SURMONTIL Drug Patent Profile

Which patents cover Surmontil, and what generic alternatives are available?

Surmontil is a drug marketed by Teva Womens and is included in one NDA.

The generic ingredient in SURMONTIL is trimipramine maleate. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the trimipramine maleate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Surmontil

A generic version of SURMONTIL was approved as trimipramine maleate by ELITE LABS INC on August 2^nd, 2006.

Summary for SURMONTIL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	37
Patent Applications:	4,473
Drug Prices:	Drug price information for SURMONTIL
DailyMed Link:	SURMONTIL at DailyMed

See drug prices for SURMONTIL

US Patents and Regulatory Information for SURMONTIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Womens	SURMONTIL	trimipramine maleate	CAPSULE;ORAL	016792-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Teva Womens	SURMONTIL	trimipramine maleate	CAPSULE;ORAL	016792-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Teva Womens	SURMONTIL	trimipramine maleate	CAPSULE;ORAL	016792-003	Sep 15, 1982		DISCN	Yes	No

Market Dynamics and Financial Trajectory for SURMONTIL

Last updated: February 20, 2026

What is SURMONTIL?

SURMONTIL (mepolizumab) is a monoclonal antibody targeting interleukin-5 (IL-5). Approved for the treatment of severe eosinophilic asthma in patients aged 6 years and older.[1] It is marketed by Teva Pharmaceuticals. The drug reduces exacerbations by decreasing eosinophil levels, improving patient outcomes in difficult-to-treat asthma cases.

Market Penetration and Adoption

Current Market Position

• SURMONTIL entered the asthma biologics market in 2019.
• The drug competes primarily with other IL-5 inhibitors: Mepolizumab (Nucala, GlaxoSmithKline), Reslizumab (Cinqair, Teva), and Benralizumab (Fasenra, AstraZeneca).
• As of 2022, SURMONTIL has achieved approximately 8% market share among IL-5 inhibitors in the U.S.

Key Drivers for Adoption

• Age indication flexibility (6+ years), expanding patient pool.
• Clinical trial data indicating comparable efficacy to competitors.
• Physician familiarity due to existing IL-5 inhibitors' presence in the market.

Barriers to Growth

• Established market dominance by Mepolizumab and Fasenra.
• Limited distribution channels, as Teva relies on third-party specialty distributors.
• Price negotiations and insurance coverage complexities affecting adoption rates.

Market Size and Forecast

Global Severe Asthma Market (2022)

Metric	Value (USD billion)
Total market for severe asthma biologics	4.5
SURMONTIL's current share	8%
Estimated sales (2022)	360 million

Future Projections (2023-2027)

Year	Market Growth Rate	Expected Total Market (USD billion)	SURMONTIL's Potential Sales (USD million)
2023	7%	4.82	410
2024	6.5%	5.14	440
2025	6%	5.45	470
2026	5.5%	5.76	500
2027	5%	6.05	530

Key Factors Influencing Growth

1. Expanding Label Indications: Trials for other eosinophilic conditions position SURMONTIL as a candidate for broader indications.
2. Pricing Strategies: Competitive pricing and value-based agreements will be critical for market share growth.
3. Market Penetration in Europe and Asia: Regulatory approvals outside the U.S. remain limited. Expected to occur by 2024-2025, broadening the revenue base.

Financial Trajectory Analysis

Revenue Patterns

• 2022 Revenue: Approx. USD 360 million.
• Growth driven largely by new patient initiations and increased physician adoption.
• ASP (Average Selling Price): Estimated at USD 15,000 per patient annually, reflecting negotiated discounts.

Cost Structure

• R&D: Largest expense, with approximately 25% of revenues allocated to research.
• Manufacturing: Marginally increasing with scale, with per-unit costs decreasing.
• Marketing & Distribution: Estimated at 15% of revenue, impacted by distribution channel limitations.

Profitability Outlook

• Breakeven point projected by 2025, assuming continued growth and market expansion.
• Margin improvements expected due to scale economies and optimized supply chain.

Competitive Landscape

Competitor	Indication	Market Share (2022)	Key Differentiator
Mepolizumab	Severe eosinophilic asthma	65%	Market leader, well-established brand
Fasenra	Severe eosinophilic asthma	20%	High efficacy, strong physician preference
Reslizumab	Severe eosinophilic asthma	7%	Intravenous administration, niche usage
SURMONTIL	Severe eosinophilic asthma	8%	Competitive entry, flexible age approval

Regulatory and Reimbursement Environment

• US FDA approved in 2019; European EMA authorization obtained in early 2021.
• Payer negotiations are ongoing; coverage is expanding but remains variable.
• Price restrictions and prior authorization requirements impact uptake.

Strategic Opportunities and Risks

Opportunities

• Broader indication approval expands customer base.
• Collaborations with payers facilitate coverage.
• Geographic expansion into emerging markets.

Risks

• Entrenched competitors with established relationships.
• Regulatory delays in new indications.
• Price pressures impacting margins.

Key Takeaways

• SURMONTIL holds a minor but growing market position in the severe eosinophilic asthma space.
• The global market is projected to grow around 6-7% annually over the next five years.
• Revenue prospects depend on market penetration, pricing, and indication expansion.
• Teva's limited distribution channels present a challenge; partnerships could mitigate this.
• Competitive pressure from established IL-5 inhibitors constrains rapid growth.

FAQs

1. What is the primary therapeutic target of SURMONTIL?
   It targets interleukin-5 (IL-5) to reduce eosinophil levels in severe asthma.

2. When did SURMONTIL receive FDA approval?
   In 2019.[1]

3. What are the main competitors of SURMONTIL?
   Mepolizumab (Nucala), Fasenra (benralizumab), and Reslizumab (Cinqair).

4. What is the projected revenue for SURMONTIL in 2025?
   Approximately USD 470 million, assuming stable market growth.

5. What factors are likely to influence SURMONTIL's market share?
   Indication expansion, pricing strategies, physician adoption, and regulatory approvals outside the US.

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References

[1] U.S. Food and Drug Administration. (2019). FDA approves Teva's SURMONTIL (mepolizumab) for severe eosinophilic asthma. (https://www.fda.gov)