Last updated: March 13, 2026
What is NDC 00536-1219?
NDC 00536-1219 refers to Linsinopril Hydrochloride, an angiotensin-converting enzyme (ACE) inhibitor used for treating hypertension and congestive heart failure. Manufactured primarily by Mylan Pharmaceuticals, it is a generic version of the branded drug Zestril.
Market Overview
Therapeutic Area and Market Size
Hypertension drugs account for approximately $20 billion annually in the U.S., with ACE inhibitors representing around 25% of that. Linsinopril's addressable market includes:
- Hypertension patients requiring ACE inhibitors.
- Patients intolerant to other classes like ARBs or calcium channel blockers.
Competition and Brand Presence
The market includes multiple generics and branded options:
| Drug |
Manufacturer |
Market Share (2022) |
Price Range (per 30-day supply) |
Notes |
| Linsinopril (NDC 00536-1219) |
Mylan |
~10% |
$4 - $8 |
One of several generics; sales depend on formulary inclusion |
| Enalapril (Zestril) |
AstraZeneca |
Leading brand |
$10 - $20 |
Branded competitor with higher price point |
| Ramipril |
Various generics |
Variable |
$4 - $8 |
Similar efficacy, multiple generic manufacturers |
Regulatory Status
The drug has FDA approval for hypertension and heart failure management. Mylan's version has had no recent patent protections, enabling competition and price erosion.
Price Trends and Projections
Historical Pricing Patterns
Between 2019 and 2022, the average wholesale price (AWP) for generic Linsinopril has decreased:
- 2019: ~$12 for a 30-day supply
- 2020: ~$8
- 2022: ~$4 - $8, depending on pharmacy and location
Influencing Factors
- Patent expirations for proprietary ACE inhibitors, increased generic competition.
- Medicaid and Medicare price negotiations reducing reimbursement rates.
- Formulary shifts favoring low-cost generics.
- Supply chain dynamics affecting raw material costs.
Short- to Medium-Term Projections
Price erosion will likely stabilize around $3 - $6 per 30-day supply by 2025. This estimate considers:
- Continued generic market penetration.
- Limited price variation due to fixed reimbursement policies.
- Market saturation.
Volume Projections
U.S. prescriptions for ACE inhibitors are expected to reach approximately 100 million annually by 2025, with Linsinopril capturing around 10% of the market.
Revenue and Market Share Outlook
Assuming a conservative average price of $5 per 30-day supply and annual prescriptions of 10 million units, the potential annual revenue is approximately $600 million in the U.S. alone.
Global markets, including Europe and Asia, could add an estimated $200 million, given similar prescribing practices and patent statuses.
Key Competitive Dynamics
- Patent landscapes favor generics for Linsinopril.
- Payer incentives support lower-cost drugs.
- Pharmaceutical companies focus on expanding indications, which might impact market size and price.
Risks to Price Stability
- Emergence of new combination drugs.
- Greater utilization of ARBs or novel agents.
- Policy shifts favoring biosimilars or newer therapy classes.
Regulatory Considerations
- Ongoing patent litigations and exclusivity periods influence market entry.
- FDA’s approval of biosimilar or interchangeable versions could pressure prices further.
Key Takeaways
- NDC 00536-1219 is a generic Linsinopril, with prices declining toward $3–$6 per 30-day supply.
- Market size in the U.S. is around $600 million annually, with room for growth in prescription volume.
- Competing generic ACE inhibitors and formulary dynamics dominate pricing.
- Price stability is threatened by future patent litigation, introduction of new drugs, and policy shifts.
- Future revenue projections depend on prescription volume growth and market penetration.
FAQs
1. What are the main competitors to NDC 00536-1219?
Other ACE inhibitors like Enalapril (Zestril) and Ramipril, including multiple generic manufacturers.
2. Will the price of this drug decrease further?
Likely, prices will stabilize around low single-digit dollar amounts due to intense generic competition.
3. What are the key factors influencing future demand?
Prescribing trends for hypertension, formulary decisions, and replacement by newer agents.
4. Are there upcoming patent challenges affecting this drug?
No imminent patent litigations are publicly reported, enabling sustained generic competition.
5. How does the market for this drug compare globally?
Similar trends toward generic adoption and price declines are observed in Europe and some Asian markets, but pricing varies by country policies.
Sources
[1] IQVIA. (2022). U.S. Prescription Drug Market Data.
[2] FDA. (2021). Drug Approvals and Patent Data.
[3] GoodRx. (2022). Hypertension Medication Price Trends.
[4] MarketWatch. (2022). Global ACE Inhibitors Market Analysis.
[5] CMS. (2022). Medicare Part D Drug Price and Utilization Data.
