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, Be Pharms, Cf Pharmtech, Cipla, Dr Reddys, Glenmark Pharms Ltd, Lupin, Mankind Pharma, Ritedose Corp, Sun Pharm, Teva Pharms Usa, and Wilshire Pharms Inc, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for ARFORMOTEROL TARTRATE

US Patents:	0
Tradenames:	2
Applicants:	13
NDAs:	14
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	43
Clinical Trials:	9
Patent Applications:	211
Drug Prices:	Drug price trends for ARFORMOTEROL TARTRATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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
Lupin	ARFORMOTEROL TARTRATE	arformoterol tartrate	SOLUTION;INHALATION	213068-001	Feb 7, 2022	AN	RX	No	No
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	AN	RX	Yes	Yes
Wilshire Pharms Inc	ARFORMOTEROL TARTRATE	arformoterol tartrate	SOLUTION;INHALATION	216815-001	Nov 25, 2022	AN	RX	No	No
Be Pharms	ARFORMOTEROL TARTRATE	arformoterol tartrate	SOLUTION;INHALATION	213762-001	Jun 22, 2021	AN	RX	No	No
Mankind Pharma	ARFORMOTEROL TARTRATE	arformoterol tartrate	SOLUTION;INHALATION	216128-001	Nov 15, 2022	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	7,145,036
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	7,473,710
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	6,589,508
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	6,866,839
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	5,795,564

ARFORMOTEROL TARTRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Arformoterol Tartrate

Introduction to Arformoterol Tartrate

Arformoterol tartrate is a long-acting beta-2 adrenergic agonist (beta-2 agonist) used primarily in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It is available in an inhalation solution form and has gained significant traction in the pharmaceutical market.

Market Size and Forecast

The global market for Arformoterol Tartrate API has been growing steadily. As of 2021, the market size for Arformoterol Tartrate oral inhalation was estimated to be around $252 million[3].

For the period from 2019 to 2030, the market is expected to see a significant expansion. The global Arformoterol Tartrate API market was estimated to be worth several million USD in 2023 and is forecast to reach a readjusted size by 2030, driven by increasing demand for COPD treatments and the growing generic drug market[1].

Regional Market Analysis

The market for Arformoterol Tartrate is segmented across various regions, including North America, Europe, Asia Pacific, South America, and the Middle East & Africa.

• North America: This region is a major market due to the high prevalence of COPD and the presence of key pharmaceutical companies. For instance, Cipla received final approval for its generic version of Arformoterol Tartrate Inhalation Solution in the U.S., which has contributed to the market growth[2].
• Europe: Europe also constitutes a significant share of the market, with countries like Germany, France, and the UK driving demand.
• Asia Pacific: This region is expected to see rapid growth due to increasing healthcare spending and a large patient population. Countries like China, Japan, and India are key contributors to this growth[1].
• South America and Middle East & Africa: These regions are also experiencing growth, albeit at a slower pace compared to the other regions.

Market Segmentation by Type and Application

The market is segmented by type and application:

• By Type:
  • Purity ≥ 99%
  • Purity < 99% The purity ≥ 99% segment is expected to dominate the market due to the stringent quality standards in pharmaceutical manufacturing[1].
• By Application:
  • Inhalation Solution
  • Others The inhalation solution segment is the primary application area, given the drug's efficacy in treating COPD through nebulized inhalation[2][3].

Key Players and Competitive Landscape

Several key players are driving the market for Arformoterol Tartrate:

• Cipla Ltd: Cipla received final approval for its generic version of Arformoterol Tartrate Inhalation Solution, which is an AN-rated generic therapeutic equivalent of Sunovion Pharmaceuticals' Brovana[2].
• Glenmark Life Sciences Ltd: Glenmark is another significant player in the global Arformoterol Tartrate market.
• MSN Laboratories Private Ltd: MSN Laboratories is also a major contributor to the market.
• Ritedose Corporation: Ritedose acquired the Arformoterol Tartrate asset from PAI Pharma, enhancing its position in the nebulized inhalation drug market[3].

