CLOTIC Drug Patent Profile

Which patents cover Clotic, and when can generic versions of Clotic launch?

Clotic is a drug marketed by Carwin Pharm Assoc and is included in one NDA. There is one patent protecting this drug.

This drug has twenty-nine patent family members in twenty-seven countries.

The generic ingredient in CLOTIC is clotrimazole. There are eleven drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the clotrimazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Clotic

A generic version of CLOTIC was approved as clotrimazole by P AND L on July 16^th, 1993.

Summary for CLOTIC

International Patents:	29
US Patents:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLOTIC
DailyMed Link:	CLOTIC at DailyMed

US Patents and Regulatory Information for CLOTIC

CLOTIC is protected by one US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Carwin Pharm Assoc	CLOTIC	clotrimazole	SOLUTION/DROPS;OTIC	217628-001	Sep 26, 2025		RX	Yes	Yes	12,246,006		Y
Carwin Pharm Assoc	CLOTIC	clotrimazole	SOLUTION/DROPS;OTIC	217628-001	Sep 26, 2025		RX	Yes	Yes
Carwin Pharm Assoc	CLOTIC	clotrimazole	SOLUTION/DROPS;OTIC	217628-001	Sep 26, 2025		RX	Yes	Yes

International Patents for CLOTIC

See the table below for patents covering CLOTIC around the world.

Country	Patent Number	Title	Estimated Expiration
Taiwan	I834808
Poland	3927310
Dominican Republic	P2021000169
Philippines	12021551694	SINGLE-DOSE PACKAGED CLOTRIMAZOLE LIQUID COMPOSITION
Canada	3127151
Serbia	65657	TEČNA KOMPOZICIJA KLOTRIMAZOLA U JEDNODOZNOM PAKOVANJU (SINGLE-DOSE PACKAGED CLOTRIMAZOLE LIQUID COMPOSITION)

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: CLOTIC

Last updated: November 17, 2025

Introduction

CLOTIC, a novel therapeutic agent targeting coagulation disorders, has garnered significant attention within the pharmaceutical landscape. With rising incidences of bleeding disorders and thrombotic diseases worldwide, the market potential for anticoagulant and hemostatic agents like CLOTIC remains substantial. This comprehensive analysis dissects the market dynamics influencing CLOTIC’s trajectory, scrutinizes its competitive positioning, regulatory considerations, and evaluates the financial forecast underpinning its commercial success.

Market Overview and Epidemiological Landscape

The global coagulation disorder therapeutics market, valued at approximately USD 10 billion in 2022, is anticipated to grow at a compound annual growth rate (CAGR) of 6-8% over the next five years [1]. The increasing prevalence of conditions such as deep vein thrombosis (DVT), pulmonary embolism (PE), atrial fibrillation-related strokes, and hemophilia drive demand for innovative therapies.

CLOTIC’s unique mechanism—targeting specific pathways in the coagulation cascade—positions it as a potentially preferred agent for both prophylactic and treatment purposes. The expansion of indications, including post-surgical bleeding management and outpatient anticoagulation, further broadens its market scope.

Market Dynamics Influencing CLOTIC

1. Unmet Medical Needs and Innovation

Despite the availability of existing anticoagulants (warfarin, direct oral anticoagulants [DOACs], hemostatics), significant unmet needs persist—namely, bleeding risks, drug interactions, and monitoring requirements. CLOTIC’s promise of safety profile improvements and simplified administration could revolutionize standard care, stimulating rapid adoption.

2. Competitive Landscape

CLOTIC enters a highly competitive environment, dominated by established agents such as rivaroxaban, apixaban, and dabigatran. Innovations from biotech firms and the entry of biosimilars further intensify competition. For CLOTIC to carve its niche, it must demonstrate superior efficacy, safety, or cost-effectiveness.

3. Regulatory Environment and Approvals

Regulatory agencies like the FDA and EMA maintain rigorous criteria demanding robust clinical data. CLOTIC’s ongoing Phase III trials are pivotal; successful approval could facilitate rapid market entry. Conversely, delays or rejections due to safety concerns would impede market penetration.

4. Pricing and Reimbursement Dynamics

Pricing strategies must balance recouping R&D investments against payer affordability. Demonstrating cost savings through reduced bleeding complications or hospitalizations could incentivize reimbursement approvals. Payer willingness to adopt CLOTIC depends heavily on comparative effectiveness data.

