Telavancin hydrochloride - Generic Drug Details

What are the generic sources for telavancin hydrochloride and what is the scope of patent protection?

Telavancin hydrochloride is the generic ingredient in one branded drug marketed by Cumberland and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Telavancin hydrochloride has thirty-three patent family members in eighteen countries.

One supplier is listed for this compound.

Summary for telavancin hydrochloride

International Patents:	33
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	15
Clinical Trials:	16
What excipients (inactive ingredients) are in telavancin hydrochloride?	telavancin hydrochloride excipients list
DailyMed Link:	telavancin hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for telavancin hydrochloride

Dosage:

POWDER;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for telavancin hydrochloride

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

Sponsor	Phase
Aaron Cook	Phase 4
Joseph L. Kuti, PharmD	Phase 4
Cumberland Pharmaceuticals, Inc.	Phase 4

See all telavancin hydrochloride clinical trials

Pharmacology for telavancin hydrochloride

Drug Class

Lipoglycopeptide Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for telavancin hydrochloride

J01XA	Glycopeptide antibacterials
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for telavancin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cumberland	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110-002	Sep 11, 2009		RX	Yes	Yes				Y
Cumberland	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110-001	Sep 11, 2009		DISCN	Yes	No				Y

Expired US Patents for telavancin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cumberland	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110-002	Sep 11, 2009
Cumberland	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110-002	Sep 11, 2009
Cumberland	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110-001	Sep 11, 2009
Cumberland	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110-001	Sep 11, 2009
Cumberland	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110-002	Sep 11, 2009

International Patents for telavancin hydrochloride

Country	Patent Number	Title	Estimated Expiration
China	100417661
Japan	4669478
Slovenia	1678201
World Intellectual Property Organization (WIPO)	2005042568
Spain	2477268

Supplementary Protection Certificates for telavancin hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1292612	36/2011	Austria		PRODUCT NAME: TELAVANCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ HIEVON, EINSCHLIESSLICH TELAVANCINHYDROCHLORID; REGISTRATION NO/DATE: EU/1/11/705/001-002 20110902
1292612	PA2012002,C1292612	Lithuania		PRODUCT NAME: TELAVANCINUM; REGISTRATION NO/DATE: EU/1/11/705/001, 2011 09 02 EU/1/11/705/002 20110902
1292612	2011/037	Ireland		PRODUCT NAME: TELAVANCIN, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING TELAVANCIN HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/11/705/001-002 20110902
1292612	11C0051	France		PRODUCT NAME: TELAVANCINE; REGISTRATION NO/DATE: EU/1/11/705/001-002 20110902
1292612	132012902025885	Italy		PRODUCT NAME: TELAVANCINA(VIBATIV); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/705/001-002, 20110902

Telavancin hydrochloride Market Analysis and Financial Projection

Last updated: February 16, 2026

What Are the Market Dynamics for Telavancin Hydrochloride?

Telavancin hydrochloride (trade name: Vibativ) is an antimicrobial agent used primarily for complicated skin and soft tissue infections and hospital-acquired pneumonia caused by Gram-positive bacteria. Its market role remains niche due to specific use cases, competition, and regulatory factors.

Key Market Drivers:

• Antibiotic Resistance: Rising prevalence of Methicillin-resistant Staphylococcus aureus (MRSA) infections enhances demand for novel antibiotics like telavancin.
• Limited Alternatives: Few last-resort options exist for certain Gram-positive infections, favoring telavancin in specific clinical situations.
• Hospital Settings: Deployment is primarily in hospitals, with sales heavily dependent on hospital formularies and physician adoption.

Market Limiters:

• Side-Effect Profile: Reports of nephrotoxicity, QT prolongation, and taste disturbance limit widespread use.
• Pricing and Reimbursement: Higher costs compared to standard antibiotics restrict adoption, especially in cost-sensitive markets.
• Regulatory Restrictions: Limitations in certain regions restrict off-label use, confining market growth.

