US Patent 9,333,195: Aclidinium Bromide Powder-Inhaler Claims, Patent Scope, and Generic-Entry Risk

US Patent 9,333,195 protects powder inhalants containing aclidinium, including aclidinium bromide, and methods of treating obstructive airway disease with those inhalants. Its strongest protection is formulation-specific: an accused product must contain the claimed aclidinium quaternary ammonium compound in a powder inhalant. The patent also covers formulations combined with beta-2 agonists, steroids, or phosphodiesterase IV inhibitors.

The patent does not claim every aclidinium product, every inhaler device, or every method of using aclidinium. Its principal commercial relevance is to dry-powder inhaler products containing aclidinium, including products marketed for chronic obstructive pulmonary disease.

What compound does US Patent 9,333,195 cover?

The compound identified in claim 1 is aclidinium in its quaternary ammonium form:

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

The positive nitrogen charge is balanced by an anion designated X-. The claim permits X- to be a pharmaceutically acceptable anion of a mono- or polyvalent acid.

Aclidinium bromide is the commercially important embodiment. In aclidinium bromide, the counterion is bromide. The claimed genus is broader than aclidinium bromide because it is not limited to bromide, chloride, iodide, or another single counterion.

Claim element	Scope
Active ingredient	The specified 3(R) aclidinium cation
Salt form	Any pharmaceutically acceptable anion of a mono- or polyvalent acid
Dosage form	Powder inhalant
Optional excipient	Pharmaceutically acceptable carrier or diluent
Expressed carrier	Lactose
Optional combination drugs	Beta-2 agonist, steroid, PDE IV inhibitor
Treatment indications	COPD, chronic bronchitis, bronchial hyperreactivity, asthma, or rhinitis

The claim is directed to the drug product and therapeutic use rather than to the inhaler hardware itself.

What are the independent claims in US 9,333,195?

Claims 1 and 9 are the principal independent claims.

Claim 1: powder inhalant composition

Claim 1 requires:

A powder inhalant;
The specified aclidinium cation;
A pharmaceutically acceptable counterion associated with the positive nitrogen.

The claim does not require lactose. It also does not require a specific particle-size distribution, carrier ratio, capsule, blister, inhaler mechanism, emitted-dose specification, or aerodynamic-performance parameter.

This makes claim 1 potentially broad at the composition level. A dry powder product containing aclidinium bromide can fall within the claim even if it uses a carrier other than lactose, provided the product satisfies the powder-inhalant limitation.

Claim 9: therapeutic method

Claim 9 covers administering an effective amount of the powder inhalant to a human or animal patient for:

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

The method claim requires use of the claim 1 powder inhalant. A method involving aclidinium delivered as a nebulized solution, metered-dose aerosol, tablet, injection, or other non-powder form would not literally satisfy the dosage-form limitation in claim 9.

How do claims 2 through 8 narrow the powder-inhaler protection?

Claims 2 through 8 create progressively narrower composition positions.

Claim	Additional limitation	Commercial relevance
2	Pharmaceutically acceptable carrier or diluent	Covers carrier-based dry powders
3	Carrier or diluent is lactose	Directly relevant to common lactose-blend inhalers
4	Beta-2 agonist	Covers aclidinium plus a bronchodilator from the beta-2 agonist class
5	Beta-2 agonist plus steroid or PDE IV inhibitor	Three-component combination
6	Steroid	Aclidinium-steroid combination
7	Steroid plus PDE IV inhibitor	Three-component combination without the beta-2 agonist requirement
8	PDE IV inhibitor	Aclidinium-PDE IV inhibitor combination

Claim 3 is narrower than claim 2 because it requires lactose. A competing product using lactose is exposed to claim 3 if it also satisfies claim 1. A product using magnesium stearate, mannitol, glucose, or another carrier may avoid claim 3 but remain exposed to claims 1 and 2 if it contains a pharmaceutically acceptable carrier.

Claims 4 through 8 do not require a particular beta-2 agonist, steroid, or PDE IV inhibitor. Their breadth depends on the ordinary meaning of those pharmacological classes and on whether the additional active ingredient is actually present in the powder inhalant.

What method-of-use protection does US 9,333,195 provide?

Claims 9 through 14 mirror the composition combinations in claims 4 through 8.

Claim	Method limitation
9	Administer the aclidinium powder inhalant for a listed respiratory disease
10	Add administration of a beta-2 agonist
11	Beta-2 agonist plus steroid or PDE IV inhibitor
12	Add administration of a steroid
13	Steroid plus PDE IV inhibitor
14	Add administration of a PDE IV inhibitor

These claims cover combination treatment even if the second medicine is administered separately, because the claims say “further comprising administering” the additional active ingredient. The physical combination therefore may not need to exist in a single inhaler for the method claims to be implicated.

