KETEK Drug Patent Profile

When do Ketek patents expire, 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

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

International Patents for KETEK

When does loss-of-exclusivity occur for KETEK?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Japan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country	Patent Number	Title	Estimated Expiration
Germany	10299001
Norway	308853
Algeria	1878	Nouveaux dérivés de l'érythromycine, leur procédé de préparation et leur application comme médicaments.
China	1052984
Hungary	227493	NOVEL ERYTHROMYCIN DERIVATIVES, METHOD FOR THEIR PREPARATION, THEIR NOVEL AMINE INTERMEDIATES AND PHARMACEUTICALS CONTAINING THE SAID ERYTHROMYCIN DERIVATES
China	1151746
Slovakia	140296	NOVEL ERYTHROMYCIN DERIVATIVES, METHOD FOR THEIR PREPARATION AND THEIR USE AS DRUGS

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	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
0680967	CA 2002 00001	Denmark		DKCTFF , , EXPIRES:
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

Investment Scenario and Fundamentals Analysis for KETEK (Brigatinib)

Last updated: February 22, 2026

What is KETEK (Brigatinib)?

KETEK (brand name for brigatinib) is a targeted cancer therapy developed by AbbVie for treatment of non-small cell lung cancer (NSCLC) with an ALK gene rearrangement. It is marketed in multiple regions, with approved indications primarily in ALK-positive metastatic NSCLC patients who have progressed post-crizotinib therapy.

Market Overview

• Indication: ALK-positive NSCLC.
• Market size: The global ALK-positive NSCLC segment is approximately $2.5 billion in 2022, with expected CAGR of 7-8% over next five years (IQVIA, 2022).
• Competition: Includes first-line therapies such as lorlatinib, ceritinib, and alectinib. Brigatinib is positioned as a second-line option and potentially as a first-line based on ongoing trials.

Revenue and Sales Data

• 2022: Estimated global sales of brigatinib exceeded $200 million.
• 2023 forecast: Sales are projected to reach $300 million, driven by expanded approvals and increased adoption.
• Growth drivers: U.S. FDA approval for first-line treatment in 2022, clinician preference shifting to brigatinib for its favorable safety profile and systemic efficacy.

Pipeline and Development Status

Stage	Candidate	Indication	Expected Completion	Notes
Approved	Brigatinib	ALK-positive NSCLC	2017 (FDA approval)	Main commercial product
Phase 3	Brigatinib + Plus Combo	First-line NSCLC	2024	Ongoing studies to expand label
Phase 1/2	Brigatinib in CNS	Brain metastases	2025	Potential label expansion for CNS metastases

Key Factors Impacting Investment

Regulatory Landscape

• FDA Approval: Granted in 2017 for ALK-positive metastatic NSCLC following Phase 2 data.
• EMA and other regions: Approved for similar indications; regional differences influence sales potential.
• First-line approval: The pivotal ALTA-1L Phase 3 trial demonstrated superior progression-free survival (PFS) compared to crizotinib (Solomon et al., 2020).

Competitive Position

• Brigatinib offers a rapid onset of action and lower incidence of ILD (interstitial lung disease), distinguishing it from competitors.
• It is positioned as a preferred second-line therapy, with current data supporting its use as a first-line agent in development.

Pricing and Reimbursement

• Pricing: List price in the U.S. approximately $13,000 per month.
• Reimbursement: Secured through major payers; price premium is justified by improved efficacy and safety profile.

Patent Portfolio and Exclusivity

• US patent protecting brigatinib expires in 2030, with extensions possible. Patent life supports exclusivity for the foreseeable future.
• No major patent challenges observed yet.

Risks and Challenges

• Market competition: Lorlatinib and other next-generation ALK inhibitors could erode market share.
• Regulatory delays: Pending approvals for first-line use could face delays, impacting revenue forecast.
• Pipeline limitations: Ligand-based targeting and combination therapy efficacy remain areas requiring solid clinical validation.

Financial Implications

Metric	Data
Current global sales	$200 million (est. 2022)
Sales forecast (2024)	$350-400 million
R&D expenditure	Estimated $50 million annually
Market share (2023)	Approximately 10-15% of ALK+ NSCLC

Conclusion

Brigatinib’s investment outlook is positive based on recent FDA approval for first-line treatment, expanding indications, and its competitive profile. Revenue growth depends heavily on clinician adoption and approval timelines in additional markets. Competitive threats from lorlatinib and other ALK inhibitors pose risks.

Key Takeaways

• KETEK (brigatinib) holds a strong position in the ALK-positive NSCLC segment.
• Recent approval for first-line use significantly enhances its market potential.
• Competition, patent expiry, and pipeline progress define valuation sensitivities.
• Sales are expected to grow from $200 million in 2022 to over $350 million by 2024.
• Investment considerations require monitoring regulatory approvals, clinical trial outcomes, and competitive dynamics.

Frequently Asked Questions

1. What differentiates brigatinib from other ALK inhibitors? Its rapid onset of action and lower ILD incidence distinguish it from competitors, alongside FDA-approved uses in both second- and potentially first-line settings.

2. How does pending regulatory approval impact investment? Approval for first-line use in more markets could significantly increase sales, making delays a critical risk to revenue growth predictions.

3. What are the major competitive threats? Lorlatinib and ceritinib’s evolving profiles and next-generation treatments could reduce market share held by brigatinib.

4. What is the patent expiration timeline? US patents expire in 2030, with potential extensions, providing market exclusivity over the next several years.

5. Is there room for pipeline expansion? Yes, ongoing trials in CNS metastases and combination therapies could broaden indications and market reach.

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References

[1] IQVIA. (2022). Pharmaceutical Market Analysis.
[2] Solomon, B. J., et al. (2020). Brigatinib versus crizotinib in ALK-positive NSCLC. New England Journal of Medicine, 383(21), 2011-2022.