Last updated: March 2, 2026
What is the drug identified by NDC 68682-0045?
NDC 68682-0045 refers to Kynmobi (apomorphine hydrochloride) sublingual film. It is approved for the treatment of "Off" episodes in Parkinson's disease under the FDA indication (approved in 2020). It offers an alternative to injectable apomorphine, aiming to improve patient compliance and reduce injection-related discomfort.
Market Size and Demand Drivers
Patient Population
- Parkinson's disease prevalence in the U.S.: Approximately 1 million cases.
- Patients experiencing "Off" episodes: About 40%–50% of Parkinson’s patients, translating to 400,000–500,000 potential users.
- Average prescription rate: Estimated at 15%–20% of eligible patients in the first three years post-launch, with potential growth to 30% as awareness increases.
Competitive Landscape
- Main competitors: Apokyn (injectable apomorphine), as well as other dopamine agonists and adjunct therapies such as levodopa.
- Differentiating factor: Sublingual delivery improves ease of administration, potentially capturing 20–30% of the "Off" episode treatment market within five years.
Market Penetration Chronology
| Year |
Estimated Market Share |
Estimated Number of Users |
Notes |
| Year 1 |
5% |
20,000 |
Limited by physician familiarity and insurance coverage |
| Year 2 |
10% |
40,000 |
Growing awareness and insurance approvals |
| Year 3 |
15% |
60,000 |
Established safety profile and formulary placements |
| Year 5 |
25% |
100,000 |
Significant penetration in neurologic centers |
Pricing Analysis
Current Price Points
- Average wholesale price (AWP): $250–$350 per package (containing 4 sublingual films, each for single dose).
- Average selling price (ASP): Approximately $250–$300 per package, considering discounts and insurance negotiations.
Cost Considerations
- Manufacturing costs: Estimated at $60–$80 per package based on active ingredient costs, excipients, packaging, and distribution.
- Reimbursement landscape: Coverage varies but generally favors branded medications within Parkinson’s therapy, with reimbursement rates around 80%–90%.
Revenue Projections
| Year |
Estimated Units Sold |
Revenue (at $300 per package) |
Notes |
| Year 1 |
10,000 |
$3,000,000 |
Launch year, early adopters |
| Year 2 |
50,000 |
$15,000,000 |
Increased formulary approvals, physician familiarity |
| Year 3 |
100,000 |
$30,000,000 |
Broader payer coverage, expanded access |
| Year 5 |
250,000 |
$75,000,000 |
Market saturation, ongoing growth |
Price Trend Projections
- Prices are expected to remain relatively stable over five years, with slight declines (~5%) due to increased competition or generic entry, if applicable.
- Manufacturers may explore value-based rebates or discounts to improve payer acceptance.
- Pricing elasticity appears low, as the drug is a critical comparator in off-episode management.
Regulatory and Policy Impacts
- FDA approval (2020): Facilitated rapid market entry.
- Insurance policies: Coverage has increased as the medication gained clinical acceptance.
- Potential delays: Customary delays in formulary inclusion could slow initial sales growth.
Key Risks
- Rapid entry of generics or biosimilars could depress prices.
- Payer resistance could limit access, reducing sales.
- Competition from oral or new injectable formulations with improved profiles.
Final Summary
NDC 68682-0045 (Kynmobi) projects steady revenue growth driven by ongoing Parkinson's disease management needs and preferences for non-injectable treatments. Price points around $250–$300 per package are sustainable through five-year projections, with potential downward pressure from market competition.
Key Takeaways
- The target addressable market is approximately 400,000–500,000 patients with "Off" episodes in Parkinson’s disease.
- Market penetration could reach 25% within five years, translating to sales of roughly 250,000 units.
- Revenue could approach $75 million annually by year five, assuming stable pricing and increasing coverage.
- Price stability is likely unless new competitive entrants emerge, potentially leading to price reductions.
- Continued growth depends on expanding formulary access and physician education.
FAQs
1. What factors influence the price-setting for NDC 68682-0045?
Pricing depends on manufacturing costs, reimbursement negotiations, competition, and clinical value. Insurers typically negotiate discounts, influencing net pricing.
2. How does the drug compare in price to injectable apomorphine?
Injectable forms are priced similarly but may vary based on administration costs, with sublingual films offering potentially lower overall treatment costs and better patient adherence.
3. What market entry barriers exist?
Regulatory approval, formulary access, physician familiarity, and insurance reimbursement can delay widespread adoption.
4. Are generics likely to impact the market?
Yes, if patent exclusivity ends, generic versions could significantly lower prices, impacting revenue projections.
5. How might future policies affect this drug?
Changes in Medicare/Medicaid reimbursement policies and Parkinson’s disease treatment guidelines could alter access and pricing strategies.
Sources:
[1] U.S. Food and Drug Administration (2020). FDA approvals for Parkinson’s therapies.
[2] IQVIA (2022). Pharmaceutical Market Data.
[3] Medicare and Medicaid Payment Policies.
[4] Publicly available pricing databases (Red Book, First Databank).
