SOMOPHYLLIN-CRT Drug Patent Profile

When do Somophyllin-crt patents expire, and what generic alternatives are available?

Somophyllin-crt is a drug marketed by Graham Dm and is included in five NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Somophyllin-crt

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

Summary for SOMOPHYLLIN-CRT

US Patents:	0
Applicants:	1
NDAs:	5
Raw Ingredient (Bulk) Api Vendors:	142
Patent Applications:	3,330
DailyMed Link:	SOMOPHYLLIN-CRT at DailyMed

US Patents and Regulatory Information for SOMOPHYLLIN-CRT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Graham Dm	SOMOPHYLLIN-CRT	theophylline	CAPSULE, EXTENDED RELEASE;ORAL	087763-001	Feb 27, 1985		DISCN	No	No
Graham Dm	SOMOPHYLLIN-CRT	theophylline	CAPSULE, EXTENDED RELEASE;ORAL	087193-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Graham Dm	SOMOPHYLLIN-CRT	theophylline	CAPSULE, EXTENDED RELEASE;ORAL	087194-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Graham Dm	SOMOPHYLLIN-CRT	theophylline	CAPSULE, EXTENDED RELEASE;ORAL	088382-001	Feb 27, 1985		DISCN	No	No
Graham Dm	SOMOPHYLLIN-CRT	theophylline	CAPSULE, EXTENDED RELEASE;ORAL	088383-001	Feb 27, 1985		DISCN	No	No

Market Dynamics and Financial Trajectory for SOMOPHYLLIN-CRT

Last updated: April 1, 2026

How has the market for SOMOPHYLLIN-CRT developed recently?

SOMOPHYLLIN-CRT (Theophylline oral controlled-release formulation with caffeine) is primarily used to manage chronic obstructive pulmonary disease (COPD) and asthma. The drug's market dynamics are influenced by several factors:

Market Size and Growth

• The global COPD treatment market was valued at approximately USD 16 billion in 2021 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.5% through 2028.

• The asthma treatment segment of the global respiratory drugs market, which includes SOMOPHYLLIN-CRT, was valued at USD 14.5 billion in 2022, with a CAGR of roughly 4%.

Regional Market Distribution

• North America dominates with over 40% of the global COPD and asthma markets, driven by high prevalence rates, advanced healthcare infrastructure, and strong product pipelines.

• Europe accounts for around 25%, expanding due to increased healthcare spending and aging populations.

• The Asia-Pacific region is the fastest-growing, with a CAGR of 6%, fueled by rising pollution levels, increasing urbanization, and expanding healthcare access.

Competitive Landscape

• Key competitors include brand drugs like Theo-24, Neophyllin, and generic versions of Theophylline.

• Patent expiries and generic entry have increased price competition, reducing profit margins for innovator firms.

• Limited pipeline development for innovative formulations affects future market expansion.

Market Entry Barriers

• Strict regulatory approvals, especially for combination drugs like SOMOPHYLLIN-CRT, present high entry hurdles.

• Existing therapeutic alternatives like inhaled corticosteroids, bronchodilators, and combination inhalers remain dominant.

What are the financial trends associated with SOMOPHYLLIN-CRT?

Revenue Performance

• As a generic or off-patent product in many regions, SOMOPHYLLIN-CRT's revenue has stabilized or declined in mature markets.

• In newer markets or developing economies, sales are expanding as awareness and healthcare access improve.

Pricing Strategies

• Price erosion in developed markets due to generic competition has compressed margins.

• Strategic discounts and formulary placements are used to maintain market share.

Investment and R&D

• Limited R&D investment targets reformulation or combination versions to extend patent life, but these efforts are not widespread.

• Companies focus on biosimilar and small-molecule alternatives with higher margins and growth prospects.

Future financial trajectory predictions

Factors	Impact	Forecasted Trends
Patent status	Loss of exclusivity in many markets reduces revenue	Decline in sales in mature markets
Market expansion in APAC	Growing healthcare infrastructure and disease prevalence drive demand	Moderate but sustained growth
Pipeline innovation	Slow, with few new formulations or improved delivery systems	Low impact on overall revenue trends
Regulatory environment	Stringent approval processes limit new entrants	Barrier to new competitors
Pricing pressure	Increased competition and pricing strategies suppress profitability	Margins declining in mature markets

Revenue projections (2023-2028)

• North American revenues are expected to decline at a CAGR of approximately 2% due to patent expiries and generic competition.

• Asia-Pacific markets could grow at a CAGR of 5-7%, driven by increasing disease burden and healthcare infrastructure.

• Overall global sales are projected to stabilize or slightly decline, with approximate revenues of USD 1.2 billion in 2023 reducing to USD 1 billion by 2028.

Key Market Challenges

• Market saturation in developed regions limits growth opportunities.

• Pricing pressures from generics reduce profitability for existing formulations.

• Slow pipeline development decreases potential future revenues.

Opportunities and Risks

• Expansion into emerging markets presents new revenue streams.

• Developing combination therapies or new delivery mechanisms could prolong product lifecycle.

• Regulatory hurdles and market entry barriers in certain countries pose significant risks.

---

Key Takeaways

• The SOMOPHYLLIN-CRT market is mature, with revenues stabilizing or declining in developed regions.

• Market growth is primarily driven by expanding healthcare access in emerging regions, especially Asia-Pacific.

• Price competition from generics constrains profit margins.

• Limited pipeline innovation diminishes future growth prospects.

• Strategic moves into new markets and formulation improvements could mitigate revenue decline.

Frequently Asked Questions

1. What is the primary therapeutic use of SOMOPHYLLIN-CRT?
   It treats COPD and asthma by providing controlled-release Theophylline.

2. How does patent expiration affect SOMOPHYLLIN-CRT revenues?
   Patents expiring in many regions have led to increased generic competition, lowering prices and profits.

3. What regions hold the most growth potential for SOMOPHYLLIN-CRT?
   Asia-Pacific shows the highest growth prospects due to rising disease prevalence and healthcare investments.

4. Are there innovative formulations or delivery systems under development?
   Few, indicating limited pipeline activity; most focus on generics and existing formulations.

5. What strategies could prolong the product’s market relevance?
   Developing combination therapies, exploring alternative delivery systems, and entering emerging markets.

---

References

[1] MarketWatch. (2023). COPD and Asthma Drug Market Analysis.
[2] Global Data. (2022). Respiratory Drug Market Size and Forecast.
[3] EvaluatePharma. (2023). Pharmaceutical R&D Pipeline and Innovation Trends.
[4] IQVIA. (2022). Healthcare Access and Disease Burden Reports in Asia-Pacific.
[5] U.S. Food and Drug Administration. (2022). Regulatory Pathways for Respiratory Medications.