ANORO ELLIPTA Drug Patent Profile

When do Anoro Ellipta patents expire, and what generic alternatives are available?

Anoro Ellipta is a drug marketed by Glaxosmithkline and is included in one NDA. There are five patents protecting this drug.

This drug has two hundred and one patent family members in forty-nine countries.

The generic ingredient in ANORO ELLIPTA is umeclidinium bromide; vilanterol trifenatate. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the umeclidinium bromide; vilanterol trifenatate profile page.

DrugPatentWatch^® Generic Entry Outlook for Anoro Ellipta

Anoro Ellipta was eligible for patent challenges on May 10, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 29, 2030. This may change due to patent challenges or generic licensing.

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ANORO ELLIPTA

International Patents:	201
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	50
Patent Applications:	532
Drug Prices:	Drug price information for ANORO ELLIPTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ANORO ELLIPTA
What excipients (inactive ingredients) are in ANORO ELLIPTA?	ANORO ELLIPTA excipients list
DailyMed Link:	ANORO ELLIPTA at DailyMed

See drug prices for ANORO ELLIPTA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ANORO ELLIPTA

Constraining patent/regulatory exclusivity:

9,750,726

NDA:

203975

Dosage:

POWDER;INHALATION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ANORO ELLIPTA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Alabama at Birmingham	PHASE2
GlaxoSmithKline	PHASE4
University of Tennessee Graduate School of Medicine	PHASE4

See all ANORO ELLIPTA clinical trials

Pharmacology for ANORO ELLIPTA

Drug Class	Anticholinergic beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Cholinergic Antagonists

US Patents and Regulatory Information for ANORO ELLIPTA

ANORO ELLIPTA is protected by five US patents.

This potential generic entry date is based on patent 9,750,726.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes	11,090,294
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes	12,396,986		Y
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes	9,750,726		Y
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes	7,488,827		Y	Y
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes	8,511,304*PED				Y

Expired US Patents for ANORO ELLIPTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013	7,776,895
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013	8,309,572
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013	5,873,360
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013	7,498,440
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013	RE44874
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013	8,183,257
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013	7,361,787

International Patents for ANORO ELLIPTA

When does loss-of-exclusivity occur for ANORO ELLIPTA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Eurasian Patent Organization

European Patent Office

France

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Norway

Peru

Poland

Portugal

Russian Federation

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Turkey

Ukraine

United Kingdom

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ANORO ELLIPTA around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2010326798
Australia	2014204459
Australia	2016262698
Australia	2017238392
Australia	2018282427
Australia	2021204302
Australia	2023219901

Supplementary Protection Certificates for ANORO ELLIPTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1425001	CR 2014 00021	Denmark		PRODUCT NAME: VILANTEROL ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER VILANTEROL TRIFENATAT; REG. NO/DATE: EU/1/13/886/001-006 20131114
1425001	C01425001/02	Switzerland		PRODUCT NAME: VILANTEROL UND FLUTICASON FUROAT; REGISTRATION NO/DATE: SWISSMEDIC 62969 09.01.2014
1740177	C300694	Netherlands		PRODUCT NAME: UMECLIDINIUMBROMIDE; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140428
1740177	CA 2014 00052	Denmark		PRODUCT NAME: UMECLIDINIUMBROMID; REG. NO/DATE: EU/1/14/922/001-003 20140428
1740177	PA2014038	Lithuania		PRODUCT NAME: UMECLIDINIUM BROMIDIUM; REGISTRATION NO/DATE: EU/1/14/922 20140428
1740177	92565	Luxembourg		PRODUCT NAME: BROMURE D'UMECLIDINUM; FIRST REGISTRATION DATE: 20140428
1740177	1490060-9	Sweden		MARKETING AUTHORIZATION NUMBER AND DATE OF GRANT/NOTIFICATION: EU/1/14/922, 2014-04-30; PERIOD OF VALIDITY (FROM - UNTIL): 20250428 - 20240429

Anoro Ellipta (umeclidinium/vilanterol) Market Dynamics and Financial Trajectory: Revenue, Competition, Patent/Exclusivity Headwinds, and Generic/Biosimilar Risk

Last updated: June 11, 2026

Anoro Ellipta (umeclidinium/vilanterol, UMEC/VI) is a long-running LAMA/LABA COPD brand whose sales trajectory has shifted from growth to maturity. Near-term revenue is driven by class competition in COPD maintenance therapy, formulary leverage by large payers, and channel mix. Downside comes from loss of marketing exclusivity for key strengths and ongoing generic/authorized generic entry risk for UMEC/VI inhalation products, which can compress price and market share unless brand-specific contracts or device-driven switching barriers offset volume migration.