For an ANDA applicant, the method claims create a labeling issue. A generic applicant may seek approval with a label that omits patented indications or combination-use language. Whether that approach avoids infringement depends on the proposed label, the approved labeling, the product’s instructions, and inducement evidence under 35 U.S.C. § 271(b).

What formulation patents protect aclidinium dry powder inhalers?

US 9,333,195 is principally a composition and method patent. It does not, based on the supplied claims, require a particular inhaler device or a narrowly defined powder-engineering profile.

The patent’s formulation protection can be divided into four levels:

Active pharmaceutical ingredient

The product must contain the specified aclidinium cation. A formulation containing a different long-acting muscarinic antagonist, such as glycopyrronium, umeclidinium, tiotropium, or revefenacin, is outside these claims.

Counterion

The claim covers pharmaceutically acceptable anions beyond bromide. This is important because changing the salt may not avoid claim 1 if the resulting compound still contains the claimed aclidinium cation and is used in a powder inhalant.

A change from bromide to another pharmaceutically acceptable anion would require analysis of:

Whether the anion is within the claim;
Whether the resulting salt remains a powder inhalant;
Whether the formulation is pharmaceutically acceptable;
Whether other patent or regulatory requirements apply.

Carrier and diluent

Lactose is expressly claimed in claim 3. A lactose-based blend is therefore a central infringement risk if the other claim elements are present.

The claims supplied do not specify:

Lactose grade;
Monohydrate or anhydrous lactose;
Carrier particle size;
Fine lactose fraction;
Drug-to-carrier ratio;
Moisture content;
Blending process; or
Device resistance.

Those parameters may be relevant to other patents in the aclidinium landscape, but they do not appear as limitations in claims 1 through 14.

Combination products

The combination claims cover aclidinium powder inhalants used with beta-2 agonists, steroids, and PDE IV inhibitors. They may be relevant to products combining a long-acting muscarinic antagonist with a long-acting beta-2 agonist or inhaled corticosteroid, subject to the exact product composition and use instructions.

How strong is the patent estate represented by US 9,333,195?

The patent has meaningful breadth in the active-ingredient and dosage-form combination, but its practical strength depends on validity and claim-construction issues.

Strength factor	Assessment
Active ingredient definition	Strong if the accused product contains aclidinium
Powder-inhalant limitation	Narrows the claim to dry-powder products
Counterion language	Broad because it is not limited to bromide
Lactose claim	Commercially relevant but narrower than claim 1
Combination claims	Potentially broad, but dependent on the actual actives and labeling
Method claims	Useful against labeled use, but vulnerable to skinny-label strategies
Device coverage	Limited on the supplied claim set
Manufacturing-process coverage	Not present in the supplied claims
Injectable, nebulized, or oral aclidinium	Outside the literal dosage-form scope

The central validity questions would include written description and enablement for the counterion genus, construction of “powder inhalant,” and whether the claimed composition was adequately disclosed across the full range of permitted salts and combinations. The combination claims also raise support and enablement questions if the specification does not adequately describe the full range of beta-2 agonists, steroids, and PDE IV inhibitors.

When does US Patent 9,333,195 lose exclusivity?

US patent term generally runs 20 years from the earliest effective nonprovisional filing date, subject to patent-term adjustment, patent-term extension, terminal disclaimers, and other statutory modifications under 35 U.S.C. §§ 154 and 156.

The issue date, May 10, 2016, does not determine the expiration date. A reliable expiration analysis must use the patent’s earliest effective filing date and the USPTO term-adjustment data. The patent number alone does not establish the final enforceable expiration date.

The patent can be distinguished from regulatory exclusivity:

Exclusivity type	Relevance
Patent term	Controlled by the patent family and USPTO adjustments
New chemical entity exclusivity	Based on FDA approval of the active ingredient
Three-year exclusivity	May apply to certain new clinical investigations
Pediatric exclusivity	Adds six months to qualifying regulatory exclusivity and listed patents
Orphan exclusivity	Applies only if the approval qualifies
Inhaler-device exclusivity	Depends on separate patents or regulatory provisions

Patent expiration and FDA exclusivity may end on different dates. A generic applicant can face an ANDA obstacle after regulatory exclusivity has expired if a listed patent remains enforceable.

What is the Orange Book status of US 9,333,195?

The relevant reference product is an aclidinium bromide inhalation powder product, historically marketed as Tudorza Pressair in the United States. The Orange Book determines whether a patent is listed against a particular approved drug product and whether an ANDA applicant must address it.

A patent can be relevant to the product without automatically being listed in the Orange Book. Listing depends on FDA rules governing patents that claim:

The approved drug substance;
The approved drug product; or
An approved method of use.

