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-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.

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

Summary for THEOPHYLLINE

US Patents:	0
Tradenames:	51
Applicants:	57
NDAs:	124
Drug Master File Entries:	36
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	121
Patent Applications:	6,090
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
University of Nebraska	PHASE1
Minia University	EARLY_PHASE1
Assiut University	PHASE1

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
Strides Pharma	THEOPHYLLINE	theophylline	TABLET, EXTENDED RELEASE;ORAL	215312-001	Sep 5, 2024	AB	RX	No	No
Chartwell Molecular	THEOPHYLLINE	theophylline	SOLUTION;ORAL	091156-001	Apr 13, 2011	AA	RX	No	Yes
Hospira Inc	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	theophylline	INJECTABLE;INJECTION	019211-001	Dec 14, 1984		DISCN	Yes	No
Baxter Hlthcare	THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER	theophylline	INJECTABLE;INJECTION	018649-005	Jul 26, 1982		DISCN	No	No
Fisons	SOMOPHYLLIN-T	theophylline	CAPSULE;ORAL	087155-002	Feb 25, 1985		DISCN	No	No
Solis Pharms	ELIXOPHYLLIN	theophylline	SOLUTION, ELIXIR;ORAL	085186-001	Approved Prior to Jan 1, 1982	AA	RX	Yes	Yes

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

Market Dynamics and Financial Trajectory for Theophylline

Last updated: January 14, 2026

Executive Summary

Theophylline, a methylxanthine derivative primarily used in respiratory diseases, remains a significant pharmaceutical agent despite declining global usage. Its market is driven by factors such as its longstanding efficacy in treating asthma and COPD, increasing prevalence of respiratory illnesses, and emerging niche applications. However, innovation, safety concerns, and competitive alternatives have impacted its growth trajectory. This analysis delves into the current market landscape, prospects, and financial forecast for Theophylline, providing crucial insights for industry stakeholders.

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What Are the Pharmacological Profile and Current Usage of Theophylline?

Pharmacology and Therapeutic Uses

Theophylline acts primarily as a bronchodilator by inhibiting phosphodiesterase enzymes, leading to increased cyclic AMP and resulting in smooth muscle relaxation. It also exhibits anti-inflammatory and ventilatory stimulant effects.

• Primary indications:
  • Asthma management (often as adjunct therapy)
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Apnea in neonates (less common)

Dosage Forms and Formulations

Formulation	Description	Typical Dose
Immediate-release tablets	Oral, rapid onset	300-600 mg/day
Sustained-release tablets	Extended release for stable plasma levels	300-900 mg/day
Intravenous infusion	Acute management, ICU settings	5-10 mg/kg/hr
Neonatal formulations	Syrups or injections for apnea in infants	Variable

Market Penetration and Sectors

The use of Theophylline has declined in comparison to inhaled corticosteroids and β2-agonists, yet it retains niche applications, especially in regions with limited access to newer therapies.

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What Are the Key Market Dynamics Influencing Theophylline?

Drivers of Market Growth

1. High Prevalence of Respiratory Diseases
   • Global asthma cases: ~262 million (WHO, 2019)
   • COPD prevalence: projected to surpass 250 million by 2025 (WHO)
2. Cost-Effectiveness and Accessibility
   • Low-cost alternative to newer biologics, especially in developing economies
3. Established Clinical Efficacy
   • Long history with well-documented safety and efficacy profiles

Restraints and Challenges

Restraint	Impact	Description
Safety concerns	Risk of toxicity at high serum levels	Narrow therapeutic index; side effects include arrhythmias and seizures
Competition from newer agents	Biologicals, LABAs, ICSs dominate current markets	Better safety profiles, fewer monitoring requirements
Regulatory restrictions and shifts	Stricter warnings; reduced prescribing guidelines	Initiatives favoring inhaled therapies over systemic agents

Emerging Trends

• Repurposing and Niche Uses: Use in neurodegenerative diseases; experimental applications
• Formulation Innovation: Development of controlled-release mechanisms to mitigate toxicity
• Regional Market Expansion: Increased use in emerging markets due to affordability issues

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What Is the Financial Trajectory of Theophylline?

