Details for Patent: 9,750,726

Which drugs does patent 9,750,726 protect, and when does it expire?

Patent 9,750,726 protects ANORO ELLIPTA and TRELEGY ELLIPTA and is included in two NDAs.

This patent has sixty-six patent family members in forty countries.

Summary for Patent: 9,750,726

Title:	Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist
Abstract:	Combinations of a muscarinic acetylcholine receptor antagonist and a beta 2 agonist for inhaled administration via the nose or mouth, and methods of using them are provided.
Inventor(s):	Darrell Baker, Mark Bruce, Glenn Crater, Brian Noga, Marian Thomas, Patrick Wire
Assignee:	Glaxo Group Ltd
Application Number:	US14/970,945
Patent Claim Types: see list of patent claims	Composition; Compound; Delivery; Dosage form;

US Patent 9,750,726: Scope, Claims, Expiration, Orange Book Status, and Trelegy Patent Landscape

US Patent 9,750,726 protects specific dry-powder inhaled combinations of umeclidinium bromide, vilanterol trifenatate, and, in the broader triple-therapy claims, fluticasone furoate. The patent maps directly to the active ingredients and dose strengths in GlaxoSmithKline's Trelegy Ellipta product: umeclidinium 62.5 mcg, vilanterol 25 mcg, and fluticasone furoate 100 mcg per dose.[1][2]

The patent's commercial importance comes from its combination-product coverage. It does not claim umeclidinium, vilanterol, fluticasone furoate, or the Ellipta inhaler platform in isolation. Its claims focus on the combination, dry-powder presentation, once-daily administration, simultaneous delivery, excipient architecture, and alternative device formats.

What drug product does US Patent 9,750,726 cover?

The chemical names in the claims correspond to the following active pharmaceutical ingredients:

Claim chemical	Drug name	Pharmacologic class	Claimed amount
4-[hydroxy(diphenyl)methyl]-1-{2-[(phenylmethyl)oxy]ethyl}-1-azoniabicyclo[2.2.2]octane bromide	Umeclidinium bromide	Long-acting muscarinic antagonist	62.5 mcg
4-{(1R)-2-[(6-{2-[(2,6-dichlorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol triphenylacetate	Vilanterol trifenatate	Long-acting beta-2 agonist	25 mcg
Fluticasone furoate	Inhaled corticosteroid	100 mcg in triple-therapy claims

The two-drug combination in claims 1-11 is umeclidinium/vilanterol. The three-drug combination in claims 8-9 and 12-17 is umeclidinium/vilanterol/fluticasone furoate.

The triple combination corresponds to Trelegy Ellipta 100/62.5/25 mcg, approved by the FDA in 2017 for chronic obstructive pulmonary disease and later expanded for asthma.[2][3]

How are the claims organized?

Independent claim structure

The patent contains three commercially significant independent claim groups.

Claim	Combination	Principal limitation
1	Umeclidinium plus vilanterol	Once-daily, simultaneous dry-powder administration
10	Umeclidinium plus vilanterol	Separate dry-powder compositions containing lactose and specified magnesium stearate levels
12	Umeclidinium plus vilanterol plus fluticasone furoate	Once-daily simultaneous dry-powder administration

Claims 2-7 narrow claim 1. Claims 11 and 13-17 narrow claims 10 and 12.

The patent therefore contains two related protection layers:

1. Broad combination-product coverage for the active ingredients and dose strengths.
2. More specific formulation and presentation coverage for carrier excipients, magnesium stearate, separate powder blends, and unit-dose packaging.

What is the scope of claim 1?

Claim 1 requires all of the following:

• Umeclidinium bromide.
• A dose of about 62.5 mcg.
• A dry-powder form.
• Vilanterol trifenatate.
• A dose of about 25 mcg.
• A dry-powder form.
• Suitability for once-daily administration.
• A presentation adapted for simultaneous administration.

This is a product claim, not a method-of-treatment claim. Infringement would generally turn on whether an accused product contains the specified ingredients and dose strengths in a dry-powder combination configured for simultaneous once-daily delivery.

The term "about" creates numerical tolerance around the claimed dose, but it does not eliminate the dose limitation. A product materially outside the 62.5/25 mcg strength profile would have a stronger non-infringement position under a literal claim analysis.

The claim does not require that the two active ingredients be physically blended into one powder. Claim 3 expressly covers both:

• Separate dry-powder compositions; and
• A single admixed dry-powder composition.

That distinction matters because a generic or follow-on product could attempt to use separate reservoirs, blisters, capsules, or powder compartments while still falling within the claim.

What formulations are protected by US Patent 9,750,726?

Claims 4-7 add formulation and packaging limitations.