For an aclidinium dry-powder product, the key Orange Book questions are:

Whether US 9,333,195 is listed against the relevant NDA;
Whether the listing is for the drug substance, drug product, or method of use;
Which claims correspond to the approved labeling;
The patent expiration date recorded by FDA;
Whether pediatric exclusivity modifies the listed date; and
Whether the listing remains active following FDA delisting decisions or sponsor corrections.

The supplied claims are product and method claims, not device-only claims. That makes the patent more likely to have Orange Book relevance than a patent directed solely to an inhaler actuator or manufacturing machine, but the claim language alone does not establish the current Orange Book entry.

What Paragraph IV challenges could target US 9,333,195?

An ANDA applicant seeking approval for generic aclidinium inhalation powder would ordinarily evaluate four certification pathways:

Certification	Effect
Paragraph I	No patent information is listed
Paragraph II	Listed patent has expired
Paragraph III	Applicant will wait until listed patent expires
Paragraph IV	Patent is invalid, unenforceable, or will not be infringed

A Paragraph IV challenge could attack US 9,333,195 on several grounds.

Non-infringement arguments

A generic applicant could argue that its product:

Is not a powder inhalant within the claim construction;
Uses a different active ingredient;
Does not contain the claimed aclidinium cation;
Does not contain a pharmaceutically acceptable counterion within the claim;
Does not include lactose, for claims requiring lactose;
Does not contain the claimed combination active;
Uses a label that omits the patented method of use.

Invalidity arguments

Potential invalidity theories could include:

Anticipation under 35 U.S.C. § 102;
Obviousness under 35 U.S.C. § 103;
Lack of written description under 35 U.S.C. § 112(a);
Lack of enablement under § 112(a);
Indefiniteness under § 112(b);
Double patenting, if applicable;
Terminal-disclaimer enforceability issues, if applicable.

The strongest prior-art attack would need to disclose the claimed aclidinium compound in a powder inhalant, not merely aclidinium as a chemical compound or a solution formulation. Prior art directed to the active ingredient alone may not anticipate claim 1 without the inhalation-powder limitation.

Which companies are most relevant to generic entry?

The commercial parties fall into four groups.

Originator and branded-product parties

Aclidinium was developed and commercialized through Almirall and regional commercialization partners, including AstraZeneca-related commercial interests for Tudorza Pressair. The relevant patent-holder analysis should distinguish:

Original applicant;
Current assignee;
NDA holder;
Listed patent owner;
Exclusive licensee; and
Litigation plaintiff.

These entities are not necessarily identical.

Generic inhalation manufacturers

Potential entrants include companies with established dry-powder inhaler capabilities, such as:

Viatris;
Teva;
Cipla;
Lupin;
Sun Pharma;
Sandoz;
Glenmark; and
Other firms with ANDA or inhalation-device platforms.

A generic entrant must address both formulation equivalence and device-related requirements. Inhaled products generally create more technical development risk than conventional oral tablets because FDA review can examine emitted dose, aerodynamic particle-size distribution, device resistance, dose uniformity, and performance across dose counters and storage conditions.

Combination-product competitors

Competitive pressure also comes from alternative long-acting bronchodilator products, including:

Tiotropium;
Glycopyrronium or glycopyrrolate;
Umeclidinium;
Formoterol combinations;
Vilanterol combinations; and
Long-acting muscarinic antagonist/inhaled corticosteroid products.

These products may compete with aclidinium commercially without infringing US 9,333,195 if they do not contain aclidinium.

What litigation and settlement issues affect the patent?

A complete litigation assessment requires the current USPTO Patent Center, FDA Orange Book, PACER, and district-court docket records. The supplied claims establish no litigation outcome, settlement, license, or covenant not to sue.

The principal litigation triggers would be:

A Paragraph IV notice letter;
An action under 35 U.S.C. § 271(e)(2);
A 30-month stay under the Hatch-Waxman framework;
A preliminary injunction request;
Claim construction concerning “powder inhalant”;
A validity challenge to the aclidinium salt genus; and
Settlement terms setting an authorized generic or entry date.

No settlement date or generic launch date should be inferred from the patent’s issuance or from the existence of an Orange Book listing.

How does US 9,333,195 compare with other aclidinium patents?

US 9,333,195 occupies the formulation-and-use segment of the aclidinium estate.

