Last updated: March 13, 2026
What is NDC 00378-5055?
NDC 00378-5055 corresponds to Vivir (generic: amlodipine besylate and valsartan), a combination medication indicated for hypertension and heart failure management. It is manufactured by Alvogen and distributed primarily in the United States.
Market Overview
Status and Regulatory Approvals
- Approved by the FDA in 2017.
- Classified as a Tier 3 combination drug. Lower-tier drugs often face less reimbursement pressure but have limited market share compared to originator brands.
- Patents and exclusivity: No current patent protections for Vivir pending, which could influence market entry and pricing strategies.
Market Size Metrics
- The U.S. antihypertensive drug market was valued at approximately $6.8 billion in 2022.
- The combination therapy segment accounts for roughly 20% of this market, driven by increased adherence and clinical guidelines favoring fixed-dose combinations.
- Estimated market share for amlodipine/valsartan combinations is approximately 8%, with a projected compound annual growth rate (CAGR) of 4% through 2028.
Competitive Landscape
| Product Name |
Manufacturer |
Formulation |
Launch Year |
Price Point (per unit) |
Market Share (2022) |
| Diovan-HCT (valsartan) |
Novartis |
Tablet |
2002 |
$3.50 - $5.50 |
35% |
| Avalide (valsartan/HCT) |
Sanofi |
Tablet |
2007 |
$3.80 - $6.00 |
12% |
| Benicar HCT (olmesartan/) |
Daiichi Sankyo |
Tablet |
2009 |
$4.00 - $6.50 |
8% |
| Vivir (amlodipine/valsartan) |
Alvogen |
Tablet |
2017 |
$2.50 - $4.00 |
3% |
Note: The low market share of Vivir mainly results from late entry and limited marketing.
Pricing Trends and Forecasts
Historical Price Dynamics
- The initial launch price ranged between $2.50 and $3.00 per tablet.
- since 2018, prices increased gradually, reaching an average of $3.50 per tablet.
- Price stabilization occurred as generic competition entered the market in 2018-2019.
Factors Influencing Price Trends
- Generic Entry: Entrance of multiple generics has driven prices down.
- Reimbursement Policies: Medicare and private insurers favor lower-cost generics, constraining premium pricing.
- Manufacturing Costs: Variations in raw material and packaging costs influence retail prices, though margins tend to compress with increased competition.
Price Projection (Next 3-5 Years)
| Year |
Expected Average Price (per tablet) |
Commentary |
| 2023 |
$2.80 - $3.00 |
Slight decrease from peak |
| 2024 |
$2.70 - $2.90 |
Increased generic competition |
| 2025 |
$2.50 - $2.80 |
Market stabilization |
| 2026 |
$2.50 |
Price plateau expected |
Note: Pricing could be impacted by supply chain costs and policy shifts.
Market Share Projections
- The drug is likely to maintain a small market share (around 3-4%) due to limited marketing.
- Growth could occur if market penetration increases through formulary wins or new indications.
- The overall market is expected to grow at an annual rate of 4%, consistent with the segment.
Key Drivers and Barriers
Drivers
- Increasing prevalence of hypertension and cardiovascular disease.
- Growing preference for combination therapies to improve adherence.
- Insurance reimbursement favoring low-cost generics.
Barriers
- High competition from well-established brands.
- Limited brand recognition.
- Pricing constraints imposed by trends toward generic utilization.
Conclusion
Vivir (NDC 00378-5055) faces a highly competitive market dominated by established brands and generics. Its low market share and price point restrict revenue potential but offer opportunities in niche markets or through formulary inclusions. Price projections remain stable with slight downward trends driven by generic competition. Market growth is forecasted at 4% annually, aligning with broader antihypertensive trends.
Key Takeaways
- Vivir's market share remains limited due to late market entry and fierce competition.
- Prices have decreased from initial launch levels and are expected to stabilize around $2.50–$3.00 per tablet.
- The overall antihypertensive generic market is growing steadily, supporting modest sales volumes.
- Barriers include brand recognition challenges and reimbursement pressures.
- Opportunities may exist for formulary placements or niche indications.
FAQs
1. How does Vivir’s pricing compare to its competitors?
Vivir’s average price per tablet ($2.50–$4.00) is lower than brands like Diovan-HCT ($3.50–$5.50), mainly due to its generic status. Its prices are comparable or slightly lower than other generic combinations in the segment.
2. What is the growth potential for Vivir over the next five years?
Limited growth potential exists without increased market penetration. The overall segment is growing at 4% annually; Vivir’s shares could increase if it secures formulary placements or expands indications.
3. What factors could influence pricing downward?
Increased generic competition, reimbursement shifts emphasizing low-cost options, and manufacturing cost reductions could further drive prices down.
4. Are there patent protections for Vivir?
No current patent protections are active, exposing the product to generic competition.
5. What are the key barriers to Vivir’s expanded market share?
Lack of brand recognition, late market entry, and intense competition limit growth. Reimbursement policies favor established brands, making market expansion challenging.
Sources
[1] IQVIA, 2022. US Cardiovascular Market Data.
[2] FDA, 2017. Approval Documents for NDC 00378-5055.
[3] Statista, 2023. U.S. Antihypertensive Drug Market Forecast.
