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Last Updated: December 22, 2024

TELAVANCIN HYDROCHLORIDE - Generic Drug Details

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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
Patent Applications:	21
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

Generic Entry Date for TELAVANCIN HYDROCHLORIDE^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: ⤷ Subscribe 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

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Glossary

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

Expired US Patents for TELAVANCIN HYDROCHLORIDE

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

International Patents for TELAVANCIN HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	1678201	CHLORHYDRATES D'UN DERIVE DE GLYCOPEPTIDE PHOSPHONATE (HYDROCHLORIDE SALTS OF A GLYCOPEPTIDE PHOSPHONATE DERIVATIVE)	⤷ Subscribe
Denmark	2495251		⤷ Subscribe
Hong Kong	1093516	HYDROCHLORIDE SALTS OF A GLYCOPEPTIDE PHOSPHONATE DERIVATIVE	⤷ Subscribe
Denmark	1678201		⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for TELAVANCIN HYDROCHLORIDE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1292612	1190036-2	Sweden	⤷ Subscribe	PRODUCT NAME: TELAVANCIN ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV INNEFATTANDE TELAVANCINHYDROKLORID; REG. NO/DATE: EU/1/11/705/001 20110902
1292612	132012902025885	Italy	⤷ Subscribe	PRODUCT NAME: TELAVANCINA(VIBATIV); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/705/001-002, 20110902
1292612	11C0051	France	⤷ Subscribe	PRODUCT NAME: TELAVANCINE; REGISTRATION NO/DATE: EU/1/11/705/001-002 20110902
1292612	C300507	Netherlands	⤷ Subscribe	PRODUCT NAME: TELAVANCINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, INCLUSIEF TELAVANCINE HYDROCLORIDE; REGISTRATION NO/DATE: EU/1/11/705/001 - 002 20110902
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

TELAVANCIN HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Telavancin Hydrochloride

Introduction

Telavancin hydrochloride, marketed under the brand name Vibativ, is a potent antibacterial agent used in the treatment of complicated skin and skin structure infections, as well as certain types of hospital-acquired bacterial pneumonia. This article delves into the market dynamics and financial trajectory of telavancin hydrochloride, highlighting its clinical significance, market performance, and financial implications.

Clinical Significance of Telavancin Hydrochloride

Telavancin hydrochloride is a semi-synthetic derivative of vancomycin, known for its bactericidal activity against gram-positive bacteria, including Methicillin-resistant Staphylococcus aureus (MRSA)[1].

Mechanism of Action

Telavancin inhibits bacterial cell wall synthesis by binding to D-Ala-D-Ala and disrupts cell membrane integrity, making it a more potent inhibitor of peptidoglycan synthesis compared to vancomycin[1].

Therapeutic Uses

It is primarily used for treating complicated skin and skin structure infections and hospital-acquired pneumonia, including ventilator-associated pneumonia (VAP)[1].

Market Performance

Sales and Revenue

Cumberland Pharmaceuticals, the company behind Vibativ, has reported significant revenue from the drug. In the third quarter of 2023, Vibativ generated $2.8 million in revenue, contributing to the company's total net revenues of $10.1 million for the quarter. Year-to-date 2023, Vibativ's revenue was $6.8 million[2].

In the second quarter of 2024, Vibativ's revenue continued to grow, reaching $2.5 million, as part of Cumberland Pharmaceuticals' total net revenue of $9.9 million for the quarter. Year-to-date 2024, Vibativ's revenue stood at $4.1 million[5].

Market Trends

The antimicrobial drugs market, which includes telavancin, is influenced by factors such as the comparative clinical benefit score of the drugs. Studies have shown that drugs with higher clinical benefit scores tend to have higher early market sales[4].

Competitive Landscape

Telavancin operates in a competitive market dominated by other antibacterial agents. However, its unique mechanism of action and effectiveness against MRSA and other gram-positive bacteria position it as a valuable option in the treatment of severe bacterial infections.

Financial Trajectory

Revenue Growth

Cumberland Pharmaceuticals has seen a sequential revenue growth of 16% in the second quarter of 2024 compared to the first quarter, with Vibativ contributing significantly to this growth[5].

Operating Expenses and Net Income

Despite the revenue growth, Cumberland Pharmaceuticals incurred total operating expenses of $10.9 million in the second quarter of 2024. The company reported an operating loss of $1.0 million for the quarter but remains optimistic about future performance, citing ongoing positive developments[5].

Research and Development

The company continues to invest in research and development, with $1.1 million spent in the second quarter of 2024. This investment is crucial for maintaining and expanding the drug's market presence[5].

Financial Metrics

Net Revenue

Third quarter 2023: $2.8 million[2]
Second quarter 2024: $2.5 million[5]
Year-to-date 2023: $6.8 million[2]
Year-to-date 2024: $4.1 million[5]

Operating Expenses

Total operating expenses for the second quarter of 2024: $10.9 million[5]
Research and development expenses for the second quarter of 2024: $1.1 million[5]

Net Income/Loss

Net loss for the third quarter of 2023: $1.0 million[2]
Adjusted earnings for the second quarter of 2024: $0.2 million[5]

Future Outlook

Reimbursement and Regulatory Environment

Cumberland Pharmaceuticals is engaged in discussions with CMS regarding the reimbursement status and pricing for its products, including Vibativ, under the Consolidated Appropriation Act 2023. This could impact future revenue and profitability[5].

Preclinical Studies and Expansion

Recent preclinical studies have shown telavancin's effectiveness against anthrax strains, suggesting potential future applications and market expansion[5].

Key Takeaways

Clinical Significance: Telavancin hydrochloride is a potent antibacterial agent effective against MRSA and other gram-positive bacteria.
Market Performance: The drug has generated significant revenue for Cumberland Pharmaceuticals, with a growing trend in sales.
Financial Trajectory: Despite operating losses, the company is optimistic about future revenue growth and positive cash flow.
Future Outlook: Ongoing regulatory discussions and preclinical studies suggest potential for expanded use and market growth.

FAQs

What is telavancin hydrochloride used for?

Telavancin hydrochloride is used in the treatment of complicated skin and skin structure infections and certain types of hospital-acquired bacterial pneumonia.

Who manufactures telavancin hydrochloride?

Telavancin hydrochloride is manufactured by Cumberland Pharmaceuticals and marketed under the brand name Vibativ.

How does telavancin hydrochloride work?

Telavancin hydrochloride inhibits bacterial cell wall synthesis and disrupts cell membrane integrity, making it bactericidal against gram-positive bacteria.

What are the financial highlights of telavancin hydrochloride in recent quarters?

In the third quarter of 2023, Vibativ generated $2.8 million in revenue. In the second quarter of 2024, it generated $2.5 million, contributing to Cumberland Pharmaceuticals' total net revenue.

What is the future outlook for telavancin hydrochloride?

The future outlook includes potential expansion into new therapeutic areas, such as treating anthrax, and ongoing discussions with CMS regarding reimbursement status.

Sources

DrugBank: Telavancin: Uses, Interactions, Mechanism of Action.
PR Newswire: Cumberland Pharmaceuticals Reports Third Quarter 2023 Financial Results.
Pharmaceuticals.gov.in: An Analysis on leveraging the patent cliff with drug sales worth USD.
ASPE: Antimicrobial drugs market returns analysis final.
Cumberland Pharmaceuticals: Cumberland Pharmaceuticals Reports 16% Sequential Revenue Growth in Second Quarter 2024.

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