RECARBRIO Drug Patent Profile

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

Recarbrio is a drug marketed by Msd Merck Co and is included in one NDA. There is one patent protecting this drug.

This drug has sixty-five patent family members in thirty-seven countries.

The generic ingredient in RECARBRIO is cilastatin sodium; imipenem; relebactam. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cilastatin sodium; imipenem; relebactam profile page.

DrugPatentWatch^® Generic Entry Outlook for Recarbrio

Recarbrio will be eligible for patent challenges on July 16, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 19, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for RECARBRIO

International Patents:	65
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	5
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for RECARBRIO
What excipients (inactive ingredients) are in RECARBRIO?	RECARBRIO excipients list
DailyMed Link:	RECARBRIO at DailyMed

See drug prices for RECARBRIO

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

NDA:

212819

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 RECARBRIO

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

Sponsor	Phase
James Whitcomb Riley Hospital for Children	Phase 4
University of Texas Southwestern Medical Center	Phase 4
Q2 Solutions	Phase 4

See all RECARBRIO clinical trials

Pharmacology for RECARBRIO

Drug Class	Penem Antibacterial Renal Dehydropeptidase Inhibitor
Mechanism of Action	Dipeptidase Inhibitors

US Patents and Regulatory Information for RECARBRIO

RECARBRIO is protected by three 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 RECARBRIO

FDA Regulatory Exclusivity protecting RECARBRIO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd Merck Co	RECARBRIO	cilastatin sodium; imipenem; relebactam	POWDER;INTRAVENOUS	212819-001	Jul 16, 2019		RX	Yes	Yes			Y	Y
Msd Merck Co	RECARBRIO	cilastatin sodium; imipenem; relebactam	POWDER;INTRAVENOUS	212819-001	Jul 16, 2019		RX	Yes	Yes
Msd Merck Co	RECARBRIO	cilastatin sodium; imipenem; relebactam	POWDER;INTRAVENOUS	212819-001	Jul 16, 2019		RX	Yes	Yes

International Patents for RECARBRIO

When does loss-of-exclusivity occur for RECARBRIO?

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

Australia

Brazil

Canada

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

European Patent Office

Honduras

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Malaysia

Mexico

Montenegro

Morocco

Netherlands

New Zealand

Nicaragua

Norway

Poland

Portugal

Russian Federation

Serbia

Slovenia

South Africa

South Korea

Spain

Ukraine

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 RECARBRIO around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20160099117	베타­락타마제 억제제 (BETA-LACTAMASE INHIBITORS)
Poland	2666774
South Korea	101648728
Hong Kong	1186180	β-內酰胺酶抑制劑 (BETA LACTAMASE INHIBITORS)

Supplementary Protection Certificates for RECARBRIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2666774	LUC00166	Luxembourg		PRODUCT NAME: RELEBACTAM, EVENTUELLEMENT SOUS FORME DE MONOHYDRATE, ET IMIPENEME; AUTHORISATION NUMBER AND DATE: EU/1/19/1420 20200217
2231667	SPC/GB20/029	United Kingdom		PRODUCT NAME: RELEBACTAM OR A MONOHYDRATE THEREOF; REGISTERED: UK EU/1/19/1420 20200217; UK PLGB 53095/0053 20200217
2231667	122020000034	Germany		PRODUCT NAME: RELEBACTAM ODER EIN MONOHYDRAT DAVON; NAT. REGISTRATION NO/DATE: EU/1/19/1420 20200213; FIRST REGISTRATION: EU EU/1/191420 20200213
2231667	20C1030	France		PRODUCT NAME: RELEBACTAM OU UN MONOHYDRATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/19/1420 20200217