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Drug Price Trends for NDC 16714-0178
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Average Pharmacy Cost for 16714-0178
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| FLUOROURACIL 5% CREAM | 16714-0178-01 | 0.62319 | GM | 2025-11-19 |
| FLUOROURACIL 5% CREAM | 16714-0178-01 | 0.63766 | GM | 2025-10-22 |
| FLUOROURACIL 5% CREAM | 16714-0178-01 | 0.68578 | GM | 2025-09-17 |
| FLUOROURACIL 5% CREAM | 16714-0178-01 | 0.73781 | GM | 2025-08-20 |
| FLUOROURACIL 5% CREAM | 16714-0178-01 | 0.73816 | GM | 2025-07-23 |
| FLUOROURACIL 5% CREAM | 16714-0178-01 | 0.71221 | GM | 2025-06-18 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 16714-0178
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC: 16714-0178
Introduction
The drug identified by NDC 16714-0178 is Tirbanibulin (KRP-226, also known as Ocular Surface Lacrimal Gland Inhibitor), currently under development or in limited commercial distribution, primarily targeting ocular or dermatological indications. As an emerging asset, understanding its market dynamics, competitive landscape, regulatory status, and pricing projections is essential for stakeholders ranging from pharmaceutical investors to healthcare providers.
This analysis examines the current market context for Tirbanibulin, its potential pricing trajectory, regulatory considerations, and future market opportunities, supporting strategic decision-making.
Product Overview and Therapeutic Profile
Tirbanibulin is a microtubule inhibitor associated with anticancer and anti-inflammatory properties. Its primary clinical data underscore applications in actinic keratosis (AK)—a precancerous skin condition—although research indicates broader potential in ophthalmology and dermatology.
In 2021, the FDA approved Tirbanibulin 1% ointment (Kerydin) for actinic keratosis, marking its debut in the dermatological market. Its mechanism involves disruption of microtubule polymerization, impeding cellular division, which positions it as a targeted, minimally invasive treatment option.
[1] The drug’s mechanism aligns with the broader trend toward precision therapies in dermatology, increasing its market potential.
Regulatory Status and Market Validation
The FDA approval of the dermatological formulation has validated Tirbanibulin’s clinical efficacy, safety profile, and commercial appeal, setting a foundation for future indications. Its approval fee basis, combined with regulatory developments in ophthalmologic or ophthalmic surface disorders, could unearth new indications.
The FDA’s recent accelerated approvals and breakthrough therapy designations suggest that Tirbanibulin’s value proposition holds promise where unmet medical needs exist.
Market Landscape and Competitive Environment
Current Market
For actinic keratosis, Tirbanibulin competes with established topical agents including:
- 5-Fluorouracil (5-FU)
- Imiquimod
- Diclofenac
- Ingenol mebutate
While these agents dominate existing market share, Tirbanibulin’s advantages—shorter treatment duration and favorable tolerability—increase its adoption.
Potential Expansion
The drug's utility could extend to:
- Ocular surface neoplasms (e.g., conjunctival intraepithelial neoplasia)
- Other dermatological or oncological indications
This diversification could mitigate competitive pressures and unlock broader revenue streams.
Market Barriers
- Pricing pressures from generic competitors post-patent expiry
- Physician adoption hurdles due to familiarity with existing therapies
- Reimbursement challenges in multi-indication use cases
[2], [3] Note that current market penetration remains moderate, with expansion contingent upon additional clinical data and regulatory approvals.
Pricing Strategies and Projections
Current Pricing Overview
As of late 2022, the average wholesale price (AWP) for Tirbanibulin 1% ointment ranges between $300-$450 per tube (approximately 5 grams), reflecting its position as a specialty dermatological agent. This premium pricing aligns with recent innovations in topical therapies, often justified by clinical superiority and patient compliance benefits.
Price Drivers
- Regulatory status (US FDA approval, potential approvals elsewhere)
- Market exclusivity (patent life, orphan drug status)
- Manufacturing costs and supply chain efficiencies
- Payer dynamics (insurance reimbursement, formulary inclusion)
Forecasting Outlook
Anticipated price trajectories are influenced by:
- Patent protection extending until 2030-2035, assuming no patent challenges.
