US Patent 8,034,809: Olodaterol Patent Scope, Claims, Expiration and Competitive Landscape

US Patent 8,034,809 protects methods of treating respiratory complaints with five specific R-configured benzoxazinone beta-2 agonists, including olodaterol hydrochloride. The broadest commercial relevance is claim 1, which covers once-daily or other therapeutic administration of olodaterol hydrochloride for respiratory disease. The patent does not claim an inhaler, formulation, device, manufacturing process, or broad chemical genus.

The patent’s primary commercial compound is olodaterol hydrochloride, marketed by Boehringer Ingelheim as Striverdi Respimat. The FDA-approved indication is once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, or COPD. The patent claims also recite asthma and other respiratory conditions, but those broader indications do not establish FDA approval for olodaterol in asthma.[1]

What does US Patent 8,034,809 cover?

US Patent 8,034,809 covers five individual hydrochloride compounds administered to treat respiratory complaints. The claims are method-of-treatment claims rather than composition-of-matter claims.

Claim group	Compound described in the claims	Commercial relevance
Claims 1-8	R-6-hydroxy-8-{1-hydroxy-2-[2-(4-methoxyphenyl)-1,1-dimethylethylamino]ethyl}-4H-benzo[1,4]oxazin-3-one hydrochloride	Olodaterol hydrochloride
Claims 9-16	R-compound with a 2,4-difluorophenyl substituent	No established FDA-approved product identified from the claims
Claims 17-24	R-compound with a 3,5-difluorophenyl substituent	No established FDA-approved product identified from the claims
Claims 25-32	R-compound with a 4-ethoxyphenyl substituent	No established FDA-approved product identified from the claims
Claims 33-40	R-compound with a 4-fluorophenyl substituent	No established FDA-approved product identified from the claims

The patent assigns a separate independent claim to each compound. Claims 2, 4, 6 and 8 specify once-daily treatment for the first compound. Claims 10, 12, 14 and 16 do the same for the second compound, with equivalent structures for the remaining compounds.

The patent therefore has five independent compound-specific treatment claims and 35 dependent claims covering treatment frequency and respiratory indications.[2]

What is the scope of claim 1?

Claim 1 covers:

A method of treating a respiratory complaint;
Administering a therapeutically effective amount;
Of the R-configured 4-methoxyphenyl benzoxazinone hydrochloride compound.

The compound in claim 1 is olodaterol hydrochloride. The claim does not limit treatment to COPD, asthma, inhalation, a particular device, a particular dose, or once-daily administration.

That structure gives claim 1 significant breadth within the olodaterol product space. A product or treatment method could fall within claim 1 even if it uses a different inhaler, excipient system, propellant-free delivery mechanism, or inhalation schedule, provided the accused conduct involves administering the claimed compound in a therapeutically effective amount to treat a respiratory complaint.

The claim does not cover every beta-2 agonist. It is limited to the expressly recited chemical structure and hydrochloride form. A different beta-2 agonist, a structurally modified analog, or a different active ingredient would not literally satisfy claim 1.

How do the dependent claims narrow the patent?

The dependent claims narrow the independent claims along two principal dimensions: treatment frequency and disease indication.

Limitation	Claims covering olodaterol hydrochloride	Legal effect
Once-daily treatment	2	Narrows claim 1 by dosing frequency
COPD	3	Narrows claim 1 to COPD treatment
COPD, once daily	4	Narrows claims 3 and 1
Asthma	5	Narrows claim 1 to asthma treatment
Asthma, once daily	6	Narrows claims 5 and 1
Listed respiratory complaints	7	Limits disease category to the listed conditions
Listed complaints, once daily	8	Combines claims 7 and 2

The same pattern applies to claims 9-40.

The dependent claims do not add a dose amount, delivery device, formulation, patient age, severity threshold, or treatment duration. Claim 7’s reference to “paediatric asthma” supplies an indication limitation, but does not add a pediatric dose or administration protocol.

Which compound in US 8,034,809 is olodaterol?

The first claimed compound is olodaterol hydrochloride, also known as BI 1744. Its chemical identity is the R-enantiomer of the substituted benzoxazinone beta-2 agonist recited in claim 1.

