UMECLIDINIUM BROMIDE - Generic Drug Details

What are the generic sources for umeclidinium bromide and what is the scope of freedom to operate?

Umeclidinium bromide is the generic ingredient in two branded drugs marketed by Glaxo Grp England and Glaxosmithkline, and is included in two NDAs. There are fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Umeclidinium bromide has one hundred and eight patent family members in thirty-seven countries.

There are two drug master file entries for umeclidinium bromide. One supplier is listed for this compound.

Summary for UMECLIDINIUM BROMIDE

International Patents:	108
US Patents:	15
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	20
Patent Applications:	619
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for UMECLIDINIUM BROMIDE
DailyMed Link:	UMECLIDINIUM BROMIDE at DailyMed

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

Constraining patent/regulatory exclusivity:

7,488,827

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

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

Sponsor	Phase
GlaxoSmithKline	Phase 4
Q2 Solutions	Phase 3
SRL Mediserch.Inc	Phase 3

See all UMECLIDINIUM BROMIDE clinical trials

Pharmacology for UMECLIDINIUM BROMIDE

Drug Class	Anticholinergic
Mechanism of Action	Cholinergic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for UMECLIDINIUM BROMIDE

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

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	7,439,393*PED				Y
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes	8,746,242*PED				Y
Glaxo Grp England	INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382-001	Apr 30, 2014		RX	Yes	Yes	9,333,310		Y
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes	7,488,827		Y	Y

Expired US Patents for UMECLIDINIUM BROMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp England	INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382-001	Apr 30, 2014	5,873,360

EU/EMA Drug Approvals for UMECLIDINIUM BROMIDE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
GlaxoSmithKline (Ireland) Limited	Incruse Ellipta (previously Incruse)	umeclidinium bromide	EMEA/H/C/002809 Indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).,	Authorised	no	no	no	2014-04-28

International Patents for UMECLIDINIUM BROMIDE

Country	Patent Number	Title	Estimated Expiration
Canada	2616193	DISTRIBUTEUR DE MEDICAMENTS (MEDICAMENT DISPENSER)
South Korea	20130102134	MEDICAMENT DISPENSER
Cyprus	1118082
South Africa	200700851	Medicament dispenser

Supplementary Protection Certificates for UMECLIDINIUM BROMIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1740177	CR 2014 00052	Denmark		PRODUCT NAME: UMECLIDINIUMBROMID; REG. NO/DATE: EU/1/14/922/001-003 20140430
1740177	122014000096	Germany		PRODUCT NAME: UMECLIDINIUMBROMID; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140428
1740177	92565	Luxembourg		PRODUCT NAME: BROMURE D'UMECLIDINUM; FIRST REGISTRATION DATE: 20140428
2506844	2018C/022	Belgium		PRODUCT NAME: EEN FARMACEUTISCH COMBINATIEPRODUCT DAT EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN UMECLIDINIUM (BV. UMECLIDINIUMBROMIDE), VILANTEROL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (BV. VILANTEROLTRIFENATAAT) EN FLUTICASONEFUROAAT OMVAT; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117

UMECLIDINIUM BROMIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Umeclidinium Bromide

Introduction to Umeclidinium Bromide

Umeclidinium bromide, a small molecule drug developed by GSK Plc, is a long-acting muscarinic receptor antagonist (LAMA) primarily used for the treatment of chronic obstructive pulmonary disease (COPD). It is often combined with vilanterol, a long-acting β2 agonist (LABA), in the form of ANORO ELLIPTA, a once-daily inhalation powder[2][4][5].

Market Size and Growth

The global market for umeclidinium bromide is part of the broader inhalable drugs market, which was valued at USD 25.0 billion in 2018 and is projected to grow at a compound annual growth rate (CAGR) of 6.3% during the forecast period. This growth is driven by the increasing prevalence of respiratory diseases such as COPD, asthma, and cystic fibrosis[3].

Key Players

The market for umeclidinium bromide is dominated by several key players, including:

• GSK Plc: The originator and primary developer of umeclidinium bromide.
• CiVentiChem Inc., NSJ Prayog Life Sciences Private Limited, Alkaloids Private Limited, Sinochem, Anhui Dexinjia Biopharm, Shenzhen HwaGen Pharmaceutical, and Jewin Pharma: These companies are involved in the manufacturing and distribution of umeclidinium bromide[1].

