UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE - Generic Drug Details

What are the generic drug sources for umeclidinium bromide; vilanterol trifenatate and what is the scope of patent protection?

Umeclidinium bromide; vilanterol trifenatate is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in one NDA. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Umeclidinium bromide; vilanterol trifenatate has three hundred and twenty-nine patent family members in forty-eight countries.

One supplier is listed for this compound.

Summary for UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

International Patents:	329
US Patents:	12
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
DailyMed Link:	UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

Constraining patent/regulatory exclusivity:

9,750,726

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 UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

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

Sponsor	Phase
SRL Mediserch.Inc	Phase 3
Parexel International Japan	Phase 3
GlaxoSmithKline	Phase 3

See all UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE clinical trials

Pharmacology for UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

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

Anatomical Therapeutic Chemical (ATC) Classes for UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

R03BB	Anticholinergics
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

US Patents and Regulatory Information for UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

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	9,750,726		Y
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes	7,498,440		Y	Y
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes	8,309,572
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes	8,746,242*PED				Y

Expired US Patents for UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

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	5,873,360
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	7,776,895
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013	7,361,787

International Patents for UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

Country	Patent Number	Title	Estimated Expiration
Cyprus	2014043
European Patent Office	1960021	DISTRIBUTEUR À UTILISER DANS UN APPAREIL DISTRIBUTEUR DE MÉDICAMENT (MANIFOLD FOR USE IN MEDICAMENT DISPENSER)
Ukraine	95768	АНТАГОНИСТЫ МУСКАРИНОВЫХ РЕЦЕПТОРОВ АЦЕТИЛХОЛИНА;АНТАГОНІСТИ МУСКАРИНОВИХ РЕЦЕПТОРІВ АЦЕТИЛХОЛІНУ (MUSCARINIC ACETYLCHOLINE RECEPTOR ANTAGONISTS)
Brazil	PI0614568	dispensador de medicamento

Supplementary Protection Certificates for UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1425001	1490033-6	Sweden		PRODUCT NAME: VILANTEROL, OCH SALTER OCH SOLVATER DAERAV; REG. NO/DATE: EU/1/13/886 20131113
1425001	C20140013 00103	Estonia		PRODUCT NAME: VILANTEROOLTRIFENATAAT;REG NO/DATE: K(2013)8089 (LOPLIK) 13.11.2013
1740177	CA 2014 00052	Denmark		PRODUCT NAME: UMECLIDINIUMBROMID; REG. NO/DATE: EU/1/14/922/001-003 20140428
1740177	C01740177/02	Switzerland		PRODUCT NAME: UMECLIDINIUM BROMID + VILANTEROL; REGISTRATION NO/DATE: SWISSMEDIC 63152 14.07.2014

UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Umeclidinium Bromide; Vilanterol Trifenatate

Introduction to Umeclidinium Bromide; Vilanterol Trifenatate

Umeclidinium bromide and vilanterol trifenatate, marketed under the brand name Anoro Ellipta, are a combination of two active ingredients used in the treatment of chronic obstructive pulmonary disease (COPD). Umeclidinium is a long-acting muscarinic antagonist (LAMA), while vilanterol is a long-acting beta2-adrenergic agonist (LABA)[1].

Market Drivers

Increasing Prevalence of Respiratory Diseases

The global respiratory drugs market, including Anoro Ellipta, is driven by the rising prevalence of respiratory diseases such as COPD, asthma, and cystic fibrosis. Factors like escalating air pollution, heightened exposure to allergens, and greater awareness of respiratory diseases contribute significantly to the demand for respiratory medications[2].

Technological Advancements

Technological advancements, particularly in drug delivery systems, play a crucial role in the market dynamics. The integration of smart technology in inhalers, such as those used for Anoro Ellipta, has improved medication adherence and management of respiratory conditions. Smart inhalers equipped with sensors and connected to mobile apps enable patients to track their medication usage and receive reminders, enhancing treatment outcomes[2].

Regulatory and Reimbursement Policies

Regulatory and reimbursement policies are key factors influencing the market. Stringent regulatory requirements ensure the safety and efficacy of new respiratory therapies, which can impact the speed at which new products are brought to market. Varying reimbursement policies across different regions affect market access and the affordability of respiratory medications. Companies must navigate these regulatory landscapes to secure favorable reimbursement rates and market entry[2].

Cost-Effectiveness and Clinical Outcomes

Comparative Studies

Studies have shown that the combination of umeclidinium bromide and vilanterol trifenatate (UMEC/VI) is cost-effective compared to other treatments. A head-to-head study demonstrated the superiority of UMEC/VI over tiotropium/olodaterol (TIO/OLO) in terms of trough forced expiratory volume in 1 second (FEV1) in symptomatic patients with COPD. This analysis found that UMEC/VI was associated with small improvements in quality-adjusted life years (QALYs) and cost savings compared to TIO/OLO[3].

