theophylline - Profile

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

Theophylline is the generic ingredient in fifty-one 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, Sun Pharma Canada, Wockhardt, B Braun, Baxter Hlthcare, Hospira Inc, Solis Pharms, 3M, Chartwell Molecular, Tris Pharma Inc, Ferndale Labs, Warner Chilcott, Monarch Pharms, Roerig, Pharm Res Assoc, 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, Medicis, and Novartis, and is included in one hundred and twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

Summary for theophylline

US Patents:	0
Tradenames:	51
Applicants:	57
NDAs:	124

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
Fleming Pharms	AEROLATE III	theophylline	CAPSULE, EXTENDED RELEASE;ORAL	085075-003	Nov 24, 1986		DISCN	No	No
Fleming Pharms	AEROLATE JR	theophylline	CAPSULE, EXTENDED RELEASE;ORAL	085075-002	Nov 24, 1986		DISCN	No	No
Fleming Pharms	AEROLATE SR	theophylline	CAPSULE, EXTENDED RELEASE;ORAL	085075-001	Nov 24, 1986		DISCN	No	No
Forest Labs	ELIXOPHYLLIN SR	theophylline	CAPSULE, EXTENDED RELEASE;ORAL	086826-001	Jan 29, 1985		DISCN	No	No
Forest Labs	ELIXOPHYLLIN SR	theophylline	CAPSULE, EXTENDED RELEASE;ORAL	086826-002	Jan 29, 1985		DISCN	No	No
Sanofi Aventis Us	SLO-BID	theophylline	CAPSULE, EXTENDED RELEASE;ORAL	088269-001	Jan 31, 1985		DISCN	No	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	4,465,660

Theophylline Investment Scenario and Fundamentals Analysis

Last updated: February 19, 2026

What Is the Current Market for Theophylline?

Theophylline is a methylxanthine drug primarily used for respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD). Its global market has experienced decline due to the availability of newer drugs with better safety profiles.

• Market Size: Estimated at USD 50 million in 2022, with a compound annual growth rate (CAGR) of approximately 2.5% over the past five years.
• Key Regions: North America (40%), Europe (30%), Asia-Pacific (20%), and rest of the world (10%).
• Market Drivers: Established generic status, affordability, and longstanding clinical familiarity.
• Market Constraints: Safety concerns, newer therapies, and regulatory challenges.

What Are the Patent and Regulatory Statuses?

• Patent Status: Theophylline's patents have expired, making it largely commoditized.
• Regulatory Status: Approved by agencies such as the FDA and EMA for respiratory conditions. No recent major approvals or changes in regulatory pathways.
• Manufacturing: Widely produced generically; little room for exclusivity-based revenue.

What Is the Uptake and Clinical Position?

• Theophylline remains an off-label option and is part of some treatment guidelines; however, it is not considered first-line therapy due to its narrow therapeutic index and side effects.
• Physicians prefer inhaled corticosteroids and beta-agonists over theophylline.
• Recent trials focus on toxicity mitigation or new formulations.

What Are the Competitive Dynamics?

Factor	Status
Generics	Dominant
Patents	Expired
Key Competitors	Multiple small manufacturers; no major players holding patents
Market Differentiation	Limited to formulation improvements or delivery methods

What Are Key Investment Entry Points?

Potential investment opportunities are limited to niche applications, reformulations, or combination therapies. No significant patent-driven growth exists; investments in innovation may require substantial R&D capital.

What Are the R&D and Innovation Trends?

• Development of controlled-release formulations.
• Efforts to improve therapeutic window and safety profile.
• Exploration of nebulized or transdermal delivery systems.

What Are Financial and Legal Risks?

• High risk of regulatory constraints.
• Low profit margins due to patent expiry and generic competition.
• Liability issues stemming from toxicity profiles.

What Are Key Takeaways for Investment Decisions?

Investments in theophylline are characterized by minimal growth prospects in traditional markets. Opportunities may exist in specific formulations or niche markets, but overall, the drug's commoditized status limits upside potential. Long-term profitability depends on innovation or niche differentiation.

FAQs

1. Is theophylline a good investment for portfolio diversification?
No. The market is saturated with generic products, and growth prospects are limited.

2. Are there upcoming patent or regulatory changes that could benefit theophylline?
No significant patent protections or recent regulatory incentives are anticipated.

3. Can reformulation strategies revive theophylline's market?
Possibly, if they target toxicity issues or improve delivery, but competition remains high.

4. What therapeutic areas could expand theophylline use?
Potentially in niche or combination therapies for refractory respiratory conditions, but evidence and regulatory approval are lacking.

5. Are there any regional markets with growth opportunities?
Emerging markets may have steady demand due to cost considerations, but overall growth is modest.

References

[1] MarketWatch. (2022). Theophylline Market Size, Share & Trends.
[2] GlobalData. (2022). Respiratory Drugs Market Analysis.
[3] U.S. Food and Drug Administration. (2023). Approved Drugs Database.
[4] European Medicines Agency. (2023). Drug Approvals and Status Reports.