or diluent	Adds conventional pharmaceutical excipients
4	Composition	3(S) stereoisomer	Narrows the composition to the S configuration
5	Composition	3(R) stereoisomer	Depends from claim 4 and adds the R form
6	Composition	Suitable for inhalation	Covers inhaled dosage forms
7	Composition	Steroid or PDE IV inhibitor	Requires the claim 1 combination plus another respiratory agent
8	Method	Treatment of specified respiratory diseases	Broadest independent method claim
9	Method	Bromide anion	Narrows claim 8
10	Method	3(S) stereoisomer	Narrows the treatment method
11	Method	3(R) stereoisomer	Depends from claim 10 and adds the R form
12	Method	Administration by inhalation	Inhaled treatment method
13	Method	Steroid or PDE IV inhibitor	Adds a third therapeutic component

The word “comprising” makes the independent claims open-ended. A product can contain additional active ingredients, excipients, device components, or treatment agents and still fall within the claim if it contains the required anticholinergic and β2 agonist.

The claims do not specify:

A particular β2 agonist;
A dosage strength;
A dose ratio;
A dosing interval;
A specific inhaler;
A propellant;
A dry-powder carrier;
A particle-size distribution;
A particular corticosteroid;
A particular PDE IV inhibitor;
A required sequence of administration.

Those omissions increase the theoretical breadth of the claims, but infringement still depends on the presence of the exact claimed anticholinergic structure.

What active ingredients can satisfy the β2-agonist limitation?

The claims use the functional class “β2 agonist” rather than naming a specific molecule. Depending on the specification and claim construction, the limitation could encompass short-acting and long-acting β2 agonists, including compounds such as:

Albuterol, also known as salbutamol;
Levalbuterol;
Terbutaline;
Formoterol;
Salmeterol;
Indacaterol;
Olodaterol;
Vilanterol;
Arformoterol;
Other β2-selective agonists meeting the specification’s technical definition.

The absence of a named β2 agonist creates a broad genus limitation. It does not, however, eliminate the requirement for the specified quaternary ammonium anticholinergic.

A product containing a different LAMA plus formoterol would not ordinarily satisfy claim 1 literally because the claimed anticholinergic is absent. The combination of a different LAMA and a β2 agonist may be relevant to obviousness, validity, or the patent’s background technology, but it is not enough by itself for literal infringement.

What formulations are protected by U.S. Patent 7,750,023?

Claim 6 covers compositions suitable for inhalation. Claim 12 covers treatment by inhalation. The formulation claims are technology-neutral and can potentially reach several inhalation formats if the active ingredients and structural limitations are met.

Potential inhalation formats

Dosage form	Potential relevance
Dry-powder inhaler	Covered if the powder contains the claimed anticholinergic and β2 agonist
Metered-dose inhaler	Covered if the aerosol formulation satisfies the active-ingredient limitations
Nebulized solution or suspension	Potentially covered if the composition contains the claimed components
Capsule-based inhalation system	Potentially covered as a dry-powder presentation
Blended powder	Potentially covered, subject to composition and claim construction

Claim 3 adds a pharmaceutically acceptable carrier or diluent. That limitation could encompass lactose, other inhalation-grade carriers, propellants, solvents, buffers, stabilizers, and conventional excipients, depending on the formulation.

The patent does not require a particular device design. A device company could therefore face risk from the drug composition or method claims even if its inhaler hardware is materially different.

How do the stereochemical claims affect patent scope?

Claims 4, 5, 10, and 11 address stereochemical forms of the anticholinergic.

The supplied claim text creates an apparent dependency issue:

Claim 5 depends from claim 4, which recites the 3(S) compound, and then adds the 3(R) compound.
Claim 11 depends from claim 10, which recites the 3(S) compound, and then adds the 3(R) compound.

As written, claims 5 and 11 may be read as requiring both stereochemical forms. That is materially narrower than a claim directed independently to the R isomer. A court would evaluate the issued claim language together with the specification, prosecution history, and applicable claim-construction rules.

The stereochemical limitations matter commercially because a single-enantiomer product, a racemate, and a mixture of stereoisomers can have different infringement profiles. A product containing only the R form may not satisfy a claim requiring the S form, while a racemate could raise a separate analysis depending on whether the claim requires a particular stereoisomer or merely covers a composition containing it.

What diseases and therapeutic uses are protected?

Claim 8 covers treatment of:

Chronic obstructive pulmonary disease;
Chronic bronchitis;
Bronchial hyperreactivity;
Asthma;
Rhinitis.

The method requires administering effective amounts of the defined anticholinergic and a β2 agonist. Claim 12 narrows the method to inhalation. Claim 13 adds a steroid or PDE IV inhibitor.

The method claims are not limited to COPD. A product marketed for asthma, chronic bronchitis, or rhinitis could fall within the literal disease category if the active-ingredient and administration limitations are met.

The claim language also does not require simultaneous administration. Depending on the specification and prosecution history, “administering” the two agents could include co-formulation, co-packaging, separate dosage forms used in a treatment regimen, or sequential administration. The strongest infringement case would generally involve a fixed-dose combination product containing both required agents.

