Cerivastatin sodium - Generic Drug Details

What are the generic drug sources for cerivastatin sodium and what is the scope of patent protection?

Cerivastatin sodium is the generic ingredient in one branded drug marketed by Bayer Pharms and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for cerivastatin sodium

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	37
DailyMed Link:	cerivastatin sodium at DailyMed

Anatomical Therapeutic Chemical (ATC) Classes for cerivastatin sodium

C10AA	HMG CoA reductase inhibitors
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

US Patents and Regulatory Information for cerivastatin sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Pharms	BAYCOL	cerivastatin sodium	TABLET;ORAL	020740-003	Jun 26, 1997		DISCN	No	No
Bayer Pharms	BAYCOL	cerivastatin sodium	TABLET;ORAL	020740-002	Jun 26, 1997		DISCN	No	No
Bayer Pharms	BAYCOL	cerivastatin sodium	TABLET;ORAL	020740-005	May 24, 1999		DISCN	No	No
Bayer Pharms	BAYCOL	cerivastatin sodium	TABLET;ORAL	020740-004	Jun 26, 1997		DISCN	No	No
Bayer Pharms	BAYCOL	cerivastatin sodium	TABLET;ORAL	020740-001	Jun 26, 1997		DISCN	No	No
Bayer Pharms	BAYCOL	cerivastatin sodium	TABLET;ORAL	020740-006	Jul 24, 2000		DISCN	No	No

Expired US Patents for cerivastatin sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Pharms	BAYCOL	cerivastatin sodium	TABLET;ORAL	020740-003	Jun 26, 1997
Bayer Pharms	BAYCOL	cerivastatin sodium	TABLET;ORAL	020740-002	Jun 26, 1997
Bayer Pharms	BAYCOL	cerivastatin sodium	TABLET;ORAL	020740-001	Jun 26, 1997
Bayer Pharms	BAYCOL	cerivastatin sodium	TABLET;ORAL	020740-006	Jul 24, 2000
Bayer Pharms	BAYCOL	cerivastatin sodium	TABLET;ORAL	020740-002	Jun 26, 1997
Bayer Pharms	BAYCOL	cerivastatin sodium	TABLET;ORAL	020740-003	Jun 26, 1997
Bayer Pharms	BAYCOL	cerivastatin sodium	TABLET;ORAL	020740-006	Jul 24, 2000

Market Dynamics and Financial Trajectory for Cerivastatin Sodium

Last updated: February 17, 2026

Cerivastatin sodium, once marketed as Baycol by Bayer, was a statin class drug approved by the FDA in 1997 for hypercholesterolemia. Withdrawal from the market occurred in 2001 due to safety concerns, primarily cases of rhabdomyolysis. Its market presence and potential for future financial gains are largely historical, with limited opportunities for significant resurgence.

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Why Did Cerivastatin Sodium Exit the Market?

Cerivastatin sodium was withdrawn following reports of severe adverse effects. Post-market surveillance identified an increased risk of rhabdomyolysis, particularly when combined with fibrates or in high-dose regimens. The FDA issued a recall in August 2001, making it the first statin to be voluntarily removed due to safety risks.

Current Market Status of Cerivastatin Sodium

• Market Presence: No longer marketed; no approved or commercially available formulations.
• Patent Status: Long expired; Bayer's patent protection ended in early 2000s.
• Legal and Safety Legacy: Used as a cautionary example in drug development and pharmacovigilance.

Potential for Reintroduction or Repurposing

Reformulation or new clinical trials face significant hurdles:

• Safety Concerns: The primary obstacle remains safety profile, with irremediable risks of rhabdomyolysis.
• Regulatory Barriers: Reapproval would require extensive clinical safety data; unlikely given historical adverse events.
• Market Demand: The presence of newer, safer statins (atorvastatin, rosuvastatin) limits demand.

Recent research explores statin derivatives or targeted drug delivery systems to minimize adverse effects, but no current pipeline includes cerivastatin sodium specifically.

Market Size and Financial Trajectory

• Historical Market Value (Pre-2001): Approximately $2 billion annually globally, driven by high-dose therapies and aggressive lipid management.
• Post-2001 Market: Decline to negligible levels; replaced by other statins with better safety profiles.
• Future Opportunities: None anticipated for cerivastatin sodium as a marketed drug; activity limited to academic research and safety case studies.

Market Dynamics

1. Competitive Landscape:

   • Dominated by atorvastatin, rosuvastatin, simvastatin.
   • Bayer exited statin market after cerivastatin's withdrawal; no new competitors for cerivastatin.

2. Regulatory Environment:

   • Tightened safety monitoring for lipid-lowering agents.
   • No indication of re-approvals for drugs with a safety profile similar to cerivastatin.

3. Research Trends:

   • Shift towards personalized medicine and alternative lipid-lowering mechanisms.
   • Focus on drugs with fewer side effects; cerivastatin’s safety issues hinder research interest.

Financial Outlook for Stakeholders

• Pharmaceutical companies: No current investment or development plans involve cerivastatin sodium.
• Investors: No significant financial trajectory expected; legacy liabilities and safety issues overshadow potential repurposing.
• Healthcare providers: No ongoing prescribing practices; replacement drugs dominate.

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Key Takeaways

• Cerivastatin sodium is obsolete as a marketed drug, discontinued due to safety concerns.
• No current pipeline or regulatory pathway exists for reintroduction.
• The global statin market continues growth, but with newer, safer options.
• Market analysis indicates negligible future revenue potential for cerivastatin sodium.
• Research interest revolves around safety improvements in statin therapy rather than reintroduction of cerivastatin.

FAQs

1. Can cerivastatin sodium be revived with reformulation?
Unlikely. The safety profile, especially rhabdomyolysis risk, remains a barrier. Regulatory agencies would require extensive new safety data.

2. Are there any ongoing clinical trials involving cerivastatin?
No. The drug is obsolete; current research focuses on novel lipid-lowering agents or improved statins.

3. How does the safety profile of cerivastatin compare to other statins?
Cerivastatin had a higher incidence of rhabdomyolysis, especially at high doses, compared to other statins like atorvastatin.

4. What is the estimated global market value for statins today?
Approximately $25 billion in 2022, with at least 5 major players dominating the market.

5. Could cerivastatin serve as a research tool?
Yes, it is used in pharmacovigilance studies or as a comparative agent in safety research but not as a therapeutic option.

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References

[1] U.S. Food and Drug Administration. "FDA Announces voluntary nationwide recall of Baycol." 2001.
[2] European Medicines Agency. "Statin safety review." 2003.
[3] Statin market report, GlobalData, 2022.