Patent category	Typical subject matter	Relationship to US 9,333,195
Compound patents	Aclidinium molecule or salts	May be broader at the chemical level
Powder formulation patents	Carrier, particle engineering, blending, stability	May overlap or create separate barriers
Device patents	Pressair or comparable inhaler mechanism	Not covered by the supplied claims
Combination patents	Aclidinium plus beta-2 agonist or steroid	Overlap with claims 4-8 and 10-14
Method patents	COPD or asthma treatment	Overlap with claims 9-14
Manufacturing patents	Salt preparation, micronization, blending, filling	Not covered by the supplied claims
Regulatory patents	FDA-listed product or use claims	Determine ANDA certification obligations

A generic product may avoid one patent category and still face another. For example, changing the carrier may avoid a lactose-specific claim but not claim 1. Changing the device may avoid a device patent but not the composition claims. Removing a combination indication may reduce method-of-use exposure while leaving product-claim exposure intact.

What generic launch scenarios exist?

Scenario 1: Paragraph III launch

The applicant accepts the patent and waits until the listed patent expiration date. This reduces litigation risk but delays market entry.

Scenario 2: Paragraph IV challenge

The applicant alleges that the patent is invalid, unenforceable, or not infringed. The sponsor may file a patent suit, triggering the statutory stay. Launch timing then depends on settlement, judgment, appeal, or stay expiration.

Scenario 3: Skinny-label launch

The applicant removes patented combination or disease-use language while retaining nonprotected indications. This strategy is more useful against the method claims than against claim 1, because a product containing aclidinium powder may still infringe the composition claim regardless of label wording.

Scenario 4: Formulation design-around

The applicant may attempt to use a different carrier, a different salt, a non-powder dosage form, or a different active ingredient. The practical value of each design-around depends on whether claims 1 and 2 remain applicable and whether separate patents cover the alternative formulation or device.

What geographic coverage does the patent provide?

US 9,333,195 provides protection only in the United States. Parallel protection must be evaluated country by country through the corresponding international and national patent-family members.

Relevant jurisdictions may include:

European Patent Convention states;
United Kingdom;
Canada;
Australia;
Japan;
China;
South Korea;
Brazil; and
Other markets where aclidinium products were approved or commercialized.

Foreign counterparts may differ in:

Claim scope;
Granted status;
Opposition history;
Patent-term adjustment;
Supplementary protection certificate eligibility;
Validity outcomes; and
Orange Book-equivalent regulatory relevance.

US claim scope cannot be exported directly to foreign jurisdictions.

Key Takeaways

US 9,333,195 claims a powder inhalant containing the specified aclidinium cation with a pharmaceutically acceptable anion.
Aclidinium bromide is the commercially important embodiment.
Claim 1 is the core composition claim and is not limited to bromide or lactose.
Claim 3 specifically covers lactose-containing formulations.
Claims 4 through 8 address combinations with beta-2 agonists, steroids, and PDE IV inhibitors.
Claims 9 through 14 cover treatment of COPD and related respiratory diseases, including combination administration.
The patent does not, based on the supplied claims, cover every aclidinium dosage form, inhaler device, or manufacturing process.
A generic dry-powder aclidinium product would face the highest direct risk under claim 1.
A skinny label may reduce method-of-use exposure but would not necessarily avoid product-claim infringement.
Patent expiration must be calculated from the patent family’s effective filing date and USPTO term adjustments, not from the 2016 issue date.
Orange Book listing, current ownership, litigation, and settlement status require docket-level verification and cannot be established from the claim text alone.

FAQs About US Patent 9,333,195

Does US 9,333,195 cover aclidinium bromide tablets?

No. The claims require a powder inhalant. An oral tablet containing aclidinium bromide would not literally satisfy the claimed dosage form.

Does changing bromide to another salt avoid US 9,333,195?

Not necessarily. Claim 1 covers the aclidinium cation associated with a pharmaceutically acceptable anion of a mono- or polyvalent acid. A different acceptable salt may remain within the claim.

Does a lactose-free aclidinium inhaler avoid the patent?

No. Lactose is required only by claim 3. A lactose-free product may still fall within claims 1 and 2.

Are tiotropium and umeclidinium covered by this patent?

No. The claims identify a specific aclidinium cation. Other long-acting muscarinic antagonists are chemically different active ingredients.

Can a generic company launch before patent expiration with a noninfringing label?

Potentially, if the product avoids enforceable composition claims and the proposed labeling does not induce infringement of the method claims. The analysis depends on the final product, label, Orange Book listings, and litigation outcome.

Sources

United States Patent and Trademark Office. (2016). U.S. Patent No. 9,333,195, powder inhalant and therapeutic method claims.
United States Code. (2023). 35 U.S.C. §§ 102, 103, 112, 154, 156, 271.
U.S. Food and Drug Administration. (2023). Approved drug products with therapeutic equivalence evaluations.
U.S. Food and Drug Administration. (2023). Orange Book: Approved drug products with therapeutic equivalence evaluations.
U.S. Food and Drug Administration. (2023). ANDA submissions: Paragraph certifications and patent listing requirements.

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
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Summary for Patent: 9,333,195