Lactose-containing formulations

Claim 4 requires a carrier comprising lactose. In practice, lactose is a common carrier in dry-powder inhalers because it supports powder handling, metering, dispersion, and dose uniformity.

A product without lactose could avoid claim 4, but it could remain exposed to claim 1 if the other limitations are met.

Magnesium stearate formulations

Claims 5 and 6 address a ternary-agent formulation. The specified ternary agent is magnesium stearate at:

• About 0.6% w/w in the umeclidinium composition; and
• About 1.0% w/w in the vilanterol composition.

Claim 10 makes these formulation limitations central to an independent claim. It requires:

• A first dry-powder composition containing umeclidinium, lactose, and approximately 0.6% w/w magnesium stearate.
• A second dry-powder composition containing vilanterol, lactose, and approximately 1.0% w/w magnesium stearate.
• Simultaneous once-daily administration.

The separate magnesium stearate concentrations are technically important. They create a formulation-specific barrier that is narrower than the active-ingredient combination claims but potentially more difficult to design around if comparable powder-performance characteristics are needed.

Unit-dose formats

Claims 7, 15, and 17 cover unit-dose presentations including:

• Capsules.
• Cartridges.
• Blisters.

The claims are not limited to the Ellipta device name. They recite functional device categories, including:

• Reservoir dry-powder inhalers.
• Unit-dose dry-powder inhalers.
• Pre-metered multi-dose dry-powder inhalers.

That language broadens the potential reach beyond one branded inhaler architecture, although an accused product must still satisfy the claimed combination and administration requirements.

How does the fluticasone furoate triple-therapy coverage work?

Claims 8 and 9 depend from claim 1 and add fluticasone furoate. Claim 9 specifies approximately 100 mcg per dose.

Claims 12-17 independently address the three-drug product. Claim 12 requires:

• Umeclidinium at 62.5 mcg per dose.
• Vilanterol at 25 mcg per dose.
• Fluticasone furoate at 100 mcg per dose.
• Dry-powder presentation.
• A carrier excipient.
• A ternary agent.
• Simultaneous once-daily administration.

Claim 13 divides the product into two compositions:

1. A first composition containing umeclidinium, vilanterol, carrier excipient, and ternary agent.
2. A second composition containing fluticasone furoate and carrier excipient.

Claim 14 identifies the preferred excipients as lactose monohydrate and magnesium stearate. Claims 15-17 add unit-dose packaging and inhaler-device limitations.

This structure allows the patent to cover both an integrated triple-therapy product and a product in which fluticasone furoate is physically separated from the umeclidinium/vilanterol powder.

Does the patent cover Trelegy Ellipta?

Yes. The claimed actives and dose strengths correspond to Trelegy Ellipta 100/62.5/25 mcg.[2]

The strongest product mapping is claim 12 and its dependent claims:

Trelegy attribute	Patent limitation
Umeclidinium 62.5 mcg	Claim 12(a)
Vilanterol 25 mcg	Claim 12(b)
Fluticasone furoate 100 mcg	Claim 12(c)
Dry powders	Claim 12
Carrier excipient	Claim 12(d)
Ternary agent	Claim 12(e)
Simultaneous administration	Claim 12
Lactose monohydrate and magnesium stearate	Claim 14
Unit-dose blister or comparable format	Claims 15 and 17

The public FDA labeling for Trelegy identifies the product as a once-daily inhaled combination containing fluticasone furoate, umeclidinium, and vilanterol.[2]

What is the Orange Book status of US Patent 9,750,726?

US Patent 9,750,726 has been listed in FDA Orange Book records for Trelegy Ellipta products.[4] Its listing gives GSK a patent-based mechanism to notify an ANDA applicant that a proposed generic product may implicate the patent.

Orange Book listing does not itself establish infringement or validity. It affects the ANDA process through the Hatch-Waxman patent-certification framework.

A generic applicant seeking approval for a product referencing Trelegy may submit:

• Paragraph III certification, accepting delayed approval until patent expiry;
• Paragraph IV certification, asserting that the patent is invalid, unenforceable, or not infringed; or
• A section viii statement where the relevant indication or use is carved out, although that route is less useful when the patent claims the product itself rather than only a method of treatment.

Because the principal claims are product claims covering the specific triple combination and doses, a section viii strategy would not by itself remove the core product-combination exposure.

When does US Patent 9,750,726 lose exclusivity?

The patent issued on September 5, 2017.[1] Its effective expiration depends on the patent's earliest effective nonprovisional priority date, patent-term adjustment, and any applicable terminal disclaimer.

The patent belongs to the early Trelegy development family and has a nominal 20-year term running into the 2030 period, subject to the USPTO-calculated patent-term adjustment. The exact enforceable expiration date should be taken from the current USPTO patent-term calculation and the applicable Orange Book listing rather than inferred solely from the issue date.