Olodaterol is a long-acting beta-2 adrenergic agonist. The approved product, Striverdi Respimat, delivers olodaterol hydrochloride through the Respimat inhalation device. The FDA-approved regimen is two inhalations once daily, providing a total daily dose of 5 micrograms of olodaterol.[1]

The patent’s claims are broader than the approved label in two respects:

The patent recites respiratory complaints that include asthma, acute asthma attacks and chronic bronchitis.
The approved US indication is maintenance treatment of airflow obstruction in COPD, not acute asthma treatment or asthma monotherapy.

A patent claim can encompass an unapproved use. FDA labeling and patent claim scope are separate legal questions.

What is the FDA and Orange Book status of US 8,034,809?

Striverdi Respimat was approved by the FDA on July 31, 2014, under NDA 203108.[1] The product is a small-molecule inhalation drug, not a biologic. Its regulatory pathway is an NDA, and any generic competitor would generally use an abbreviated new drug application, or ANDA.

US 8,034,809 has been associated with the US Orange Book patent estate for Striverdi Respimat. The patent’s ordinary term is generally reported as expiring on December 23, 2025, based on the relevant priority and filing history.[3] The exact blocking position for a generic applicant depends on the complete Orange Book listing, patent-term adjustment, any patent-term extension, and the status of other listed patents.

Regulatory or patent event	Date or status
US patent	8,034,809
Patent holder	Boehringer Ingelheim-related entity
Product	Striverdi Respimat
Active ingredient	Olodaterol hydrochloride
FDA approval	July 31, 2014
NDA	203108
FDA pathway	NDA
Generic pathway	ANDA
Reported patent expiration	December 23, 2025
Biologic exclusivity	Not applicable
Orange Book relevance	Product and method-of-use patent estate

The FDA Orange Book should be treated as the operative source for listed patents and pediatric information blocking an ANDA applicant. Patent expiration shown in a commercial database is not, by itself, a complete determination of generic launch timing.[3]

When does olodaterol lose exclusivity?

Olodaterol’s practical exclusivity is determined by a combination of FDA regulatory exclusivity and patent protection.

The relevant milestones are:

FDA approval: July 31, 2014.
New chemical entity exclusivity, if granted for the active moiety: generally five years from approval.
Reported expiration of US 8,034,809: December 23, 2025.
Potential generic launch: dependent on the full Orange Book estate, ANDA approval, Paragraph IV litigation, settlement terms and any applicable pediatric extension.

The five-year NCE period would have ended before the reported patent expiration. As a result, the principal commercial barrier has been patent protection rather than FDA NCE exclusivity.

If an ANDA applicant files a Paragraph IV certification against a listed patent, the first applicant’s notice and litigation can affect the timing of approval. A 30-month stay may apply if the patent owner or NDA holder files an infringement action within the statutory period.[4]

What Paragraph IV challenges affect olodaterol?

A Paragraph IV challenge would require an ANDA applicant to certify that a listed patent is invalid, unenforceable or will not be infringed by the proposed generic product. The applicant would then need to provide notice to the patent owner and NDA holder.

For US 8,034,809, the main potential challenge theories would be:

Invalidity theories

An ANDA applicant could challenge:

Anticipation based on prior disclosure of the exact R-enantiomer and hydrochloride salt;
Obviousness based on prior beta-2 agonists, benzoxazinone scaffolds and stereochemical optimization;
Written description or enablement, particularly for the full respiratory-complaint scope;
Indefiniteness of “respiratory complaints” or “therapeutically effective amount.”

The compound-specific structure and defined R configuration reduce the breadth of an obviousness attack compared with a broad Markush claim. The method language, however, creates potential issues concerning the breadth of the disease language and the evidentiary support for all claimed indications.

Noninfringement theories

A generic applicant could argue that its product does not infringe if it:

Uses a different active ingredient;
Does not contain olodaterol hydrochloride;
Is labeled only for a use outside the asserted method claims;
Does not include the claimed indication in its labeling;
Does not direct once-daily use, where the asserted claim requires that limitation.

A “skinny label” strategy can be relevant for method-of-use patents. It is less effective against a claim that broadly covers administering olodaterol hydrochloride to treat respiratory complaints, because the product’s principal COPD indication would likely correspond to the scope of claim 1 and claims 3-4.

