GLYCOPYRROLATE; INDACATEROL MALEATE - Generic Drug Details

What are the generic drug sources for glycopyrrolate; indacaterol maleate and what is the scope of freedom to operate?

Glycopyrrolate; indacaterol maleate is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Glycopyrrolate; indacaterol maleate has one hundred and forty-eight patent family members in forty countries.

Summary for GLYCOPYRROLATE; INDACATEROL MALEATE

International Patents:	148
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
DailyMed Link:	GLYCOPYRROLATE; INDACATEROL MALEATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for GLYCOPYRROLATE; INDACATEROL MALEATE

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.

Anatomical Therapeutic Chemical (ATC) Classes for GLYCOPYRROLATE; INDACATEROL MALEATE

R03AC	Selective beta-2-adrenoreceptor agonists
R03A	ADRENERGICS, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

US Patents and Regulatory Information for GLYCOPYRROLATE; INDACATEROL MALEATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015		DISCN	Yes	No			Y
Novartis	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015		DISCN	Yes	No			Y
Novartis	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015		DISCN	Yes	No			Y	Y

Expired US Patents for GLYCOPYRROLATE; INDACATEROL MALEATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015
Novartis	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015
Novartis	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015
Novartis	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015

International Patents for GLYCOPYRROLATE; INDACATEROL MALEATE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1663164	PROCEDES DE PREPARATION DE COMPOSITIONS PHARMACEUTIQUES (METHODS FOR PREPARING PHARMACEUTICAL COMPOSITIONS)
United Kingdom	0321607
Brazil	0011324	Agonistas de Adrenoceptores Beta 2, Processo de Preparação dos Mesmos, seu Uso e Composição Farmacêutica compreendendo os mesmos
Portugal	1747036

Supplementary Protection Certificates for GLYCOPYRROLATE; INDACATEROL MALEATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1183240	SPC/GB10/009	United Kingdom		PRODUCT NAME: INDACATEROL OR A SALT THEREOF; REGISTERED: UK EU/1/09/593/001 20091130; UK EU/1/09/593/002 20091130; UK EU/1/09/593/003 20091130; UK EU/1/09/593/004 20091130; UK EU/1/09/593/005 20091130; UK EU/1/09/593/006 20091130; UK EU/1/09/593/007 20091130; UK EU/1/09/593/008 20091130; UK EU/1/09/593/009 20091130; UK EU/1/09/593/010 20091130
1183240	CA 2010 00006	Denmark		PRODUCT NAME: INDACATEROL ELLER ET SALT DERAF, HERUNDER INDACATEROLMALEAT
1183240	91651	Luxembourg		91651, EXPIRES: 20241130
1183240	7/2010	Austria		PRODUCT NAME: INDACATEROL UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/09/593/001-010 20091130

GLYCOPYRROLATE; INDACATEROL MALEATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Glycopyrrolate and Indacaterol Maleate

Introduction

Glycopyrrolate and indacaterol maleate, when combined, form a potent therapeutic agent for the treatment of chronic obstructive pulmonary disease (COPD). This combination, available under various brand names such as Utibron Neohaler and Ultibro Breezhaler, has significant implications for both market dynamics and financial trajectories.

Therapeutic Indication and Mechanism

Therapeutic Indication The combination of glycopyrrolate and indacaterol maleate is indicated for the long-term, maintenance treatment of airflow obstruction in patients with COPD, including those with chronic bronchitis and/or emphysema[1][2][5].

Mechanism of Action

• Indacaterol Maleate: Acts as a long-acting beta2-adrenergic agonist (LABA), providing bronchodilation by stimulating beta2 receptors in the lungs.
• Glycopyrrolate: Functions as a long-acting muscarinic antagonist (LAMA), blocking muscarinic acetylcholine receptors to prevent bronchoconstriction[2][5].

Market Demand

The demand for COPD treatments is driven by the increasing prevalence of the disease, particularly among older adults and those exposed to environmental and occupational hazards. The global COPD market is expected to grow due to the rising incidence of COPD and the need for effective management strategies.

Competitive Landscape

The COPD treatment market is highly competitive, with several other combination therapies and monotherapies available. However, the combination of glycopyrrolate and indacaterol maleate offers a unique profile with complementary mechanisms of action, enhancing its competitive position.

Clinical Efficacy and Safety

Clinical Trials Extensive clinical trials have demonstrated the efficacy and safety of this combination. For example, phase 3 studies involving over 2,000 patients showed significant improvements in lung function and symptom control compared to monotherapies and placebo[1][2].

