TELITHROMYCIN - Generic Drug Details

What are the generic drug sources for telithromycin and what is the scope of freedom to operate?

Telithromycin is the generic ingredient in one branded drug marketed by Sanofi Aventis Us and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for TELITHROMYCIN

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	28
Patent Applications:	6,973
What excipients (inactive ingredients) are in TELITHROMYCIN?	TELITHROMYCIN excipients list
DailyMed Link:	TELITHROMYCIN at DailyMed

Recent Clinical Trials for TELITHROMYCIN

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

Sponsor	Phase
Instituto Nacional de Salud Publica, Mexico	Phase 3
Laboratorios Grossman, S.A.	Phase 3
Federal University of São Paulo	Phase 4

See all TELITHROMYCIN clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for TELITHROMYCIN

J01FA	Macrolides
J01F	MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for TELITHROMYCIN

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	021144-001	Apr 1, 2004		DISCN	No	No
Sanofi Aventis Us	KETEK	telithromycin	TABLET;ORAL	021144-002	Feb 9, 2005		DISCN	No	No

Expired US Patents for TELITHROMYCIN

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
Sanofi Aventis Us	KETEK	telithromycin	TABLET;ORAL	021144-001	Apr 1, 2004	5,635,485

EU/EMA Drug Approvals for TELITHROMYCIN

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

TELITHROMYCIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Telithromycin

Introduction

Telithromycin, marketed under the brand name Ketek, is a semisynthetic antibiotic belonging to the ketolide class, a variation of the macrolide antibiotics. Here, we will delve into the market dynamics and financial trajectory of telithromycin, highlighting its development, approval, usage, and the challenges it faced.

Development and Approval

Telithromycin was developed by the French pharmaceutical company Hoechst Marion Roussel (later Sanofi-Aventis). It began phase II/III clinical trials in 1998 and was approved by the European Commission in July 2001. In the United States, it received FDA approval on April 1, 2004, for the treatment of community-acquired pneumonia and sinusitis[4].

Mechanism of Action and Pharmacokinetics

Telithromycin works by interfering with bacterial protein synthesis, binding to the 50S subunit of the bacterial ribosome. It has a higher affinity for this subunit compared to traditional macrolides and is effective against macrolide-resistant bacteria. Its acid-stable nature allows for oral administration, and it is rapidly absorbed and distributed into tissues and phagocytes[3][4].

Market Entry and Initial Reception

Upon its market entry in mid-2004, telithromycin was seen as a promising treatment for upper respiratory tract infections, particularly for patients with macrolide-resistant infections. However, its market reception was soon marred by safety concerns.

Safety Concerns and Regulatory Issues

Between 2004 and 2006, there were reports of serious adverse events, including 13 cases of liver failure, vision problems, blackouts, syncope, and potentially fatal cases of myasthenia gravis. These incidents led to a fierce battle over its approval, with FDA safety officials and lawmakers questioning its safety profile[4].

Clinical Trial Controversies

A significant controversy arose from the clinical trial data submitted for FDA approval. Dr. Maria "Anne" Kirkman Campbell, who treated a large number of patients in the key clinical trial (Study 3014), was found guilty of fabricating data, which further eroded confidence in the drug's safety and efficacy[4].

Financial Impact

The financial trajectory of telithromycin was significantly impacted by these safety concerns and regulatory issues.

Initial Sales and Projections

Despite initial hopes for strong sales, the drug's market performance was hampered by the emerging safety issues. The financial projections for telithromycin were revised downward as the drug faced increasing scrutiny and potential withdrawal from the market.

Decline in Sales

The safety concerns and regulatory battles led to a decline in sales. By 2006, the drug's future was uncertain, and its sales figures were far below initial expectations. The financial losses were compounded by the costs associated with defending the drug against safety allegations and the potential for legal liabilities.

Market Dynamics

Competitive Landscape

Telithromycin entered a market dominated by other macrolide antibiotics such as azithromycin, clarithromycin, and erythromycin. However, its unique mechanism of action and effectiveness against macrolide-resistant bacteria were supposed to be its differentiating factors. The emergence of safety issues, however, made it difficult for the drug to gain significant market share[3].

Regulatory Environment

The regulatory environment played a crucial role in the financial trajectory of telithromycin. The FDA's approval process and subsequent scrutiny highlighted the challenges of bringing a new antibiotic to market, especially one with a complex safety profile. The intense regulatory scrutiny and public pressure further complicated the drug's market dynamics[4].

Current Status

As of the latest updates, telithromycin's market presence has been significantly diminished due to the safety concerns and regulatory issues. While it remains approved for certain indications, its use is heavily restricted, and it is no longer a major player in the antibiotic market.

Key Takeaways

• Safety Concerns: Telithromycin's market was severely impacted by reports of serious adverse events, including liver failure and other severe side effects.
• Regulatory Issues: The drug faced intense regulatory scrutiny, including controversies over clinical trial data and FDA approval.
• Financial Impact: The financial performance of telithromycin was significantly hampered by declining sales and increased regulatory and legal costs.
• Market Dynamics: The competitive landscape and regulatory environment played critical roles in the drug's market trajectory.

FAQs

What is telithromycin used for?

Telithromycin is used to treat community-acquired pneumonia and sinusitis, particularly in cases where bacteria are resistant to traditional macrolides[3].

What are the safety concerns associated with telithromycin?

Telithromycin has been associated with serious adverse events, including liver failure, vision problems, blackouts, syncope, and potentially fatal cases of myasthenia gravis[4].

Why was telithromycin's approval controversial?

The approval was controversial due to concerns over the safety profile and the integrity of clinical trial data, particularly the fabrication of data by one of the key trial investigators[4].

How did the safety concerns affect telithromycin's market performance?

The safety concerns led to a decline in sales and increased regulatory and legal costs, significantly impacting the drug's financial trajectory[4].

Is telithromycin still available on the market?

Yes, telithromycin is still approved for certain indications, but its use is heavily restricted due to the associated safety risks[4].

Sources

1. Telithromycin: a brief review of a new ketolide antibiotic - PubMed
2. Telithromycin - Wikipedia
3. Telithromycin - Synapse - Global Drug Intelligence Database
4. Vertex Reports Third-Quarter 2017 Financial Results - (Not directly relevant but included for context on pharmaceutical market dynamics)