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

Constraining patent/regulatory exclusivity:

7,531,623

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
Theravance Biopharma, US, Inc.	Phase 4
Joseph L. Kuti, PharmD	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	022110-001	Sep 11, 2009		DISCN	Yes	No	7,531,623			Y
Cumberland	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110-002	Sep 11, 2009		RX	Yes	Yes	7,531,623			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	022110-001	Sep 11, 2009	8,158,580
Cumberland	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110-002	Sep 11, 2009	7,544,364
Cumberland	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110-002	Sep 11, 2009	7,008,923
Cumberland	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110-001	Sep 11, 2009	7,208,471
Cumberland	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110-001	Sep 11, 2009	8,101,575
Cumberland	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110-001	Sep 11, 2009	6,635,618
Cumberland	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110-002	Sep 11, 2009	8,101,575

International Patents for TELAVANCIN HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Denmark	1678201
European Patent Office	1678201	CHLORHYDRATES D'UN DERIVE DE GLYCOPEPTIDE PHOSPHONATE (HYDROCHLORIDE SALTS OF A GLYCOPEPTIDE PHOSPHONATE DERIVATIVE)
Japan	2007534630
Cyprus	1113773
Japan	4669478
Canada	2726967	CHLORHYDRATES D'UN DERIVE DE GLYCOPEPTIDE PHOSPHONATE (HYDROCHLORIDE SALTS OF A GLYCOPEPTIDE PHOSPHONATE DERIVATIVE)
Australia	2004285924	Hydrochloride salts of a glycopeptide phosphonate derivative

Supplementary Protection Certificates for TELAVANCIN HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1292612	132012902025885	Italy		PRODUCT NAME: TELAVANCINA(VIBATIV); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/705/001-002, 20110902
1292612	2011C/045	Belgium		PRODUCT NAME: VIBATIV - TELAVANCINE; AUTHORISATION NUMBER AND DATE: EU/1/11/705-001 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	C300507	Netherlands		PRODUCT NAME: TELAVANCINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, INCLUSIEF TELAVANCINE HYDROCLORIDE; REGISTRATION NO/DATE: EU/1/11/705/001 - 002 20110902
1292612	122011100062	Germany		PRODUCT NAME: TELAVANCIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON, EINSCHLIESSLICH TELAVANCINHYDROCHLORID; REGISTRATION NO/DATE: EU/1/11/705/001-002 20110902
1292612	SPC/GB11/056	United Kingdom		PRODUCT NAME: TELAVANCIN, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING TELAVANCIN HYDROCHLORIDE; REGISTERED: UK EU/1/11/705/001 20110906; UK EU/1/11/705/002 20110906
1292612	PA2012002	Lithuania		PRODUCT NAME: TELAVANCINUM; REGISTRATION NO/DATE: EU/1/11/705/001, 2011 09 02 EU/1/11/705/002 20110902

Market Dynamics and Financial Trajectory for Telavancin Hydrochloride

Last updated: July 31, 2025

Introduction

Telavancin hydrochloride, marketed as Vibativ, is a semi-synthetic lipoglycopeptide antibiotic developed by Allergan (acquired by AbbVie in 2020). Approved by the U.S. Food and Drug Administration (FDA) in 2013 for complicated skin and soft tissue infections (cSSTIs) and hospital-acquired pneumonia including ventilator-associated pneumonia (VAP), telavancin targets resistant bacterial strains, notably methicillin-resistant Staphylococcus aureus (MRSA). Its unique mechanism and clinical efficacy establish its position within the anti-infective landscape, but market dynamics and financial prospects are shaped by regulatory, competitive, and clinical factors.

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Market Overview and Demand Drivers

The global anti-infectives market has seen robust growth driven by rising antimicrobial resistance (AMR), increasing hospitalizations for severe infections, and the paucity of novel antibiotics. According to IQVIA, the anti-infectives market reached approximately $50 billion in 2022, with a compounded annual growth rate (CAGR) of 3-4% over the past five years [[1]].

Telavancin's targeted niche—treating MRSA-related infections—aligns with urgent clinical needs in hospital settings, especially amidst diminishing effectiveness of traditional agents like vancomycin. The drug benefits from the growing prevalence of resistant pathogens and the persistent demand for potent, alternative antibiotics.

However, the adoption of telavancin faces hurdles: its high cost (~$1,200 per vial), safety profile concerns, and restraining factors from clinical guidelines that favor established therapies such as vancomycin, linezolid, or daptomycin. Also, recent regulations and stewardship efforts aim to curb antibiotics' overuse, possibly impacting sales.

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Regulatory and Clinical Landscape Impact

FDA and Global Approvals:

• Approved in 2013 by the FDA for cSSTIs and VAP, with subsequent regulatory reviews in Europe and other regions.
• Post-approval, the drug's use is primarily confined to hospital formulary and infectious disease specialist settings.

Clinical Positioning and Guidelines:

• Based on clinical trials, telavancin demonstrated non-inferiority to vancomycin. However, the safety profile, especially risks of nephrotoxicity and taste disturbances, attenuated enthusiasm among clinicians [[2]].
• Guidelines from CDC and Infectious Diseases Society of America (IDSA) list telavancin as an alternative rather than first-line, influencing prescribing behaviors.

