INDACATEROL MALEATE - Generic Drug Details

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

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

Indacaterol maleate has eighty-six patent family members in thirty-nine countries.

Summary for INDACATEROL MALEATE

International Patents:	86
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	43
Clinical Trials:	24
Patent Applications:	384
DailyMed Link:	INDACATEROL MALEATE at DailyMed

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

Constraining patent/regulatory exclusivity:

8,479,730

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 INDACATEROL MALEATE

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

Sponsor	Phase
Mundipharma Research Limited	Phase 2/Phase 3
Novartis Pharmaceuticals	Phase 4
Novartis Pharmaceuticals	Phase 3

See all INDACATEROL MALEATE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for 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 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	ARCAPTA NEOHALER	indacaterol maleate	POWDER;INHALATION	022383-001	Jul 1, 2011		DISCN	Yes	No	6,878,721		Y	Y
Novartis	ARCAPTA NEOHALER	indacaterol maleate	POWDER;INHALATION	022383-001	Jul 1, 2011		DISCN	Yes	No	8,479,730		Y

Expired US Patents for INDACATEROL MALEATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	ARCAPTA NEOHALER	indacaterol maleate	POWDER;INHALATION	022383-001	Jul 1, 2011	8,067,437
Novartis	ARCAPTA NEOHALER	indacaterol maleate	POWDER;INHALATION	022383-001	Jul 1, 2011	8,796,307
Novartis	ARCAPTA NEOHALER	indacaterol maleate	POWDER;INHALATION	022383-001	Jul 1, 2011	8,658,673

International Patents for INDACATEROL MALEATE

Country	Patent Number	Title	Estimated Expiration
Czech Republic	302403	Agonisté beta-2-adrenoceptoru (Beta 2-adrenoreceptor agonists)
South Africa	200608728	Inhaler device
New Zealand	550625	Inhaler device with capsule piercing means comprising a pair of opposed spring biased push buttons that each include at least one piercing element
Cyprus	1111555
Taiwan	I353857
China	1953779	Inhaler device

Supplementary Protection Certificates for INDACATEROL MALEATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1267866	132014902244065	Italy		PRODUCT NAME: INDACATEROLO O UN SUO SALE, IN PARTICOLARE IL SALE MALEATO, E GLICOPIRRONIO O UN SUO SALE, IN PARTICOLARE IL SALE BROMURO, IN ASSOCIAZIONE(ULTIBRO BREEZHALER); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/862, 20130919
1183240	C 2010 011	Romania		PRODUCT NAME: INDACATEROL SI SARURILE SALE ACCEPTABILE FARMACEUTICINDACATEROL(R)-5-[2-(5,6-DIETIL-INDAN-2-ILAMINO]-1-HIDROXIETIL]-8-HIDROXI-1H-CHINOLIN-2-ONA; NATIONAL AUTHORISATION NUMBER: RO EU/1/09/593/001, RO EU/1/09/593/002, RO EU/1/09/593/003, RO EU/1/09/593/004, RO EU/1/09/593/005, RO EU/1/09/593/006, RO EU/1/09/593/007, RO EU/1/09/593/008, RO EU/1/09/593/009, RO EU/1/09/593/010; DATE OF NATIONAL AUTHORISATION: 20091130; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/09/593/001, EMEA EU/1/09/593/002, EMEA EU/1/09/593/003, EMEA EU/1/09/593/004, EMEA EU/1/09/593/005, EMEA EU/1/09/593/006, EMEA EU/1/09/593/007, EMEA EU/1/09/593/008, EMEA EU/1/09/593/009, E [...]
1183240	SPC009/2010	Ireland		SPC009/2010: 20100813, EXPIRES: 20241129
1183240	7/2010	Austria		PRODUCT NAME: INDACATEROL UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/09/593/001-010 20091130
1183240	10C0006	France		PRODUCT NAME: INDACATEROL OU UN SEL DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/09/593/001 DU 20091130; REGISTRATION NO/DATE AT EEC: EU/1/09/593/001-010 DU 20091130
1183240	C300437	Netherlands		PRODUCT NAME: INDACATEROL, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/09/593/001-010 20091130

INDACATEROL MALEATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Indacaterol Maleate

Introduction

Indacaterol maleate, a long-acting β2-adrenergic receptor agonist, has been a significant player in the treatment of chronic obstructive pulmonary disease (COPD) and asthma. Developed by Novartis Pharma AG, this drug has undergone extensive clinical trials and has been approved in several regions. Here, we delve into the market dynamics and financial trajectory of indacaterol maleate.

Mechanism and Therapeutic Areas

Indacaterol maleate works by selectively agonizing the β2-adrenergic receptors, leading to bronchodilation. This mechanism makes it an effective treatment for COPD and asthma, improving lung function and reducing symptoms[1][4][5].

Market Approval and Regulatory Status

Indacaterol maleate was first approved in the EU on November 29, 2009. Since then, it has gained approvals in various regions, solidifying its position in the respiratory disease treatment market[1].