Economic Impact

The cost-effectiveness of UMEC/VI is significant, especially from a healthcare system perspective. The study from the Spanish National Healthcare System perspective indicated that UMEC/VI was less costly and more effective than TIO/OLO, resulting in cost savings of €393 per patient over a 3-year period[3].

Market Share and Competitive Dynamics

Global Market Position

The global respiratory drugs market, in which Anoro Ellipta competes, is dominated by North America, driven by the rising incidence of respiratory diseases in the region. Recent product approvals, such as the FDA approval of Moderna's mRNA vaccine for respiratory syncytial virus (RSV), have positively impacted market growth[2].

Competitive Landscape

The respiratory drugs market is characterized by a mix of established pharmaceutical giants and emerging biotech firms. Market leaders, including GlaxoSmithKline, the manufacturer of Anoro Ellipta, continue to dominate with their extensive portfolios of inhaled corticosteroids, bronchodilators, and combination therapies. However, the rise of biologics and novel therapies has intensified competition, driving innovation and potentially disrupting traditional market leaders[2].

Patent and Generic Entry

Patent Protection

Anoro Ellipta is protected by multiple patents, with the earliest date for generic entry anticipated to be November 29, 2030, subject to patent challenges or generic licensing. The drug has 329 patent family members in 48 countries, indicating strong intellectual property protection[4].

Impact of Generic Entry

The potential entry of generic versions of umeclidinium bromide and vilanterol trifenatate could significantly impact the market dynamics and financial trajectory of Anoro Ellipta. Generic competition often leads to reduced prices and increased market competition, which could affect the revenue and market share of the branded product[4].

Financial Trajectory

Current Market Performance

The global respiratory drug delivery market, which includes Anoro Ellipta, has been growing steadily. The market was projected to reach USD 52.37 billion by 2021 from USD 36.10 billion in 2016, at a CAGR of 6.5% during the forecast period. This growth is driven by the increasing preference for pulmonary drug delivery, technological advancements, and the rising incidence of respiratory diseases[5].

Future Projections

Given the ongoing trends, the respiratory drugs market, including Anoro Ellipta, is expected to continue growing. The increasing prevalence of respiratory diseases, coupled with advancements in drug delivery systems and personalized medicine, will drive the demand for effective respiratory therapies. However, the financial trajectory will also be influenced by regulatory and reimbursement policies, as well as the potential entry of generic competitors[2].

Key Takeaways

• Increasing Demand: The growing global prevalence of respiratory diseases drives the demand for respiratory medications like Anoro Ellipta.
• Technological Advancements: Smart inhalers and other technological advancements improve treatment outcomes and medication adherence.
• Cost-Effectiveness: UMEC/VI has been shown to be cost-effective compared to other treatments, offering improvements in QALYs and cost savings.
• Competitive Landscape: The market is competitive, with established pharmaceutical companies and emerging biotech firms driving innovation.
• Patent Protection: Anoro Ellipta is protected by multiple patents until at least 2030, subject to patent challenges or generic licensing.

FAQs

What are the active ingredients in Anoro Ellipta?

Anoro Ellipta contains umeclidinium bromide, a long-acting muscarinic antagonist (LAMA), and vilanterol trifenatate, a long-acting beta2-adrenergic agonist (LABA)[1].

What is the primary use of Anoro Ellipta?

Anoro Ellipta is used in the treatment of chronic obstructive pulmonary disease (COPD)[1].

How does the combination of umeclidinium bromide and vilanterol trifenatate compare to other treatments?

Studies have shown that the combination of UMEC/VI is cost-effective and offers superior clinical outcomes compared to other treatments like TIO/OLO[3].

What is the expected date for generic entry of Anoro Ellipta?

The earliest date for generic entry of Anoro Ellipta is anticipated to be November 29, 2030, subject to patent challenges or generic licensing[4].

How does the integration of smart technology in inhalers impact the market?

The integration of smart technology in inhalers improves medication adherence and management of respiratory conditions, enhancing treatment outcomes and driving market growth[2].

Sources

1. FDA Approval Document: Umeclidinium and Vilanterol - FDA Approval[1].
2. DelveInsight Report: Global Respiratory Drugs Market Insights[2].
3. Cost-Effectiveness Analysis: Umeclidinium Bromide/Vilanterol vs. Tiotropium/Olodaterol[3].
4. Drug Patent Watch: Anoro Ellipta Patents and Generic Entry[4].
5. MarketsandMarkets Report: Pulmonary/Respiratory Drug Delivery Market[5].