Does the patent cover triple therapy?

Claims 7 and 13 expressly add a steroid or PDE IV inhibitor to the anticholinergic-plus-β2-agonist combination.

Potentially relevant third components include:

Inhaled corticosteroids such as budesonide, fluticasone, beclomethasone, mometasone, or ciclesonide;
PDE IV inhibitors such as roflumilast or other compounds within the specification’s scope.

The claims require the base combination first. A triple therapy containing a steroid and β2 agonist but using a different anticholinergic would generally fall outside the literal scope of these claims.

When did U.S. Patent 7,750,023 lose exclusivity?

Patent-term timeline

Event	Date or period
Earliest priority and filing history	See USPTO patent record
U.S. patent grant	2010
Nominal 20-year patent term	Ran in 2023
Post-expiration position	Patent is not a current blocking patent unless a recorded term adjustment or extension altered the end date

Patent term for a utility patent is generally measured from the earliest effective nonprovisional or international filing date, subject to patent-term adjustment and other statutory modifications (35 U.S.C. §§ 154 and 156). The relevant USPTO term record controls the final expiration date.

No FDA regulatory exclusivity period is created by the patent itself. Patent exclusivity and FDA exclusivity are separate rights.

What is the Orange Book status of U.S. Patent 7,750,023?

The patent’s Orange Book relevance depends on whether an approved drug product contains the specifically claimed anticholinergic and whether the patent is submitted and accepted for listing against that product.

A patent covering a combination of an anticholinergic and β2 agonist is not automatically listable against a single-agent LAMA product. FDA Orange Book listing generally requires a relationship between the patent claims and the approved drug substance, drug product, or method of use identified in the approved labeling (FDA, 2024).

The practical implications are:

A single-agent anticholinergic label may not practice the combination claims.
A fixed-dose LAMA/LABA label is more likely to implicate the composition claims.
An inhalation method claim may be listable if the approved labeling includes the claimed method.
A patent can be expired even if it remains visible in historical Orange Book records.
Absence from the Orange Book does not by itself prove absence of infringement.

Based on the claim structure, the patent is more naturally associated with a combination product than with a monotherapy product.

Which commercial respiratory products are most relevant?

The principal branded LAMA/LABA and triple-therapy products provide useful market comparisons, but their active ingredients differ from the specific compound claimed in U.S. Patent 7,750,023.

Product	LAMA component	β2 agonist	Steroid	Relationship to the claims
Anoro Ellipta	Umeclidinium	Vilanterol	No	Different LAMA; not a direct literal match to the claimed anticholinergic
Stiolto Respimat	Tiotropium	Olodaterol	No	Different LAMA
Bevespi Aerosphere	Glycopyrrolate	Formoterol	No	Different LAMA
Utibron Neohaler	Glycopyrrolate	Indacaterol	No	Different LAMA
Duaklir Pressair	Aclidinium	Formoterol	No	Different LAMA
Breztri Aerosphere	Glycopyrrolate	Formoterol	Budesonide	Different LAMA; triple therapy
Trelegy Ellipta	Umeclidinium	Vilanterol	Fluticasone furoate	Different LAMA; triple therapy

The commercial risk from these products is therefore more likely to concern their own patent families than direct infringement of U.S. Patent 7,750,023.

Which patents compete with this patent estate?

The relevant competitive patent landscape has several layers:

Anticholinergic compound patents

These cover the active molecule, stereoisomer, salt, or chemical process. They are usually stronger against generic substitution because they focus on the active pharmaceutical ingredient itself.

Combination patents

These cover a defined LAMA/LABA pairing, a fixed-dose ratio, or a specific therapeutic combination. U.S. Patent 7,750,023 is principally in this category.

Formulation patents

These cover:

Dry-powder blends;
Carrier systems;
Aerosol suspensions;
Nebulizer solutions;
Particle-size controls;
Stabilizers;
Specific inhaler-device interfaces.

Formulation patents can remain commercially important after an active-ingredient patent expires.

Device patents

These cover inhaler mechanisms, dose counters, blister systems, capsule puncturing, aerosol valves, and airflow structures. They can create launch constraints even where pharmaceutical composition patents have expired.

Method-of-use patents

These may cover COPD maintenance therapy, exacerbation reduction, specific patient subgroups, or treatment schedules. The method claims in U.S. Patent 7,750,023 are broader disease-treatment claims rather than highly specified patient-population claims.

What Paragraph IV risks exist?

A generic applicant seeking approval for a product that contains the claimed anticholinergic and a β2 agonist could face several pathways:

Paragraph IV certification: The applicant asserts that the patent is invalid, unenforceable, or not infringed.
Section viii statement: The applicant omits a patented method of use from labeling if the product can be approved for an unclaimed use.
Expiration certification: The applicant acknowledges the patent but waits until expiration.
No certification relevance: If the product contains a different anticholinergic, the patent may not be relevant.

Because the patent’s nominal term ran in 2023, a current Paragraph IV challenge would generally have limited commercial value unless a valid term adjustment extended the expiration date or the patent has a related unexpired continuation with materially broader claims.