H1: Anoro Ellipta (umeclidinium vilanterol) sales forecast, revenue drivers, and COPD competition risk

---

How have Anoro Ellipta sales trended and what is the financial trajectory?

Short answer: Anoro Ellipta has moved into a mature, value-preserving phase typical of established fixed-dose COPD combinations, with growth flattening as competitive pressure increases and payer formularies tighten.

Revenue shape: maturity signals

• COPD maintenance inhalers have faced sustained competitive intensity from other LAMA/LABA and triple-therapy (LAMA/LABA/ICS) regimens.
• Brands that remain dominant typically rely on:
  • high persistence (patient retention on inhaler)
  • formulary positioning and preferred tier status
  • differentiated inhaler usability and dosing convenience
  • payers’ contracting terms

What the financial trajectory depends on

1. Mix of stable COPD vs exacerbation-prone patients
   • Triple therapy uptake (LAMA/LABA/ICS) diverts demand from dual therapy for exacerbation-prone segments.
2. Inhaler switching and adherence
   • Device fit matters. Ellipta’s user experience and once-daily dosing help persistence relative to some competitors.
3. Price and rebates under formulary pressure
   • As generics expand, branded contracts increasingly behave like “value-dependent” volume plays.

Near-term outcome

• If Anoro maintains preferred positioning and retention, revenue can hold up in nominal terms even as unit growth slows.
• If UMEC/VI product availability expands (including authorized generics or multiple generics), revenue shifts toward a steep decline pattern due to price compression and channel reallocations.

---

What market dynamics affect Anoro Ellipta demand in COPD maintenance therapy?

Short answer: Demand is governed by COPD guideline treatment pathways, payer formulary dynamics, and competitor product substitution, especially triple therapy escalation.

Guideline-driven substitution risks

• Current COPD practice often escalates:
  • from dual therapy to triple therapy for frequent exacerbations
  • based on blood eosinophils, symptom burden, and exacerbation history
• Triple therapy brands can displace LAMA/LABA combinations when payer and clinician incentives align.

Payer and PBM leverage

• COPD inhalers are high-burden chronic therapies. PBMs frequently:
  • require step edits
  • promote preferred LAMA/LABA or triple-therapy classes
  • apply utilization management tied to diagnosis codes and exacerbation proxies
• Once a competitor gains preferred status in a class, branded volume can decline quickly despite clinical equivalence.

Channel mix and contracting

• Many mature brands show revenue sensitivity to:
  • channel inventory management
  • wholesaler buying patterns
  • buy-and-bill policies for certain settings (where applicable)
• Contracting terms increasingly determine net sales more than list price.

---

How does Anoro Ellipta compare with other LAMA/LABA COPD inhalers on competition and switching?

Short answer: Anoro competes with other once-daily LAMA/LABA options and faces stronger displacement pressure from triple-therapy brands for exacerbation-prone patients.

Direct competitor set for market share

Key comparative categories:

• LAMA/LABA fixed-dose inhalers (competing for stable COPD maintenance)
• Triple-therapy inhalers (competing for higher-risk patients and exacerbation prevention)

Where Anoro’s positioning typically helps

• Established prescribing base and patient familiarity with Ellipta
• Once-daily convenience supports adherence and persistence

Where competitors pressure Anoro

• Differentiated inhaler devices, patient-relevant factors, and payer-preferred contracting
• Triple-therapy switching in exacerbation-prone patients

---

What FDA regulatory and labeling factors can change Anoro Ellipta’s commercial trajectory?

Short answer: Label expansions or restrictions can alter the eligible patient segment and prescriber behavior, but in mature COPD brands the larger driver is formulary placement rather than new indications.

Commercial sensitivity to labeling

• COPD maintenance therapy labeling influences:
  • which lines of therapy are appropriate
  • whether clinicians can justify early use versus after other inhalers fail
• Safety/tolerability considerations influence persistence, especially in older populations with comorbidities.

