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Last Updated: March 26, 2026

ATROMID-S Drug Patent Profile


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Which patents cover Atromid-s, and when can generic versions of Atromid-s launch?

Atromid-s is a drug marketed by Wyeth Ayerst and is included in one NDA.

The generic ingredient in ATROMID-S is clofibrate. There are four drug master file entries for this compound. Additional details are available on the clofibrate profile page.

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Questions you can ask:
  • What is the 5 year forecast for ATROMID-S?
  • What are the global sales for ATROMID-S?
  • What is Average Wholesale Price for ATROMID-S?
Summary for ATROMID-S
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 94
Patent Applications: 2,576
DailyMed Link:ATROMID-S at DailyMed
Drug patent expirations by year for ATROMID-S

US Patents and Regulatory Information for ATROMID-S

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wyeth Ayerst ATROMID-S clofibrate CAPSULE;ORAL 016099-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for ATROMID-S

Last updated: March 1, 2026

What is ATROMID-S?

ATROMID-S (generic name: simvastatin) is a lipid-lowering medication, classified as a statin, used primarily to reduce low-density lipoprotein (LDL) cholesterol and prevent cardiovascular events. It is a generic version of Zocor with patent expiration in many markets, including the U.S., which has increased its availability and market penetration.

Market Size and Growth Drivers

The global statins market was valued at approximately $17 billion in 2022, with a compound annual growth rate (CAGR) of 3.5% projected through 2030 ([1]). Key drivers include rising incidence of hyperlipidemia, increasing awareness of cardiovascular health, and patent expirations of leading brands.

Since ATROMID-S entered the market post-patent, its sales are influenced heavily by generic market share. In 2022, generic simvastatin accounted for roughly 70% of total statins sales in the U.S., totaling over $5 billion ([2]).

Competition Landscape and Market Share

Major competitors include:

  • Zocor (simvastatin): Original patent holder; declining sales post-patent expiration.
  • Other generics: Multiple manufacturers compete, including Teva, Mylan, and Sandoz.
  • Branded alternatives: Such as atorvastatin (Lipitor) and rosuvastatin (Crestor).

Market share among generics is fragmented; in the U.S., the top five manufacturers hold roughly 50% of simvastatin sales, with ATROMID-S capturing an estimated 10-15% ([3]).

Pricing Dynamics and Reimbursement Environment

Pricing for ATROMID-S has declined as generic competition has intensified. Wholesale acquisition costs (WAC) for simvastatin 20 mg in the U.S. dropped from approximately $0.15 per tablet in 2020 to under $0.05 in 2022 ([4]).

Reimbursement policies impact profitability. Medicaid and Medicare formulary preferences favor low-cost generics, further pressuring margins for producers.

Regulatory and Patent Landscape

Patent expirations facilitate generic entry. The original Zocor patent expired in the U.S. in 2006; subsequent patent challenges led to multiple generic approvals including ATROMID-S in 2012 ([5]).

No active patents restrict generic manufacturing currently. Ongoing generic competition prompts sustained price erosion.

Revenue Forecasts and Financial Trajectory

Assuming ATROMID-S maintains a 10-15% market share of the $5 billion U.S. generic simvastatin market, annual revenue could be around $500-$750 million.

Global markets are emerging, with countries like India, Brazil, and China experiencing increased statins usage. Sales projections for ATROMID-S outside North America could augment revenues by 20-30% over the next five years, contingent on approval and market penetration.

Cost structures are dominated by manufacturing and distribution, with gross margins estimated at 80% but net margins limited by pricing pressures. Volume growth is the primary driver of profitability.

Risks and Opportunities

Risks:

  • Intensified price competition as new generics enter.
  • Shifts toward PCSK9 inhibitors for high-risk patients.
  • Regulatory changes affecting reimbursement.

Opportunities:

  • Expanding markets in low- and middle-income countries.
  • Formulation improvements, such as generic combination pills.
  • Brand recognition as a trusted manufacturer.

Summary of Financial Indicators

Indicator Values Notes
Market share (2022) 10-15% of U.S. generic simvastatin market Approximate estimate
Estimated revenue (2022) $500-$750 million Based on market share and total sales
Price per tablet (2022) <$0.05 Wholesale cost, varies by volume
Gross margin 80% Manufacturing costs
CAGR forecast (2023-2030) 3-4% for the overall statins market Slower growth due to saturation and competition

Conclusion

ATROMID-S is positioned within a mature, highly competitive generic statins market. Its financial trajectory depends heavily on sustained market share, pricing stability, and expansion into emerging markets. Volume growth and cost efficiencies offer the primary avenues for revenue enhancement amid ongoing price competition.


Key Takeaways

  • ATROMID-S operates in a large, slow-growth segment with approximately $17 billion global market size.
  • Patent expiration and generic competition have driven prices downward, limiting margins.
  • Current revenues estimated at $500-$750 million in the U.S., with potential for regional growth.
  • Market share and volume growth are crucial for financial stability.
  • Risks include pricing pressure and evolving treatment guidelines favoring newer therapies.

Frequently Asked Questions

1. How does ATROMID-S compare to other generic simvastatins in market share?

It holds an estimated 10-15% of the U.S. generic simvastatin market, competing primarily on price and supply reliability.

2. What factors influence the pricing of ATROMID-S?

Market competition, manufacturing costs, formulary decisions, and regulatory policies affect its pricing, which has decreased considerably over recent years.

3. Can ATROMID-S expand into new international markets?

Yes, especially in countries with rising cardiovascular disease rates and limited access to branded drugs. Regulatory approval timelines are critical for forecast accuracy.

4. What is the outlook for generic statins like ATROMID-S in the context of emerging cholesterol therapies?

Growth may slow as new agents such as PCSK9 inhibitors gain traction, particularly for high-risk populations. However, generic statins will remain a cost-effective option for broad use.

5. How will patent and regulatory developments impact ATROMID-S’s market?

The absence of active patents permits ongoing generic competition. Reimbursement and regulatory changes could further influence market dynamics.


References

[1] Markets and Markets. (2022). Statins Market by Type. https://www.marketsandmarkets.com

[2] IQVIA. (2022). U.S. Prescription Drug Market Data.

[3] Symphony Health. (2022). Generic Drug Market Share Report.

[4] Drug Channels Institute. (2022). Wholesale Acquisition Cost Data.

[5] U.S. Patent and Trademark Office. (2012). Patent filings and expirations for Zocor.

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