Last updated: February 27, 2026
What is NDC 46122-0782?
The drug identified by NDC 46122-0782 is Orladeyo (berotralstat), indicated for the prevention of hereditary angioedema (HAE) attacks in adults and pediatric patients aged 12 years and older. It is an oral, once-daily medication approved by the FDA in December 2020.
Market Landscape
Market Size and Epidemiology
- Hereditary Angioedema (HAE) affects approximately 1 in 50,000 individuals worldwide.
- In the U.S., the prevalence is estimated at approximately 5,000 to 7,000 patients.
- The disease causes recurrent swelling attacks in the extremities, face, larynx, and abdomen, often necessitating ongoing prophylaxis.
Current Treatment Options
- C1 esterase inhibitor (C1-INH) replacement therapies (e.g., Berinert, Haegarda)
- Bradykinin receptor antagonists (e.g., icatibant)
- Kallikrein inhibitors (e.g., lanadelumab, now competing with berotralstat)
Competitive Landscape
| Drug |
Indication |
Route |
Launch Year |
Market Share (2022) |
Annual Revenue (USD) |
Key Features |
| Berotralstat (Orladeyo) |
HAE prophylaxis |
Oral |
2020 |
20% of HAE prophylaxis market |
Estimated $150M |
First oral for prophylaxis |
| Lanadelumab (Takhzyro) |
HAE prophylaxis |
Subcutaneous |
2018 |
40% |
Estimated $650M |
Higher efficacy, subq |
| C1-INH (Haegarda) |
IV prophylaxis |
Intravenous |
2014 |
25% |
~$250M |
IV administration |
| Icatibant (Firazyr) |
Acute attacks |
Subcutaneous |
2009 |
15% |
<$100M |
Acute treatment |
Market Dynamics
- The approval of Orladeyo expanded prophylactic options to include an oral medication, increasing its adoption.
- Patient preference for oral therapies could shift market share from injectable treatments.
- Insurance coverage and reimbursement policies influence medication access.
- The upcoming pipeline includes next-generation kallikrein inhibitors and gene therapies, possibly altering the competitive landscape over the next five years.
Price Analysis
Current Pricing
- Orladeyo (berotralstat) is listed at approximately $17,580 per year per patient (source: GoodRx, 2023).
- Pricing varies by payer, region, and pharmacy discounts but remains consistent across the U.S.
Cost Comparison
| Drug |
Approximate Annual Cost |
Administration Route |
Year of Market Entry |
| Orladeyo |
$17,580 |
Oral |
2020 |
| Lanadelumab (Takhzyro) |
$600,000 |
Subcutaneous |
2018 |
| C1-INH (Haegarda) |
$250,000 |
IV |
2014 |
| Icatibant (Firazyr) |
$45,000 |
Subcutaneous |
2009 |
Note: Costs are approximate and subject to variation.
Price Trends and Projections
- Pricing Stability: Orladeyo's price has remained relatively stable since launch, consistent with novel oral medications.
- Market Penetration: Increased use of Orladeyo in prophylaxis could pressure injectable therapies to reevaluate pricing strategies.
- Potential Discounting: To expand market uptake, manufacturers may offer rebates or discounts, especially in competitive insurance negotiations.
Future Price Projections (Next 3-5 Years)
- Minimal evidence suggests significant price reduction due to the drug's novel oral administration and limited direct competitors.
- Price may stabilize or slightly decrease (by 2-5%) as market penetration increases and generic or biosimilar options emerge, which are currently not available.
- Pricing in international markets will likely be lower, aligned with local healthcare systems and reimbursement policies.
Key Drivers Affecting Market and Price
- Regulatory Developments: Pending approvals for new HAE prophylaxis medications could impact Orladeyo’s market share and pricing.
- Insurance Coverage: Reimbursement policies influence patient access, impacting volume and revenue.
- Pipeline Interruptions: Introduction of gene therapies and longer-acting agents could reduce demand for oral prophylactics, affecting pricing strategies.
Summary of Key Data Points
- U.S. market for HAE prophylaxis drugs estimated at $1.1 billion (2022), with Orladeyo holding an approximate $150M revenue share.
- Orladeyo's annual list price (~$17,580) is competitive as an oral alternative to injectable therapies.
- Projected adoption growth of 10-15% annually over the next three years, with price stabilization.
Key Takeaways
- NDC 46122-0782 (Orladeyo) operates in a niche but growing market with increasing demand for oral prophylactic options.
- The drug's premium price reflects innovation rather than exclusivity; competitive dynamics remain stable given its unique route of administration.
- Market penetration will be influenced by formulary decisions, patient preferences, and pipeline developments.
FAQs
1. How does Orladeyo compare to injectable therapies in effectiveness?
Efficacy is comparable, with similar reductions in attack frequency. Oral administration offers convenience, which can improve adherence.
2. What is the potential for price reductions in the next five years?
Likely minimal, unless new competitors enter or patent protections lapse, which could drive discounts.
3. Will insurance coverage impact Orladeyo's market share?
Yes, coverage policies and prior authorization requirements influence patient access and market penetration.
4. Are there upcoming regulatory or pipeline developments that could affect prices?
Pipeline innovations, including gene therapies, may shift demand but are unlikely to significantly reduce existing oral drug prices initially.
5. How does international pricing compare?
International prices tend to be lower due to different healthcare systems, reimbursement models, and market sizes.
Sources
[1] FDA. (2020). FDA approval package for Orladeyo.
[2] IQVIA. (2022). U.S. Prescription Market Data.
[3] GoodRx. (2023). Drug pricing information.
[4] National Hereditary Angioedema Foundation. (2022). Epidemiology and Treatment Data.
[5] EvaluatePharma. (2023). Global drug sales and revenue predictions.
