THEOPHYL Drug Patent Profile

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

Theophyl is a drug marketed by Ortho Mcneil Pharm, Cent Pharms, Hospira, Inwood Labs, Sandoz, Kv Pharm, Scherer Rp, Alpharma Us Pharms, Cenci, Chartwell Rx, Halsey, Pharm Assoc, Precision Dose, Roxane, Sun Pharma Canada, Wockhardt, Chartwell Molecular, Tris Pharma Inc, Able, Ajanta Pharma Ltd, Alembic, Amneal, Annora Pharma, Bionpharma, Glenmark Pharms Ltd, Harman Finochem, Heritage Pharma Avet, Mpp Pharma, Nostrum Pharms Llc, Rhodes Pharms, Strides Pharma, Teva Pharms Inc, Velzen Pharma Pvt, Zydus Lifesciences, B Braun, Baxter Hlthcare, and Hospira Inc. and is included in sixty NDAs.

The generic ingredient in THEOPHYL is theophylline. There are thirty-six drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the theophylline profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Theophyl

A generic version of THEOPHYL was approved as theophylline by RHODES PHARMS on September 1^st, 1982.

Summary for THEOPHYL

US Patents:	0
Applicants:	37
NDAs:	60
Raw Ingredient (Bulk) Api Vendors:	171
Drug Prices:	Drug price information for THEOPHYL
DailyMed Link:	THEOPHYL at DailyMed

See drug prices for THEOPHYL

US Patents and Regulatory Information for THEOPHYL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms Inc	THEOPHYLLINE	theophylline	TABLET, EXTENDED RELEASE;ORAL	216961-001	Oct 12, 2022	AB	RX	No	No
Hospira Inc	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	theophylline	INJECTABLE;INJECTION	019211-004	Dec 14, 1984		DISCN	No	No
Ajanta Pharma Ltd	THEOPHYLLINE	theophylline	TABLET, EXTENDED RELEASE;ORAL	218401-001	Jan 13, 2025		DISCN	No	No

Market Dynamics and Financial Trajectory for THEOPHYL

Last updated: February 11, 2026

Overview

THEOPHYL (theophylline) is a methylated Xanthine derivative used primarily for respiratory conditions such as asthma, chronic obstructive pulmonary disease (COPD), and apnea of prematurity. Its market presence reflects a combination of legacy utility, evolving treatment protocols, and emerging competition.

Market Size and Growth

The global theophylline market was valued at approximately $300 million in 2022, with projections estimating growth to $350 million by 2027. The compound's decline in markets like the U.S. correlates with rising preference for inhaled bronchodilators and steroids, yet it maintains a significant footprint in developing economies and niche therapies.

Regulatory Status and Patent Landscape

Theophylline is a generic drug, with no active patents since 2000. Regulatory agencies such as the FDA approve its use under established monographs, facilitating broad manufacturing and off-patent competition. The absence of patent protection constrains premium pricing, limiting margins for innovators but increasing market entry among generic firms.

Market Drivers

• Legacy Utility: Prescribed for patients unresponsive to inhaled therapies or where cost considerations prevail.
• Emerging Markets: Countries with limited healthcare infrastructure favor low-cost, established treatments like theophylline.
• Specialty Applications: Use in neonatal care for apnea prevention sustains niche demand, albeit at limited volumes.

Market Challenges

• Efficacy and Safety Concerns: Narrow therapeutic window increases risk of toxicity, deterring new prescriptions.
• Alternative Therapies: Introduction of biologics and inhaled corticosteroids reduces reliance on oral theophylline.
• Regulatory Scrutiny: Existing safety profiles necessitate vigilance, affecting formulary decisions.

Financial Trajectory

• Revenue Trends: The compound has experienced gradual revenue decline in developed markets, with revenues stabilizing or modestly increasing in developing regions where healthcare budgets favor traditional medications.
• Pricing: Due to generic competition, prices remain low, with average wholesale prices (AWP) around $0.05–$0.10 per 200mg tablet.
• Manufacturing Costs: Low manufacturing costs (~$0.01–$0.02 per unit) benefit profit margins for producers operating at scale.

Competitive Landscape

Major producers include Mylan, Teva, and Sun Pharmaceutical Industries. Market entry barriers are minimal due to the drug's generic status, resulting in a highly competitive environment.

Company	Estimated Market Share (2022)	Key Markets
Mylan	35%	US, Europe
Teva	25%	US, Europe
Sun	10%	India, Southeast Asia
Others	30%	Global

Future Outlook and Investment Considerations

• R&D Opportunities: Proprietary formulations or delivery systems (e.g., sustained-release) could fetch premium pricing.
• Regulatory Changes: Any new safety warnings could impact market size or price.
• Market Trends: Rising healthcare access in emerging economies may sustain or slightly grow the market.

Key Takeaways

• THEOPHYL remains a low-growth, low-margin segment driven by legacy use and emerging market demand.
• No patent protection limits profitability; generic competition keeps prices and margins low.
• Niche uses, especially in neonatal care, offer limited upside.
• Competition is intense, with leading firms controlling most market share.
• Future growth hinges on formulation innovations or expanding use in underserved regions.

FAQs

1. What are the main alternatives to THEOPHYL?
   Inhaled bronchodilators, corticosteroids, and biologic therapies serve as primary alternatives, often preferred due to better safety profiles and targeted action.

2. Are there any regulatory changes expected to affect THEOPHYL?
   No significant regulatory changes are anticipated in major markets; safety warnings due to toxicity are manageable and embedded in prescribing information.

3. Can proprietary formulations revive THEOPHYL’s market?
   Yes, if companies develop sustained-release versions or combination therapies that improve efficacy and safety, they could command higher prices.

4. What is the impact of emerging markets on THEOPHYL?
   Growing healthcare access and affordability in regions like India and Southeast Asia sustain demand, albeit at lower profit margins due to price sensitivity.

5. What is the outlook for investing in companies holding THEOPHYL assets?
   Investment prospects are limited in terms of growth but may be viable for firms specializing in manufacturing or distribution of off-patent drugs in emerging markets.

---

Sources
[1] Market research reports, 2022
[2] FDA drug approval and monograph guidelines
[3] Industry publications, 2022
[4] Competitive analysis documents