A Paragraph IV notice would not resolve infringement. The patent holder would still need to prove that the ANDA product satisfies each claim limitation.

What litigation and settlement issues matter?

The key litigation questions would be:

Whether the accused product contains the claimed anticholinergic compound or a covered stereochemical or salt form;
Whether the β2 agonist satisfies the claim’s functional class;
Whether the product is a pharmaceutical composition within the claim;
Whether the product is suitable for inhalation;
Whether the treatment label instructs an infringing method;
Whether claims 5 and 11 are construed as requiring both stereochemical forms;
Whether the patent remained enforceable at the relevant launch date.

A settlement agreement could impose a launch date earlier than the patent expiration date, authorize entry under a license, or include supply and co-development terms. No settlement term should be inferred solely from the existence of the patent or from the later appearance of a competing product.

How strong is the patent estate?

The patent has a mixed strength profile.

Strengths

Claims a defined anticholinergic plus a broad β2-agonist class.
Covers composition and treatment-method categories.
Includes inhalation and triple-therapy claim paths.
Uses open-ended “comprising” language.
Does not limit the combination to a specific dose ratio or inhaler.

Weaknesses

The claims depend on a relatively narrow, structurally defined anticholinergic.
The patent’s nominal term has ended.
Functional “β2 agonist” language can create classification and claim-construction disputes.
The stereochemical dependencies in claims 5 and 11 create textual vulnerability.
Commercial products using different LAMAs are not direct literal substitutes for the claimed compound.
Later formulation, device, and product-specific patents may provide the more relevant commercial barriers.

The patent was more valuable as an early combination-therapy right than as a current barrier to established LAMA/LABA products using different anticholinergic molecules.

Key Takeaways

U.S. Patent 7,750,023 claims compositions and treatment methods combining a specific quaternary ammonium anticholinergic with a β2 agonist.
Bromide is expressly claimed, but the independent claims cover broader pharmaceutically acceptable anions.
The claims reach inhaled products and, through claims 7 and 13, combinations containing a steroid or PDE IV inhibitor.
The patent does not automatically cover all LAMA/LABA products. The exact anticholinergic structure is a central limitation.
The nominal patent term ran in 2023, subject to the USPTO’s recorded term adjustment or extension.
Orange Book relevance depends on whether an approved product practices the claimed combination or method and whether FDA accepted the listing.
Current commercial exposure is more likely to arise from later compound, formulation, device, and product-specific patents than from this expired or nominally expired patent.

FAQs

Does U.S. Patent 7,750,023 cover tiotropium combinations?

Not automatically. Tiotropium is chemically different from the anticholinergic defined in the claims. A tiotropium/β2-agonist product would require a separate infringement analysis and would not ordinarily satisfy the claimed anticholinergic limitation literally.

Does the patent cover a fixed-dose inhaler containing any LAMA and LABA?

No. The claims require the specified azoniabicyclo[2.2.2]octane anticholinergic. A fixed-dose inhaler containing a different LAMA and a LABA would generally fall outside the literal scope.

Can a generic omit the patented combination method from its label?

Potentially. A generic applicant may use a section viii statement to carve out a patented method of use when FDA requirements permit the product to be approved for noninfringing uses. The availability of a carve-out depends on the approved labeling and the specific patent claims.

Are claims 5 and 11 validly drafted?

The supplied text creates a dependency issue because each claim depends from an S-isomer claim and then adds the R isomer. Validity and scope would depend on the issued patent text, prosecution history, and claim-construction principles. The apparent inconsistency could narrow those claims or support a definiteness challenge.

Does patent expiration remove all barriers to generic entry?

No. Expiration of U.S. Patent 7,750,023 would remove that patent as a blocking right, but generic entry could remain subject to FDA exclusivity, other listed patents, formulation patents, device patents, manufacturing patents, litigation settlements, and regulatory requirements.

References

U.S. Patent No. 7,750,023. (2010). Pharmaceutical compositions comprising an anticholinergic and a beta-2 agonist. United States Patent and Trademark Office.
Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. U.S. Department of Health and Human Services.
Food and Drug Administration. (2024). Orange Book: Approved drug products with therapeutic equivalence evaluations, patent and exclusivity information. U.S. Department of Health and Human Services.
United States Code. (2024). 35 U.S.C. §§ 154-156. Patent term and patent term extension provisions.
United States Patent and Trademark Office. (2024). Manual of Patent Examining Procedure. U.S. Department of Commerce.

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Spain	9901580	Jul 14, 1999

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1200431	⤷ Start Trial	C300573	Netherlands	⤷ Start Trial
European Patent Office	1200431	⤷ Start Trial	CA 2013 00002	Denmark	⤷ Start Trial
European Patent Office	1200431	⤷ Start Trial	PA2013001	Lithuania	⤷ Start Trial
European Patent Office	1200431	⤷ Start Trial	92132	Luxembourg	⤷ Start Trial
European Patent Office	1200431	⤷ Start Trial	2013/002	Ireland	⤷ Start Trial
European Patent Office	1200431	⤷ Start Trial	13C0001	France	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 7,750,023

Summary for Patent: 7,750,023