REZULIN Drug Patent Profile

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

Rezulin is a drug marketed by Pfizer Pharms and is included in one NDA.

The generic ingredient in REZULIN is troglitazone. Additional details are available on the troglitazone profile page.

Summary for REZULIN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	91
Clinical Trials:	2
Patent Applications:	3,978
DailyMed Link:	REZULIN at DailyMed

Recent Clinical Trials for REZULIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Novartis	Phase 2
National Cancer Institute (NCI)	Phase 2
Dana-Farber Cancer Institute	Phase 2

See all REZULIN clinical trials

US Patents and Regulatory Information for REZULIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer Pharms	REZULIN	troglitazone	TABLET;ORAL	020720-001	Jan 29, 1997		DISCN	No	No
Pfizer Pharms	REZULIN	troglitazone	TABLET;ORAL	020720-003	Aug 4, 1997		DISCN	No	No
Pfizer Pharms	REZULIN	troglitazone	TABLET;ORAL	020720-002	Jan 29, 1997		DISCN	No	No

Expired US Patents for REZULIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer Pharms	REZULIN	troglitazone	TABLET;ORAL	020720-002	Jan 29, 1997
Pfizer Pharms	REZULIN	troglitazone	TABLET;ORAL	020720-003	Aug 4, 1997
Pfizer Pharms	REZULIN	troglitazone	TABLET;ORAL	020720-002	Jan 29, 1997
Pfizer Pharms	REZULIN	troglitazone	TABLET;ORAL	020720-002	Jan 29, 1997
Pfizer Pharms	REZULIN	troglitazone	TABLET;ORAL	020720-003	Aug 4, 1997
Pfizer Pharms	REZULIN	troglitazone	TABLET;ORAL	020720-001	Jan 29, 1997

International Patents for REZULIN

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

Country	Patent Number	Title	Estimated Expiration
Turkey	9902033
Iceland	5194
Norway	314747
Eurasian Patent Organization	199900725
Denmark	0719143
China	1131391

Supplementary Protection Certificates for REZULIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0139421	SPC/GB97/084	United Kingdom		PRODUCT NAME: TROGLITAZONE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK 10949/0277 19970729; UK 10949/0278 19970729; UK 10949/0279 19970729; UK 06384/0005 19970729; UK 06384/0006 19970729; UK 06384/0007 19970729

REZULIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Rezulin

Introduction

Rezulin, known by its generic name troglitazone, was an oral antihyperglycemic agent used to treat type 2 diabetes. It was introduced to the market with high hopes but ultimately faced a tumultuous and short-lived career due to severe safety concerns.

Approval and Initial Market Reception

Rezulin was approved by the FDA in January 1997 and was marketed by Warner-Lambert Parke-Davis. Initially, it was seen as a promising treatment for type 2 diabetes, helping patients respond better to insulin and reduce blood sugar levels[4].

Safety Concerns and Liver Toxicity

However, the drug's market life was marred by reports of liver toxicity. By December 1998, medical authorities in the UK had pulled Rezulin from the market due to 130 cases of liver damage worldwide, including six deaths. In the U.S., the FDA received 88 reports of liver failure "possibly or probably related to use of the drug," resulting in 61 deaths and 10 liver transplants, with three of those patients dying[1].

FDA Action and Market Withdrawal

The FDA, after reviewing safety data, concluded that Rezulin posed an unacceptable risk to patients compared to other drugs in the same class, such as Avandia (rosiglitazone) and Actos (pioglitazone). On March 21, 2000, Warner-Lambert voluntarily withdrew Rezulin from the U.S. market at the FDA's recommendation[1].

Financial Impact

Rezulin had significant sales before its withdrawal. In 1999, the drug generated $625 million in sales, and over 1.9 million prescriptions had been written for it. However, the withdrawal led to a substantial financial hit for Warner-Lambert. The company had to make arrangements for the return of existing stock and reimburse patients for unused supplies[1].

Market Alternatives

The FDA suggested that patients switch to Avandia or Actos, which offered the same benefits without the liver toxicity associated with Rezulin. This transition was facilitated by the fact that these alternative drugs had recently been approved and were already on the market[1].

Consumer and Physician Response

The withdrawal of Rezulin led to a mixed response from consumers and physicians. While some managed care organizations had already removed Rezulin from their formularies due to safety concerns, others were left to navigate the transition to alternative treatments. Endocrinologists at the Mayo Clinic, for example, had stopped prescribing Rezulin in October 1999 due to the rising concerns about its safety[1].

Competitive Effects

The withdrawal of Rezulin had both positive and negative competitive effects on the market. On one hand, it increased the residual demand for other drugs in the same therapeutic class, potentially benefiting competitors like Avandia and Actos. However, it also led to negative spillovers, as consumers became concerned about the safety of the entire class of thiazolidinediones, potentially reducing overall utilization of these drugs[3].

Public and Regulatory Scrutiny

The controversy surrounding Rezulin was highly publicized, with groups like Public Citizen calling for its withdrawal from the market as early as 1998. The FDA's decision to withdraw Rezulin was seen as a response to mounting evidence of its safety risks, and it highlighted the regulatory body's role in ensuring drug safety[1].

Global Impact

Rezulin was not only withdrawn from the U.S. market but also from Japan, where it was sold under the brand name Noscal. This global action underscored the severity of the safety concerns associated with the drug[1].

Financial Trajectory Post-Withdrawal

The financial trajectory of Warner-Lambert post-withdrawal was marked by the loss of a significant revenue stream. The company had to absorb the costs of recalling the drug, reimbursing patients, and managing the public relations fallout. This event likely contributed to a reevaluation of their product portfolio and risk management strategies.

Key Takeaways

• Safety Concerns: Rezulin was withdrawn due to severe liver toxicity, resulting in numerous deaths and liver transplants.
• Market Alternatives: Patients were advised to switch to safer alternatives like Avandia and Actos.
• Financial Impact: The withdrawal led to significant financial losses for Warner-Lambert.
• Competitive Effects: The withdrawal had both positive and negative effects on the market, with potential benefits to competitors but also reduced overall utilization of similar drugs.
• Regulatory Scrutiny: The FDA's action highlighted the importance of drug safety and regulatory oversight.

FAQs

What was the primary reason for Rezulin's withdrawal from the market?

Rezulin was withdrawn from the market due to reports of severe liver toxicity, including cases of liver failure and deaths.

How many patients were affected by Rezulin's liver toxicity?

The FDA received reports of 88 cases of liver failure "possibly or probably related to use of the drug," resulting in 61 deaths and 10 liver transplants.

What alternative drugs were recommended by the FDA after Rezulin's withdrawal?

The FDA recommended switching to Avandia (rosiglitazone) and Actos (pioglitazone), which offered the same benefits without the liver toxicity associated with Rezulin.

What was the financial impact of Rezulin's withdrawal on Warner-Lambert?

Rezulin generated $625 million in sales in 1999, but its withdrawal led to significant financial losses, including the costs of recalling the drug and reimbursing patients.

How did the withdrawal of Rezulin affect the market for other thiazolidinediones?

The withdrawal led to both positive and negative effects, with potential benefits to competitors like Avandia and Actos but also reduced overall utilization of similar drugs due to consumer safety concerns.

Sources

1. Relias Media: "With demise of Rezulin, FDA suggests alternatives"
2. UCB: "UCB on Growth Path for a Decade Plus"
3. NBER: "The Competitive Effects of Drug Withdrawals"
4. RxList: "Rezulin (Troglitazone (removed from the US market 3/21/00))"