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:	37
Patent Applications:	2,743
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
Bayer Pharms	BAYCOL	cerivastatin sodium	TABLET;ORAL	020740-005	May 24, 1999		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	020740-004	Jun 26, 1997	5,006,530
Bayer Pharms	BAYCOL	cerivastatin sodium	TABLET;ORAL	020740-001	Jun 26, 1997	5,006,530
Bayer Pharms	BAYCOL	cerivastatin sodium	TABLET;ORAL	020740-006	Jul 24, 2000	5,006,530
Bayer Pharms	BAYCOL	cerivastatin sodium	TABLET;ORAL	020740-005	May 24, 1999	5,177,080
Bayer Pharms	BAYCOL	cerivastatin sodium	TABLET;ORAL	020740-006	Jul 24, 2000	5,177,080
Bayer Pharms	BAYCOL	cerivastatin sodium	TABLET;ORAL	020740-003	Jun 26, 1997	5,177,080
Bayer Pharms	BAYCOL	cerivastatin sodium	TABLET;ORAL	020740-004	Jun 26, 1997	5,177,080

International Patents for BAYCOL

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

Country	Patent Number	Title	Estimated Expiration
Australia	652977
Canada	2057444	ACIDE PYRIDYLDIHYDROXYHEPTENOIQUE ET SES SELS (SUBSTITUTED PYRIDYL-DIHYDROXY-HEPTENOIC ACID AND ITS SALTS)
Japan	H01216974	SUBSTITUTED PYRIDINES
Italy	8821317
Austria	141261
Denmark	23389
Germany	3801406

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

BAYCOL Market Analysis and Financial Projection Experimental

The Rise and Fall of Baycol: Understanding Market Dynamics and Financial Trajectory

Introduction

Baycol, also known as Lipobay, was a statin medication developed by Bayer to reduce cholesterol levels. Its journey from market introduction to eventual withdrawal is a complex tale of marketing strategies, safety concerns, and significant financial impacts.

Early Development and Market Entry

Baycol was introduced to the market in the late 1990s, initially available in low doses. The drug was aggressively priced, which helped it gain traction, especially in the large US market. Bayer emphasized the safety and cost-effectiveness of Baycol in its marketing efforts, positioning it as a competitive alternative to other statins[1].

Initial Market Performance

Despite a strong launch effort, Baycol's initial market performance was disappointing. By the first quarter of 1999, Baycol had only achieved a 3% statin prescription share in the US, which was significantly lower than expected. However, the introduction of a 0.4 mg dosage in May 1999 helped Baycol compete more effectively in the US market, particularly in the segment accounting for about 50% of statin prescriptions[1].

Safety Concerns and Regulatory Actions

Post-marketing reports revealed that Baycol was associated with rhabdomyolysis, a serious side effect, especially when used in conjunction with gemfibrozil. This led to several regulatory actions, including a change in US labeling to include a contraindication for concurrent use with gemfibrozil and the restriction of the maximum dose to 0.4 mg. Despite these measures, the incidence of rhabdomyolysis with Baycol monotherapy was still higher than with other statins[1].

Impact on Market Share and Sales

By the second quarter of 2000, Baycol's US statin prescription share had doubled to 6%, allowing it to surpass other statins like Lescol and Mevacor. However, the safety concerns and regulatory actions began to erode consumer and healthcare provider confidence. The suspension of the 0.8 mg dosage in the UK further exacerbated the situation, providing competitors with an opportunity to capitalize on the negative publicity[1].

Withdrawal from the Market

In August 2001, Bayer withdrew Baycol from the worldwide market due to reports of serious side effects and deaths associated with its use. This decision was made after over 100 deaths were linked to the drug, leading to a significant backlash against Bayer and the pharmaceutical industry as a whole[2].

Financial Consequences

The withdrawal of Baycol had profound financial implications for Bayer. The company faced multiple lawsuits, including a federal multi-district litigation, which resulted in confidential settlements for affected patients and their families. The financial impact extended beyond legal costs; it also affected the sales and profitability of Bayer's pharmaceutical division. The Health Care segment, which had seen significant growth partly due to Baycol, experienced a decline following the drug's withdrawal[2][3].

Strategic Repositioning

Following the Baycol debacle, Bayer had to reposition its pharmaceutical division strategically. The company focused on other successful products like Cipro, Adalat, and Avelox to mitigate the losses. Bayer also invested in research alliances, such as the one with CuraGen, to enhance its pharmaceutical research platform[3].

Market Dynamics Post-Withdrawal

The withdrawal of Baycol significantly altered the statin market dynamics. Competitors quickly capitalized on the situation, and other statins gained market share. The incident also heightened regulatory scrutiny and public awareness of drug safety, leading to more stringent safety protocols and labeling requirements for statins[1].

Lessons Learned

The Baycol case highlights the importance of rigorous post-marketing surveillance and the need for transparent communication about drug safety. It also underscores the financial risks associated with drug development and marketing, particularly when safety concerns arise.

Key Takeaways

• Aggressive Marketing: Initial success was driven by aggressive pricing and marketing strategies.
• Safety Concerns: Post-marketing reports of rhabdomyolysis led to regulatory actions and eventual withdrawal.
• Financial Impact: Significant financial losses, legal settlements, and a decline in pharmaceutical division profitability.
• Strategic Repositioning: Focus on other successful products and research alliances to recover.
• Market Dynamics: Changed market landscape with increased regulatory scrutiny and public awareness of drug safety.

FAQs

What was Baycol, and what was its intended use?

Baycol, also known as Lipobay, was a statin medication developed by Bayer to reduce cholesterol levels.

Why was Baycol withdrawn from the market?

Baycol was withdrawn due to reports of serious side effects, including rhabdomyolysis, and deaths associated with its use.

What were the financial consequences for Bayer?

Bayer faced significant financial losses, including legal settlements, a decline in sales and profitability of its pharmaceutical division, and the need for strategic repositioning.

How did the withdrawal of Baycol affect the statin market?

The withdrawal of Baycol altered the statin market dynamics, with competitors gaining market share and increased regulatory scrutiny on drug safety.

What lessons can be learned from the Baycol case?

The case highlights the importance of rigorous post-marketing surveillance, transparent communication about drug safety, and the financial risks associated with drug development and marketing.

Sources

1. Journal of Medical Marketing: "The rise and fall of Baycol / Lipobay" - CiteSeerX.
2. Lieff Cabraser: "Baycol Injuries Class Action Lawsuit".
3. Bayer Stockholders' Newsletter: "Q1 2001" - Bayer.