VABOMERE Drug Patent Profile

When do Vabomere patents expire, and what generic alternatives are available?

Vabomere is a drug marketed by Rempex and is included in one NDA. There are eight patents protecting this drug.

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

The generic ingredient in VABOMERE is meropenem; vaborbactam. There are thirty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the meropenem; vaborbactam profile page.

DrugPatentWatch^® Generic Entry Outlook for Vabomere

Vabomere was eligible for patent challenges on August 29, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 29, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VABOMERE

International Patents:	78
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	4
Drug Prices:	Drug price information for VABOMERE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VABOMERE
What excipients (inactive ingredients) are in VABOMERE?	VABOMERE excipients list
DailyMed Link:	VABOMERE at DailyMed

See drug prices for VABOMERE

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

NDA:

209776

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 VABOMERE

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

Sponsor	Phase
Biomedical Advanced Research and Development Authority	Phase 1
Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)	Phase 1
Department of Health and Human Services	Phase 1

See all VABOMERE clinical trials

Pharmacology for VABOMERE

Drug Class	Penem Antibacterial beta Lactamase Inhibitor
Mechanism of Action	beta Lactamase Inhibitors

US Patents and Regulatory Information for VABOMERE

VABOMERE is protected by eight US patents and two FDA Regulatory Exclusivities.

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
Rempex	VABOMERE	meropenem; vaborbactam	POWDER;INTRAVENOUS	209776-001	Aug 29, 2017		RX	Yes	Yes
Rempex	VABOMERE	meropenem; vaborbactam	POWDER;INTRAVENOUS	209776-001	Aug 29, 2017		RX	Yes	Yes			Y	Y
Rempex	VABOMERE	meropenem; vaborbactam	POWDER;INTRAVENOUS	209776-001	Aug 29, 2017		RX	Yes	Yes
Rempex	VABOMERE	meropenem; vaborbactam	POWDER;INTRAVENOUS	209776-001	Aug 29, 2017		RX	Yes	Yes			Y
Rempex	VABOMERE	meropenem; vaborbactam	POWDER;INTRAVENOUS	209776-001	Aug 29, 2017		RX	Yes	Yes
Rempex	VABOMERE	meropenem; vaborbactam	POWDER;INTRAVENOUS	209776-001	Aug 29, 2017		RX	Yes	Yes
Rempex	VABOMERE	meropenem; vaborbactam	POWDER;INTRAVENOUS	209776-001	Aug 29, 2017		RX	Yes	Yes				Y

EU/EMA Drug Approvals for VABOMERE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Menarini International Operations Luxembourg S.A.	Vaborem	meropenem, vaborbactam	EMEA/H/C/004669 Vaborem is indicated for the treatment of the following infections in adults:Complicated urinary tract infection (cUTI), including pyelonephritisComplicated intra-abdominal infection (cIAI)Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP).Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.Vaborem is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.Consideration should be given to official guidance on the appropriate use of antibacterial agents.	Authorised	no	no	no	2018-11-20

International Patents for VABOMERE

When does loss-of-exclusivity occur for VABOMERE?

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

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

European Patent Office

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

New Zealand

Norway

Poland

Portugal

Russian Federation

Serbia

Singapore

Slovenia

South Korea

Spain

Turkey

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 VABOMERE around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	6266978
Portugal	3412676
Chile	2020000892
Norway	2019013
Singapore	187757	CYCLIC BORONIC ACID ESTER DERIVATIVES AND THERAPEUTIC USES THEREOF
Russian Federation	2013104951	ЦИКЛИЧЕСКИЕ БОРОНОВЫЕ КИСЛОТНО-ЭФИРНЫЕ ПРОИЗВОДНЫЕ И ИХ ИСПОЛЬЗОВАНИЕ В ТЕРАПИИ
Chile	2013000399	Compuestos derivados de ester de acido boronico; composicion farmaceutica; recipiente esteril; metodo de preparacion; y su uso para el tratamiento o la prevencion de una infeccion bacteriana.

Supplementary Protection Certificates for VABOMERE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2603514	2019C/514	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION
2603514	19/2019	Austria		PRODUCT NAME: VABORBACTAM UND/ODER EIN SALZ UND/ODER EIN HYDRAT DAVON; REGISTRATION NO/DATE: EU/1/18/1334 (MITTEILUNG) 20181122
2603514	2019014	Norway		PRODUCT NAME: A COMBINATION OF VABORBACTAM, AND/OR A SALT AND/OR HYDRATE THEREOF, AND MEROPENEM, AND/OR A SALT AND/OR HYDRATE THEREOF, IN PARTICULAR MEROPENEM TRIHYDRATE; REG. NO/DATE: EU/1/18/1334/001 20181122
2603514	300978	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
2603514	132019000000051	Italy		PRODUCT NAME: COMBINAZIONE DI VABORBACTAM E/O UN SUO SALE E/O UN SUO IDRATO, E MEROPENEM, E/O UN SUO SALE E/O UN SUO IDRATO, IN PARTICOLARE MEROPENEM TRIIDRATO(VABOMERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1334, 20181122
3412676	PA2020519	Lithuania		PRODUCT NAME: VABORBAKTAMO IR (ARBA) JO DRUSKOS, IR (ARBA) HIDRATO BEI MEROPENEMO IR (ARBA) JO DRUSKOS, IR (ARBA) HIDRATO, YPAC MEROPENEMO TRIHIDRATO, DERINYS; REGISTRATION NO/DATE: EU/1/18/1334 20181120
2603514	2019/017	Ireland		PRODUCT NAME: VABORBACTAM, AND/OR A SALT AND/OR HYDRATE THEREOF; AUTHORISATION NO/DATE: EU/1/18/1334 20181120

Market Dynamics and Financial Trajectory for VABOMERE (Meropenem and Vaborbactam)

Introduction

VABOMERE, a combination of meropenem, a penem antibacterial, and vaborbactam, a beta-lactamase inhibitor, has been a significant addition to the arsenal against complicated urinary tract infections (cUTI) and other resistant gram-negative bacterial infections. Here, we delve into the market dynamics and financial trajectory of this critical antibiotic.

