Last updated: March 2, 2026
What is the drug with NDC 67457-0583?
NDC 67457-0583 is a medication approved by the FDA that corresponds to Mycapssa (octreotide capsule). It is indicated for the treatment of acromegaly in adult patients who are responding to octreotide therapy.
Current Market Status
- Approval date: August 2019
- Formulation: Oral capsule
- Market entry: Launched by Chiasma, Inc.
- Target population: Estimated at approximately 4,000-5,000 U.S. patients with acromegaly (per NIH and industry estimates).
Commercial Landscape
Competitors
- Sandostatin (octreotide) injectable formulations (IM and SC), existing since 1988
- Signifor (pasireotide), approved for acromegaly since 2014
- Pasireotide LAR, long-acting injection
- Pegvisomant (Somavert), non-octreotide option for acromegaly
Market penetration
- Mycapssa faces competition from established injectables with broader physician familiarity.
- Oral delivery positions Mycapssa as a convenience alternative, potentially expanding patient adherence.
Adoption factors
- Physician acceptance: Limited, pending more real-world efficacy data
- Patient acceptance: Increased due to convenience of oral administration
- Insurance coverage: Generally supportive, but some restrictions apply; coverage varies by payer
Price Analysis
Current Pricing
- Wholesale acquisition cost (WAC): Approximately $6,047 per 30-count supply (30 capsules)
- Average retail price: Estimated at $7,500–$8,000 per month
- Patient out-of-pocket: Can vary; estimates range from $20–$200 per month with insurance
Pricing Context
| Drug |
Formulation |
Monthly Price (USD) |
Year of Approval |
Notes |
| Mycapssa |
Oral capsule |
$7,500–$8,000 |
2019 |
First oral octreotide approved |
| Sandostatin LAR |
Intramuscular injection |
$2,500–$3,000 |
1988 |
Older, injectables dominate |
| Signifor |
Subcutaneous/IV |
$10,000–$12,000 |
2014 |
More expensive, niche use |
Price Projections
- Short-term (1-2 years): Price will stabilize around current levels until market share expands.
- Mid-term (3-5 years): Potential price decrease of 10–15% due to increased competition and payer negotiations.
- Long-term (5+ years): Possible discounts or formulary inclusion benefits could reduce effective consumer costs by 20–30%.
Market Drivers and Risks
Drivers
- Convenience and improved adherence.
- Growing awareness of oral alternatives among physicians.
- Demographics and increased diagnosis rates in the U.S. healthcare market.
Risks
- Slow adoption due to physician and patient preference for injectables.
- Potential price erosion with increased competition or biosimilar entry.
- Insurance coverage limitations impacting patient access.
Regulatory and Policy Factors
- Physician prescribing habits influenced by the established efficacy of injectables.
- Payer policies may favor less expensive injectables unless differentiation in adherence and quality of life is demonstrated.
Investment and Strategic Considerations
- The niche market size limits revenue potential but benefits from high pricing and recurring prescriptions.
- Strategic positioning as a first-mover oral therapy could expand use beyond traditional injection patients.
- Collaboration with payers for formulary inclusion will be critical for growth.
Key Takeaways
- NDC 67457-0583 (Mycapssa) is an oral octreotide capsule approved for acromegaly.
- Market presence is limited but positions for growth driven by demand for oral formulations.
- Current pricing is $7,500–$8,000 per month, with potential for slight reductions over 3–5 years.
- Market expansion depends on physician acceptance, patient preference, and payer coverage.
- Long-term pricing likely to decline as competition increases and market penetration deepens.
FAQs
1. How does the pricing of Mycapssa compare to injectable octreotide?
- Mycapssa’s monthly cost of approximately $7,500–$8,000 exceeds that of injectables, which typically range from $2,500–$3,000. The higher price reflects convenience and oral administration benefits.
2. What factors could impact the future price of Mycapssa?
- Greater market penetration, increased competition, payer negotiations, and potential biosimilar entry could lead to price reductions.
3. What is the estimated patient population for this drug?
- Approximately 4,000–5,000 patients in the U.S. with acromegaly.
4. How does insurance coverage influence the drug’s price and access?
- Insurance coverage reduces out-of-pocket costs; coverage restrictions could limit access unless demonstrated benefits justify reimbursement.
5. What are the key growth opportunities for this drug?
- Expanding physician awareness and acceptance, improving patient adherence, and achieving wider payer formulary inclusion.
References
[1] U.S. Food and Drug Administration. (2019). FDA approves first oral treatment for acromegaly.
[2] Chiasma, Inc. (2019). Mycapssa (octreotide capsules) prescribing information.
[3] IQVIA. (2022). U.S. Prescription Drug Market Data.
[4] NIH. (2021). Acromegaly Overview.
