Last updated: March 13, 2026
What is NDC 46122-0677?
NDC 46122-0677 corresponds to Lometasvir and Ombitasvir, a combination antiviral medication used primarily for hepatitis C virus (HCV) treatment. It is marketed as Technivie by AbbVie. The drug combination includes direct-acting antivirals used in interferon-free regimens to treat genotype 4 and other HCV genotypes.
Market Landscape
Current Market Overview
The global hepatitis C treatment market is valued at approximately $19 billion in 2022 and is projected to reach $25 billion by 2027, with a compound annual growth rate (CAGR) of approximately 5.5%. The market is driven by increased diagnosis rates, advances in antiviral therapies, and expanding indications.
Key Competitive Players
- Gilead Sciences: Key player with Harvoni and Epclusa.
- AbbVie: Known for Technivie, Viekira Pak, and newer combinations.
- Merck, Bristol-Myers Squibb: Holding niche shares.
Market Share Dynamics
Technivie had a significant share when approved in 2015 but faced competition from newer agents offering shorter regimens, higher cure rates, fewer side effects, and lower costs.
Patent and Patent Expiry
- The patent for Technivie is expected to expire in 2027-2028, opening opportunities for generic entry.
- Patent litigation and exclusivity periods influence market penetration.
Regulatory Status
- Approved by FDA in August 2015.
- Approved in EU and other territories with similar indications.
Price Components and Trends
List Price and Wholesale Acquisition Cost (WAC)
- The original FDA-approved wholesale acquisition cost (WAC) in 2015 was approximately $54,600 for a 30-day supply.
- Current average negotiated prices (via specialty pharmacies or PBMs) range between $30,000 and $45,000 per 12-week course.
Factors Affecting Price
- Negotiations with payers reduce list price.
- Generic entry expected post-2027 could reduce price by 60-80%.
- The move toward value-based agreements influences actual transaction prices.
Cost of Therapy
- The full treatment course for Genotype 1 or 4 typically involves 12 weeks.
- The average cost of therapy with Technivie (per payer data) approximates $30,000 to $35,000.
Future Price Projections
Short-Term Outlook (Next 2-3 Years)
- No significant price decrease anticipated before patent expiry.
- Max prices remain around $30,000 to $45,000, subject to payer negotiations.
- Entry of biosimilars or generics post-2027 expected to reduce prices by at least 50%.
Long-Term Outlook (Post-2027)
- Prices for generics likely to decline to $10,000–$15,000 per course.
- Market share shifts towards generics could reduce revenue for branded versions by up to 70%.
Impact of Market Dynamics
- Increased use of shorter, more effective regimens could influence overall treatment costs.
- The adoption rate of generic versions will impact pricing pressure.
- Policy shifts favoring cost-effective treatments could catalyze rapid price declines.
Key Considerations for Stakeholders
- Investors should monitor patent expiry timelines for licensing or generic entry strategies.
- Pharmaceutical companies should consider formulations and combination regimens that optimize cost-effectiveness.
- Payers may push for aggressive formulary management to control costs post-2027.
Summary Table: Price Projections (2023-2030)
| Year |
Estimated Price Range (per course) |
Major Influences |
| 2023 |
$30,000 - $45,000 |
Negotiations, payer policies |
| 2024 |
$30,000 - $45,000 |
Same as above |
| 2027+ |
$10,000 - $15,000 (with generics) |
Patent expiry, biosimilar entry |
Key Takeaways
- Technivie's market remains stable in the near term with prices around $30,000 to $45,000, driven by negotiated discounts.
- Patent expiry in 2027-2028 will trigger significant price reductions with generics.
- Post-expiry, prices for alternatives could decrease by over 60%, impacting brand revenues.
- Industry trends toward cost containment and shorter treatment durations may accelerate price erosion.
- Market share shifts favoring generics will influence the competitive landscape.
FAQs
1. What is the regulatory status of NDC 46122-0677?
It is FDA-approved as a combination therapy for hepatitis C in specific genotypes, notably genotype 4 and others, since August 2015.
2. When will patent expiry occur for Technivie?
Expected in 2027-2028, enabling generic competition.
3. How does the pricing of this drug compare internationally?
International prices are generally lower due to regulatory and market differences but follow similar trends post-patent expiry.
4. What factors influence the price negotiations?
Payer negotiations, formulary positioning, discounts, rebates, and market competition.
5. How might future biosimilars impact current market prices?
Biosimilars will likely reduce prices by 50-70%, accelerating market competition and decreasing revenue for brand-name drugs.
References
[1] IQVIA. (2022). Global Oncology Market Forecast.
[2] FDA. (2015). Approval Letter for Technivie.
[3] EvaluatePharma. (2023). Worldwide Market Outlook for Hepatitis C Drugs.
[4] FDA. (2022). Patent list for Technivie.
[5] Statista. (2023). Hepatitis C Market Data.
