Last updated: February 20, 2026
What is NDC 00074-0616?
NDC 00074-0616 is a drug marketed as Ascendis Pharma's TransCon PTH (parathyroid hormone). It is a long-acting recombinant human parathyroid hormone designed for the treatment of hypoparathyroidism. It represents a novel therapeutic option, aiming to improve management of this rare endocrine disorder.
Market Size and Demand Drivers
Incidence and Prevalence
- Hypoparathyroidism affects approximately 20,000-25,000 patients in the United States.[1]
- The majority of cases are caused by surgical removal of the parathyroid glands, with autoimmune and genetic factors accounting for a minority.
Current Treatment Landscape
- Standard treatment involves calcium and active vitamin D supplementation.
- Off-label use of recombinant PTH (e.g., Natpara/Natpar, NDC 71345-0120) addresses symptoms but has limitations like injection frequency and bioavailability.
Market Potential
| Parameter |
Data |
| US hypoparathyroidism population |
20,000 – 25,000 |
| Estimated diagnosed population |
80% of total, i.e., 16,000 – 20,000 |
| Current annual treatment spend |
~$2,000 – $4,000 per patient |
| Potential adoption rate (5-year horizon) |
30% – 50% of diagnosed patients |
Competitive Landscape
- Natpara (NDC 71345-0120): Previously the only FDA-approved PTH therapy before recall in 2019.
- TransCon PTH offers longer dosing intervals (weekly injections), potentially increasing adherence.
Regulatory Status and Market Entry
- Phase 3 trials completed; awaiting or in the process of FDA submission.
- No current FDA-approved long-acting PTH therapy; potential for market entry dominated by Natpara's regulatory history and Indication.
Price Analysis and Projection
Current Drug Pricing
| Drug |
NDC |
Price per unit |
Dosing frequency |
Annual cost per patient |
| Natpara |
71345-0120 |
~$58,000 |
Daily |
~$58,000 – 70,000 |
| TransCon PTH |
Not yet marketed |
Pending Approval |
Weekly |
Estimated $70,000 – 90,000 |
Price Projection Assumptions
- TransCon PTH will launch at a premium to Natpara due to convenience and longer dosing intervals.
- Initial pricing: $75,000 – $80,000 annually.
- Price adjustments based on payer negotiations, market penetration, and competitive responses.
- Volume growth expected to be moderate initially (10%-15% annually), increasing as insurance coverage expands.
Revenue Projections
| Year |
Patients (Estimated) |
Market Penetration |
Estimated Revenue |
Comments |
| 2024 |
1,000 – 1,500 |
5% – 10% |
$75M – $120M |
Launch period, limited payer coverage |
| 2025 |
2,000 – 3,000 |
15% – 20% |
$150M – $240M |
Growing acceptance and coverage |
| 2026 |
3,500 – 5,000 |
20% – 30% |
$262.5M – $400M |
Expanded indication or broader payer coverage |
Market Challenges and Risks
- Regulatory hurdles could delay approval.
- High development costs and pricing pressures.
- Competition from biosimilars or alternative treatments.
- Insurance reimbursement policies could limit profitability.
Key Takeaways
- The market for long-acting PTH therapies like TransCon PTH is limited by the rarity of hypoparathyroidism but offers high-per-patient revenue potential.
- Early adoption will depend heavily on FDA approval, payer acceptance, and clinician familiarity.
- Initial price points are projected at $75,000–$80,000 annually, with total market revenue possibly reaching several hundred million dollars within five years of launch.
FAQs
1. When is TransCon PTH expected to launch?
Pending FDA approval, expected within 1-2 years from submission.
2. How does TransCon PTH compare pricing-wise to Natpara?
It is projected to be priced higher initially ($75,000–$80,000 vs. Natpara’s ~$58,000), due to longer dosing intervals and improved adherence.
3. What factors could influence market size?
Payer coverage, regulatory approvals, clinician adoption, and patient acceptance.
4. Are there competitors in the long-acting PTH space?
Currently, no FDA-approved long-acting PTH therapies; Natpara is the closest competitor. Future biosimilar entrants could pose a threat.
5. How will market growth be affected by disease prevalence?
Limited prevalence caps the total market size; growth relies on improved diagnosis, treatment adherence, and expanded indications.
References
[1] Mayo Clinic. (2022). Hypoparathyroidism. Retrieved from https://www.mayoclinic.org/diseases-conditions/hypoparathyroidism/symptoms-causes/syc-20373210
