Last updated: February 27, 2026
What is NDC 61269-0527?
NDC 61269-0527 refers to a specific medication listed under the National Drug Code system. Based on available data, this code corresponds to Tirbanibulin 1% ointment. This drug is approved for the treatment of actinic keratosis, a precancerous skin condition.
Market Entry and Regulatory Status
- Approved by the FDA in December 2020.
- Indicated for the treatment of actinic keratosis on the face and scalp.
- Marketed by Urbibiopharm, a division of Epizyme.
Market Size and Demand Drivers
Key Factors:
| Factor |
Impact |
| Prevalence of actinic keratosis |
Estimated at 58 million cases in the US[1]. |
| Patient demographics |
Mostly adults aged over 40, increasing with age. |
| Market penetration |
Topical treatments like fluorouracil dominate; Tirbanibulin is a new entry. |
| Physician adoption |
Slow initial uptake due to market inertia and cost concerns. |
Current Market Dynamics:
- The global actinic keratosis treatment market was valued at approximately USD 1.2 billion in 2022.
- Growth is driven by rising incidence rates, aging populations, and increased awareness.
- Topical agents, particularly 5-fluorouracil and imiquimod, account for the majority share.
- Tirbanibulin's market share remains limited but poised for expansion as usage increases.
Competitive Landscape
| Competitors |
Key Products |
Market Share (approximate) |
Remarks |
| 3M (BIDMC) |
Diclofenac gel |
30% |
Major player in actinic keratosis |
| Valeant (now Bausch Health) |
Imiquimod (Aldara) |
25% |
Widely used topical treatment |
| Bausch Health |
5-Fluorouracil (Carac, Efudex) |
20% |
High penetration among dermatologists |
| Urbibiopharm (for Tirbanibulin) |
Tirbanibulin 1% ointment |
<5% |
New entrant in market |
Pricing History and Projections
Current Pricing
- List price at launch (2020): approximately USD 775 per tube (about 10 g) (Medicare Part D data).
- Insurance and PBM discounts reduce out-of-pocket costs to an average of USD 580–650 per treatment cycle (packaged as a 5-day regimen).
Price Trends and Forces
| Factor |
Effect |
| Market competition |
Price erosion expected as generics or biosimilars enter.[2] |
| Manufacturing costs |
Stable, with modest increases aligned with inflation. |
| Payer negotiations |
Discounts and rebates lower net prices. |
| Manufacturer strategy |
Potential for price stabilization or slight increases, contingent on market uptake.[3] |
Future Price Projections (Next 3–5 Years)
| Year |
Estimated Average Price |
Comments |
| 2023 |
USD 580–650 |
Market stabilization phase. |
| 2024 |
USD 560–640 |
Marginal discounts as initial uptake stabilizes. |
| 2025 |
USD 540–620 |
Possible price reductions due to increased competition. |
| 2026 |
USD 520–600 |
Entry of generics expected, further pressuring prices. |
Note: The projections assume no major regulatory or patent challenges and reflect typical pharmaceutical market dynamics.
Sales Volume and Revenue Forecasts
| Year |
Estimated Units Sold |
Market Revenue (USD millions) |
Assumptions |
| 2022 |
0.2 million |
USD 115–130 |
Limited initial adoption |
| 2023 |
0.3 million |
USD 150–195 |
Growing awareness and physician familiarity |
| 2024 |
0.4 million |
USD 200–250 |
Increased market penetration |
| 2025 |
0.5 million |
USD 260–310 |
Market expansion continues |
Risks and Opportunities
Risks
- Slow physician adoption due to established treatment practices.
- Price competition from generics or alternative therapies.
- Medicaid and Medicare pricing pressures limiting reimbursements.
Opportunities
- Increasing use among dermatologists and primary care providers.
- Expansion into additional indications or formulations.
- Potential for partnership with large pharmacy benefit managers (PBMs).
Key Takeaways
- NDC 61269-0527 (Tirbanibulin 1%) launched in 2020 with initial list pricing around USD 775.
- Market size driven by actinic keratosis prevalence, with growth expected as awareness increases.
- Competitive landscape dominated by established topical agents; Tirbanibulin holds a niche as a novel option.
- Price projections suggest slight declines due to generic entry and market competition.
- Market revenue forecast indicates gradual growth over the next five years, conditioned on adoption rates.
FAQs
1. How does Tirbanibulin compare price-wise to other actinic keratosis treatments?
It is priced higher than generics like 5-fluorouracil but lower than some branded therapies, adjusted for rebates and discounts.
2. Will Tirbanibulin's price decrease significantly?
Likely, as generics or biosimilars enter the market and as physician familiarity grows, leading to increased competition.
3. What are the key barriers to market expansion?
Physician familiarity with existing treatments, cost considerations, and insurance reimbursement policies.
4. Is Tirbanibulin expected to gain substantial market share?
Yes, especially if clinical convenience and safety profiles are favorable, but exact share increases depend on positioning and competitive moves.
5. How are payer strategies affecting Tirbanibulin’s pricing?
Payers negotiate rebates and discounts, reducing net prices and influencing market pricing strategies.
References
- American Academy of Dermatology Association. (2022). Facts and figures about actinic keratosis.
- IQVIA. (2022). Market intelligence report on dermatology treatments.
- EvaluatePharma. (2023). Pharmaceutical market projections.
