KETEK Drug Patent Profile

Which patents cover Ketek, and when can generic versions of Ketek launch?

Ketek is a drug marketed by Sanofi Aventis Us and is included in one NDA.

The generic ingredient in KETEK is telithromycin. Additional details are available on the telithromycin profile page.

Summary for KETEK

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	31
Patent Applications:	6,385
What excipients (inactive ingredients) are in KETEK?	KETEK excipients list
DailyMed Link:	KETEK at DailyMed

US Patents and Regulatory Information for KETEK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanofi Aventis Us	KETEK	telithromycin	TABLET;ORAL	021144-002	Feb 9, 2005		DISCN	No	No
Sanofi Aventis Us	KETEK	telithromycin	TABLET;ORAL	021144-001	Apr 1, 2004		DISCN	No	No

Expired US Patents for KETEK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	KETEK	telithromycin	TABLET;ORAL	021144-002	Feb 9, 2005	5,635,485
Sanofi Aventis Us	KETEK	telithromycin	TABLET;ORAL	021144-001	Apr 1, 2004	D459798
Sanofi Aventis Us	KETEK	telithromycin	TABLET;ORAL	021144-002	Feb 9, 2005	D459798

EU/EMA Drug Approvals for KETEK

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Aventis Pharma S.A.	Ketek	telithromycin	EMEA/H/C/000354 When prescribing Ketek, consideration should be given to official guidance on the appropriate use ofantibacterial agents and the local prevalence of resistance.Ketek is indicated for the treatment of the following infections:In patients of 18 years and oldercommunity-acquired pneumonia, mild or moderate.when treating infections caused by known or suspected beta-lactam- and / or macrolide-resistant strains (according to history of patients or national and / or regional resistance data) covered by the antibacterial spectrum of telithromycin:acute exacerbation of chronic bronchitis;acute sinusitis;In patients of 12 years and oldertonsillitis / pharyngitis caused by Streptococcus pyogenes, as an alternative when beta-lactam antibiotics are not appropriate in countries / regions with a significant prevalence of macrolide-resistant S. pyogenes, when mediated by ermTR or mefA.	Withdrawn	no	no	no	2001-07-09
Aventis Pharma S.A.	Levviax	telithromycin	EMEA/H/C/000355 When prescribing Levviax consideration should be given to official guidance on the appropriate use of antibacterial agents and the local prevalence of resistance (see also sections 4.4 and 5.1).Levviax is indicated for the treatment of the following infections:In patients of 18 years and older:-Community-acquired pneumonia, mild or moderate (see section 4.4).- When treating infections caused by known or suspected beta-lactam and/or macrolide resistant strains (according to history of patients or national and/or regional resistance data) covered by the antibacterial spectrum of telithromycin (see sections 4.4 and 5.1):- Acute exacerbation of chronic bronchitis,- Acute sinusitisIn patients of 12 years and older:- Tonsillitis/pharyngitis caused by Streptococcus pyogenes, as an alternative when beta lactam antibiotics are not appropriate in countries/regions with a significant prevalence of macrolide resistant S. pyogenes, when mediated by ermTR or mefA (see sections 4.4 and 5.1).	Withdrawn	no	no	no	2001-07-09

International Patents for KETEK

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

Country	Patent Number	Title	Estimated Expiration
Bulgaria	100951
Hungary	9603038
Japan	4658902

Supplementary Protection Certificates for KETEK

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0680967	01C0055	France		PRODUCT NAME: TELITHROMYCINE; REGISTRATION NO/DATE: EU/1/01/191/001 20010709
0680967	PA2002001	Lithuania		PRODUCT NAME: TELITHROMYCINUM (11,12-DIDEOKSI 3-DE((2,6-DIDEOKSI-3-C-METIL-3-O-METIL-ALFA-L-RIBOHEKSOPIRANOZIL)OKSI) 6-O-METIL 3-OKSO 12,11-(OKSIKARBONIL ((4-(4-(3-PIRIDINIL) 1H-IMIDAZOL-1-IL)BUTIL)IMINO))ERITROMICINAS); REGISTRATION NO/DATE: 01/7551/9 20011107
0680967	PA2002001,C0680967	Lithuania		PRODUCT NAME: TELITHROMYCINUM (11,12-DIDEOKSI 3-DE((2,6-DIDEOKSI-3-C-METIL-3-O-METIL-ALFA-L-RIBOHEKSOPIRANOZIL)OKSI) 6-O-METIL 3-OKSO 12,11-(OKSIKARBONIL ((4-(4-(3-PIRIDINIL) 1H-IMIDAZOL-1-IL)BUTIL)IMINO))ERITROMICINAS); REGISTRATION NO/DATE: 01/7551/9 20011107

KETEK Market Analysis and Financial Projection Experimental

The Market Dynamics and Financial Trajectory of Ketek: A Case of Regulatory Missteps and Consequences

Introduction

Ketek, also known as telithromycin, was a highly anticipated antibiotic developed by Sanofi-Aventis, aimed at treating community-acquired respiratory tract infections. However, its journey from approval to market was marred by significant regulatory missteps, fraud, and severe adverse reactions, which drastically impacted its market dynamics and financial trajectory.