Manufacturing and supply continuity

• Sustained availability prevents “lost persistence” when patients are forced to switch devices.

---

What patents protect Anoro Ellipta and when does it lose exclusivity?

Short answer: Anoro’s exclusivity position is time-bound and can erode via marketing exclusivity expiration and patent expiry, enabling generic entry that compresses branded net sales.

Exclusivity and patent stack mechanics

Revenue compression risk increases when:

• key formulation or method-of-use patents expire
• device or delivery-system patents expire
• marketing exclusivity expires such that ANDAs can enter without infringing

Practical impact

• As patent cliffs approach and carve-outs expire, branded products typically experience:
  • anticipation-buy by channels ahead of launch
  • post-launch price erosion
  • market share migration to generics/authorized generics

Note: This response does not list specific patent numbers or expiration dates because no Orange Book / FDA listing and litigation dataset was provided in the prompt.

---

What is the generic and Paragraph IV litigation risk for Anoro Ellipta?

Short answer: Generic entry risk is the key structural downside lever for a mature brand, with Paragraph IV challenges often catalyzing earliest generic timelines.

How generic entry typically hits branded COPD combinations

• Launch usually triggers:
  • immediate price compression
  • rapid share shift if payers place generics on lower tiers
  • contract renegotiation for remaining branded inventory
• Authorized generics can accelerate net sales declines.

Commercial mitigation pathways

Brands that slow erosion typically rely on:

• continued preferred formulary status via contracting
• patient switching barriers (device familiarity and adherence)
• shifting to expanded indications or differentiated disease segments (when available)

---

What is the Orange Book status of Anoro Ellipta, and what does it imply for launch timing?

Short answer: Orange Book status determines whether ANDA filers can launch based on patent and exclusivity carve-outs. Without Orange Book listings in the input, a precise status map cannot be produced.

Why Orange Book status matters for revenue

• The earliest generic launch date is driven by:
  • active patent expirations and any remaining exclusivity
  • whether patents are listed for the specific dosage forms and strengths
• Even if some patents expire earlier, later-listed patents can delay full commercial freedom.

---

What financial sensitivity does Anoro face if UMEC/VI generics launch?

Short answer: If UMEC/VI generics launch broadly, Anoro’s revenue typically declines sharply due to price compression and volume migration, with the magnitude driven by payer behavior and competitive differentiation.

Revenue scenario logic

1. If generics enter on favorable tiers
   • fastest share loss
   • largest net price compression
2. If branded retains preferred status
   • slower volume erosion
   • larger impact occurs through list-to-net reductions and rebate pressure
3. If multiple competitors launch
   • competitive pressure multiplies, accelerating share and price declines

---

How does Anoro’s market risk compare with other COPD maintenance brands?

Short answer: The risk profile is comparable to other mature dual-therapy COPD inhalers with looming patent/exclusivity changes: revenue tends to plateau until patent cliffs, then drops with generics unless differentiated by contracting and persistence.

Key differentiators across brands

• device competitiveness and patient switching cost
• triple-therapy presence in the portfolio (internal cannibalization can either cushion or worsen outcomes)
• strength of payer contracts and formulary entrenchment

---

Key takeaways

• Anoro Ellipta is in a mature COPD maintenance position where incremental growth is constrained by class competition and triple-therapy substitution.
• The biggest structural revenue downside is generic entry risk for UMEC/VI inhalation products, which typically triggers rapid price erosion and market share migration.
• Commercial resilience depends on persistence, formulary positioning, and contracting terms that preserve net price and share through the exclusivity-to-generic transition.
• A complete, decision-grade view of timing and risk requires mapping Orange Book listings, patent expirations, and any Paragraph IV or settlement outcomes, which are not included in the prompt.

---

FAQs

1. How do COPD payer formularies typically treat LAMA/LABA dual therapy versus triple therapy?
2. What drives persistence on Ellipta devices after patients switch from another inhaler?
3. How fast do branded COPD inhalers lose net price after generic UMEC/VI entry?
4. Do authorized generics accelerate branded revenue declines more than “first generic” launches?
5. What contracting structures (rebates, step edits, tier placement) most influence Anoro’s net sales?

---

References (APA)

1. No cited sources were provided in the prompt; no external datasets (FDA Orange Book, Purple Book, clinical trial registries, earnings transcripts, or court dockets) were supplied, so references cannot be generated from primary material.