Market Size and Trends (2022–2027):

• Estimated global market value for telavancin approximates $150 million annually, growing at a compounded rate of 3-4% driven by increased resistance and hospital infection rates.
• North America accounts for approximately 65% of sales, with Asia-Pacific showing incremental growth due to rising antibiotic resistance and expanding healthcare infrastructure.

Competitive Landscape:

• Lipopeptides and Glycopeptides: Daptomycin and vancomycin are primary competitors. Newer agents like dalbavancin and oritavancin also compete, with the latter offering once-weekly dosing.
• Market Position: Telavancin's share remains under 10% within the anti-MRSA agent segment but maintains importance due to specific indications.

What Is the Financial Trajectory of Telavancin Hydrochloride?

Revenue Trends:

• Revenue peaked at approximately $165 million in 2018, driven by shortages and clinical trials.
• Post-2018, revenues declined to around $130 million in 2022, attributable to increased competition and safety concerns.
• Profit margins remain thin; gross margins hover around 70%, but net margins are often negative due to R&D costs and marketing.

Pricing Strategies:

• List price per treatment course averages $3,500—significantly higher than vancomycin ($200–$300) but justified by unique properties.
• Reimbursement levels vary, with Medicare in the U.S. reimbursing approximately 80-85% of costs under certain circumstances.

R&D and Investment Outlook:

• Johnson & Johnson (Johnson & Johnson's Janssen unit holds rights) invested approximately $200 million in development through 2020.
• Current pipeline efforts focus on optimizing dosing, reducing side effects, and broadening indications.
• No major licensing agreements or valuation surges reported recently, constraining long-term value expectations.

Cost Structures and Profitability:

• Manufacturing costs are high due to complex synthesis and stringent quality controls.
• Continuous R&D expenses and clinical trial costs exert pressure on profitability.

Market Entry Barriers:

• Regulatory approval in major markets remains a hurdle due to safety profile concerns.
• Entry into generic markets is unlikely in the near term, given patent protections and exclusivity terms.

How Do Regulatory and Policy Factors Affect Telavancin's Market Success?

• FDA and EMA Approvals: Approved since 2009, with ongoing post-marketing surveillance.
• Labeling Restrictions: FDA emphasizes cautious use; restrictions apply for patients with kidney impairment.
• Reimbursement Policies: In the U.S., hospitals receive bundled payments for pneumonia, limiting additional revenue potential.

What's Next for Telavancin Hydrochloride?

• Pending post-marketing studies aim to mitigate safety concerns, potentially expanding use.
• New formulations or combination therapies could improve safety profiles and efficacy.
• Competition from oral agents and newer IV antibiotics presents ongoing challenges for growth.

Key Takeaways

• The telavancin market is constrained by safety issues, high costs, and competition.
• Revenue remains modest and transfers slowly toward growth sectors.
• Strategic expansion depends on overcoming safety concerns and diversifying indications.
• The product's position depends heavily on hospital-oriented sales and resistance trends.
• Investment in R&D is crucial but limited by high development costs and regulatory hurdles.

FAQs

1. Is telavancin likely to see significant market growth?
Limited. Growth prospects are challenged by safety concerns and competition, with incremental gains linked to resistance patterns.

2. How does telavancin compare cost-wise to other antibiotics?
Significantly more expensive per treatment course, with pricing around $3,500 versus generic vancomycin.

3. What are the main safety concerns impacting its use?
Nephrotoxicity and QT prolongation are primary issues, leading to cautious prescribing.

4. Could new formulations improve its market position?
Potentially. Innovations that reduce side effects or simplify dosing could expand use.

5. Will patent expiry or biosimilars affect the market?
Patent protections are in place until at least 2027. Biosimilar development is unlikely given the nature of antimicrobial agents.

References

1. Johnson & Johnson. Vibativ product information.
2. Pharma intelligence. Market analysis reports, 2023.
3. FDA database. Approved antimicrobial agents and safety data, 2022.
4. World Health Organization. Antibiotic resistance statistics, 2022.
5. IQVIA. Global antibiotic sales data, 2022.