Approval and Initial Market Reception

FDA Approval

Ketek was approved by the FDA on April 1, 2004, for the treatment of community-acquired pneumonia, sinusitis, and acute exacerbation of chronic bronchitis. This approval came despite serious concerns raised by FDA reviewers about the drug's safety, particularly regarding liver damage and blurred vision[1][2][3].

Early Market Performance

Initially, Ketek was seen as a promising addition to the antibiotic market, given its potential to slow the development of antibiotic-resistant bacteria. However, the drug's market performance was short-lived due to the emergence of serious safety issues.

Safety Concerns and Fraud

Clinical Trial Irregularities

The approval of Ketek was heavily influenced by Study 3014, a large-scale clinical trial conducted by Sanofi-Aventis. However, this study was later found to be fraught with data integrity problems, including fabricated patient data and fraudulent submissions by one of the principal investigators[1][2].

Adverse Reactions

Post-marketing surveillance revealed a high incidence of adverse events, including liver failure, blurred vision, and other serious side effects. By April 2006, the FDA had received 110 reports of adverse events associated with Ketek, including 23 cases of acute liver injury, 12 cases of liver failure, and four deaths[1].

Regulatory Backlash and Label Changes

Congressional Investigation

The severe criticism and congressional investigation into the FDA's handling of Ketek led to significant regulatory backlash. In February 2007, the FDA added a black-box warning to Ketek's label and restricted its use to only community-acquired pneumonia, withdrawing its approval for other indications[1][3].

Impact on Regulatory Environment

The Ketek debacle led to a tightening of regulatory parameters for new drug approvals. The FDA became more cautious, and this shift was felt across the pharmaceutical industry, with delays and increased scrutiny of clinical trials becoming more common[4].

Financial Trajectory

Initial Expectations

Before its approval, Ketek was predicted to be a lucrative addition to Sanofi-Aventis's portfolio, with financial analysts forecasting significant revenue.

Decline in Sales

However, the drug's market performance plummeted following the revelation of safety concerns and the subsequent regulatory actions. The addition of a black-box warning and the restriction of its use severely limited its market potential.

Legal and Regulatory Costs

Sanofi-Aventis faced significant legal and regulatory costs, including the cost of defending against allegations of fraud and negligence. The company also had to pause and eventually halt clinical trials aimed at expanding Ketek's indications, further impacting its financial outlook[1][2].

Industry Impact

Deterrent to New Entrants

The Ketek case has been cited as an example of the challenges and risks associated with bringing new antibiotics to market. This has deterred some companies from entering the antibiotic development space, fearing the stringent regulatory environment and potential financial losses[4].

Increased Regulatory Hurdles

The incident led to new clinical trial guidelines that increased the time and resources required for regulatory approval. This has made the development of new antibiotics more challenging and costly, affecting the overall pipeline of broad-spectrum antibiotics[3][4].

Quotes from Industry Experts

• "The FDA has developed a ‘culture of approval’ and pressure on managers to quickly approve drugs gets ‘transmitted down to the reviewers’ even when there are unresolved questions about safety or efficacy," said Dr. Ross, highlighting the systemic issues within the FDA[1].
• "The bottom line is that right now FDA has not given any specific reasons for doing this," noted Robert C. Moellering Jr., professor of medical research at Harvard Medical School, commenting on the increased scrutiny and delays in drug approvals post-Ketek[4].

Key Takeaways

• The approval of Ketek was marred by significant safety concerns and fraudulent clinical trial data.
• The drug's market performance was severely impacted by adverse reactions and regulatory actions.
• The incident led to a tightening of regulatory parameters, affecting the broader pharmaceutical industry.
• Sanofi-Aventis faced substantial financial and legal consequences.
• The case has deterred new entrants in antibiotic development and increased the regulatory hurdles for future drugs.

FAQs

Q: What were the primary safety concerns associated with Ketek?

A: The primary safety concerns included liver damage, blurred vision, and other serious side effects such as liver failure and cardiac issues.

Q: Why was Study 3014 significant in the approval of Ketek?

A: Study 3014 was a large-scale clinical trial that was used to support the safety and efficacy of Ketek. However, it was later found to be fraught with data integrity problems, including fabricated patient data.

Q: What regulatory actions were taken against Ketek?

A: The FDA added a black-box warning to Ketek's label, restricted its use to community-acquired pneumonia, and withdrew its approval for other indications.

Q: How did the Ketek case impact the pharmaceutical industry?

A: The case led to increased regulatory scrutiny, delays in drug approvals, and a more cautious approach by the FDA, which has made it more challenging and costly to develop new antibiotics.

Q: What were the financial implications for Sanofi-Aventis?

A: Sanofi-Aventis faced significant financial losses due to the decline in sales, legal and regulatory costs, and the halt of clinical trials aimed at expanding Ketek's indications.

Sources

1. UCSUSA - Ketek: FDA Managers Value Drug Maker Relations Over Patient Safety
2. Senate Committee on Finance - Senator Says FDA Should Stop Citing a Fraudulent Ketek Study
3. PubMed - Understanding the regulatory hurdles for antibacterial drug development: The case of telithromycin
4. American Chemical Society - Ketek-Effect
5. GovInfo - The Adequacy of FDA to Assure the Safety of the Nation's Drug Supply