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VIBATIV Drug Patent Profile

Which patents cover Vibativ, and what generic alternatives are available?

Vibativ is a drug marketed by Cumberland and is included in one NDA. There is one patent protecting this drug.

This drug has thirty-three patent family members in eighteen countries.

The generic ingredient in VIBATIV is telavancin hydrochloride. One supplier is listed for this compound. Additional details are available on the telavancin hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Vibativ

Vibativ was eligible for patent challenges on September 11, 2013.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 1, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VIBATIV

International Patents:	33
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	16
Clinical Trials:	14
Patent Applications:	8
Drug Prices:	Drug price information for VIBATIV
What excipients (inactive ingredients) are in VIBATIV?	VIBATIV excipients list
DailyMed Link:	VIBATIV at DailyMed

See drug prices for VIBATIV

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

Constraining patent/regulatory exclusivity:

7,531,623

NDA:

022110

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 VIBATIV

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 VIBATIV clinical trials

Pharmacology for VIBATIV

Drug Class

Lipoglycopeptide Antibacterial

US Patents and Regulatory Information for VIBATIV

VIBATIV is protected by one US patents.

This potential generic entry date is based on patent 7,531,623.

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

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 VIBATIV

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

International Patents for VIBATIV

See the table below for patents covering VIBATIV around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	1678201
Brazil	0111222
South Korea	101166250
World Intellectual Property Organization (WIPO)	0182971
Poland	207101
Japan	2008222718	REDUCTIVE ALKYLATION PROCESS ON GLYCOPEPTIDE

Supplementary Protection Certificates for VIBATIV

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	C 2012 002	Romania		PRODUCT NAME: TELAVANCIN SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIAINCLUZAND CLORHIDRAT DE TELAVANCIN; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/705/001, RO EU/1/11/705/002; DATE OF NATIONAL AUTHORISATION: 20110902; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/705/001, EU/1/11/705/002; DATE OF FIRST AUTHORISATION IN EEA: 20110902
1292612	PA2012002	Lithuania		PRODUCT NAME: TELAVANCINUM; REGISTRATION NO/DATE: EU/1/11/705/001, 2011 09 02 EU/1/11/705/002 20110902
1292612	2011C/045	Belgium		PRODUCT NAME: VIBATIV - TELAVANCINE; AUTHORISATION NUMBER AND DATE: EU/1/11/705-001 20110902
1292612	1190036-2	Sweden		PRODUCT NAME: TELAVANCIN ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV INNEFATTANDE TELAVANCINHYDROKLORID; REG. NO/DATE: EU/1/11/705/001 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

VIBATIV Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for VIBATIV (Telavancin)

Introduction

VIBATIV, also known as telavancin, is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic developed for the treatment of complicated skin and soft tissue infections, as well as nosocomial pneumonia, including those caused by Gram-positive bacteria such as methicillin-resistant Staphylococcus aureus (MRSA). Here, we delve into the market dynamics and financial trajectory of VIBATIV.

Mechanism of Action and Clinical Efficacy

VIBATIV operates through a dual mechanism of action, inhibiting bacterial cell wall synthesis and disrupting bacterial cell membrane function. This unique mechanism makes it effective against difficult-to-treat pathogens, including MRSA. Clinical trials, such as the ATTAIN studies, have demonstrated VIBATIV's efficacy, showing higher clinical cure rates compared to vancomycin in certain patient populations[1][4].

Market Approval and Distribution

VIBATIV has received marketing authorization in various regions, including Russia, for the treatment of multiple infections caused by Gram-positive bacteria. Theravance Biopharma plans to market VIBATIV through a network of partners in markets outside the United States where the drug is approved[1].

Sales Performance

The sales performance of VIBATIV has been tracked over several years. Initially, the drug stabilized at around $5 million in quarterly sales about 27 quarters after its market entry, before decreasing around the 37th quarter. This pattern is consistent with many antimicrobial drugs that see a stabilization and then a decline in sales as other drugs enter the market[3].

Quarterly and Annual Sales

In recent financial reports, Cumberland Pharmaceuticals, which distributes VIBATIV among other products, has reported the following sales figures:

• For the third quarter of 2024, VIBATIV generated $1 million in net revenue.
• Year-to-date 2024, VIBATIV contributed $5.1 million to the company's net revenues[2].
• In 2023, VIBATIV generated $8.8 million in net revenue for Cumberland Pharmaceuticals[5].

