THEOPHYLLINE - Generic Drug Details

What are the generic sources for theophylline and what is the scope of patent protection?

Theophylline is the generic ingredient in fifty-two branded drugs marketed by Fleming Pharms, Forest Labs, Sanofi Aventis Us, Graham Dm, Endo Operations, Schering, Whitby, Schwarz Pharma, Ortho Mcneil Pharm, Cent Pharms, Hospira, Inwood Labs, Sandoz, Scherer Rp, Fisons, Kv Pharm, Cenci, Lannett, Panray, Alpharma Us Pharms, Chartwell Rx, Halsey, Pharm Assoc, Precision Dose, Roxane, Taro, Wockhardt, B Braun, Baxter Hlthcare, Hospira Inc, Nostrum Labs Inc, 3M, Chartwell Molecular, Tris Pharma Inc, Ferndale Labs, Warner Chilcott, Monarch Pharms, Roerig, Pharm Res Assoc, Nostrum Pharms Llc, Able, Alembic, Amneal, Annora Pharma, Bionpharma, Glenmark Pharms Ltd, Harman Finochem, Heritage Pharma Avet, Rhodes Pharms, Strides Pharma, Teva Pharms Inc, Velzen Pharma Pvt, Zydus Lifesciences, Medicis, and Novartis, and is included in one hundred and twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-six drug master file entries for theophylline. Twenty-six suppliers are listed for this compound.

Summary for THEOPHYLLINE

US Patents:	0
Tradenames:	52
Applicants:	55
NDAs:	123
Drug Master File Entries:	36
Finished Product Suppliers / Packagers:	26
Raw Ingredient (Bulk) Api Vendors:	170
Clinical Trials:	111
Patent Applications:	6,795
Drug Prices:	Drug price trends for THEOPHYLLINE
What excipients (inactive ingredients) are in THEOPHYLLINE?	THEOPHYLLINE excipients list
DailyMed Link:	THEOPHYLLINE at DailyMed

See drug prices for THEOPHYLLINE

See drug sales revenues for THEOPHYLLINE

Recent Clinical Trials for THEOPHYLLINE

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

Sponsor	Phase
Tanta University	N/A
LG Chem	Phase 1
Medical College of Wisconsin	Phase 1/Phase 2

See all THEOPHYLLINE clinical trials

Pharmacology for THEOPHYLLINE

Drug Class

Methylxanthine

Medical Subject Heading (MeSH) Categories for THEOPHYLLINE

Bronchodilator Agents

Phosphodiesterase Inhibitors

Purinergic P1 Receptor Antagonists

Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for THEOPHYLLINE

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 THEOPHYLLINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
B Braun	THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER	theophylline	INJECTABLE;INJECTION	019212-002	Nov 7, 1984		DISCN	No	No
Glenmark Pharms Ltd	THEOPHYLLINE	theophylline	TABLET, EXTENDED RELEASE;ORAL	212184-002	Jun 3, 2021	AB	RX	No	No
Monarch Pharms	QUIBRON-T/SR	theophylline	TABLET, EXTENDED RELEASE;ORAL	087563-001	Jun 21, 1983		DISCN	No	No
Sanofi Aventis Us	SLO-BID	theophylline	CAPSULE, EXTENDED RELEASE;ORAL	087893-001	Jan 31, 1985		DISCN	No	No
Forest Labs	ELIXOPHYLLIN	theophylline	CAPSULE;ORAL	085545-001	Jul 31, 1984		DISCN	No	No
B Braun	THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER	theophylline	INJECTABLE;INJECTION	019826-003	Aug 14, 1992		DISCN	Yes	No

Expired US Patents for THEOPHYLLINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Monarch Pharms	QUIBRON-T/SR	theophylline	TABLET, EXTENDED RELEASE;ORAL	087563-001	Jun 21, 1983

THEOPHYLLINE Market Analysis and Financial Projection Experimental

Theophylline Market Dynamics and Financial Trajectory

Market Overview

Theophylline, a bronchodilator used primarily in the treatment of respiratory disorders such as asthma and chronic obstructive pulmonary disease (COPD), is a significant player in the pharmaceutical market. Here’s a detailed look at the market dynamics and financial trajectory of theophylline.

Current Market Valuation

As of 2022, the global theophylline and aminophylline market was valued at approximately $318 million. This valuation is expected to grow, albeit at a slow pace, with a projected Compound Annual Growth Rate (CAGR) of 2% from 2022 to 2032, reaching a market value of $387.64 million by 2032[1].

Growth Drivers

Increasing Incidence of Respiratory Diseases

The rising incidence of respiratory conditions such as asthma and COPD is a major driver of the theophylline market. These diseases are becoming more prevalent due to demographic factors like aging populations and environmental pollution, thereby increasing the demand for theophylline-based treatments[4].