Pharmacokinetics and Efficacy

Umeclidinium bromide is characterized by its rapid absorption and elimination, with a maximum plasma concentration (Tmax) achieved within 5 minutes. This pharmacokinetic profile supports its efficacy as a once-daily treatment for COPD, providing sustained bronchodilation and symptom relief[2].

Regulatory Approval and Patent Landscape

Umeclidinium bromide was first approved globally in Iceland in February 2014 and has since received regulatory clearance in various regions. The drug is protected by several patents, with the earliest generic entry expected on November 29, 2030, subject to patent challenges or generic licensing[4][5].

Market Drivers

Several factors drive the market growth for umeclidinium bromide:

• Increasing Prevalence of Respiratory Diseases: COPD, asthma, and other respiratory conditions are on the rise, increasing the demand for effective treatments like umeclidinium bromide[3].
• Awareness and Education: Initiatives such as COPD Awareness Month, organized by companies like Mylan, help raise awareness about available treatments, including inhalable drugs like umeclidinium bromide[3].
• Improving Healthcare Infrastructure: In regions like the Asia Pacific, improving healthcare infrastructure and rising patient awareness are expected to boost the market for inhalable drugs[3].

Regional Insights

Geographically, the market for inhalable drugs, including umeclidinium bromide, is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa. North America and Europe currently dominate the market, but the Asia Pacific region is anticipated to be the fastest-growing segment due to improving healthcare infrastructure and increasing disposable income[3].

Financial Trajectory

The financial trajectory of umeclidinium bromide is closely tied to the overall growth of the inhalable drugs market. Here are some key financial indicators:

• Market Valuation: The global inhalable drugs market, which includes umeclidinium bromide, was valued at USD 25.0 billion in 2018 and is expected to grow significantly over the forecast period[3].
• Revenue Growth: The CAGR of 6.3% for the inhalable drugs market indicates a steady and significant revenue growth for umeclidinium bromide and its combination products like ANORO ELLIPTA[3].
• Generic Entry: The expected generic entry in 2030 could impact the market dynamics, potentially reducing the revenue for branded versions of umeclidinium bromide but also expanding access to the drug[5].

Competitive Landscape

The competitive landscape for umeclidinium bromide is characterized by strong competition among pharmaceutical companies. GSK Plc, as the originator, holds a significant market share, but other companies are also involved in the manufacturing and distribution of this drug. The potential for generic entry and ongoing R&D efforts in targeting muscarinic acetylcholine receptors (mAChRs) suggest a dynamic and competitive market environment[1][4].

Future Outlook

The future outlook for umeclidinium bromide is promising due to several factors:

• Continued R&D: Ongoing research and development in targeting mAChRs present opportunities for innovative drugs and competition in the pharmaceutical industry[4].
• Growing Demand: The escalating prevalence of respiratory conditions ensures a growing demand for effective treatments like umeclidinium bromide[3].
• Regulatory Environment: The successful regulatory clearance and ongoing patent protection until 2030 provide a stable environment for the drug's continued market presence[4][5].

Key Takeaways

• Umeclidinium bromide is a critical component in the treatment of COPD, offering once-daily maintenance therapy.
• Market growth is driven by the increasing prevalence of respiratory diseases and improving healthcare infrastructure.
• Key players include GSK Plc and several other pharmaceutical companies involved in manufacturing and distribution.
• Regulatory approval and patent protection are crucial for the drug's market presence.
• Future outlook is positive, with ongoing R&D and growing demand for respiratory treatments.

FAQs

1. What is umeclidinium bromide used for?

   • Umeclidinium bromide is used for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema[5].

2. Who developed umeclidinium bromide?

   • Umeclidinium bromide was developed by GSK Plc[4].

3. When was umeclidinium bromide first approved?

   • Umeclidinium bromide was first approved globally in Iceland in February 2014[4].

4. What is the expected generic entry date for umeclidinium bromide?

   • The earliest date for generic entry is expected to be November 29, 2030, subject to patent challenges or generic licensing[5].

5. What are the key drivers of the market growth for umeclidinium bromide?

   • The key drivers include the increasing prevalence of respiratory diseases, awareness and education initiatives, and improving healthcare infrastructure[3].

Sources

1. Global Umeclidinium Bromide Market Research Report 2024 - Valuates Reports
2. A Randomized Crossover Trial - PLOS ONE
3. Inhalable Drugs Market Size, Share, Growth Analysis - SkyQuest
4. A Comprehensive Review of Umeclidinium Bromide's R&D Innovations - Synapse
5. When do the ANORO ELLIPTA patents expire, and when will generic entry occur? - Drug Patent Watch