ARFORMOTEROL TARTRATE Drug Patent Profile

When do Arformoterol Tartrate patents expire, and when can generic versions of Arformoterol Tartrate launch?

Arformoterol Tartrate is a drug 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 seventeen NDAs.

The generic ingredient in ARFORMOTEROL TARTRATE is arformoterol tartrate. There are four drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the arformoterol tartrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Arformoterol Tartrate

A generic version of ARFORMOTEROL TARTRATE was approved as arformoterol tartrate by CIPLA on June 22^nd, 2021.

Summary for ARFORMOTEROL TARTRATE

US Patents:	0
Applicants:	17
NDAs:	17
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	52
Clinical Trials:	9
Patent Applications:	203
Drug Prices:	Drug price information 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
Aiping Pharm Inc	ARFORMOTEROL TARTRATE	arformoterol tartrate	SOLUTION;INHALATION	214901-001	Apr 2, 2024	AN	RX	No	No
Lexenpharm	ARFORMOTEROL TARTRATE	arformoterol tartrate	SOLUTION;INHALATION	218156-001	Nov 18, 2024	AN	RX	No	No
Cipla	ARFORMOTEROL TARTRATE	arformoterol tartrate	SOLUTION;INHALATION	207306-001	Jun 22, 2021	AN	RX	No	No
Ritedose Corp	ARFORMOTEROL TARTRATE	arformoterol tartrate	SOLUTION;INHALATION	214736-001	Mar 2, 2022	AN	RX	No	No
Lupin	ARFORMOTEROL TARTRATE	arformoterol tartrate	SOLUTION;INHALATION	213068-001	Feb 7, 2022	AN	RX	No	No
Teva Pharms Usa	ARFORMOTEROL TARTRATE	arformoterol tartrate	SOLUTION;INHALATION	200293-001	Nov 9, 2021	AN	RX	No	No

ARFORMOTEROL TARTRATE Market Analysis and Financial Projection

Last updated: February 11, 2026

What Is the Market Position of ARFORMOTEROL TARTRATE?

ARFORMOTEROL TARTRATE is a bronchodilator used primarily in the management of chronic obstructive pulmonary disease (COPD). Its market presence is limited, given the availability of alternative agents with established efficacy profiles. It is a synthetic selective β2-adrenergic receptor agonist, inhaled via nebulizer or inhaler.

How Does the Market for ARFORMOTEROL TARTRATE Compare to Other Bronchodilators?

The global COPD drug market was valued at approximately USD 18.4 billion in 2022, with a compound annual growth rate (CAGR) of around 4.2% expected through 2030 [1].

Key competitors include:

• Long-acting β2-agonists (LABAs): salmeterol, formoterol
• Long-acting muscarinic antagonists (LAMAs): tiotropium
• Combination products (LABA + LAMA)
• Inhaled corticosteroids (ICS)

ARFORMOTEROL TARTRATE's market share remains minor relative to established agents, partly due to:

• Limited clinical trials compared to competitors
• Lack of recent approval in major markets like the U.S. and Europe
• Absence of combination therapy formulations

What Is the Regulatory Status of ARFORMOTEROL TARTRATE?

ARFORMOTEROL TARTRATE's approval status varies:

• Japan: Approved for COPD management under the brand name "Boehringer Ingelheim" formulations
• Europe and the U.S.: Not approved for any indication; no recent filings or regulatory activity reported
• Other markets: Limited or unreported approvals

This restricts its commercial deployment primarily to specific regions, constraining global sales.

What Are Projected Revenue Trends for ARFORMOTEROL TARTRATE?

Due to its limited approval and low market penetration, ARFORMOTEROL TARTRATE's revenue remains minimal:

Year	Estimated Revenue (USD millions)	Notes
2022	< 10	Predominantly sales in Japan
2023	Stable with slight decline	Market saturation and competition increases
2024+	Expected decline or stagnation	Lack of broader regulatory approval, limited R&D activity

The compound annual growth rate for ARFORMOTEROL TARTRATE sales is projected near zero or negative relative to the overall COPD market growth.

What Are Key Factors Impacting the Financial Trajectory?

Patent and Exclusivity

• Patent protections for ARFORMOTEROL TARTRATE have expired in some jurisdictions, leading to generic competitors.
• No new patent filings or exclusivity extensions are currently reported.

R&D and Pipeline Activity

• No significant ongoing clinical trials or pipeline development for ARFORMOTEROL TARTRATE.
• Drug development focus shifts toward combination therapies and novel delivery systems.

Market Trends

• The COPD therapeutic market favors multi-agent inhalers combining LABAs, LAMAs, and ICS.
• New formulations, such as once-daily inhalers and triple therapies, are commercially dominant.
• Standalone agents like ARFORMOTEROL TARTRATE face challenges gaining market share.

Competitive Pressures

• Existing agents have established clinical evidence, long-term safety data, and broad approval.
• Generic availability reduces pricing and margins.

What Is the Outlook for Future Investment and Development?

Few R&D investments target ARFORMOTEROL TARTRATE specifically. Companies typically prioritize broader-acting drugs or combination therapies offering improved outcomes.

Potential inflection points include:

• Repurposing the drug with novel delivery mechanisms
• Developing combination formulations incorporating ARFORMOTEROL TARTRATE
• Market expansion into regions with limited COPD management options

Without significant innovation, its financial trajectory is likely to remain flat or decline gradually.

Key Takeaways

• ARFORMOTEROL TARTRATE has limited global market penetration, mainly in Japan.
• Its revenue is negligible compared to COPD market leaders.
• Expired patents and high competition constrain profitability.
• Lack of ongoing clinical development minimizes prospects for growth.
• The global COPD market is driven by combination therapies, limiting opportunities for standalone agents like ARFORMOTEROL TARTRATE.

FAQs

1. What are the primary competitors to ARFORMOTEROL TARTRATE?
Salmeterol, formoterol, and tiotropium dominate for COPD treatment, with established long-term safety and efficacy profiles.

2. Why is ARFORMOTEROL TARTRATE market limited?
Lack of recent approvals, limited clinical trials, expired patents, and competition from combination therapies reduce its market presence.

3. Can ARFORMOTEROL TARTRATE be developed into new formulations?
Potential exists for innovative delivery systems or combination products, but no current plans are publicly reported.

4. Is ARFORMOTEROL TARTRATE used outside Japan?
Primarily in Japan; markets like Europe and the U.S. do not recognize or approve it.

5. What is the potential for revenue growth in this segment?
Limited without breakthrough clinical data, broad regulatory approval, or innovative formulations.

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Sources:

[1] Grand View Research. COPD Market Size and Trends, 2022.