Vabomere is a drug owned by Rempex Pharmaceuticals Inc A Wholly Owned Sub Of Melinta Therapeutics Llc. It is protected by 7 US drug patents filed from 2017 to 2022 out of which none have expired yet. Vabomere's patents will be open to challenges from 29 August, 2026. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 06, 2039. Details of Vabomere'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. | |||
| US8680136 | Cyclic boronic acid ester derivatives and therapeutic uses thereof |
Aug, 2031
(6 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11376237 | Methods of treating bacterial infections |
Apr, 2039
(14 years from now) | Active |
| US11007206 | Cyclic boronic acid ester derivatives and therapeutic uses thereof |
Aug, 2031
(6 years from now) | Active |
| US10183034 | Therapeutic uses of pharmaceutical compositions comprising cyclic boronic acid ester derivatives |
Aug, 2031
(6 years from now) | Active |
| US10172874 | Pharmaceutical compositions comprising cyclic boronic acid ester derivatives |
Aug, 2031
(6 years from now) | Active |
| US9694025 | Cyclic boronic acid ester derivatives and therapeutic uses thereof |
Aug, 2031
(6 years from now) | Active |
| US10561675 | Cyclic boronic acid ester derivatives and therapeutic uses thereof |
Aug, 2031
(6 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 Vabomere's patents.
Latest Legal Activities on Vabomere's Patents
Given below is the list of recent legal activities going on the following patents of Vabomere.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Record Petition Decision of Granted to Make Entity Status large | 18 Jul, 2024 | US11007206 |
| Email Notification Critical | 30 Jan, 2024 | US9694025 |
| Mail O.P. Petition Decision | 30 Jan, 2024 | US9694025 |
| Mail-Record Petition Decision of Granted to Make Entity Status large | 26 Jan, 2024 | US9694025 |
| O.P. Petition Decision | 25 Jan, 2024 | US9694025 |
| Record Petition Decision of Granted to Make Entity Status large | 25 Jan, 2024 | US9694025 |
| Petition Entered | 05 Jan, 2024 | US9694025 |
| Payment of Maintenance Fee under 1.28(c) | 05 Jan, 2024 | US9694025 |
| Email Notification Critical | 06 Dec, 2023 | US9694025 |
| Mail O.P. Petition Decision | 06 Dec, 2023 | US9694025 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Vabomere and ongoing litigations to help you estimate the early arrival of Vabomere generic.
Vabomere's Litigations
Vabomere been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Nov 25, 2016, against patent number US10561675. The petitioner , challenged the validity of this patent, with Rempex Pharmaceuticals, Inc. as the respondent. Click below to track the latest information on how companies are challenging Vabomere's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US10561675 | November, 2016 |
Decision
(28 Aug, 2018) | Rempex Pharmaceuticals, Inc. | |
FDA has granted some exclusivities to Vabomere. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Vabomere, 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 Vabomere.
Exclusivity Information
Vabomere holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Vabomere's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 29, 2022 |
| Generating Antibiotic Incentives Now(GAIN) | Aug 29, 2027 |
US patents provide insights into the exclusivity only within the United States, but Vabomere 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 Vabomere's family patents as well as insights into ongoing legal events on those patents.
Vabomere's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Vabomere's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 06, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Vabomere Generics:
There are no approved generic versions for Vabomere as of now.
About Vabomere
Vabomere is a drug owned by Rempex Pharmaceuticals Inc A Wholly Owned Sub Of Melinta Therapeutics Llc. It is used for complicated urinary tract infections caused by specified susceptible microorganisms in patients 18 years of age and older. Vabomere uses Meropenem; Vaborbactam as an active ingredient. Vabomere was launched by Rempex in 2017.
Approval Date:
Vabomere was approved by FDA for market use on 29 August, 2017.
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 Vabomere is 29 August, 2017, its NCE-1 date is estimated to be 29 August, 2026.
Active Ingredient:
Vabomere uses Meropenem; Vaborbactam as the active ingredient. Check out other Drugs and Companies using Meropenem; Vaborbactam ingredient
Treatment:
Vabomere is used for complicated urinary tract infections caused by specified susceptible microorganisms in patients 18 years of age and older.
Dosage:
Vabomere is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1GM/VIAL;1GM/VIAL | POWDER | Prescription | INTRAVENOUS |