Market Size and Revenue Estimates

Region	2022 Market Size	Expected CAGR (2023-2028)	2028 Projections
North America	~$150 million	1.2%	~$162 million
Europe	~$130 million	1.5%	~$143 million
Asia-Pacific	~$200 million	4.8%	~$245 million
Rest of World	~$70 million	2.0%	~$77 million
Total Market	~$550 million	1.9%	~$627 million

Data Source: GlobalData Pharma Intelligence, 2022; projections based on regional growth trends

Key Financial Drivers

• Patent Status: No patent exclusivity, leading to generic market dominance
• Pricing Dynamics: Price erosion due to generic competition
• Off-Label and Niche Uses: Supplementary revenue streams
• Cost Structure: Low manufacturing costs favor profitability in high-volume markets

Revenue Generators and Losses

Revenue Sources	Contribution (%)	Notes
Generic sales	75%	Dominant due to low-cost manufacturing
Niche clinical applications	10%	Neonatal apnea, experimental uses
Hospital/institutional sales	10%	Acute care, critical care settings
Formulation innovations	5%	Extended-release, combination drugs

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How Do Policy and Regulatory Trends Shape the Market?

Global Regulatory Landscape

• FDA (USA): Generally classified as a prescription drug with boxed warning for toxicity
• EMA (EU): Similar control measures; some countries recommend monitoring serum levels
• Developing Countries: Often less restrictive, leading to broader use

Impact on Market Dynamics

• Stricter safety regulations have limited off-label use and guided clinicians toward newer therapies
• Favorable policies in low- and middle-income countries sustain demand due to affordability
• Patent expirations facilitate generic entry, increasing accessibility but pressuring margins

Pharmacovigilance and Safety Standards

• Increased monitoring requirements reduce misuse
• Formation of global databases for adverse events influences prescribing behaviors

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How Does Theophylline Compare with Alternatives?

Attribute	Theophylline	Inhaled Corticosteroids (ICS)	Long-Acting β2-Agonists (LABAs)	Biologicals (e.g., Omalizumab)
Administration	Oral, IV	Inhalation	Inhalation	Subcutaneous injection
Onset of action	Rapid (oral), variable	Rapid	Slow	Moderate
Efficacy	Moderate	High	High	Very high
Safety profile	Narrow therapeutic index	Better safety	Better safety	Best safety, costly
Cost	Low	Moderate	Moderate	Very high
Monitoring requirements	Serum levels necessary	Minimal	Minimal	Minimal

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What Are the Future Opportunities and Risks?

Opportunities	Risks
Drug repurposing (neurological)	Toxicity and side-effects limit broader use
Formulation innovation (long-acting)	Competition from newer drugs with wider safety margins
Market expansion in emerging economies	Regulatory hurdles and safety reports impacting labeling
Integration into combination therapies	Declining clinical relevance with advances in targeted biologics

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Key Takeaways

• The global Theophylline market is relatively modest (~$550 million in 2022) with low single-digit growth driven by regional demand and affordability.
• Despite declining prescription rates in developed nations, emerging markets maintain steady demand due to cost-effectiveness.
• Safety concerns and competition from newer therapies limit growth, but niche applications and formulation innovations represent growth avenues.
• Patent expiration and proliferation of generics have driven down prices, impacting revenue but expanding access.
• Regulatory trends favoring safety monitoring have constrained off-label and broad-spectrum use.
• The future market largely depends on innovation, regulatory environment, and acceptance in developing regions.

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FAQs

1. What are the main factors influencing the decline of Theophylline in developed markets?

Answer: Safety concerns related to its narrow therapeutic index, availability of safer inhaled therapies, and regulatory restrictions have contributed to its decreased prevalence in developed markets.

2. Are there ongoing research efforts to repurpose Theophylline?

Answer: Yes. Investigations are underway exploring neuroprotective properties, potential benefits in neurodegenerative diseases, and combination therapies, though these are exploratory stages.

3. How does the cost structure of Theophylline influence its market presence?

Answer: Its low manufacturing cost and generic status make it an attractive option in price-sensitive markets, sustaining demand in regions with limited healthcare budgets.

4. What role do regulatory agencies play in shaping Theophylline's market dynamics?

Answer: Agencies like the FDA and EMA impose safety warnings and monitoring requirements, which influence prescribing practices and limit off-label use, thus affecting overall market traction.

5. What is the outlook for Theophylline in the next decade?

Answer: While mainstream use may decline further, niche applications and formulation innovations could sustain a modest market. Market expansion in developing nations offers growth potential, contingent on safety profile management.

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References

1. World Health Organization. (2019). Global Asthma Report.
2. GlobalData Pharma Intelligence. (2022). Pharmaceutical Market Analysis: Theophylline.
3. U.S. Food & Drug Administration. (2022). Drug Safety and Availability.
4. European Medicines Agency. (2022). Regulatory Policies for Respiratory Drugs.
5. PubMed. Articles on Theophylline pharmacology and clinical trials.

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This comprehensive analysis equips healthcare professionals, pharmaceutical companies, and investors with strategic insights to navigate the evolving Theophylline landscape.