Xerava is a drug owned by Tetraphase Pharmaceuticals Inc. It is protected by 4 US drug patents filed from 2019 to 2023 out of which none have expired yet. Xerava's patents will be open to challenges from 28 August, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 19, 2037. Details of Xerava'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. | |||
| US10961190 | Crystalline forms of eravacycline |
Oct, 2037
(11 years from now) | Active |
| US11578044 | Crystalline forms of eravacycline |
Oct, 2037
(11 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). | |||
| US8906887 | C7-fluoro substituted tetracycline compounds |
Dec, 2030
(5 years from now) | Active |
| US8796245 | C7-fluoro substituted tetracycline compounds |
Aug, 2029
(3 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 Xerava's patents.
Latest Legal Activities on Xerava's Patents
Given below is the list of recent legal activities going on the following patents of Xerava.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| transaction for FDA Determination of Regulatory Review Period | 29 Feb, 2024 | US8906887 |
| transaction for FDA Determination of Regulatory Review Period | 23 Feb, 2024 | US8906887 |
| Recordation of Patent Grant Mailed
Critical | 14 Feb, 2023 | US11578044 |
| Patent Issue Date Used in PTA Calculation
Critical | 14 Feb, 2023 | US11578044 |
| Email Notification
Critical | 26 Jan, 2023 | US11578044 |
| Issue Notification Mailed
Critical | 25 Jan, 2023 | US11578044 |
| Application Is Considered Ready for Issue
Critical | 09 Jan, 2023 | US11578044 |
| Dispatch to FDC | 09 Jan, 2023 | US11578044 |
| Supplemental Papers - Oath or Declaration | 05 Jan, 2023 | US11578044 |
| Issue Fee Payment Verified
Critical | 05 Jan, 2023 | US11578044 |
FDA has granted several exclusivities to Xerava. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Xerava, 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
Xerava.
Exclusivity Information
Xerava holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Xerava's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 27, 2023 |
| Generating Antibiotic Incentives Now(GAIN) | Aug 27, 2028 |
Several oppositions have been filed on Xerava'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 Xerava's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Xerava patents.
Xerava's Oppositions Filed in EPO
Xerava has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jul 18, 2018, by Sandoz Ag. This opposition was filed on patent number EP15180611A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP15180611A | Jul, 2018 | Sandoz AG | Revoked |
US patents provide insights into the exclusivity only within the United States, but
Xerava 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 Xerava's family patents as well as insights into
ongoing legal events
on those patents.
Xerava's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Xerava's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 19, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xerava Generics:
There are no approved generic versions for Xerava as of now.
About Xerava
Xerava is a drug owned by Tetraphase Pharmaceuticals Inc. It is used for treating complicated intra-abdominal infections in adults aged 18 years and older. Xerava uses Eravacycline Dihydrochloride as an active ingredient. Xerava was launched by Tetraphase Pharms in 2018.
Approval Date:
Xerava was approved by FDA for market use on 27 August, 2018.
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 Xerava is 27 August, 2018, its NCE-1 date is estimated to be 28 August, 2027.
Active Ingredient:
Xerava uses Eravacycline Dihydrochloride as the active ingredient. Check out other Drugs and Companies using Eravacycline Dihydrochloride ingredient
Treatment:
Xerava is used for treating complicated intra-abdominal infections in adults aged 18 years and older.
Dosage:
Xerava is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 50MG BASE/VIAL | POWDER | Prescription | INTRAVENOUS |
| EQ 100MG BASE/VIAL | POWDER | Prescription | INTRAVENOUS |