Clinical Efficacy and Safety

Clinical trials have demonstrated the efficacy and safety of indacaterol maleate. It shows a rapid onset of action within 5 minutes and maintains bronchodilation for at least 24 hours. Studies have also highlighted its comparable safety profile to other long-acting β2-agonists, with significant improvements in lung function parameters such as FEV1 and PEF[4][5].

Market Competition

The respiratory disease market is highly competitive, with several long-acting bronchodilators available. However, indacaterol maleate's once-daily dosing regimen and its rapid onset of action give it a competitive edge. It competes with other β2-agonists like formoterol and salmeterol, as well as antimuscarinic agents like tiotropium[5].

Financial Performance of Novartis

Novartis, the originator of indacaterol maleate, has seen significant financial impacts from the drug's sales. While the company's financial reports do not break down sales figures specifically for indacaterol maleate, the drug's approval and market performance have contributed to Novartis's overall pharmaceutical revenue. In 2007, Novartis faced challenges due to generic competition affecting other key products, but the introduction of new drugs like indacaterol helped mitigate these losses[2].

Patent Cliff and Generic Competition

The pharmaceutical industry is often affected by the patent cliff, where drugs lose their patent protection and face generic competition. Indacaterol maleate, having been approved in 2009, is nearing the end of its patent life in some regions. This could lead to generic versions entering the market, potentially impacting Novartis's revenue from this drug. However, the development of fixed-dose combinations and other formulations can help extend the drug's market exclusivity[3].

Pricing and Revenue

The pricing of indacaterol maleate varies by region and is influenced by regulatory and market factors. In general, long-acting bronchodilators are priced competitively, and indacaterol maleate is no exception. The drug's revenue has been substantial, contributing to Novartis's respiratory portfolio. However, exact revenue figures are not publicly disclosed in detail.

Impact of Combination Therapies

Indacaterol maleate is also being developed in combination with other drugs, such as glycopyrronium bromide and mometasone furoate, for the treatment of asthma. These combination therapies can expand the drug's market reach and potentially increase revenue. The use of the acetate salt instead of the maleate salt in some combinations may also offer different market dynamics and regulatory pathways[4].

Safety and Tolerability

Both indacaterol maleate and its acetate salt have demonstrated a good safety profile in clinical trials. The drugs are well-tolerated, with minimal adverse effects, which is crucial for long-term patient compliance and market acceptance. However, differences in adverse event reporting, such as coughing, have been noted between the two salts[4].

Future Outlook

As indacaterol maleate approaches the end of its patent life, Novartis will need to strategize to maintain market share. This could involve developing new formulations, combination therapies, or expanding into new markets. The drug's efficacy and safety profile make it a valuable asset, and its future financial trajectory will depend on how effectively these strategies are implemented.

Key Statistics

• Approval Date: November 29, 2009 (EU)[1]
• Onset of Action: Within 5 minutes[5]
• Duration of Bronchodilation: At least 24 hours[5]
• FEV1 Improvement: 186 mL (maleate), 146 mL (acetate) compared to placebo[4]
• Systemic Exposure: Comparable between maleate and acetate salts[4]

Key Takeaways

• Indacaterol maleate is a once-daily β2-adrenergic receptor agonist approved for COPD and asthma.
• It has a rapid onset of action and maintains bronchodilation for at least 24 hours.
• The drug competes in a highly competitive respiratory disease market but has a competitive edge due to its dosing regimen.
• Novartis's financial performance has been influenced by the drug's sales, though specific figures are not disclosed.
• The drug is nearing the end of its patent life, which could lead to generic competition.
• Combination therapies and new formulations are being developed to extend market exclusivity.

FAQs

1. What is the primary mechanism of action of indacaterol maleate?

   • Indacaterol maleate works by selectively agonizing the β2-adrenergic receptors, leading to bronchodilation.

2. When was indacaterol maleate first approved?

   • Indacaterol maleate was first approved in the EU on November 29, 2009.

3. How does indacaterol maleate compare to other long-acting β2-agonists?

   • Indacaterol maleate has a once-daily dosing regimen and a rapid onset of action within 5 minutes, giving it a competitive edge.

4. What are the potential financial impacts of the patent cliff on indacaterol maleate?

   • The patent cliff could lead to generic competition, potentially reducing Novartis's revenue from the drug.

5. Are there any combination therapies involving indacaterol maleate?

   • Yes, indacaterol maleate is being developed in combination with glycopyrronium bromide and mometasone furoate for the treatment of asthma.

Sources

1. Synapse - Indacaterol Maleate - Drug Targets, Indications, Patents.
2. Novartis - 20-F-2007.
3. Pharmaceuticals.gov.in - An Analysis on leveraging the patent cliff with drug sales worth USD.
4. PubMed - Lung function, pharmacokinetics, and tolerability of inhaled indacaterol maleate and indacaterol acetate.
5. PubMed - Indacaterol maleate for the treatment of chronic obstructive pulmonary disease.