Recarbrio is a drug owned by Merck Sharp And Dohme Corp A Sub Of Merck And Co Inc. It is protected by 1 US drug patent filed in 2019 out of which none have expired yet. Recarbrio's patents will be open to challenges from 16 July, 2028. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 21, 2033. Details of Recarbrio's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8487093 | β-lactamase inhibitors |
Mar, 2033
(8 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Recarbrio's patents.
Latest Legal Activities on Recarbrio's Patents
Given below is the list of recent legal activities going on the following patents of Recarbrio.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Notice of Final Determination -Eligible | 23 Nov, 2022 | US8487093 |
| FDA Final Eligibility Letter Critical | 01 Aug, 2022 | US8487093 |
| transaction for FDA Determination of Regulatory Review Period | 05 Nov, 2021 | US8487093 |
| transaction for FDA Determination of Regulatory Review Period | 04 Nov, 2021 | US8487093 |
| Second letter to regulating agency to determine regulatory review period | 12 Jul, 2021 | US8487093 |
| Letter from FDA or Dept of Agriculture re PTE application | 04 Jan, 2021 | US8487093 |
| Initial letter Re: PTE Application to regulating agency | 29 Sep, 2020 | US8487093 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Sep, 2020 | US8487093 |
| Post Issue Communication - Certificate of Correction | 07 Oct, 2015 | US8487093 |
| SE - Mail Supplemental Examination Petition Granted | 13 Aug, 2015 | US8487093 |
FDA has granted several exclusivities to Recarbrio. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Recarbrio, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Recarbrio.
Exclusivity Information
Recarbrio holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Recarbrio's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 16, 2024 |
| Generating Antibiotic Incentives Now(GAIN) | Jul 16, 2029 |
US patents provide insights into the exclusivity only within the United States, but Recarbrio is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Recarbrio's family patents as well as insights into ongoing legal events on those patents.
Recarbrio's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Recarbrio's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 21, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Recarbrio Generics:
There are no approved generic versions for Recarbrio as of now.
About Recarbrio
Recarbrio is a drug owned by Merck Sharp And Dohme Corp A Sub Of Merck And Co Inc. It is used for treating complicated urinary tract infections. Recarbrio uses Cilastatin Sodium; Imipenem; Relebactam as an active ingredient. Recarbrio was launched by Msd Merck Co in 2019.
Can you believe Recarbrio received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Recarbrio was approved by FDA for market use on 16 July, 2019.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Recarbrio is 16 July, 2019, its NCE-1 date is estimated to be 16 July, 2028.
Active Ingredient:
Recarbrio uses Cilastatin Sodium; Imipenem; Relebactam as the active ingredient. Check out other Drugs and Companies using Cilastatin Sodium; Imipenem; Relebactam ingredient
Treatment:
Recarbrio is used for treating complicated urinary tract infections.
Dosage:
Recarbrio is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | POWDER | Prescription | INTRAVENOUS |