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 seven patents protecting this drug.

This drug has seventy patent family members in thirty 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:	70
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	4
Formulation / Manufacturing:	see details
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 Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)	Phase 1
Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)	Phase 1

See all VABOMERE clinical trials

Pharmacology for VABOMERE

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

Anatomical Therapeutic Chemical (ATC) Classes for VABOMERE

J01DH	Carbapenems
J01D	OTHER BETA-LACTAM ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J01DH	Carbapenems
J01D	OTHER BETA-LACTAM ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for VABOMERE

VABOMERE is protected by seven 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.

Patents protecting VABOMERE

FDA Regulatory Exclusivity protecting VABOMERE

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

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 pyelonephritis, Complicated 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

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
Norway	2019014
South Korea	20130099923	CYCLIC BORONIC ACID ESTER DERIVATIVES AND THERAPEUTIC USES THEREOF
Hungary	S1900017
Russian Federation	2013104951	ЦИКЛИЧЕСКИЕ БОРОНОВЫЕ КИСЛОТНО-ЭФИРНЫЕ ПРОИЗВОДНЫЕ И ИХ ИСПОЛЬЗОВАНИЕ В ТЕРАПИИ
Poland	3412676

Supplementary Protection Certificates for VABOMERE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2603514	C02603514/02	Switzerland		PRODUCT NAME: VABORBACTAM UND MEROPENEM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67797 01.07.2021
3412676	PA2020521,C3412676	Lithuania		PRODUCT NAME: VABORBAKTAMAS IR (ARBA) JO DRUSKA, IR (ARBA) JO HIDRATAS; REGISTRATION NO/DATE: EU/1/18/1334 20181120
2603514	122019000027	Germany		PRODUCT NAME: KOMBINATION VON VABORBACTAM, ODER EIN SALZ ODER EIN HYDRAT DAVON, UND MEROPENEM, ODER EIN SALZ ODER EIN HYDRAT DAVON, INSBESONDERE MEROPENEMTRIHYDRAT; REGISTRATION NO/DATE: EU/1/18/1334 20181120
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
2603514	2019013	Norway		PRODUCT NAME: VABORBACTAM, AND/OR A SALT AND/OR HYDRATE THEREOF; REG. NO/DATE: EU/1/18/1334 20181113