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. Four 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:	4
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	38
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
Mahidol University	Phase 2/Phase 3
Medical College of Wisconsin	Phase 1/Phase 2
University of Oklahoma	Phase 1/Phase 2

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
Intl Medication	AMINOPHYLLINE	aminophylline	INJECTABLE;INJECTION	087868-001	Nov 10, 1983		DISCN	No	No
Vangard	AMINOPHYLLINE	aminophylline	TABLET;ORAL	088319-001	Oct 3, 1983		DISCN	No	No
Purepac Pharm	AMINOPHYLLINE	aminophylline	TABLET;ORAL	084699-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Valeant Pharm Intl	AMINOPHYLLINE	aminophylline	TABLET;ORAL	084563-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Intl Medication	AMINOPHYLLINE	aminophylline	INJECTABLE;INJECTION	087867-001	Nov 10, 1983		DISCN	No	No

AMINOPHYLLINE Market Analysis and Financial Projection Experimental

Aminophylline Market Dynamics and Financial Trajectory

Market Overview

Aminophylline, a derivative of theophylline, is a crucial medication in the treatment of respiratory disorders such as asthma and Chronic Obstructive Pulmonary Disease (COPD). It acts as a bronchodilator and smooth muscle relaxant, aiding in the dilation of airways and improving breathing.

Market Size and Growth

The global aminophylline market is projected to experience moderate growth over the next few years. As of 2022, the market was valued at $280 million and is expected to reach $350 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 2.50% from 2023 to 2030[2][4][5].

Drivers of Market Growth

Several factors are driving the growth of the aminophylline market:

Increasing Prevalence of Respiratory Disorders

The rising prevalence of respiratory diseases globally, particularly COPD, is a significant driver. COPD affects approximately 12% of the general population and is the third leading cause of mortality worldwide, resulting in 3 million deaths annually[1][4].

Demand for Cost-Effective Treatment Options

There is a surging demand for cost-effective treatment options, which aminophylline fulfills due to its availability in various forms, including oral medications, injections, and intravenous administration[2][4].

Preference for Oral Medications

Patients' rising preference for oral medications is another key factor. Oral administration of aminophylline, in the form of tablets or capsules, is preferred for its ease of use and non-invasive nature, contributing to the market's growth[4][5].

Geographical Analysis

North America

North America dominates the aminophylline market due to its well-established healthcare infrastructure, advanced medical research facilities, and high prevalence of respiratory disorders. The region's substantial healthcare expenditure and the presence of major pharmaceutical companies further bolster its leading position[1][4][5].

Asia-Pacific

The Asia-Pacific region is also witnessing positive growth due to the increased presence of generic manufacturers and the growing geriatric population. This region offers significant market opportunities, especially in countries like China, Japan, and India[4].

Market Segments

The aminophylline market is segmented by type, application, end-user, and geography.

Route of Administration

The oral segment is expected to dominate the market during the forecast period due to its convenience and widespread use. Oral administration is preferred by patients for its ease of use and non-invasive nature[5].

End-User

The market is used in various settings, including hospitals, clinics, and homecare. The demand from these sectors is driven by the rising prevalence of respiratory diseases and growing healthcare needs[5].

Distribution Channel

The online pharmacies segment is projected to have the highest CAGR due to the growing trend of digital healthcare and e-commerce. Online pharmacies offer easy access to aminophylline, especially for patients in remote areas or those seeking discreet purchasing options[5].

Innovations and Research Activities

Personalized Medicine

Advancements in personalized medicine and the development of patient-centric therapies are driving the demand for aminophylline. These innovations enable more targeted and effective treatment options for patients with respiratory disorders[1].

Drug Development

Increasing drug development and research activities are also boosting the market. New formulations and delivery methods, such as fast-acting bronchodilators, are expanding market opportunities and improving treatment outcomes[3][4].

Challenges and Opportunities

Narrow Therapeutic Range

Aminophylline has a narrow therapeutic range, which requires careful dosage monitoring. This can be a challenge but also presents opportunities for innovation in drug delivery systems and patient monitoring technologies[5].

Emerging Economies

Emerging economies offer significant investment potential due to the expanding demand for respiratory care and the development of healthcare infrastructure. These regions are expected to contribute substantially to the market's growth in the coming years[3].

Key Market Players

The aminophylline market includes several key players who are driving innovation and growth. These companies are focused on research and development, as well as expanding their distribution channels to meet the growing demand for aminophylline[2].

Financial Trajectory

The financial trajectory of the aminophylline market is positive, with a projected CAGR of 2.50% to 2.8% from 2023 to 2030. The market is expected to reach $353.2 million by 2030, driven by the increasing prevalence of respiratory diseases and the growing demand for cost-effective and convenient treatment options[2][4][5].

"Aminophylline acts as a bronchodilator and smooth muscle relaxant, aiding in the dilation of airways and improving breathing. The market is driven by the increasing prevalence of respiratory diseases globally, coupled with the rising awareness about available treatment options."[2]

Key Takeaways

• The global aminophylline market is expected to grow at a CAGR of 2.50% to 2.8% from 2023 to 2030.
• The market is driven by the increasing prevalence of respiratory disorders and the preference for oral medications.
• North America dominates the market due to its advanced healthcare infrastructure and high prevalence of respiratory disorders.
• Innovations in personalized medicine and drug delivery systems are key drivers of market growth.
• Emerging economies offer significant investment potential due to the expanding demand for respiratory care.

FAQs

1. What is the current market size of the aminophylline market?

The global aminophylline market was valued at $280 million in 2022[2].

2. What is the projected growth rate of the aminophylline market?

The market is expected to grow at a CAGR of 2.50% to 2.8% from 2023 to 2030[2][4][5].

3. Which region dominates the aminophylline market?

North America dominates the market due to its well-established healthcare infrastructure and high prevalence of respiratory disorders[1][4][5].

4. What are the main drivers of the aminophylline market growth?

The main drivers include the increasing prevalence of respiratory disorders, the demand for cost-effective treatment options, and the preference for oral medications[2][4].

5. What are the potential challenges in the aminophylline market?

One of the key challenges is the narrow therapeutic range of aminophylline, which requires careful dosage monitoring[5].

Sources:

1. Grand View Research - Aminophylline Market Size, Share And Growth Report, 2030
2. IndustryARC - Aminophylline Market Size Report 2023 - 2030
3. Market Research Intellect - Aminophylline Injection Market on the Rise: Boosted by Respiratory Disease Burdens
4. Data Bridge Market Research - Global Aminophylline Market – Industry Trends and Forecast to 2029
5. Stratistics MRC - Aminophylline Market Forecasts to 2030 - Global Analysis By Route of Administration, End-User, and Geography