Consensi is a drug owned by Purple Biotech Ltd. It is protected by 5 US drug patents filed from 2018 to 2021 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 14, 2038. Details of Consensi's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10945960 | Celecoxib and amlodipine formulation and method of making the same |
Jun, 2038
(12 years from now) | Active |
| US10925835 | Celecoxib and amlodipine formulation and method of making the same |
Jun, 2038
(12 years from now) | Active |
| US10350171 | Celecoxib and amlodipine formulation and method of making the same |
Jun, 2038
(12 years from now) | Active |
| US9408837 | Ameliorating drug-induced elevations in blood pressure by adjunctive use of antihypertensive drugs |
Feb, 2030
(4 years from now) | Active |
| US9662315 | Ameliorating drug-induced elevations in blood pressure by adjunctive use of antihypertensive drugs |
May, 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 Consensi's patents.
Latest Legal Activities on Consensi's Patents
Given below is the list of recent legal activities going on the following patents of Consensi.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 16 Jan, 2023 | US10350171 |
| Patent Issue Date Used in PTA Calculation
Critical | 16 Mar, 2021 | US10945960 |
| Recordation of Patent Grant Mailed
Critical | 16 Mar, 2021 | US10945960 |
| Issue Notification Mailed
Critical | 24 Feb, 2021 | US10945960 |
| Recordation of Patent Grant Mailed
Critical | 23 Feb, 2021 | US10925835 |
| Patent Issue Date Used in PTA Calculation
Critical | 23 Feb, 2021 | US10925835 |
| Dispatch to FDC | 10 Feb, 2021 | US10945960 |
| Application Is Considered Ready for Issue
Critical | 10 Feb, 2021 | US10945960 |
| Issue Fee Payment Verified
Critical | 08 Feb, 2021 | US10945960 |
| Issue Fee Payment Received
Critical | 08 Feb, 2021 | US10945960 |
FDA has granted several exclusivities to Consensi. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Consensi, 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
Consensi.
Exclusivity Information
Consensi holds 1 exclusivities. All of its exclusivities have expired in 2021. Details of Consensi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Combination(NC) | May 31, 2021 |
US patents provide insights into the exclusivity only within the United States, but
Consensi 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 Consensi's family patents as well as insights into
ongoing legal events
on those patents.
Consensi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Consensi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 14, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Consensi Generics:
There are no approved generic versions for Consensi as of now.
How can I launch a generic of Consensi before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Consensi's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Consensi's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Consensi -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2.5 mg/200 mg, 5 mg/200 mg, 10 mg/200 mg | 29 Jun, 2020 | 1 | 14 Jun, 2038 |
About Consensi
Consensi is a drug owned by Purple Biotech Ltd. It is used for treating adult patients with hypertension and osteoarthritis. Consensi uses Amlodipine Besylate; Celecoxib as an active ingredient. Consensi was launched by Purple Biotech in 2018.
Approval Date:
Consensi was approved by FDA for market use on 31 May, 2018.
Active Ingredient:
Consensi uses Amlodipine Besylate; Celecoxib as the active ingredient. Check out other Drugs and Companies using Amlodipine Besylate; Celecoxib ingredient
Treatment:
Consensi is used for treating adult patients with hypertension and osteoarthritis.
Dosage:
Consensi is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 10MG BASE;200MG | TABLET | Discontinued | ORAL |
| EQ 2.5MG BASE;200MG | TABLET | Discontinued | ORAL |
| EQ 5MG BASE;200MG | TABLET | Discontinued | ORAL |