No specific Paragraph IV complaint, judicial holding or settlement agreement is established solely by the claim text supplied. A current litigation conclusion requires the operative court docket and FDA patent listing.

How strong is the patent estate for olodaterol?

US 8,034,809 is strong against literal use of olodaterol hydrochloride for respiratory treatment, but it is not a complete product monopoly.

Strength factor	Assessment
Chemical specificity	Strong; the claims recite a defined R-enantiomer and hydrochloride salt
Core COPD use	Strong; claim 1 is not limited to a particular device or schedule
Once-daily use	Strong where once-daily administration is proven
Asthma scope	Legally recited but commercially limited by FDA labeling
Formulation protection	Not provided by the supplied claims
Inhaler-device protection	Not provided by the supplied claims
Manufacturing protection	Not provided by the supplied claims
Alternative salts or forms	Potential design-around issue, subject to equivalence and other patents
Other olodaterol patents	May provide separate formulation, device or use barriers
Biosimilar protection	Not relevant because olodaterol is a small molecule

The patent’s most valuable feature is the active-ingredient-specific treatment claim. An ANDA applicant cannot avoid that claim merely by substituting a different inhaler if the generic still administers olodaterol hydrochloride to treat COPD.

The patent is less comprehensive against a competitor that develops a different long-acting beta-2 agonist. The four additional compounds in claims 9, 17, 25 and 33 expand the patent’s chemical coverage, but they do not create a broad genus covering all related beta-2 agonists.

What formulations and devices are protected?

The supplied claims do not claim:

A metered-dose inhaler;
A soft-mist inhaler;
A dry-powder inhaler;
A specific propellant;
A particular excipient;
A particle-size distribution;
A dose cartridge;
A nozzle or spray mechanism;
A combination with tiotropium or another bronchodilator;
A manufacturing process.

The commercial Striverdi product uses the Respimat device, but infringement of US 8,034,809 does not require use of Respimat. Separate patents may protect the formulation, cartridge, inhaler or combination product. Those patents must be reviewed independently from the compound-specific method claims.

This distinction matters for generic entry. A generic company could potentially avoid a device patent while still infringing the active-ingredient method claims, or avoid the method patent while encountering device or formulation patents.

What litigation and settlement risks affect generic entry?

Generic entry risk depends on the combined Orange Book estate rather than US 8,034,809 alone.

The principal scenarios are:

Scenario	Commercial result
No ANDA Paragraph IV challenge	Entry generally waits for patent expiry or an authorized arrangement
Paragraph IV challenge with no suit	FDA approval can proceed subject to regulatory conditions
Timely patent litigation	Potential 30-month approval stay
Early invalidity or noninfringement win	Earlier launch may become possible
Settlement with delayed entry	Launch date depends on the settlement terms
At-risk launch	Generic launches before final patent resolution, creating damages and injunction risk
Patent expiry without successful challenge	Entry begins after regulatory approval and applicable exclusivity

A settlement agreement could permit entry before the stated patent expiration if the NDA holder grants a license, but no such settlement should be inferred from the claims. Reverse-payment analysis would require the actual agreement and FTC or court record.[5]

How does olodaterol compare with competing long-acting bronchodilators?

Olodaterol competes primarily in the once-daily long-acting bronchodilator segment.

Product	Active ingredient	Class	Typical commercial positioning
Striverdi Respimat	Olodaterol	LABA	Once-daily COPD maintenance
Spiriva Respimat	Tiotropium	LAMA	Once-daily COPD maintenance
Incruse Ellipta	Umeclidinium	LAMA	Once-daily COPD maintenance
Arcapta Neohaler	Indacaterol	LABA	Once-daily COPD maintenance
Anoro Ellipta	Umeclidinium/vilanterol	LAMA/LABA	Once-daily COPD maintenance
Stiolto Respimat	Tiotropium/olodaterol	LAMA/LABA	Once-daily COPD maintenance
Bevespi Aerosphere	Glycopyrrolate/formoterol	LAMA/LABA	Twice-daily COPD maintenance

The principal combination-product risk is Stiolto Respimat, which combines tiotropium and olodaterol. A generic olodaterol product could compete with Striverdi but would not necessarily replicate the clinical or commercial position of the fixed-dose LAMA/LABA combination.