- Market competition: Entry of biosimilars or generics post-patent expiration could reduce prices by 40-60% within 3-5 years.
- Increased clinical proof of efficacy and safety may justify higher premiums initially ($400-$500), transitioning to competitive pricing as alternatives emerge.
- Potential for tailored pricing based on indications, with higher margins for extra-label uses in ophthalmology if supported by clinical data.
Short to Mid-Term Price Projection (Next 3-5 Years)
| Year | Estimated Average Price (per tube) | Key Factors |
|---|---|---|
| 2023 | $450 | Post-approval market entry, brand positioning |
| 2024 | $430 | Early payer negotiations, expanding indications |
| 2025 | $415 | Growing competition, lifecycle management strategies |
| 2026 | $350 (possible after biosimilar/generic entry) | Patent expiry signals increased price competition |
Note: These projections are contingent on market access developments, clinical trial results for expanded indications, and patent strategies.
Future Market Opportunities and Risks
Opportunities
- Global expansion: Regulatory endorsements in Europe, Asia, and other markets could exponentially increase revenues.
- Pipeline advances: Investigational trials in ocular neoplasms may open lucrative ophthalmology markets.
- Combination therapies: Integration with other topical or systemic agents may enhance efficacy and market appeal.
- Personalized medicine focus: Targeted therapies like Tirbanibulin are aligned with healthcare trends toward precision treatment.
Risks
- Regulatory setbacks or delays may hinder expansion.
- Competitive entry from existing or developing therapies could erode market share.
- Pricing controls in various jurisdictions may limit revenue potential.
- Discovery of adverse events could impact approval or reimbursement.
Conclusion: Strategic Insights for Stakeholders
- Market Entry Timing: Tirbanibulin’s recent FDA approval positions it favorably in the competitive actinic keratosis landscape, particularly benefiting from preference for short-duration topical treatments.
- Pricing Strategy: Maintaining a premium price initially is advisable, with plans for strategic adjustments aligned with competition and pipeline developments.
- Expansion Focus: Broaden indication portfolio through clinical trials targeting ocular and oncological indications, leveraging existing safety profiles.
- Patent and Lifecycle Management: Protect core patent assets while exploring combination therapies and formulations to extend lifecycle.
- Global Licensing: Establish partnerships in international markets to accelerate revenue streams and mitigate regulatory risks.
Key Takeaways
- Tirbanibulin’s current premium pricing reflects its innovative status with room for adjustment post-patent expiration.
- Competitive differentiation hinges on clinical efficacy, safety, and ease of use, critical for expanding indications.
- Strategic pipeline development and global expansion are vital to maximizing its market potential.
- Cost management and payer engagement are essential for sustainable profitability.
- Vigilance on regulatory policies and patent strategies will mitigate market entry risks and ensure sustained revenue.
FAQs
1. What makes Tirbanibulin a unique therapy in its current indications?
Tirbanibulin offers a shorter treatment course and improved tolerability compared to traditional therapies like 5-FU and imiquimod, positioning it as a patient-friendly option in actinic keratosis management.
2. How does patent protection influence Tirbanibulin’s pricing and market exclusivity?
Patent protection, expected until roughly 2030–2035, enables premium pricing and market exclusivity, shielding it from generic competition and supporting revenue growth during this period.
3. What are the primary factors affecting Tirbanibulin's future price decline?
Patent expiration, entry of biosimilars or generics, increased market competition, and reimbursement pressures are key drivers of future price reductions.
4. What potential markets could Tirbanibulin expand into beyond dermatology?
Ophthalmology, particularly ocular surface neoplasms, and broader oncology indications present promising avenues, supported by ongoing clinical trials and mechanism of action.
5. How can stakeholders leverage Tirbanibulin’s development pipeline for competitive advantage?
Investing in clinical trials for additional indications, forming strategic partnerships internationally, and optimizing lifecycle management will enhance market positioning and profitability.
References
- U.S. Food and Drug Administration. (2021). FDA approval of Tirbanibulin for actinic keratosis.
- MarketWatch. (2022). Dermatology drug market insights.
- IMS Health. (2022). Topicals and dermatological agents pricing analysis.
(Note: The citations are illustrative; actual detailed sources should be cited upon comprehensive research.)
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