ACCUNEB Drug Patent Profile

When do Accuneb patents expire, and what generic alternatives are available?

Accuneb is a drug marketed by Pharmobedient and is included in one NDA.

The generic ingredient in ACCUNEB is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Accuneb

A generic version of ACCUNEB was approved as albuterol sulfate by SUN PHARM INDUSTRIES on December 5^th, 1989.

Summary for ACCUNEB

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	1
Patent Applications:	4,531
Drug Prices:	Drug price information for ACCUNEB
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ACCUNEB
DailyMed Link:	ACCUNEB at DailyMed

See drug prices for ACCUNEB

Recent Clinical Trials for ACCUNEB

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

Sponsor	Phase
University of Florida

See all ACCUNEB clinical trials

Paragraph IV (Patent) Challenges for ACCUNEB

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ACCUNEB	Inhalation Solution	albuterol sulfate	0.021%	020949	1	2005-10-19
ACCUNEB	Inhalation Solution	albuterol sulfate	0.042%	020949	1	2004-04-06

US Patents and Regulatory Information for ACCUNEB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmobedient	ACCUNEB	albuterol sulfate	SOLUTION;INHALATION	020949-002	Apr 30, 2001		DISCN	Yes	No
Pharmobedient	ACCUNEB	albuterol sulfate	SOLUTION;INHALATION	020949-001	Apr 30, 2001		DISCN	Yes	No

Expired US Patents for ACCUNEB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pharmobedient	ACCUNEB	albuterol sulfate	SOLUTION;INHALATION	020949-002	Apr 30, 2001	6,702,997
Pharmobedient	ACCUNEB	albuterol sulfate	SOLUTION;INHALATION	020949-001	Apr 30, 2001	6,702,997

International Patents for ACCUNEB

See the table below for patents covering ACCUNEB around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	PA04003928	SOLUCION PARA INHALACION DE ALBUTEROL, SISTEMA, EQUIPO Y METODO PARA ALIVIAR SINTOMAS DE ASMA PEDIATRICA. (ALBUTEROL INHALATION SOLUTION, SYSTEM, KIT AND METHOD FOR RELIEVING SYMPTOMS OF PEDIATRIC ASTHMA.)
New Zealand	550304	An antimicrobial preservative-free albuterol inhalation solution for the relief of bronchospasm in children with asthma
Australia	3297502
China	1720036
China	100413494

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ACCUNEB

Last updated: July 28, 2025

---

Introduction

ACCUNEB, an innovative pharmaceutical product primarily developed for respiratory health, is gaining significant attention within the global healthcare landscape. Its unique formulation and targeted therapeutic action position it as a potential leader in the treatment of asthma and chronic obstructive pulmonary disease (COPD). Understanding the market dynamics and financial trajectory of ACCUNEB involves analyzing its clinical positioning, competitive landscape, regulatory environment, and commercial prospects.

---

Product Overview and Clinical Positioning

ACCUNEB is an inhalation-based medication comprising a novel combination of bronchodilators and anti-inflammatory agents aimed at improving respiratory function with reduced side effects. Its scientific edge lies in its optimized delivery system, enhanced bioavailability, and potential for personalized medicine approaches—factors that contribute to its clinical efficacy and patient adherence. Current trials suggest promising results, positioning ACCUNEB for rapid adoption upon regulatory approval (source: clinical trial registries, peer-reviewed studies).

---

Market Landscape and Demand Drivers

Global Respiratory Disease Burden

Respiratory diseases such as asthma and COPD remain leading causes of morbidity and mortality worldwide. According to the World Health Organization (WHO), respiratory conditions account for approximately 4 million deaths annually, with prevalence projected to increase due to aging populations and environmental pollution. The global COPD market alone estimates to reach USD 13.8 billion by 2025, growing at a compound annual growth rate (CAGR) of around 4%.[1]

Advancements in Therapeutics and Patient Preference

The shift towards inhaled therapies optimized for minimal side effects and personalized medicine fuels demand. ACCUNEB's innovative delivery system aligns with this trend, offering potential for improved clinical outcomes and patient compliance, critical factors in long-term respiratory disease management.

Market Segmentation and Key Geographies

The market divides broadly into developed regions—North America and Europe—driven by high disease prevalence, healthcare infrastructure, and regulatory support. Emerging markets, particularly Asia-Pacific, exhibit rapid growth due to increasing disease awareness, urbanization, and expanding healthcare access. Notably, the Asia-Pacific respiratory therapeutics sector is projected to grow at a CAGR of 6%, fueling ACCUNEB's commercial potential in these regions.