FDA regulatory exclusivity is separate from patent exclusivity:

Protection	Relevance to Trelegy
New drug application approval	FDA approval for the branded product
Orphan-drug exclusivity	Not the principal protection for Trelegy
New chemical entity exclusivity	Not applicable to the full combination in the same manner as a newly approved single active ingredient
Patent protection	Combination, formulation, and presentation claims
Pediatric exclusivity	Applies only if granted and reflected in FDA records
Orange Book listing	Supports Hatch-Waxman notice and litigation procedures

Patent expiration does not automatically guarantee immediate generic launch. Remaining patents, regulatory exclusivities, litigation stays, settlements, device rights, and manufacturing issues can affect entry timing.

Which companies are challenging the Trelegy patent estate?

Publicly available Orange Book and court records should be reviewed on a continuing basis for Paragraph IV notices and ANDA litigation involving Trelegy. US Patent 9,750,726 is only one part of the broader Trelegy estate, and a challenger would likely evaluate multiple listed patents covering:

• The umeclidinium/vilanterol combination.
• The triple combination with fluticasone furoate.
• Powder formulations.
• Device architecture.
• Dose metering and delivery.
• Manufacturing and particle-engineering techniques.

The absence of a confirmed public challenge to this individual patent would not establish that the patent is unchallenged. Paragraph IV notices are often served privately before litigation becomes visible in federal court dockets.

What patent litigation affects US Patent 9,750,726?

The principal litigation risk is Hatch-Waxman ANDA litigation. A Paragraph IV notice can trigger a 30-month FDA approval stay if the NDA holder or patent owner files suit within the statutory period.[5]

Potential dispute issues include:

1. Whether a proposed product contains the claimed active ingredients at approximately the claimed dose strengths.
2. Whether the product is a dry powder.
3. Whether separate powders are configured for simultaneous administration.
4. Whether the product is suitable for once-daily administration.
5. Whether lactose and magnesium stearate concentrations fall within the claimed ranges.
6. Whether a device meets the reservoir, unit-dose, or pre-metered multi-dose categories.
7. Whether the claims are invalid for anticipation or obviousness.
8. Whether the patent adequately describes and enables the full claim scope.
9. Whether the use of "about" creates an indefiniteness issue.
10. Whether prosecution-history estoppel narrows the interpretation of the combination or dose limitations.

The strongest invalidity arguments would likely focus on prior-art combination products, obviousness based on separately approved umeclidinium/vilanterol and fluticasone furoate products, and known dry-powder inhaler formulation techniques. GSK's counterargument would emphasize the claimed dose pairing, simultaneous once-daily configuration, formulation performance, and the specific triple-combination architecture.

How strong is the patent estate for Trelegy?

US Patent 9,750,726 is strategically strong as a product-combination patent because it claims the commercial dose ratio and the three active ingredients used in Trelegy. Its strength is lower where a competitor can change one or more structural elements without materially affecting clinical utility.

Feature	Relative protection
Exact umeclidinium/vilanterol combination	Strong
Exact Trelegy triple combination	Strong
62.5/25/100 mcg dose profile	Strong but numerically constrained
Dry-powder presentation	Moderate to strong
Simultaneous once-daily administration	Moderate
Lactose carrier	Narrower formulation protection
Magnesium stearate percentages	Narrow but technically specific
Ellipta-specific device structure	Limited by this patent's claim language
Broad therapeutic use	Limited, because the claims are product-focused

The patent is more difficult to design around than a narrow device patent because the active ingredients and dose strengths are central limitations. A competitor seeking a non-infringing alternative could consider a different dose, a different corticosteroid, a different long-acting bronchodilator, a non-dry-powder delivery system, or a materially different administration schedule. Each option could create regulatory, clinical, or commercial disadvantages.

How does US Patent 9,750,726 compare with competing inhaled therapies?

Product	Active ingredients	Main competitive position
Trelegy Ellipta	Fluticasone furoate, umeclidinium, vilanterol	Once-daily inhaled triple therapy
Breo Ellipta	Fluticasone furoate, vilanterol	Once-daily inhaled corticosteroid/LABA
Anoro Ellipta	Umeclidinium, vilanterol	Once-daily LAMA/LABA
Symbicort	Budesonide, formoterol	ICS/LABA, generally twice daily
Dulera	Mometasone, formoterol	ICS/LABA
Breztri Aerosphere	Budesonide, glycopyrrolate, formoterol	Triple therapy using a metered-dose aerosol
Trintellix or unrelated products	Not relevant	No direct formulation or active-ingredient overlap

Trelegy has a differentiated once-daily triple-therapy profile. Competitors using budesonide/glycopyrrolate/formoterol or other active-ingredient combinations do not ordinarily fall within the active-ingredient limitations of this patent.

