Orbactiv is a drug owned by Melinta Therapeutics Llc. It is protected by 5 US drug patents filed from 2014 to 2017. Out of these, 3 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 16, 2035. Details of Orbactiv's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US5998581 | Reductive alkylation of glycopeptide antibiotics |
Nov, 2017
(6 years ago) |
Expired
|
| US5840684 | Glycopeptide antibiotic derivatives |
Nov, 2020
(3 years ago) |
Expired
|
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8420592 | Methods of treatment using single doses of oritavancin |
Aug, 2029
(5 years from now) | Active |
| US9682061 | Methods of treating bacterial infections using oritavancin |
Apr, 2030
(5 years from now) | Active |
| US9649352 | High purity oritavancin and method of producing same |
Jul, 2035
(10 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 Orbactiv's patents.
Latest Legal Activities on Orbactiv's Patents
Given below is the list of recent legal activities going on the following patents of Orbactiv.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 28 Sep, 2020 | US9649352 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 28 Sep, 2020 | US9682061 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 15 Sep, 2020 | US8420592 |
| Recordation of Patent Grant Mailed | 20 Jun, 2017 | US9682061 |
| Patent Issue Date Used in PTA Calculation | 20 Jun, 2017 | US9682061 |
| Email Notification | 01 Jun, 2017 | US9682061 |
| Issue Notification Mailed | 31 May, 2017 | US9682061 |
| Patent Issue Date Used in PTA Calculation | 16 May, 2017 | US9649352 |
| Dispatch to FDC | 16 May, 2017 | US9682061 |
| Recordation of Patent Grant Mailed | 16 May, 2017 | US9649352 |
FDA has granted several exclusivities to Orbactiv. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Orbactiv, 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 Orbactiv.
Exclusivity Information
Orbactiv holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2024. Details of Orbactiv's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 06, 2019 |
| Generating Antibiotic Incentives Now(GAIN) | Aug 06, 2024 |
Several oppositions have been filed on Orbactiv's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Orbactiv's generic, the next section provides detailed information on ongoing and past EP oppositions related to Orbactiv patents.
Orbactiv's oppositions filed in EPO
Orbactiv has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jan 13, 2017, by Prüfer & Partner Mbb. This opposition was filed on patent number EP09810708A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP09810708A | Jan, 2017 | Prüfer & Partner mbB | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Orbactiv 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 Orbactiv's family patents as well as insights into ongoing legal events on those patents.
Orbactiv's family patents
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Generic Launch
Generic Release Date:
Orbactiv's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 16, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Orbactiv Generics:
There are no approved generic versions for Orbactiv as of now.
About Orbactiv
Orbactiv is a drug owned by Melinta Therapeutics Llc. It is used for treating bacterial skin and skin structure infections. Orbactiv uses Oritavancin Diphosphate as an active ingredient. Orbactiv was launched by Melinta Therap in 2014.
Market Authorisation Date:
Orbactiv was approved by FDA for market use on 06 August, 2014.
NCE-1 date:
NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Orbactiv is 06 August, 2014, its NCE-1 date is estimated to be 07 August, 2023
Active Ingredient:
Orbactiv uses Oritavancin Diphosphate as the active ingredient. Check out other Drugs and Companies using Oritavancin Diphosphate ingredient
Treatment:
Orbactiv is used for treating bacterial skin and skin structure infections.
Dosage:
Orbactiv is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 400MG BASE/VIAL | POWDER | Prescription | INTRAVENOUS |