BAYCOL Drug Patent Profile

Which patents cover Baycol, and what generic alternatives are available?

Baycol is a drug marketed by Bayer Pharms and is included in one NDA.

The generic ingredient in BAYCOL is cerivastatin sodium. Additional details are available on the cerivastatin sodium profile page.

Summary for BAYCOL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	83
Patent Applications:	3,721
DailyMed Link:	BAYCOL at DailyMed

US Patents and Regulatory Information for BAYCOL

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	020740-001	Jun 26, 1997		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	020740-002	Jun 26, 1997		DISCN	No	No
Bayer Pharms	BAYCOL	cerivastatin sodium	TABLET;ORAL	020740-003	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 BAYCOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Pharms	BAYCOL	cerivastatin sodium	TABLET;ORAL	020740-005	May 24, 1999
Bayer Pharms	BAYCOL	cerivastatin sodium	TABLET;ORAL	020740-003	Jun 26, 1997
Bayer Pharms	BAYCOL	cerivastatin sodium	TABLET;ORAL	020740-005	May 24, 1999
Bayer Pharms	BAYCOL	cerivastatin sodium	TABLET;ORAL	020740-001	Jun 26, 1997
Bayer Pharms	BAYCOL	cerivastatin sodium	TABLET;ORAL	020740-004	Jun 26, 1997

International Patents for BAYCOL

See the table below for patents covering BAYCOL around the world.

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1004552
Finland	101069
European Patent Office	0325130	Pyridines substituées (Substituted pyridines)
European Patent Office	0491226	Acide pyridyl dihydroxy hepténoique substitué et ses sels (Substituted pyridyl-dihydroxyheptenoic acid and its salts)
Italy	MI912125

Supplementary Protection Certificates for BAYCOL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0491226	98C0026	Belgium		PRODUCT NAME: CERIVASTATINE NATRIUM; NAT. REGISTRATION NO/DATE: 187 IS 304 F 3 19980302; FIRST REGISTRATION: GB PL 00010/0226 19970213

Market Dynamics and Financial Trajectory for BAYCOL (Cerivastatin)

Last updated: July 31, 2025

Introduction

BAYCOL (cerivastatin) is a statin-class pharmaceutical initially developed by Bayer AG to lower cholesterol levels and manage hyperlipidemia. Launched in the late 1990s, BAYCOL quickly gained attention due to its potent lipid-lowering effects. However, its market presence was abruptly curtailed following severe adverse events associated with its use. This article analyzes the complex market dynamics that influenced BAYCOL’s trajectory and examines the financial implications for Bayer and the broader pharmaceutical industry.

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Market Introduction and Initial Growth

When BAYCOL received FDA approval in 1997, it entered a burgeoning market for cholesterol-lowering therapies, driven by increasing awareness of cardiovascular disease (CVD) risk factors. The statin class was rapidly expanding, with drugs like pravastatin and simvastatin dominating the market. BAYCOL distinguished itself as one of the most potent statins, capable of significantly reducing LDL cholesterol levels with once-daily dosing.

Bayer’s aggressive marketing campaigns targeted cardiologists and primary care physicians, emphasizing BAYCOL's efficacy and convenience. Early sales figures reflected strong market demand; within the first few years, it secured a notable portion of the hyperlipidemia treatment market and became a key revenue driver for Bayer’s pharmaceutical division.

Market Dynamics Influencing Growth

1. Competitive Landscape
   BAYCOL entered a competitive environment populated by established statins with proven safety profiles. Despite its potency, BAYCOL’s market penetration was initially limited by prescribers' cautious approach and existing therapeutic preferences. Later, it gained acceptability due to its favorable lipid-lowering effects.

2. Regulatory Environment and Post-Marketing Surveillance
   Rigorous post-marketing studies were conducted to evaluate safety, especially concerning rare adverse effects. Bayer collaborated with health agencies, but the full risk profile of BAYCOL remained under scrutiny, especially after reports of muscle-related side effects surfaced.

3. Efficacy and Safety Concerns
   The key market dynamic shifted dramatically when reports of rhabdomyolysis, a severe muscle breakdown leading to renal failure and death, emerged in patients taking BAYCOL [1]. These adverse events were more frequent compared to other statins, raising alarms among clinicians.

Crisis and Market Contraction

In August 2001, Bayer voluntarily withdrew BAYCOL from the U.S. market after an increased incidence of rhabdomyolysis was linked to its use, especially in higher doses and in combination with fibrates. The withdrawal was a pivotal event, reflecting the profound impact of safety concerns on market confidence and sales.