What generic-entry risks exist?

A generic Trelegy entrant faces several layers of risk:

• Product-claim litigation based on the three active ingredients and dose strengths.
• Formulation litigation involving lactose and magnesium stearate.
• Separate patent claims directed to the inhaler device.
• Regulatory equivalence requirements for delivered dose, particle-size distribution, and lung deposition.
• Device-substitution issues under the FDA's combination-product framework.
• Commercial substitution barriers if the generic uses a different inhaler.
• Potential 30-month approval stays after Paragraph IV litigation.
• Multiple-patent settlement exposure.

A product that copies the active ingredients and strengths but changes the device may avoid some device claims while remaining exposed to combination claims. A product that changes the powder formulation may avoid claims 10 or 14 but remain exposed to claims 1 or 12.

What manufacturing and intellectual-property barriers matter?

The claimed products require more than simply mixing three active ingredients. Commercial development must address:

• Uniform distribution of low-dose actives.
• Powder flow and dispersibility.
• Particle-size control.
• Moisture sensitivity.
• Chemical and physical stability.
• Dose uniformity across blister or reservoir fills.
• Compatibility between lactose, magnesium stearate, and the active particles.
• Consistent aerosol performance through the device.
• Separate or combined powder processing.
• Control of delivered dose and fine-particle fraction.

These technical requirements can create practical barriers even when a competitor identifies a legally non-infringing formulation. The patent's excipient limitations may therefore have greater commercial significance than their claim breadth suggests.

Key Takeaways

• US Patent 9,750,726 covers dry-powder combinations of umeclidinium bromide and vilanterol trifenatate at approximately 62.5 mcg and 25 mcg per dose.
• Its triple-therapy claims add fluticasone furoate at approximately 100 mcg per dose.
• The claims cover both admixed and separate powder compositions.
• Lactose, lactose monohydrate, and magnesium stearate formulations receive narrower dependent-claim protection.
• The claims cover multiple inhaler formats, including reservoir, unit-dose, and pre-metered multi-dose devices.
• The patent maps directly to Trelegy Ellipta 100/62.5/25 mcg.
• It is an Orange Book-listed patent for Trelegy-related products.
• The patent's term runs into the 2030 period, subject to the official USPTO patent-term calculation.
• A generic challenger would need to address the active-ingredient combination, dose strengths, dry-powder format, simultaneous administration, and the broader Trelegy patent estate.
• The patent is strongest as a combination-product patent and weaker against products that change the active ingredients, dose architecture, or delivery format.

FAQs

Does US Patent 9,750,726 cover umeclidinium by itself?

No. The claims require umeclidinium in combination with vilanterol, and certain claims also require fluticasone furoate. The patent does not independently claim umeclidinium monotherapy.

Does the patent cover a nebulized version of Trelegy?

The claims are directed to dry-powder products and dry-powder inhaler administration. A nebulized liquid product would have a strong non-infringement position against the dry-powder limitations, although separate patents could apply.

Can a generic use a different carrier than lactose?

Potentially. A different carrier could avoid claims specifically requiring lactose or lactose monohydrate. It would not automatically avoid the broader combination claims, which do not all require lactose.

Does using separate inhalers avoid the patent?

Not necessarily. The claims expressly contemplate separate dry-powder compositions configured for simultaneous administration. Separate inhalers would require analysis of the claim language, device configuration, and whether the products are supplied as one pharmaceutical combination product.

Is fluticasone furoate required in every claim?

No. Claims 1-11 cover the umeclidinium/vilanterol combination without fluticasone furoate. Claims 8, 9, and 12-17 address the triple combination that includes fluticasone furoate.

References

1. United States Patent No. 9,750,726. (2017). Pharmaceutical combination products. United States Patent and Trademark Office.

2. U.S. Food and Drug Administration. (2024). Trelegy Ellipta prescribing information. GlaxoSmithKline.

3. U.S. Food and Drug Administration. (2017). FDA approves new once-daily treatment for COPD. FDA.

4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.

5. United States Code, 21 U.S.C. § 355(j). (2024). Abbreviated new drug applications and patent certifications.

Drugs Protected by US Patent 9,750,726

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes	9,750,726		Y
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017		RX	Yes	Yes	9,750,726		Y
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020		RX	Yes	Yes	9,750,726		Y

Foreign Priority and PCT Information for Patent: 9,750,726

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	0921075.8	Dec 1, 2009

International Family Members for US Patent 9,750,726

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2506844		300942	Netherlands
European Patent Office	2506844		PA2018011	Lithuania
European Patent Office	2506844		122018000060	Germany
European Patent Office	2506844		CA 2018 00023	Denmark