RECARBRIO Drug Patent Profile
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When do Recarbrio patents expire, 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 seventy-one patent family members in thirty-eight 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 was eligible for patent challenges on July 16, 2023.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be March 21, 2033. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Questions you can ask:
- What is the 5 year forecast for RECARBRIO?
- What are the global sales for RECARBRIO?
- What is Average Wholesale Price for RECARBRIO?
Summary for RECARBRIO
| International Patents: | 71 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 5 |
| Drug Prices: | Drug price information for RECARBRIO |
| What excipients (inactive ingredients) are in RECARBRIO? | RECARBRIO excipients list |
| DailyMed Link: | RECARBRIO at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for RECARBRIO
*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 |
|---|---|
| University of Pittsburgh Medical Center | Phase 4 |
| Merck Sharp & Dohme LLC | Phase 4 |
| Hartford Hospital | Phase 4 |
Pharmacology for RECARBRIO
| Drug Class | Penem Antibacterial Renal Dehydropeptidase Inhibitor beta Lactamase Inhibitor |
| Mechanism of Action | Dipeptidase Inhibitors beta Lactamase Inhibitors |
US Patents and Regulatory Information for RECARBRIO
RECARBRIO is protected by three US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of RECARBRIO is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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
.beta.-lactamase inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTIONS (CIAI)
.beta.-lactamase inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA AND VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA (HABP/VABP)
.beta.-lactamase inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS, INCLUDING PYELONEPHRITIS (CUTI)
FDA Regulatory Exclusivity protecting RECARBRIO
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Msd Merck Co | RECARBRIO | cilastatin sodium; imipenem; relebactam | POWDER;INTRAVENOUS | 212819-001 | Jul 16, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Msd Merck Co | RECARBRIO | cilastatin sodium; imipenem; relebactam | POWDER;INTRAVENOUS | 212819-001 | Jul 16, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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
Patent: 09206119
Patent: Beta-lactamase inhibitors
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0906871
Patent: composto, composição farmacêutica, método para tratar uma infecção bacteriana, uso do composto, e, processo para preparar um composto
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 12783
Patent: INHIBITEURS DE LA BETA-LACTAMASE (BETA-LACTAMASE INHIBITORS)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1918407
Patent: Beta-lactamase inhibitors
Estimated Expiration: ⤷ Sign Up
Patent: 2827067
Patent: Beta-lactamase inhibitor
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 31438
Patent: INHIBIDORES DE BETA-LACTAMASA
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 626
Patent: INHIBIDORES DE BETA-LACTAMASA
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0131123
Estimated Expiration: ⤷ Sign Up
Patent: 0150269
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 14900
Estimated Expiration: ⤷ Sign Up
Patent: 16243
Estimated Expiration: ⤷ Sign Up
Patent: 20023
Estimated Expiration: ⤷ Sign Up
Patent: 20024
Estimated Expiration: ⤷ Sign Up
Patent: 20025
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 31667
Estimated Expiration: ⤷ Sign Up
Patent: 66774
Estimated Expiration: ⤷ Sign Up
Dominican Republic
Patent: 010000218
Patent: INHIBIDORES DE BETA-LACTAMASA
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 10010345
Patent: INHIBIDORES DE BETA-LACTAMASA
Estimated Expiration: ⤷ Sign Up
Patent: 10010568
Patent: INHIBIDORES DE LA RENINA
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 31667
Patent: INHIBITEURS DE BÊTA-LACTAMASE (BETA-LACTAMASE INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Patent: 66774
Patent: Inhibiteurs de bêta-lactamase (Beta-lactamase Inhibitors)
Estimated Expiration: ⤷ Sign Up
France
Patent: C1030
Estimated Expiration: ⤷ Sign Up
Patent: C1031
Estimated Expiration: ⤷ Sign Up
Patent: C1032
Estimated Expiration: ⤷ Sign Up
Honduras
Patent: 10001395
Patent: INHIBIDORES DE BETA-LACTAMASA
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 43809
Patent: BETA-LACTAMASE INHIBITORS
Estimated Expiration: ⤷ Sign Up
Patent: 86180
Patent: β-內酰胺酶抑制劑 (BETA LACTAMASE INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 00504
Estimated Expiration: ⤷ Sign Up
Patent: 00513
Estimated Expiration: ⤷ Sign Up
Patent: 000023
Estimated Expiration: ⤷ Sign Up
Patent: 000024
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 6395
Patent: N-הטרוציקליל-7-אוקסו-6-סולפאוקסי-6,1-דיאזאביציקלו[1.2.3]אוקטן-2-קרבוקסאמידים ותכשירים רוקחיים המכילים אותם (N-heterocyclyl-7-oxo-6-sulfooxy-1,6-diazabicyclo[3.2.1]octane-2-carboxamides and pharmaceutical compositions comprising them)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 38509
Estimated Expiration: ⤷ Sign Up
Patent: 22020
Estimated Expiration: ⤷ Sign Up
Patent: 97164
Estimated Expiration: ⤷ Sign Up
Patent: 11207900
Patent: β-LACTAMASE INHIBITOR
Estimated Expiration: ⤷ Sign Up
Patent: 11510012
Estimated Expiration: ⤷ Sign Up
Patent: 12214475
Patent: β-LACTAMASE INHIBITOR
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 231667
Estimated Expiration: ⤷ Sign Up
Patent: 666774
Estimated Expiration: ⤷ Sign Up
Patent: 2020516
Estimated Expiration: ⤷ Sign Up
Patent: 2020517
Estimated Expiration: ⤷ Sign Up
Patent: 2020518
Estimated Expiration: ⤷ Sign Up
Luxembourg
Patent: 0165
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 2532
Patent: BETA-LACTAMASE INHIBITORS
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 10007823
Patent: INHIBIDORES DE BETA-LACTAMASA. (BETA-LACTAMASE INHIBITORS.)
