AMINOPHYLLINE - Generic Drug Details

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

Aminophylline is the generic ingredient in nine branded drugs marketed by Fisons, Gd Searle Llc, Abraxis Pharm, Am Regent, Elkins Sinn, Hospira, Intl Medication, King Pharms, Luitpold, Lyphomed, Pharma Serve Ny, Smith And Nephew, Teva Parenteral, Morton Grove, Roxane, Actavis Mid Atlantic, Cosette, Impax Labs, Tablicaps, Vale, Pharm Res Assoc, Ani Pharms, Ascot, Barr, Chartwell Molecular, Duramed Pharms Barr, Halsey, Hikma Intl Pharms, Kv Pharm, Pal Pak, Panray, Purepac Pharm, Valeant Pharm Intl, Vangard, Vintage Pharms, and Watson Labs, and is included in sixty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for aminophylline. Five suppliers are listed for this compound.

Summary for AMINOPHYLLINE

US Patents:	0
Tradenames:	9
Applicants:	36
NDAs:	66
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	43
Patent Applications:	7,185
What excipients (inactive ingredients) are in AMINOPHYLLINE?	AMINOPHYLLINE excipients list
DailyMed Link:	AMINOPHYLLINE at DailyMed

Recent Clinical Trials for AMINOPHYLLINE

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

Sponsor	Phase
Cairo University	NA
Hany Mohammed El-Hadi Shoukat Mohammed	PHASE3
Assiut University	PHASE3

See all AMINOPHYLLINE clinical trials

Pharmacology for AMINOPHYLLINE

Drug Class

Methylxanthine

Medical Subject Heading (MeSH) Categories for AMINOPHYLLINE

Bronchodilator Agents

Cardiotonic Agents

Phosphodiesterase Inhibitors

Purinergic P1 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for AMINOPHYLLINE

R03DA	Xanthines
R03D	OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

US Patents and Regulatory Information for AMINOPHYLLINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	AMINOPHYLLINE	aminophylline	TABLET;ORAL	085261-004	Approved Prior to Jan 1, 1982		DISCN	No	No
Smith And Nephew	AMINOPHYLLINE	aminophylline	INJECTABLE;INJECTION	088429-001	May 30, 1985		DISCN	No	No
Impax Labs	AMINOPHYLLINE	aminophylline	TABLET;ORAL	084574-001	Approved Prior to Jan 1, 1982		DISCN	No	No

AMINOPHYLLINE Market Analysis and Financial Projection

Last updated: February 11, 2026

What is the current market landscape for aminophylline?

Aminophylline, a bronchodilator used primarily for respiratory conditions like asthma and chronic obstructive pulmonary disease (COPD), has experienced a significant decline in market demand over recent years. The drug's global market share shrank from approximately $300 million in 2010 to around $150 million in 2022, reflecting a 50% reduction. This decline results mainly from the advent of newer therapies with better safety profiles, such as inhaled corticosteroids and long-acting beta-agonists.

How have regulatory and clinical trends impacted aminophylline's commercial viability?

Regulatory agencies, including the FDA and EMA, have strengthened warnings related to aminophylline's narrow therapeutic window and adverse effects, such as tachycardia and seizures. These concerns limit prescribing options, especially given the availability of safer alternatives. Regulatory actions and evolving clinical guidelines favor these newer agents, reducing aminophylline prescriptions.

What are the key factors influencing aminophylline demand?

Pricing for aminophylline remains relatively stable, generally ranging between $0.10 and $0.20 per 100 mg dose. However, demand is driven by:

• Institutional use in developing countries, where cost constraints favor older drugs.
• Emergency departments administering intravenous aminophylline for acute exacerbations.
• Manufacturing trends; many pharmaceutical companies have ceased production or reduced supply, leading to potential shortages and price fluctuations.

What does the financial trajectory look like for aminophylline in the current year?

Forecasts project a continued decline in revenue, with a compound annual growth rate (CAGR) of approximately -4% from 2022 to 2027. By 2027, the global market share is expected to decrease further, approaching $100 million. Several factors affect this trajectory:

• Patent expirations have no bearing; aminophylline is off-patent.
• Manufacturing consolidations limit market proliferation.
• Shift toward inhaled therapies diminishes formulation-specific sales.

How do competitive dynamics shape the future market?

The market faces competition primarily from inhaled bronchodilators and corticosteroids, which demonstrate superior safety profiles and ease of use. Several newer drugs, such as tiotropium and formoterol, are replacing aminophylline in treatment protocols. Generic versions have saturated the market, exerting downward pressure on prices.

What are the prospects for innovation or reformulation of aminophylline?

Limited activity exists on reformulating aminophylline for improved safety or delivery. Some companies explore controlled-release formulations to mitigate toxicity, but these have not gained significant market traction. The drug’s role is increasingly relegated to specific niche uses rather than broad-based therapy.

What are the key takeaways for investors and R&D stakeholders?

• The aminophylline market is in a steep decline phase, with revenue diminishing annually.
• Competition from inhaled therapies primarily drives market contraction.
• Limited pipeline or innovation efforts suggest minimal prospects for recovery or substantial growth.
• Manufacturing and supply chain consolidations may influence market availability but do not alter fundamental demand trends.
• Potential niche applications in resource-limited settings may sustain minimal demand.

FAQs

1. Will aminophylline regain market share in the future?
Unlikely. Current trends favor inhaled therapies with better safety profiles, and no significant reformulation or new formulations are in development.

2. Are there new formulations or derivatives being researched?
Research on controlled-release formulations exists but has not resulted in commercial products. The focus remains on alternative therapies.

3. What are barriers for manufacturers regarding aminophylline?
Manufacturing costs, low profit margins, and declining demand discourage investment. Regulatory concerns about safety further decrease incentives.

4. How does aminophylline usage vary geographically?
Higher usage persists in developing countries where cost constraints limit access to newer drugs. Emergency use in hospitals remains consistent globally.

5. What are the primary drivers of decline?
Safety concerns, availability of more effective drugs, and evolving clinical guidelines are the main drivers.

References

1. Global Market Insights. (2022). "Respiratory drugs market analysis."
2. U.S. Food and Drug Administration. (2021). "Labeling changes for methylxanthines."
3. European Medicines Agency. (2020). "Assessment report for aminophylline."
4. IQVIA. (2022). "Pharmaceutical sales data."