Financial Performance and Revenue

The financial performance of the Arformoterol Tartrate market is robust, driven by the demand for COPD treatments. Here are some key financial metrics:

• Revenue: The market generated approximately $252 million in revenue in 2021, with Brovana, the branded version, having US sales of around $438 million for the 12-month period ending April 2021[2][3].
• Forecast: The market is expected to grow significantly, with forecasts indicating a substantial increase in revenue by 2030.

Growth Factors and Trends

Several factors are driving the growth of the Arformoterol Tartrate market:

• Increasing Prevalence of COPD: The rising incidence of COPD globally is a major driver, as more patients require long-term maintenance treatments.
• Generic Drug Market: The approval and launch of generic versions of Arformoterol Tartrate have made the drug more accessible and affordable, contributing to market growth[2].
• Advancements in Inhalation Technology: Improvements in nebulized inhalation solutions have enhanced the efficacy and convenience of Arformoterol Tartrate, making it a preferred treatment option[5].

Challenges and Restraints

Despite the growth, the market faces some challenges:

• Regulatory Hurdles: Obtaining regulatory approvals, especially for generic versions, can be a lengthy and complex process.
• Competition: The presence of other COPD treatments and the competitive landscape among pharmaceutical companies can impact market share.
• COVID-19 Impact: The pandemic has highlighted the need for agile supply chain management and responsive public health strategies, which can affect market dynamics[1].

Clinical Significance and Efficacy

Arformoterol tartrate has demonstrated significant clinical efficacy in treating COPD:

• Pharmacology: It acts as a potent, selective beta-2 adrenergic agonist, providing long-acting bronchodilation and improving lung function in patients with COPD[5].
• Clinical Studies: Various studies have shown that arformoterol tartrate provides sustained improvement in lung function with fewer side effects compared to other treatments[5].

Analytical Techniques and Pharmacokinetics

The drug's pharmacokinetics and analytical techniques are well-studied:

• Absorption and Distribution: Arformoterol tartrate is well-absorbed through the lungs when administered via a standard jet nebulizer[5].
• Analytical Techniques: Advanced methodologies have been employed for the determination and quantification of arformoterol tartrate, ensuring its quality and efficacy[5].

Conclusion

The market for Arformoterol Tartrate is poised for significant growth, driven by increasing demand for COPD treatments, the expansion of the generic drug market, and advancements in inhalation technology. Key players like Cipla and Ritedose are driving this growth through their strategic moves and product offerings.

Key Takeaways

• Growing Market Size: The global market for Arformoterol Tartrate is expected to expand significantly by 2030.
• Regional Growth: North America, Europe, and Asia Pacific are key regions driving market growth.
• Generic Versions: The approval of generic versions has increased market accessibility and affordability.
• Clinical Efficacy: Arformoterol tartrate has demonstrated significant clinical efficacy in treating COPD.
• Regulatory and Competitive Challenges: The market faces challenges related to regulatory approvals and competition from other COPD treatments.

FAQs

1. What is Arformoterol Tartrate used for? Arformoterol Tartrate is used for the long-term, twice-daily maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema[2].

2. Who are the key players in the Arformoterol Tartrate market? Key players include Cipla Ltd, Glenmark Life Sciences Ltd, MSN Laboratories Private Ltd, and Ritedose Corporation[1][2][3].

3. What is the market size of Arformoterol Tartrate? The market size for Arformoterol Tartrate oral inhalation was approximately $252 million in 2021, with forecasts indicating significant growth by 2030[1][3].

4. How does Arformoterol Tartrate work? Arformoterol Tartrate acts as a potent, selective beta-2 adrenergic agonist, providing long-acting bronchodilation and improving lung function in patients with COPD[5].

5. What are the challenges faced by the Arformoterol Tartrate market? The market faces challenges related to regulatory approvals, competition from other COPD treatments, and the impact of the COVID-19 pandemic on supply chain management[1].

Sources

1. QYResearch: Arformoterol Tartrate API - Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030.
2. PR Newswire: Cipla receives final approval for generic version of Sunovion Pharmaceuticals Inc.'s Brovana.
3. Ritedose: Ritedose Reaches Milestone with Asset Purchase Becomes largest generic drug maker of its kind.
4. Cognitive Market Research: Global Arformoterol Market Report 2024 Edition.
5. Bioline International: Arformoterol Tartrate - Bioline International.