Financial Impact and Operating Expenses

The financial performance of VIBATIV is intertwined with the overall financial health of its distributors. Here are some key financial metrics:

Revenue Contribution

VIBATIV contributes a significant portion to Cumberland Pharmaceuticals' revenue, though it is not the top-grossing product. For example, in 2023, VIBATIV accounted for approximately 22% of the company's total net revenue from its four main products[5].

Operating Expenses

The total operating expenses for Cumberland Pharmaceuticals, which include costs associated with selling, marketing, research, and development, as well as general and administrative expenses, have been substantial. For instance, in 2023, total operating expenses were $49.1 million, with selling and marketing expenses being one of the highest components[5].

Net Income/Loss

Despite the revenue generated by VIBATIV, Cumberland Pharmaceuticals has reported net losses. For the third quarter of 2024, the company reported a net loss of $1.5 million. This trend is consistent with previous years, where the company has struggled to achieve profitability due to high operating expenses[2][5].

Healthcare Costs and Outcomes

Studies have compared the healthcare costs and outcomes associated with VIBATIV versus other antibiotics like vancomycin. These analyses have shown that while VIBATIV may have higher drug and nephrotoxicity costs, it can lead to lower intensive care unit and ventilator costs. Additionally, VIBATIV has been associated with higher clinical cure rates in certain patient populations[4].

Competitive Landscape

VIBATIV operates in a competitive market filled with other antimicrobial drugs. The sales trajectories of these drugs vary widely, with some achieving peak sales years after their approval. For example, Avycaz and Bridion have shown significant sales growth, while others like Veltassa and Rubraca have had slower starts but eventually increased their sales over time[3].

Future Outlook

The future financial trajectory of VIBATIV will depend on several factors, including market competition, the emergence of new antimicrobial drugs, and the ongoing need for effective treatments against MRSA and other Gram-positive bacteria. Cumberland Pharmaceuticals' strategy to continue supporting VIBATIV through its distribution network and potentially expanding its market reach could influence its future sales performance.

Key Takeaways

• Clinical Efficacy: VIBATIV has demonstrated strong clinical efficacy against MRSA and other Gram-positive bacteria.
• Sales Performance: The drug has stabilized at around $5 million in quarterly sales before declining, a common pattern for antimicrobial drugs.
• Financial Contribution: VIBATIV contributes significantly to Cumberland Pharmaceuticals' revenue but is part of a broader portfolio.
• Operating Expenses: High operating expenses have impacted the company's profitability.
• Healthcare Costs: VIBATIV can offer cost savings in certain healthcare settings despite higher drug costs.
• Competitive Landscape: The market is competitive, with varying sales trajectories among antimicrobial drugs.

FAQs

What is VIBATIV used for?

VIBATIV is used for the treatment of complicated skin and soft tissue infections, as well as nosocomial pneumonia, including those caused by Gram-positive bacteria such as MRSA.

How does VIBATIV work?

VIBATIV works through a dual mechanism of action, inhibiting bacterial cell wall synthesis and disrupting bacterial cell membrane function.

Who distributes VIBATIV?

Cumberland Pharmaceuticals is one of the companies that distributes VIBATIV.

What are the sales figures for VIBATIV in recent years?

In 2023, VIBATIV generated $8.8 million in net revenue for Cumberland Pharmaceuticals. For the third quarter of 2024, it contributed $1 million to the company's net revenues.

How does VIBATIV compare to other antibiotics in terms of healthcare costs?

VIBATIV may have higher drug and nephrotoxicity costs but can lead to lower intensive care unit and ventilator costs, resulting in similar overall healthcare costs compared to vancomycin.

Sources

1. Theravance Biopharma: "Theravance Biopharma Announces Marketing Authorization for VIBATIV(R) (Telavancin) in Russia for Treatment of Multiple Infections Caused by Gram-Positive Bacteria, Including MRSA"[1].
2. Cumberland Pharmaceuticals: "Cumberland Pharmaceuticals Reports Third Quarter 2024 Financial Results and Company Update"[2].
3. NCBI: "MARKET PERFORMANCE ANALYSIS - Antimicrobial Drugs"[3].
4. Theravance Biopharma: "New Data for VIBATIV(R) (telavancin) Reported in Presentations at IDWeek™ 2016"[4].
5. Cumberland Pharmaceuticals: "Cumberland Pharmaceuticals Reports Annual 2023 Financial Results"[5].