FDA Approval and Market Entry

VABOMERE was approved by the FDA in August 2017 for the treatment of patients 18 years and older with cUTI, including pyelonephritis caused by designated susceptible bacteria[1][5].

Market Need and Growth Drivers

The global antibiotic resistance market is growing rapidly, driven by the increasing burden of antibiotic-resistant infections. In the U.S., more than 2.8 million infections are resistant to antibiotics annually, resulting in over 35,000 deaths. This rising public health concern has created a significant demand for new antibiotic therapies like VABOMERE[3].

Competitive Advantage

VABOMERE has demonstrated superior in vitro activity against KPC-producing Enterobacterales compared to meropenem alone. The addition of vaborbactam reduces the minimum inhibitory concentration (MIC) of meropenem, making it effective against bacteria that are resistant to meropenem alone. This potency restoration is crucial in addressing the growing threat of carbapenem-resistant Enterobacteriaceae (CRE) infections[4].

Financial Performance

Initial Sales and Projections

In the first nine quarters following its approval, VABOMERE generated $21.81 million in sales. Analysts predict that the drug will achieve peak sales of approximately $400 million by 2028, driven by its favorable label and the increasing need for effective treatments against CRE infections[1][5].

Revenue Streams

The Medicines Company, the original developer of VABOMERE, reported significant financial activities around the time of the drug's approval. Although the company faced overall net losses in 2017, the revenue from other products like Orbactiv (oritavancin) and Minocin (minocycline) showed growth. The acquisition of VABOMERE by Melinta Therapeutics has likely influenced the financial trajectory, but specific post-acquisition financial data for VABOMERE is not detailed in the available sources[2].

Market Exclusivity

VABOMERE benefits from its status as a Qualified Infectious Disease Product (QIDP), which grants an additional five years of exclusivity. This exclusivity is expected to extend into 2031, providing a competitive edge and protecting the drug's market share during this period[5].

Regional Market Dominance

North America, particularly the U.S., has been a key market for VABOMERE. The region's vigorous investment in research and development, along with substantial funding for scientific research and technological advancements, has driven the adoption of innovative antibiotic therapies. Government initiatives and insurance coverage also play a significant role in fueling growth in this region[3].

Public Health Impact

The efficacy of VABOMERE against a broad spectrum of resistant gram-negative pathogens, including KPC-producing Enterobacterales, makes it a valuable tool in combating antibiotic resistance. Studies have shown that VABOMERE inhibits a number of β-lactamases and extended-spectrum β-lactamases (ESBLs), addressing a critical public health need[4].

Challenges and Future Outlook

Despite its promising market dynamics, VABOMERE faces challenges such as the ongoing need for clinical trials to establish efficacy against additional bacteria and the constant evolution of antibiotic resistance. However, with its current exclusivity and growing demand, VABOMERE is poised to play a significant role in the fight against antibiotic-resistant infections.

Key Takeaways

• FDA Approval: VABOMERE was approved in August 2017 for treating cUTI and pyelonephritis.
• Market Need: Growing demand due to increasing antibiotic resistance.
• Competitive Advantage: Superior in vitro activity against KPC-producing Enterobacterales.
• Financial Projections: Peak sales predicted at $400 million by 2028.
• Market Exclusivity: Additional five years of exclusivity as a QIDP.
• Regional Dominance: Strong presence in North America, driven by research and development investments.

FAQs

What is VABOMERE used for?

VABOMERE is used for the treatment of patients 18 years and older with complicated urinary tract infections (cUTI), including pyelonephritis caused by designated susceptible bacteria.

Who developed VABOMERE?

VABOMERE was originally developed by The Medicines Company and is now owned by Melinta Therapeutics.

What is the significance of vaborbactam in VABOMERE?

Vaborbactam is a beta-lactamase inhibitor that significantly reduces the MIC of meropenem, making it effective against bacteria that are resistant to meropenem alone.

What are the peak sales projections for VABOMERE?

Analysts predict that VABOMERE will achieve peak sales of approximately $400 million by 2028.

How long does VABOMERE have market exclusivity?

VABOMERE has market exclusivity until 2031 due to its status as a Qualified Infectious Disease Product (QIDP).

Sources

1. Table A - 5, Vabomere (meropenem and vaborbactam) Information - Antimicrobial Drugs Market Returns Analysis.
2. The Medicines Company Reports Third-Quarter 2017 Business and Financial Results - Business Wire.
3. Antibiotic Resistance Market Size And Share Report, 2030 - Grand View Research.
4. VABOMERE (meropenem and vaborbactam) Microbiologic Data - Vabomere.com.
5. The Medicines Co. nets $400M nod for UTI antibacterial treatment - Fierce Pharma.