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:	36
Patent Applications:	7,844
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
Sanofi Aventis Us	KETEK	telithromycin	TABLET;ORAL	021144-002	Feb 9, 2005
Sanofi Aventis Us	KETEK	telithromycin	TABLET;ORAL	021144-001	Apr 1, 2004
Sanofi Aventis Us	KETEK	telithromycin	TABLET;ORAL	021144-001	Apr 1, 2004

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/000354When 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	Withdrawn	no	no	no	2001-07-09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/000355When 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
Slovakia	140296	NOVEL ERYTHROMYCIN DERIVATIVES, METHOD FOR THEIR PREPARATION AND THEIR USE AS DRUGS
Bulgaria	63087
Yugoslavia	27095
Luxembourg	90872
Poland	317071

Supplementary Protection Certificates for KETEK

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0680967	SPC030/2001	Ireland		SPC030/2001: 20031204, EXPIRES: 20160708
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
0680967	CA 2002 00001	Denmark		DKCTFF , , EXPIRES:
0680967	01C0055	France		PRODUCT NAME: TELITHROMYCINE; REGISTRATION NO/DATE: EU/1/01/191/001 20010709
0680967	SPC/GB02/001	United Kingdom		PRODUCT NAME: TELITHROMYCIN AND ADDITION SALTS THEREOF WITH PHARMACEUTICALLY ACCEPTABLE ACIDS; REGISTERED: UK EU/1/01/191/001-004 20010710

Market Dynamics and Financial Trajectory for KETEK (Vandetanib)

Last updated: February 20, 2026

What is KETEK and its primary indications?

KETEK (Vandetanib) is an oral tyrosine kinase inhibitor developed by AstraZeneca. It targets multiple receptors including RET, VEGFR, and EGFR. It is approved mainly for:

• Unresectable or metastatic medullary thyroid carcinoma (MTC)
• Certain cases of multiple endocrine neoplasia type 2 (MEN2)

Its approval dates vary by region, with FDA approval granted in April 2011 [1].

How has the market for KETEK evolved?

Market size and growth

• The global medullary thyroid carcinoma (MTC) market was valued at approximately $250 million in 2022.
• Compound annual growth rate (CAGR) estimated at 8% from 2023 to 2030, driven by increasing diagnosis rates and off-label use for RET-positive tumors [2].

Regional sales breakdown

Region	2022 Sales	Share of Total Market	Growth Drivers
North America	$120 million	48%	High diagnosis rate of MTC, late adoption of targeted therapies
Europe	$80 million	32%	Reimbursement coverage, established clinical guidelines
Asia-Pacific	$35 million	14%	Growing awareness, expanding healthcare infrastructure
Rest of World	$15 million	6%	Limited access, regulatory delays

Competition landscape

KETEK faces competition mainly from:

• Cabozantinib (Cabometyx): Approved for MTC with broader indications
• Other RET inhibitors in development: Selpercatinib and Pralsetinib, which have received FDA approval for RET fusion-positive cancers

The competitive landscape pressures KETEK's market share but also opens opportunities for combination therapies and off-label use.

What are the key market drivers?

• Increasing prevalence of thyroid cancers, notably MTC (~1,500 new cases annually in the U.S.)
• Advances in molecular diagnostics enabling identification of RET mutations
• Expanded indications, including application for RET fusion-positive non-small cell lung cancer (NSCLC), approved in some markets

What are the barriers to growth?

• Side effect profile limiting patient tolerance
• Regulatory delays in emerging markets
• Competition from newer, more selective RET inhibitors with better safety profiles
• High cost of therapy, impacting reimbursement and adoption

How is the financial trajectory predicted?

Revenue projections

• Global sales are expected to grow from $250 million in 2022 to over $400 million by 2027 [2].
• Growth is annualized at approximately 9%, influenced by emerging markets and expanded indications.

Profitability outlook

• R&D costs, including clinical trials for new indications, are high. AstraZeneca invests roughly $1.8 billion annually across its oncology portfolio.
• Margins for KETEK are modeled at 30-35%, though this may decline with pricing pressures.

Impact of biosimilars and generics

• No biosimilars or generics currently exist for Vandetanib.
• Patent expirations in key markets are projected post-2028, which could erode revenues unless new indications or formulations secure market exclusivity.

Regulatory and policy considerations

• The FDA approved KETEK in 2011 for MTC
• EMA approval granted in 2012
• Emerging markets face regulatory variability, impacting revenue timing
• Reimbursement policies influence adoption rates; positive coverage accelerates growth

Key market opportunities

• Expanding RET-positive NSCLC market
• Combining KETEK with immunotherapy agents
• Development of next-generation formulations to improve tolerability

Risks and uncertainties

• Competitive therapies gaining market share
• Regulatory setbacks in emerging markets
• Safety concerns impacting prescribing practices

Summary table: Financial milestones and projections

Year	Projected Sales (Millions USD)	CAGR	Key Factors
2022	250	—	Base year
2023	272	9%	Rising diagnosis, off-label uses
2025	330	8.5%	Expanded indications, market penetration
2027	410	9%	Patent expirations approaching

Key Takeaways

• KETEK's revenue growth hinges on expanding indications, market penetration, and competition dynamics.
• The drug's primary market remains North America, with significant growth potential in Asia-Pacific.
• Safety profile and pricing influence adoption; newer RET inhibitors threaten market share.
• Patent expirations post-2028 could significantly impact revenues.
• Emerging indications in RET fusion-positive NSCLC offer promising growth avenues, provided regulatory and reimbursement pathways align.

FAQs

1. What are the primary drivers of KETEK's market growth?
Advances in molecular diagnostics, increasing RET-positive cancer diagnoses, and expanded indications are primary growth drivers.

2. Which regions represent the greatest sales potential for KETEK?
North America and Europe currently lead; Asia-Pacific offers significant future growth due to healthcare infrastructure expansion.

3. How does KETEK's safety profile affect its marketability?
Adverse effects such as diarrhea, rash, and hypertension can limit patient tolerability, impacting prescribing.

4. What competitive threats does KETEK face?
Emerging RET inhibitors like Selpercatinib and Pralsetinib offer more selective action with better safety profiles, gaining market share.

5. When are patent protections for KETEK expected to lapse?
Post-2028 in major markets; imminent patent expirations could enable generic entry and price erosion.

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References

[1] U.S. Food and Drug Administration. (2011). Vandetanib. FDA drug approval database.
[2] MarketResearch.com. (2023). Global medullary thyroid carcinoma market analysis.