Arformoterol tartrate - Generic Drug Details

What are the generic sources for arformoterol tartrate and what is the scope of freedom to operate?

Arformoterol tartrate is the generic ingredient in two branded drugs marketed by Aiping Pharm Inc, Alembic, Aucta, Cipla, Dr Reddys, Glenmark Pharms Ltd, Lexenpharm, Lupin, Mankind Pharma, Micro Labs, Neocubes Pharma, Ritedose Corp, Saba Ilac Sanayi, Slate Run Pharma, Sun Pharm, Teva Pharms Usa, and Wilshire Pharms Inc, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for arformoterol tartrate. Sixteen suppliers are listed for this compound.

Summary for arformoterol tartrate

US Patents:	0
Tradenames:	2
Applicants:	17
NDAs:	18
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	52
Clinical Trials:	9
Patent Applications:	435
Drug Prices:	Drug price trends for arformoterol tartrate
What excipients (inactive ingredients) are in arformoterol tartrate?	arformoterol tartrate excipients list
DailyMed Link:	arformoterol tartrate at DailyMed

See drug prices for arformoterol tartrate

Recent Clinical Trials for arformoterol tartrate

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

Sponsor	Phase
University of California, Los Angeles	Phase 4
Dartmouth-Hitchcock Medical Center	Phase 4
Sunovion	Phase 2

See all arformoterol tartrate clinical trials

Pharmacology for arformoterol tartrate

Drug Class	beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists

Anatomical Therapeutic Chemical (ATC) Classes for arformoterol tartrate

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

R03CC	Selective beta-2-adrenoreceptor agonists
R03C	ADRENERGICS FOR SYSTEMIC USE
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

Paragraph IV (Patent) Challenges for ARFORMOTEROL TARTRATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BROVANA	Inhalation Solution	arformoterol tartrate	Eq. 0.015 mg base/ 2 mL	021912	1	2009-10-01

US Patents and Regulatory Information for arformoterol tartrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glenmark Pharms Ltd	ARFORMOTEROL TARTRATE	arformoterol tartrate	SOLUTION;INHALATION	213132-001	Jun 22, 2021		DISCN	No	No
Alembic	ARFORMOTEROL TARTRATE	arformoterol tartrate	SOLUTION;INHALATION	214779-001	May 10, 2022	AN	RX	No	No
Mankind Pharma	ARFORMOTEROL TARTRATE	arformoterol tartrate	SOLUTION;INHALATION	216128-001	Nov 15, 2022	AN	RX	No	Yes
Aucta	ARFORMOTEROL TARTRATE	arformoterol tartrate	SOLUTION;INHALATION	218380-001	Feb 3, 2025	AN	RX	No	No
Saba Ilac Sanayi	ARFORMOTEROL TARTRATE	arformoterol tartrate	SOLUTION;INHALATION	218429-001	Apr 25, 2025	AN	RX	No	No
Ritedose Corp	ARFORMOTEROL TARTRATE	arformoterol tartrate	SOLUTION;INHALATION	214736-001	Mar 2, 2022	AN	RX	No	No
Teva Pharms Usa	ARFORMOTEROL TARTRATE	arformoterol tartrate	SOLUTION;INHALATION	200293-001	Nov 9, 2021	AN	RX	No	No

Expired US Patents for arformoterol tartrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006

Market Dynamics and Financial Trajectory for ARFORMOTEROL TARTRATE

Last updated: July 28, 2025

Introduction

ARFORMOTEROL TARTRATE, a long-acting beta-2 adrenergic receptor agonist (LABA), plays a prominent role in the management of chronic obstructive pulmonary disease (COPD). As a potent bronchodilator, it offers a targeted approach to symptom control and disease progression mitigation. This analysis examines the current market landscape, the underlying drivers influencing demand, competitive positioning, and projected financial trajectories for ARFORMOTEROL TARTRATE within the respiratory therapeutic sector.

Market Landscape and Dynamics

Global COPD Market Overview

COPD affects approximately 200 million individuals worldwide, with prevalence rising due to rising smoking rates, air pollution, and aging populations [1]. The global COPD therapeutics market was valued at USD 10 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 6-8% through 2030 [2]. Long-acting bronchodilators like ARFORMOTEROL TARTRATE occupy a critical niche within combination therapy protocols, driving steady demand.

Therapeutic Positioning of ARFORMOTEROL TARTRATE

ARFORMOTEROL TARTRATE's mechanism offers sustained bronchodilation, typically administered via inhalation devices. Its profile favors chronic management over acute episodes, aligning with patient and healthcare provider preferences for maintenance therapy. The drug's efficacy, long half-life, and favorable side-effect profile bolster its competitive advantage.