Patent Life and Market Exclusivity:

• Patents expired in the U.S. in 2022, opening avenues for generic competition that could significantly erode pricing and revenue.
• AbbVie's strategic push for line extensions or formulations might mitigate immediate generic threats but requires time and capital.

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Competitive Dynamics

Key Competitors:

• Vancomycin: The standard-of-care, with generics available at low cost; safety and dosing limitations serve as competitive disadvantages.
• Linezolid (Zyvox): Oral option, broader indications, but higher cost and hematologic toxicity risks.
• Daptomycin (Cubicin): IV-only, effective for MRSA bacteremia, but limited in pneumonia efficacy.
• Other lipoglycopeptides like Dalbavancin and Oritavancin: Long-acting formulations with increasing adoption, especially for outpatient therapy, potentially encroaching on hospital-based use.

Market Challenges:

• The proliferation of long-acting agents (dalbavancin, oritavancin) reduces hospitalization time and costs, making hospital-based telavancin less attractive.
• Antibiotic stewardship programs discourage the use of broad-spectrum agents unless clearly indicated, impacting sales volume.

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Financial Trajectory and Outlook

Sales Performance:

• Since approval, telavancin has achieved modest sales, approximately $50 - $70 million annually globally [[3]].
• Year-over-year growth has been stagnant or slightly declining, owing to competitive pressure and safety concerns.

Growth Prospects:

• Market potential adversities:

  • Expiration of patents in 2022 enables generic manufacturers to introduce cheaper alternatives, reducing revenue potential.
  • Clinical practice shifts favoring other antibiotics and outpatient long-acting agents diminish hospital-based inpatient sales.

• Market expansion opportunities:

  • Development of new formulations (e.g., oral, inhaled) could extend clinical utility, increase access, and open new revenue streams.
  • Strategic indication expansion—such as adding treatment for diabetic foot infections or osteomyelitis—could diversify revenue.

Pricing and Reimbursement:

• High drug costs limit adoption, especially with reimbursement pressures in hospital and payer settings.
• Favorable reimbursement policies or inclusion in outpatient parenteral antibiotic therapy (OPAT) programs could bolster financial performance.

Potential for Lifecycle Management:

• Next-generation formulations or fixed-dose combinations may prolong market viability.
• Companion diagnostics or antimicrobial stewardship programs tailored to telavancin's profile can solidify niche positioning.

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Risks and Opportunities

Risks:

• Rapid generic erosion post-patent expiry will substantially diminish revenue.
• Safety concerns, especially nephrotoxicity, may limit regulatory approval for new indications or formulations.
• Competition from newer, more convenient agents could render telavancin obsolete outside niche cases.

Opportunities:

• Adoption in settings with high MRSA prevalence and limited alternatives.
• Use in multidrug-resistant infections where few options exist.
• Strategic partnerships or licensing arrangements may accelerate global market access and revenue.

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Key Takeaways

• Market Potential: Telavancin's growth prospects are constrained by its patent expiry, safety concerns, and stiff generic competition. Its niche role in MRSA infections preserves some market share but limits large-scale revenue expansion.
• Revenue Outlook: Current annual sales hover around $50-70 million; significant declines are anticipated as generics enter the market. Efforts to expand indications or develop alternative formulations are critical for maintaining financial relevance.
• Competitive Challenges: Evolving antimicrobial landscape favors long-acting agents and oral therapies, challenging telavancin's hospital-based sales model.
• Strategic Focus: Innovation in delivery systems, expanding clinical indications, and aligning with antimicrobial stewardship initiatives can enhance its market position.
• Long-term Viability: Post-patent expiry, telavancin's future hinges on competitive differentiation, regulatory strategy, and clinical positioning within the broader antibiotic market.

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FAQs

1. What are the primary factors influencing telavancin's market performance?
Market performance depends on safety profile, patent status, competition from generic antibiotics, clinical guideline positioning, and emergence of alternative therapies like long-acting lipoglycopeptides.

2. How does telavancin compare to other MRSA antibiotics in efficacy and safety?
Telavancin is non-inferior to vancomycin for its approved indications but has a higher risk of nephrotoxicity and taste disturbances. Competing agents like linezolid and daptomycin offer different safety profiles and administration routes.

3. What is the impact of patent expiration on telavancin’s sales?
Patent expiration in 2022 enables generic entry, significantly reducing pricing and sales volume, likely leading to substantial revenue decline unless mitigated by new formulations or indications.

4. Are there upcoming clinical developments that could rejuvenate telavancin’s market?
Potential improvements include oral or inhaled formulations and expanded indications, but none are currently FDA-approved or in late-stage development, limiting near-term impact.

5. How do antimicrobial stewardship policies affect telavancin’s market?
Stewardship programs promote judicious antibiotic use, often favoring narrow-spectrum, cost-effective agents like vancomycin. This trend can restrict telavancin's use to specific cases, limiting sales opportunities.

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References

[1] IQVIA. "Global Anti-Infectives Market Report," 2022.

[2] S. Khandelwal et al., "Clinical efficacy and safety of telavancin," Infectious Diseases Journal, 2015.

[3] EvaluatePharma. "Vibativ Sales Data," 2022.