Estimated Expiration: ⤷ Sign Up
Montenegro
Patent: 089
Patent: INHIBITORI BETA-LAKTAMAZE (BETA-LACTAMASE INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 025
Patent: مثبطات بيتا اكتاماز
Estimated Expiration: ⤷ Sign Up
Netherlands
Patent: 1050
Estimated Expiration: ⤷ Sign Up
Patent: 1051
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 6861
Patent: Nitrogen-containing bridged ring compounds as beta-lactamase inhibitors
Estimated Expiration: ⤷ Sign Up
Nicaragua
Patent: 1000115
Patent: INHIBIDORES DE BETA-LACTAMASA.
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 20024
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 31667
Estimated Expiration: ⤷ Sign Up
Patent: 66774
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 31667
Estimated Expiration: ⤷ Sign Up
Patent: 66774
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 45314
Patent: ИНГИБИТОРЫ БЕТА-ЛАКТАМАЗ (BETA-LACTAMASE INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 052
Patent: INHIBITORI BETA-LAKTAMAZE (BETA-LACTAMASE INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Patent: 862
Patent: INHIBITORI BETA-LAKTAMAZE (BETA-LACTAMASE INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 31667
Estimated Expiration: ⤷ Sign Up
Patent: 66774
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1005333
Patent: BETA-LACTAMASE INHIBITORS
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1648728
Estimated Expiration: ⤷ Sign Up
Patent: 1800610
Estimated Expiration: ⤷ Sign Up
Patent: 100130176
Patent: BETA-LACTAMASE INHIBITORS
Estimated Expiration: ⤷ Sign Up
Patent: 160099117
Patent: 베타락타마제 억제제 (BETA-LACTAMASE INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 33744
Estimated Expiration: ⤷ Sign Up
Patent: 33826
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 1966
Patent: ІНГІБІТОРИ БЕТА-ЛАКТАМАЗ[ИНГИБИТОРЫ БЕТА-ЛАКТАМАЗ (BETA-LACTAMASE INHIBITORS)
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Japan | 5038509 | ⤷ Sign Up | |
| Ecuador | SP10010345 | INHIBIDORES DE BETA-LACTAMASA | ⤷ Sign Up |
| Russian Federation | 2445314 | ИНГИБИТОРЫ БЕТА-ЛАКТАМАЗ (BETA-LACTAMASE INHIBITORS) | ⤷ Sign Up |
| European Patent Office | 2666774 | Inhibiteurs de bêta-lactamase (Beta-lactamase Inhibitors) | ⤷ Sign Up |
| Japan | 5422020 | ⤷ Sign Up | |
| Croatia | P20131123 | ⤷ Sign Up | |
| Portugal | 2666774 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RECARBRIO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2231667 | PA2020516,C2231667 | Lithuania | ⤷ Sign Up | PRODUCT NAME: RELEBAKTAMAS ARBA JO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/19/1420 20200213 |
| 2231667 | 30/2020 | Austria | ⤷ Sign Up | PRODUCT NAME: RELEBACTAM ODER EIN MONOHYDRAT DAVON; REGISTRATION NO/DATE: EU/1/19/1420 (MITTEILUNG) 20200217 |
| 2666774 | 20C1032 | France | ⤷ Sign Up | PRODUCT NAME: RELEBACTAM OPTIONNELLEMENT SOUS FORME DE MONOHYDRATE, IMIPENEME ET CILASTATINE OPTIONNELLEMENT SOUS FORME DE SEL SODIQUE; REGISTRATION NO/DATE: EU/1/19/1420 20200217 |
| 2231667 | 2020023 | Norway | ⤷ Sign Up | PRODUCT NAME: RELEBACTAM ELLER ET MONOHYDRAT DERAV; REG. NO/DATE: EU/1/19/1420 20200220 |
| 2231667 | 2020C/522 | Belgium | ⤷ Sign Up | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE |
| 2666774 | PA2020518,C2666774-2 | Lithuania | ⤷ Sign Up | PRODUCT NAME: RELEBAKTAMAS, PASIRINKTINAI MONOHIDRATO PAVIDALU, SU IMIPENEMU IR CILASTATINU, PASIRINKTINAI NATRIO DRUSKOS PAVIDALU; REGISTRATION NO/DATE: EU/1/19/1420 20200213 |
| 2666774 | LUC00166 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: RELEBACTAM, EVENTUELLEMENT SOUS FORME DE MONOHYDRATE, ET IMIPENEME; AUTHORISATION NUMBER AND DATE: EU/1/19/1420 20200217 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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