Cost-Effectiveness

Theophylline is recognized for its cost-effectiveness. Studies have shown that at a willingness-to-pay threshold of £20,000, there is a 75% chance of theophylline being cost-effective, and at £30,000, this chance increases to 64%. This cost-effectiveness is particularly evident in reducing hospital admission costs associated with exacerbations of COPD[2].

Innovations in Pharmaceutical Research

Continuous research and development in pharmaceuticals are leading to novel formulations and delivery systems for theophylline. These innovations are improving the safety and efficacy profiles of theophylline-based drugs, which in turn is driving market growth[4].

Market Segmentation

By Application

The theophylline market is segmented primarily by application, with asthma being the most significant segment. Other applications include insomnia and various other respiratory conditions. The demand for theophylline in treating asthma and COPD is the main driver of market expansion[4].

By Product

The market is also segmented by product type, including injections, tablets, and capsules. These different forms of administration offer convenience and flexibility to patients, contributing to the market's growth[4].

By Geography

Geographically, the North American region is expected to hold a significant market share due to the well-established healthcare infrastructure and the increasing incidence of lung diseases in the aging population. Other regions such as Europe, Asia-Pacific, and the Middle East are also contributing to the market's growth[1].

Competitive Landscape

The theophylline market is highly competitive, with numerous international and regional companies vying for market share. Key players such as GlaxoSmithKline plc, Altor BioScience Corporation, Ono Pharmaceutical Corporation Ltd., and Octapharma AG are implementing various strategies including product portfolio expansion, regional development, mergers, and acquisitions to strengthen their market positions[1].

Financial Projections

Global Theophylline Market Size

The global theophylline market was valued at $421.2 million in 2023 and is projected to reach $660.1 million by 2031, growing at a CAGR of 6% from 2024 to 2031. This growth trajectory indicates robust market dynamics driven by the increasing incidence of respiratory conditions and advancements in pharmaceutical research[4].

Revenue Growth

The revenue growth of the theophylline market is anticipated to be steady, driven by the expanding demand for bronchodilator drugs. The market's financial trajectory is influenced by factors such as the rising prevalence of respiratory diseases, improved drug formulations, and strategic partnerships between pharmaceutical companies and healthcare providers[4].

Challenges and Opportunities

Declining Use in Some Regions

Despite its global significance, the use of theophylline in some regions, such as the United States, has been declining due to the advent of new and more effective treatments for asthma, including inhaled glucocorticoids and long-acting inhaled β-receptor agonists. The narrow therapeutic index and potential side effects of theophylline have also contributed to this decline[5].

Opportunities in Emerging Markets

However, there are significant opportunities in emerging markets where access to healthcare is improving, and the incidence of respiratory diseases is on the rise. Strategic partnerships and innovations in drug delivery systems can help tap into these markets and drive further growth[4].

Key Takeaways

• The global theophylline market is valued at $318 million in 2022 and is expected to reach $387.64 million by 2032.
• The market is driven by the increasing incidence of respiratory diseases and the cost-effectiveness of theophylline.
• Innovations in pharmaceutical research and development are improving the safety and efficacy of theophylline-based drugs.
• The North American region holds a significant market share due to its well-established healthcare infrastructure.
• The competitive landscape is characterized by major players adopting various business strategies to expand their market presence.

FAQs

1. What is the current market valuation of the theophylline and aminophylline market?

The current market valuation of the theophylline and aminophylline market is approximately $318 million as of 2022[1].

2. What is the projected growth rate of the theophylline market from 2022 to 2032?

The theophylline market is projected to grow at a CAGR of 2% from 2022 to 2032[1].

3. What are the primary drivers of the theophylline market?

The primary drivers include the increasing incidence of respiratory diseases, cost-effectiveness, and innovations in pharmaceutical research[1][4].

4. Which region is expected to hold a significant market share in the theophylline market?

The North American region is expected to hold a significant market share due to its well-established healthcare infrastructure and the rising incidence of lung diseases[1].

5. What are the challenges facing the theophylline market in some regions?

The challenges include the declining use of theophylline in regions like the United States due to the advent of new treatments and the narrow therapeutic index of theophylline[5].

Cited Sources

1. Future Market Insights, "Theophylline And Aminophylline Market Size, Demand & Trends – FMI"
2. NCBI, "Cost-effectiveness - NCBI"
3. Statista Market Forecast, "Bronchodilator Drugs - Germany | Statista Market Forecast"
4. Market Research Intellect, "Theophylline Market Size, Trends and Projections"
5. Mayo Clinic Proceedings, "Theophylline: Recent Advances in the Understanding of Its Mode of Action and Clinical Use"