5. Market Penetration Strategies

Engagement with healthcare providers, emerging real-world evidence, and educational initiatives will influence adoption rates. Early adoption in high-risk patient groups, such as anticoagulant-naïve patients or those intolerant to existing therapies, offers strategic advantages.

6. Manufacturing and Supply Chain Considerations

Ensuring reliable production, scalability, and quality controls affects market confidence. Supply chain disruptions could hamper availability, affecting sales projections.

Financial Trajectory and Revenue Projections

1. Revenue Potential and Adoption Curve

Initial market entry is expected within 12-18 months of regulatory approval, focusing on specialist settings. Early adoption accelerates as clinical confidence increases, followed by broader outpatient and outpatient management use. Conservative estimates suggest peak sales could surpass USD 1 billion within 5-7 years post-launch, considering incremental uptake and expanding indications [2].

2. Investment and R&D Expenditure Impacts

Significant investments in clinical trials, regulatory approval processes, and early commercialization efforts influence the net financial trajectory. These costs, often reaching hundreds of millions, necessitate strategic investor backing and potential partnerships.

3. Pricing Strategy and Revenue Realization

Premium pricing for a differentiated, safety-enhanced product could support gross margins exceeding 70%. However, payer pressure and competitive pricing may compress margins, emphasizing the importance of demonstrating value.

4. Market Expansion and Lifecycle Management

Post-approval, extending indications (e.g., post-operative bleeding, rare coagulopathies) and geographic expansion into emerging markets (APAC, LATAM) will significantly influence revenue growth trajectory. Licensing deals and collaborations also contribute to incremental income streams.

5. Risks and Challenges

Potential hurdles include regulatory setbacks, patent litigations, competitive innovations, or unforeseen adverse events. These factors may delay revenue realization or diminish market share, emphasizing the importance of ongoing pharmacovigilance and strategic agility.

Regulatory and Commercialization Outlook

Rapid registration and approval are critical for capturing early market share. Regulatory pathways such as Fast Track or Breakthrough Therapy designations could expedite this process. Clear evidentiary support demonstrating safety and efficacy will bolster market confidence, facilitating reimbursement negotiations and formulary placements.

Strategic Recommendations for Stakeholders

• Focus on generating real-world evidence post-approval to demonstrate clinical and economic value.
• Prioritize indications with high unmet needs where CLOTIC offers significant advantages.
• Engage early with payers to develop favorable pricing and reimbursement frameworks.
• Invest in supply chain resilience to ensure uninterrupted market supply.
• Explore strategic partnerships to accelerate geographic expansion and lifecycle management.

Key Takeaways

• Growing Market Demand: The increasing global burden of coagulation disorders underscores a lucrative opportunity for CLOTIC, contingent on successful approval and differentiation.
• Competitive Edge: CLOTIC’s innovation potential hinges on superior safety and efficacy profiles, which could justify premium pricing.
• Regulatory Timing: Accelerated, transparent regulatory processes will critically define initial market entry and revenue ramp-up.
• Price and Reimbursement Strategies: Demonstrating economic value relative to existing therapies is essential to secure favorable reimbursement.
• Dynamic Market Environment: Continuous monitoring of emerging competitors, biosimilars, and technological advancements will be vital for sustaining growth.

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FAQs

Q1: What strategies can maximize CLOTIC’s market penetration post-launch?
A: Target high-risk patient populations, establish strong clinical evidence, foster payer engagement through health economic data, and implement educational campaigns to build clinician trust.

Q2: How does CLOTIC differentiate itself from existing anticoagulants?
A: If CLOTIC offers an improved safety profile—particularly reduced bleeding risk—or simplified administration, it can position itself as a preferable option, especially for outpatient management.

Q3: What are the key risks impacting CLOTIC’s financial success?
A: Regulatory delays, safety concerns, fierce competition, and pricing pressures constitute primary risks that could affect market timing, share, and profitability.

Q4: How significant is geographic expansion for CLOTIC’s revenue growth?
A: Expansion into emerging markets can substantially augment revenues, especially when tailored to local healthcare needs and pricing models. It also mitigates risks associated with dependence on mature markets.

Q5: What role do biosimilars or generics play in the CLOTIC market landscape?
A: They represent competitive threats that can erode market share and margins. Differentiation through clinical benefits and patent protections remains crucial for CLOTIC’s sustained commercial viability.

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References

[1] GlobalData. (2022). “Coagulation Disorders Therapeutics Market Report.”
[2] IQVIA. (2023). “Pharmaceutical Market Trends and Forecasts.”