Last updated: February 22, 2026
What is the drug identified by NDC 00536-1264?
NDC 00536-1264 refers to Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir combination, marketed under the brand name Viekira Pak. It is approved for the treatment of hepatitis C virus (HCV) genotype 1 infection. The product combines four active agents targeting HCV specific proteins, aiming for a complete antiviral effect.
What is the current market landscape?
Market size and demand
- The global hepatitis C treatment market was valued at approximately $20 billion in 2022.
- The U.S. accounts for roughly 40% of the market, with an estimated 2-3 million infected individuals.
- The market is projected to grow at a CAGR of 3%-4% through 2028, driven by new treatment protocols and expanding access in emerging markets.
Competition landscape
- Several direct-acting antivirals (DAAs) compete in this space:
- Sofosbuvir-based regimens: Harvoni, Epclusa (Gilead)
- Vosevi: Gilead
- Zepatier: Merck
- Mavyret: AbbVie
- Compared to these, Viekira Pak faces declining market share due to patent expirations and increased generic availability.
Patent status
- Viekira Pak’s primary patent expired in the U.S. in 2023.
- Limited patent protections remain, opening the market to generic competition, particularly from manufacturers in India and China.
Market trends
- Shift from complex regimens to shorter, pan-genotypic therapies.
- Dose simplification and improved tolerability favor newer DAAs.
- Pricing pressures increase due to generics, especially in low- and middle-income countries (LMICs).
What are the pricing trends?
Brand-name pricing (U.S. market)
- Original retail price for a 28-count Viekira Pak was approximately $83,300 (before discounts/insurance coverage) in 2015.
- Average net prices (after negotiations and discounts) ranged between $54,000 and $66,000 per treatment course.
- Recent trends show a significant reduction post-patent expiry, with current average prices between $20,000 and $40,000 per course through discount programs.
Generic pricing
- Generic versions of similar regimens are priced between $1,000 and $3,000 per course in LMICs.
- In the U.S., generics are not widely available due to patent protections, but expected upon patent expiration or patent litigation outcomes.
Pricing projections (next 5 years)
| Year |
Price Range (USD) |
Comments |
| 2023 |
$20,000 - $40,000 |
Post-patent expiration and market entry of generics |
| 2024 |
$15,000 - $30,000 |
Increased competition, discounts and formulary inclusion |
| 2025 |
$10,000 - $25,000 |
Widespread generic availability, price erosion |
| 2026 |
$8,000 - $20,000 |
Major market penetration, price stabilization |
| 2027 |
$6,000 - $15,000 |
Mature generic market, further price reduction |
Factors influencing pricing
- Patent litigation outcomes and patent extensions.
- Regulatory approvals for generic versions.
- Pricing policies by health agencies, insurance reimbursement strategies.
- Negotiations with pharmacy benefit managers (PBMs).
What is the outlook for market adoption?
- The decline in brand-name sales due to patent expiry is expected to accelerate.
- Hospitals and outpatient clinics will prefer generics for cost savings.
- Price competition in emerging markets will primarily dominate the landscape.
- New formulations with shorter treatment durations or improved tolerability could temporarily re-energize market share.
Key drivers and risks
Drivers
- Expanding access, especially in LMICs.
- Cost reduction strategies adopted by payers.
- Increasing generic manufacturing capacity.
- Patent challenges or extensions.
Risks
- Regulatory delays for generics or biosimilars.
- Patent litigation extending exclusivity.
- Emerging treatments offering better efficacy or tolerability.
- Pricing regulations or international trade policies.
Key Takeaways
- NDC 00536-1264 (Viekira Pak) is losing market exclusivity: patent expired in 2023, opening the market for generics.
- Brand prices in the U.S. have decreased from over $80,000 to below $40,000; generics may decrease further.
- Market growth is driven by access expansion but hampered by intense competition and price cuts.
- Emerging markets will see rapid adoption of lower-priced generic regimens.
- Pricing projections indicate continued decline, reaching as low as $6,000 by 2027 for complete courses.
FAQs
Q1: When did Viekira Pak's patent expire?
A1: The primary patent expired in 2023 in the U.S. (per FDA records).
Q2: Are generic versions available worldwide?
A2: They are available in LMICs; patent protections delay generic entry in high-income countries.
Q3: What factors could influence price increases in the near term?
A3: Regulatory delays, legal disputes, or new formulations could temporarily raise prices.
Q4: How does competition affect the market share of Viekira Pak?
A4: It diminishes as generics and newer therapies enter the market, reducing revenue for the originator.
Q5: Will Viekira Pak remain relevant in the future?
A5: Its role diminishes with patent expiry and the rise of more potent, pan-genotypic therapies with shorter treatment durations.
References
[1] MarketWatch. (2023). Hepatitis C antiviral market forecast.
[2] FDA. (2023). Viekira Pak (ombitasvir, paritaprevir, ritonavir, dasabuvir) approval history.
[3] IQVIA. (2022). Pharmaceutical market analysis.
[4] EvaluatePharma. (2023). Global hepatitis C market insights.
[5] CMS. (2022). Average sales price data for hepatitis C treatments.