Adverse Events Common adverse events include nasopharyngitis, hypertension, back pain, and oropharyngeal pain. Serious adverse events such as COPD exacerbations and cardiovascular events are also monitored, but the overall safety profile supports its use in COPD management[2].

Regulatory Approvals

The combination has received regulatory approvals in various regions, including the FDA approval for Utibron Neohaler in the United States and TGA approval for Ultibro Breezhaler in Australia[1][5].

Financial Trajectory

Revenue Growth The financial trajectory for glycopyrrolate and indacaterol maleate combination products has been positive, driven by strong sales and market penetration. The global COPD market, valued in billions, continues to grow, and this combination therapy is a significant contributor to this growth.

Pricing Strategies Pricing strategies play a crucial role in the financial success of these drugs. The cost-effectiveness of the combination therapy, compared to using separate LABA and LAMA treatments, can influence prescribing decisions and patient adherence. However, the pricing must balance profitability with accessibility to ensure widespread adoption[3].

Patent Landscape

Patent Expirations The patent landscape for these drugs is critical for their financial trajectory. As patents expire, generic versions can enter the market, potentially reducing revenue for the original manufacturers. However, the combination of glycopyrrolate and indacaterol maleate has a complex patent profile that extends its market exclusivity[3].

Market Penetration and Adoption

Prescription Trends The adoption of this combination therapy is influenced by prescription trends and guidelines from respiratory societies such as the Global Initiative for Chronic Obstructive Lung Disease (GOLD). Positive recommendations and inclusion in treatment guidelines enhance market penetration[5].

Patient Compliance Patient compliance is another factor affecting the financial trajectory. The ease of use of inhaler devices like the Neohaler and Breezhaler, along with the twice-daily or once-daily dosing regimens, can improve adherence and thus revenue[2][5].

Future Outlook

Emerging Markets The future outlook for glycopyrrolate and indacaterol maleate combination products is promising, particularly in emerging markets where the prevalence of COPD is increasing. Expanding into these markets can provide significant revenue growth opportunities.

Innovative Delivery Systems Continuous innovation in delivery systems and formulations can further enhance the market position of these drugs. Improvements in inhaler technology and patient-friendly designs can increase patient satisfaction and compliance.

Key Takeaways

• Therapeutic Efficacy: The combination of glycopyrrolate and indacaterol maleate is highly effective in managing COPD symptoms.
• Market Demand: Growing demand driven by the increasing prevalence of COPD.
• Regulatory Approvals: Approved in multiple regions, including the US and Australia.
• Financial Trajectory: Positive revenue growth due to strong sales and market penetration.
• Pricing Strategies: Balancing cost-effectiveness with profitability.
• Patent Landscape: Complex patent profile extending market exclusivity.
• Future Outlook: Promising growth opportunities in emerging markets and through innovative delivery systems.

FAQs

Q: What is the primary indication for the combination of glycopyrrolate and indacaterol maleate? A: The primary indication is for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including those with chronic bronchitis and/or emphysema.

Q: How do glycopyrrolate and indacaterol maleate work together? A: Glycopyrrolate acts as a long-acting muscarinic antagonist (LAMA), while indacaterol maleate acts as a long-acting beta2-adrenergic agonist (LABA), providing complementary bronchodilation.

Q: What are the common adverse events associated with this combination therapy? A: Common adverse events include nasopharyngitis, hypertension, back pain, and oropharyngeal pain.

Q: Has this combination therapy received regulatory approvals? A: Yes, it has received approvals from regulatory bodies such as the FDA and TGA.

Q: What is the impact of patent expirations on the financial trajectory of these drugs? A: Patent expirations can lead to the entry of generic versions, potentially reducing revenue for the original manufacturers, but the complex patent profile of this combination extends its market exclusivity.

Sources

1. FDA Document: Erika Torjusen NDA 207930 Glycopyrrolate/Indacaterol Inhalation Powder/ Neohaler.
2. RxList: Utibron Neohaler (Indacaterol and Glycopyrrolate Inhalation Powder).
3. Pharmaceuticals.gov.in: An Analysis on leveraging the patent cliff with drug sales worth USD.
4. FDA Document: 207930Orig1s000 - accessdata.fda.gov.
5. TGA Document: Attachment: Extract from Clinical Evaluation: Indacaterol maleate/Glycopyrronium bromide Proprietary Product Name: Ultibro Breezhaler.