Biosimilar competition is irrelevant. Olodaterol is a chemically synthesized small molecule, so the competitive pathway is generic substitution through ANDA litigation and regulatory review, not the abbreviated biologics license application process under the Public Health Service Act.[6]

What geographic coverage does US 8,034,809 provide?

US 8,034,809 provides rights enforceable in the United States only. It does not directly control:

European Union sales;
United Kingdom sales;
Canadian sales;
Japanese sales;
Emerging-market sales;
Manufacturing outside the United States, unless the conduct falls within US statutory provisions.

The corresponding international patent family may contain counterpart applications with different claim scope, prosecution histories and expiration dates. A global launch analysis must separate US product claims from foreign compound, formulation, use and device patents.

What are the main design-around strategies?

Potential design-around routes include:

Using a different beta-2 agonist, such as indacaterol, formoterol or vilanterol.
Developing a structurally distinct olodaterol analog.
Using a different stereoisomer, subject to other patent claims and clinical viability.
Using a different salt or solid-state form, subject to literal and equivalents analysis.
Pursuing a non-COPD label, although clinical and regulatory value may be limited.
Avoiding once-daily labeling to avoid dependent claims 2, 4, 6 and 8, while still confronting claim 1.
Designing a separate device or formulation, which does not avoid claim 1 if olodaterol hydrochloride remains the active ingredient.

The first strategy is the most commercially realistic. The remaining strategies may avoid individual claim limitations but can encounter other patents, regulatory obstacles or the doctrine of equivalents.

Key Takeaways

US 8,034,809 is primarily an olodaterol hydrochloride method-of-treatment patent.
Claim 1 is the central commercial claim and broadly covers therapeutic administration for respiratory complaints.
Claims 2-8 narrow olodaterol treatment by once-daily dosing and named respiratory diseases.
Claims 9-40 cover four additional R-configured benzoxazinone hydrochlorides.
The claims do not directly protect the Respimat device, formulation, inhaler cartridge or manufacturing process.
Striverdi Respimat was approved by FDA on July 31, 2014, for once-daily COPD maintenance treatment.
The reported expiration date for US 8,034,809 is December 23, 2025.
Generic entry depends on the full Orange Book patent estate, Paragraph IV activity, litigation and any settlement.
Biosimilar competition does not apply; olodaterol is a small-molecule generic product.
The strongest design-around is substitution of a different active ingredient, not merely a different inhaler.

FAQs About US Patent 8,034,809

Is US 8,034,809 a composition-of-matter patent?

No. The supplied claims are methods of treatment. They recite administration of specific hydrochloride compounds but do not claim the compounds as compositions standing alone.

Does US 8,034,809 cover olodaterol inhalers?

It can cover the use of olodaterol hydrochloride delivered through an inhaler, but the claims do not require the Respimat device or any particular inhaler.

Does the patent cover olodaterol for asthma?

The claims expressly recite asthma and several asthma subcategories. The FDA-approved US labeling for Striverdi Respimat is directed to COPD maintenance treatment, so patent scope and approved-use scope differ.

Can a generic olodaterol product launch after December 23, 2025?

Potentially, but the date does not independently guarantee launch. Other Orange Book patents, regulatory review, pediatric extensions, litigation outcomes and settlement restrictions can affect the actual entry date.

Are the four non-olodaterol compounds commercially important?

They expand the patent’s chemical and treatment coverage, but the principal commercial value is concentrated in the first compound, olodaterol hydrochloride, because it corresponds to the FDA-approved Striverdi product.

References

U.S. Food and Drug Administration. (2014). Striverdi Respimat prescribing information. FDA.
United States Patent and Trademark Office. (2011). U.S. Patent No. 8,034,809, methods for the treatment of respiratory complaints. USPTO.
U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.
21 U.S.C. § 355(j)(2)(A)(vii)(IV), (j)(5)(B)(iii).
Federal Trade Commission. (2013). Authorized generic drugs: Short-term effects and long-term impact. FTC.
U.S. Food and Drug Administration. (2020). Generic drugs and biologics: Regulatory pathways. FDA.

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Germany	10 2004 024 454	May 14, 2004

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2005243469	⤷ Start Trial
Brazil	PI0511102	⤷ Start Trial
Canada	2562859	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 8,034,809

Summary for Patent: 8,034,809