Regulatory Environment and Market Access

Regulatory approvals in key markets such as the U.S., EU, and Japan underpin product availability. However, market access hinges upon reimbursement policies, patent life, and pharmacoeconomic evaluations. The expiration of patents and the emergence of biosimilars or generics can significantly influence pricing strategies and market share.

Competitive Landscape

ARFORMOTEROL TARTRATE contends with established LABAs like salmeterol, formoterol, and vilanterol, compounded with newer entrants like tiotropium and fixed-dose combination products. Its competitive edge may derive from superior inhaler technology, improved pharmacokinetics, or unique formulation advantages.

Market Drivers

• Aging Population: Increased demand due to demographic shifts.
• Pipeline Approvals: Regulatory approvals for ARFORMOTEROL-based combination products.
• Clinical Guidelines: Favorable inclusion in COPD management guidelines (e.g., GOLD guidelines).
• Patient Preference: Shift toward long-acting inhalers with minimal dosing frequency.

Market Challenges

• Patent Expirations: Risk of generic competition.
• Pricing Pressures: Particularly in markets emphasizing cost-containment.
• Emerging Therapies: Novel treatments such as biologics or gene therapies may influence future demand.

Financial Trajectory

Historical Performance and Revenue Streams

As a newer entrant or off-patent drug, ARFORMOTEROL TARTRATE’s revenue depends heavily on market penetration and pricing strategies. Historically, sales phase-out or decline may occur following patent expiry. Yet, if incorporated into combination inhalers or licensed rapidly in emerging markets, revenue streams can stabilise or even grow.

Projected Sales Growth

Based on current market forecasts, the segment of COPD treated with LABAs is expected to grow at a CAGR of 6-8%. For ARFORMOTEROL TARTRATE, assuming strategic partnerships, formulation improvements, and expanding geographical reach, an annual revenue growth of 5-7% is plausible over the next five years.

Profitability Outlook

Gross margins for inhaled bronchodilators typically hover between 60-75%, influenced by manufacturing costs, R&D investments, and market pricing power. With optimized scale and minimized generic competition, net profit margins could stabilize at approximately 20-25%. The key to sustainable profitability lies in maintaining patent protections or developing follow-on formulations.

Investment and R&D Considerations

Continued investment in formulation innovation, usage optimization, or combination therapy development sustains competitive edge. Entering emerging markets with high COPD prevalence also offers opportunity to accelerate sales growth. R&D expenses, however, can vary significantly depending on clinical trial requirements and regulatory pathways.

Market Entry and Expansion Strategies

• Biosimilar and Generic Development: Mitigates patent expiry effects.
• Partnerships & Licensing: Accelerate access in high-growth regions.
• Product Differentiation: Innovations in inhaler technology or formulation chemistry to sustain market share.

Conclusion

ARFORMOTEROL TARTRATE’s market dynamics reflect a confluence of demographic drivers, regulatory influences, competitive advancements, and evolving treatment paradigms. Financial well-being hinges on strategic positioning, innovation, and adaptation to patent landscapes. The drug’s future trajectory appears promising, contingent upon successful market penetration, sustained patent protection, and integration within combination therapies.

Key Takeaways

• Growing COPD Prevalence makes ARFORMOTEROL TARTRATE an attractive long-term investment.
• Competitive Positioning depends on inhaler technology, clinical efficacy, and formulary access.
• Patent Management and Biosimilar Strategies are critical to maintaining profitability.
• Emerging Markets present substantial growth opportunities due to high COPD burdens.
• R&D and Strategic Partnerships will determine market share and revenue growth potential.

FAQs

1. What factors influence the market potential of ARFORMOTEROL TARTRATE?
Market potential depends on demographic trends, regulatory approvals, competitive positioning, patent protections, and clinical efficacy in COPD management.

2. How does patent expiry impact ARFORMOTEROL TARTRATE’s financial trajectory?
Patent expiry generally exposes products to generic or biosimilar competition, leading to price erosion and revenue decline unless offset by new formulations, patents, or strategic licensing.

3. What competitive advantages can ARFORMOTEROL TARTRATE leverage?
Advanced inhaler device technology, favorable pharmacokinetics, formulation innovations, or integration into combination therapies can provide competitive advantages.

4. How are emerging markets influencing the outlook for ARFORMOTEROL TARTRATE?
Emerging markets with high COPD prevalence offer significant growth opportunities through lower-cost formulations and local partnerships, expanding global reach.

5. What role do clinical guidelines play in shaping the demand for ARFORMOTEROL TARTRATE?
Inclusion in authoritative guidelines like GOLD enhances clinical adoption, driving steady demand and influencing reimbursement policies.

References

[1] World Health Organization. (2021). Global surveillance report on chronic respiratory diseases.
[2] MarketsandMarkets. (2022). COPD therapeutics market forecast.