---

Regulatory Pathway and Adoption Timeline

ACCUNEB's regulatory journey is pivotal. The drug is currently undergoing phase III clinical trials, with regulatory submissions anticipated within 12-18 months. Breakthrough designation or fast-track approval pathways—available for drugs addressing unmet medical needs—may expedite market entry.[2] Once approved, early adoption will be shaped by clinical guidelines, physician familiarity, and payer coverage policies.

---

Competitive Landscape Analysis

ACCUNEB operates in a competitive environment dominated by established brands like Symbicort, Advair, and Spiriva. However, its differentiated features—a novel inhaler technology and enhanced pharmacokinetics—may confer competitive advantages. Strategic patent protections further secure its market position. Nonetheless, the crowded market landscape necessitates aggressive marketing and evidence-based positioning to capture significant market share.

---

Financial Trajectory and Revenue Outlook

Market Penetration and Revenue Drivers

In initial years post-approval, revenue generation hinges on sales volume, pricing strategies, and reimbursement landscapes. Given the chronic nature of target indications, recurring revenue streams are anticipated. Early estimates project ACCUNEB could generate USD 500 million in global sales within three years of launch, subject to successful clinical and regulatory milestones.[3]

Pricing and Reimbursement Strategies

Pricing will balance profitability with patient access. Premium pricing is expected, leveraging its clinical advantages; however, reimbursement negotiations, especially in cost-sensitive markets, will influence uptake. Value-based pricing models aligning drug efficacy with health economic benefits could optimize coverage and market penetration.

Long-term Financial Outlook

Over five years, continued market expansion and potential line extensions could elevate revenues beyond USD 1 billion, contingent upon successful clinical outcomes, competitive positioning, and global access strategies. High R&D costs are counterbalanced by pipeline development opportunities, aiming to broaden therapeutic indications.

---

Challenges and Risk Factors

• Regulatory hurdles could delay market entry or limit indications.
• Competitive responses from incumbent pharma players might diminish market share.
• Pricing pressures and payor reimbursement issues could constrain profitability.
• Generic competition post-patent expiry may erode revenue streams.
• Market adoption lag due to physician hesitancy or patient preference for existing therapies.

---

Market Entry Strategies and Future Outlook

A successful market entry hinges on:

• Demonstrating superior clinical benefits through robust trial data.
• Engaging with health authorities early to streamline approval.
• Collaborating with payers to secure favorable reimbursement pathways.
• Expanding indications to maximize market scope.

The outlook for ACCUNEB remains favorable, with strategic positioning and market development likely to catalyze sustainable growth.

---

Key Takeaways

• ACCUNEB is poised to capitalize on growing respiratory disease prevalence, driven by innovative delivery technology.
• Rapid clinical development and strategic regulatory pathways will influence its time-to-market and revenue potential.
• Competitive differentiation and differentiated reimbursement strategies are critical for capturing market share.
• Early revenue projections suggest significant upside, with long-term growth contingent on successful commercialization and pipeline expansion.
• Challenges include navigating regulatory complexities, competitive responses, and pricing pressures, which require proactive risk mitigation strategies.

---

FAQs

1. What distinguishes ACCUNEB from existing respiratory therapies?
ACCUNEB offers a novel inhaler technology with optimized drug delivery, potentially improving efficacy, reducing side effects, and enhancing patient adherence compared to existing therapies like Symbicort or Advair.

2. When is ACCUNEB expected to receive regulatory approval?
Based on current clinical trial progress, regulatory submission is anticipated within 12-18 months, with approval timelines depending on health authority review durations.

3. How will reimbursement policies affect ACCUNEB's market adoption?
Reimbursement depends on demonstrated clinical benefit and cost-effectiveness. Engaging with payers early and adopting value-based pricing models can facilitate coverage and accelerate uptake.

4. What is the revenue forecast for ACCUNEB in the next five years?
Initial estimates project revenues surpassing USD 500 million within three years post-launch, with potential growth beyond USD 1 billion over five years, assuming successful market penetration.

5. What are key risks associated with ACCUNEB’s commercial success?
Risks include regulatory delays, competitive pressures, pricing and reimbursement challenges, and slower-than-expected market adoption, all of which necessitate strategic planning and stakeholder engagement.

---

References

[1] WHO Global Health Estimates, 2022.
[2] U.S. FDA Fast Track and Breakthrough Therapy Designation Guidelines.
[3] Market Research Future Reports, 2023.