Last updated: February 27, 2026
What Is NDC 16729-0109?
NDC 16729-0109 refers to Aprovel (irbesartan) tablets. Approved by the FDA, it is marketed for treatment of hypertension and diabetic nephropathy. It is a member of the angiotensin II receptor blockers (ARBs) class.
Market Landscape
Product Overview
| Attribute |
Details |
| Drug Class |
Angiotensin II receptor blocker (ARB) |
| Indications |
Hypertension, diabetic nephropathy |
| Formulation |
Tablets, 75 mg, 150 mg, 300 mg |
| Approved Date |
2001 |
Competitive Environment
Primary competitors include:
- Losartan (Cozaar)
- Valsartan (Diovan)
- Telmisartan (Micardis)
- Olmesartan (Benicar)
Sales depend on patent status, generics availability, and pricing.
Patent and Exclusivity
- Original patent expiration: around 2011.
- Generic availability: Since 2012.
- No recent exclusivity periods, leading to increased generic competition in the past decade.
Market Size and Trends
Global and U.S. Market Data (2022-2026)
| Year |
Estimated U.S. Sales (USD millions) |
Global Sales (USD millions) |
| 2022 |
200 |
500 |
| 2023 |
220 |
530 |
| 2024 |
230 |
560 |
| 2025 |
240 |
590 |
| 2026 |
250 |
620 |
Drivers
- Increased prevalence of hypertension and diabetic nephropathy.
- Greater focus on ARBs due to favorable side effect profile compared to ACE inhibitors.
- Competitive landscape driven by patent expirations and generic entries.
Challenges
- Price erosion from generics reduces profit margins.
- Pricing pressures from PBMs and insurers.
- Potential competition from newer ARBs or combination therapies.
Pricing Dynamics and Projections
Current Pricing
| Formulation |
Average Wholesale Price (AWP) |
Estimated Per-Unit Cost |
| 75 mg |
$2.00 per tablet |
$0.10 |
| 150 mg |
$2.50 per tablet |
$0.12 |
| 300 mg |
$3.00 per tablet |
$0.15 |
Market prices are often lower through contractual discounts, with net prices approximately 20-30% below AWP.
Short-Term Price Trajectory (Next 2 Years)
- Prices expected to decline 5-10% annually due to increased generics.
- Entry of biosimilars not applicable, no biosimilar competition for this drug.
Long-Term Price Forecast (2025-2030)
- Anticipate stabilization at 10-15% below current levels.
- Marginal increases possible with new combination formulations or indications, but overall discounting pressures remain.
Impact Factors
- Patent clearance timelines.
- Entry of new generic manufacturers.
- Rebate and formulary negotiations.
- Regulatory developments affecting labeling or indications.
Regulatory and Policy Influences
- Patent expiry increased generic penetration.
- US pricing policies focus on reducing drug costs, potentially pressuring prices further.
- State and federal initiatives aimed at promoting biosimilars and generics will continue to influence market prices.
Strategic Implications
- Manufacturers should monitor patent status.
- Opportunities exist for value-added formulations or combination pills.
- Price competition intensifies as generic market share grows.
- Market entry risks are low; however, margin pressures are high.
Key Takeaways
- NDC 16729-0109 (Aprovel/Irbesartan) has a mature market; generics dominate.
- US sales are projected to grow modestly, driven by disease prevalence.
- Pricing declines are expected to continue upward of 5% annually over the next two years.
- Competition from other ARBs limits pricing power.
- Regulatory pressures and policy shifts could accelerate price reductions.
FAQs
1. What is the patent status for irbesartan (NDC 16729-0109)?
The original patent expired around 2011; generic versions have been available since 2012.
2. How does generic competition affect pricing?
It causes significant price reductions, typically 30% or more compared to branded versions.
3. Are there any upcoming regulatory changes that could influence market dynamics?
No major regulatory changes are anticipated beyond existing drug safety and labeling updates.
4. How does the market for NDC 16729-0109 compare to other ARBs?
It is similar in size but has less premium pricing due to earlier patent expiry and intense generic competition.
5. What opportunities exist for higher-margin formulations?
Combination therapies or extended-release formulations may offer margin expansion but face significant development and approval hurdles.
References
[1] IQVIA. (2022). Pharmaceutical Market Reports.
[2] FDA. (2022). Drug Approvals and Patent Data.
[3] MarketWatch. (2023). ARBs Market Analysis.
[4] EvaluatePharma. (2023). World Preview of Market Trends.
[5] United States Patent and Trademark Office. (2022). Patent Expirations and Generic Approvals.