The crisis resulted in immediate revenue losses for Bayer, and its reputation suffered. The incidence of adverse effects, particularly among vulnerable patient groups, caused prescribers to shift towards alternative treatments with better safety profiles. Bayer’s stock price reacted negatively, and significant legal liabilities emerged from lawsuits filed by affected patients and families.

Financial Trajectory Post-Withdrawal

The financial fallout from BAYCOL’s withdrawal was substantial. Bayer reported a one-time expense of approximately €3 billion in 2001 related to the recall, including legal liabilities and loss of future revenue stream [2]. The impact extended beyond direct costs, as Bayer faced damage to its corporate reputation and a decline in overall R&D confidence.

Strategically, Bayer shifted focus toward newer, safer lipid-lowering agents, including other statins and PCSK9 inhibitors. The BAYCOL crisis prompted stricter regulatory scrutiny of new drug applications and reinforced the importance of comprehensive post-marketing surveillance.

Legacy and Industry Impact

The BAYCOL episode serves as a cautionary tale within the pharmaceutical industry. It underscored the critical importance of pharmacovigilance and risk management, especially for drugs targeting large populations. For Bayer, the financial loss prompted a reevaluation of pipeline diligence, leading to more rigorous safety assessments in subsequent product development.

The episode also influenced regulatory policies globally, fostering more stringent requirements for post-marketing safety data collection. It contributed to the evolving landscape of pharmaceutical risk management, emphasizing patient safety alongside market profitability.

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Market Evolution and Current Landscape

Today, the market for lipid-lowering therapies is characterized by a broad array of treatments, from statins to injectable biologics targeting PCSK9 pathways. The failure of BAYCOL illustrates how safety issues can rapidly reshape market dynamics, leading to shifts in prescriber preferences and regulatory oversight.

Bayer has since diversified its portfolio, focusing on other therapeutic areas such as oncology and radiology, with less exposure to high-risk cardiovascular drugs. The case of BAYCOL remains a key study in drug safety, regulation, and market resilience.

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Key Market Drivers Post-2001

• Innovation in Lipid Management
  The development of PCSK9 inhibitors (e.g., evolocumab, alirocumab) has redefined the market, emphasizing safety and efficacy, partly driven by lessons from BAYCOL.

• Regulatory Stringency
  Post-BAYCOL, agencies mandated more comprehensive safety profiling, influencing pharmaceutical R&D strategies.

• Patient Safety Prioritization
  Increasing awareness and patient advocacy groups champion safety, affecting prescriber decisions and market offerings.

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Key Takeaways

• Safety First: The BAYCOL case underscores that drug safety can abruptly derail even promising products, emphasizing the importance of rigorous post-market surveillance and risk management.

• Market Volatility: The late-1990s to early-2000s statin market experienced rapid shifts fueled by emerging safety data, affecting sales, reputation, and strategic direction for pharmaceutical firms.

• Regulatory Impact: Increased regulatory demands post-BAYCOL led to more transparent safety data requirements, influencing drug development pipelines.

• Financial Implications: The immediate financial impact of drug withdrawals can reach billions, affecting corporate valuation and investor confidence.

• Innovation Driven by Lessons Learned: Future therapies, especially in high-stakes markets like cardiovascular disease, prioritize a thorough safety profile, leveraging advances to mitigate similar risks.

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FAQs

1. What caused the withdrawal of BAYCOL from the market?
   BAYCOL was withdrawn in 2001 after reports of rhabdomyolysis, a severe muscle condition linked to its use, especially at higher doses and in combination with other drugs [1].

2. How did BAYCOL's failure impact Bayer’s financial standing?
   The withdrawal led to approximately €3 billion in expenses in 2001, including legal liabilities and loss of revenue, significantly impacting Bayer’s financial health and strategic focus [2].

3. What lessons did the pharmaceutical industry learn from the BAYCOL incident?
   The incident highlighted the necessity of comprehensive pharmacovigilance, rigorous safety assessments, and transparent reporting to prevent similar tragedies and safeguard public health.

4. How did regulatory agencies respond post-BAYCOL?
   Agencies imposed stricter safety requirements for post-marketing monitoring, influencing drug approval and surveillance processes worldwide.

5. What alternative treatments emerged after BAYCOL’s market exit?
   Following BAYCOL’s withdrawal, other statins like atorvastatin and rosuvastatin gained prominence, alongside newer biologic options like PCSK9 inhibitors, which offer improved safety profiles.

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References

[1] Food and Drug Administration. "Update on Cerivastatin (BAYCOL) and the Risk of Rhabdomyolysis." 2001.
[2] Bayer Annual Report 2001. "Financial Impact of BAYCOL Recall."