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 six patents protecting this drug.

This drug has fifty-two patent family members in twenty-six 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:	52
US Patents:	6
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 Generic Entry Opportunity 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

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 six 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
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

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

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
Canada	2807546	DERIVES CYCLIQUES D'ESTERS D'ACIDE BORONIQUE ET LEURS UTILISATIONS THERAPEUTIQUES (CYCLIC BORONIC ACID ESTER DERIVATIVES AND THERAPEUTIC USES THEREOF)
Japan	2020002178	環状ボロン酸エステル誘導体およびその治療的使用 (CYCLIC BORONIC ACID ESTER DERIVATIVES AND THERAPEUTIC USES THEREOF)
South Korea	20190066084	고리형 보론산 에스터 유도체의 제조방법 (METHOD FOR PREPARING CYCLIC BORONIC ACID ESTER DERIVATIVES)
Mexico	348653	DERIVADOS ESTER DE ACIDO BORONICO CICLICO Y SUS USOS TERAPEUTICOS. (CYCLIC BORONIC ACID ESTER DERIVATIVES AND THERAPEUTIC USES THEREOF.)
Japan	2017052794	環状ボロン酸エステル誘導体およびその治療的使用 (CYCLIC BORONIC ACID ESTER DERIVATIVES AND THERAPEUTIC USES THEREOF)

Supplementary Protection Certificates for VABOMERE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2603514	19C1022	France		PRODUCT NAME: VABORBACTAM, ET/OU UN SEL ET/OU UN HYDRATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/18/1334 20181122
2603514	CA 2019 00016	Denmark		PRODUCT NAME: VABORBACTAM, OG/ELLER ET SALT OG/ELLER HYDRAT HERAF; REG. NO/DATE: EU/1/18/1334 20181122
2603514	1990019-0	Sweden		PRODUCT NAME: VABORBACTAM, AND /OR A SALT AND/OR HYDRATE THEREOF; REG. NO/DATE: EU/1/18/1334 20181122
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	19C1021	France		PRODUCT NAME: COMBINAISON DE VABORBACTAME, ET/OU D'UN SEL ET/OU D'UN HYDRATE DE CELUI-CI, ET DE MEROPENEME, ET/OU D'UN SEL ET/OU D'UN HYDRATE DE CELUI-CI, EN PARTICULIER DE MEROPENEME TRIHYDRATE; REGISTRATION NO/DATE: EU/1/18/1334 20181122