Cleviprex is a drug owned by Chiesi Usa Inc. It is protected by 5 US drug patents filed from 2013 to 2021. Out of these, 3 drug patents are active and 2 have expired. Cleviprex's patents have been open to challenges since 01 August, 2012. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 10, 2031. Details of Cleviprex'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. | |||
| US5856346 | Short-acting dihydropyridines |
Jan, 2021
(3 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11103490 | Clevidipine emulsion formulations containing antimicrobial agents |
Oct, 2031
(6 years from now) | Active |
| US10010537 | Clevidipine emulsion formulations containing antimicrobial agents |
Oct, 2031
(6 years from now) | Active |
| US8658676 | Clevidipine emulsion formulations containing antimicrobial agents |
Oct, 2031
(6 years from now) | Active |
| US5856346 | Short-acting dihydropyridines |
Jan, 2021
(3 years ago) |
Expired
|
| US5739152 | Pharmaceutical emulsion |
Apr, 2015
(9 years ago) |
Expired
|
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 Cleviprex's patents.
Latest Legal Activities on Cleviprex's Patents
Given below is the list of recent legal activities going on the following patents of Cleviprex.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 03 Jan, 2022 | US10010537 |
| Patent Issue Date Used in PTA Calculation Critical | 31 Aug, 2021 | US11103490 |
| Recordation of Patent Grant Mailed Critical | 31 Aug, 2021 | US11103490 |
| Email Notification Critical | 12 Aug, 2021 | US11103490 |
| Issue Notification Mailed Critical | 11 Aug, 2021 | US11103490 |
| Dispatch to FDC | 23 Jul, 2021 | US11103490 |
| Email Notification Critical | 02 Jul, 2021 | US11103490 |
| Mail Response to 312 Amendment (PTO-271) Critical | 02 Jul, 2021 | US11103490 |
| Response to Amendment under Rule 312 Critical | 29 Jun, 2021 | US11103490 |
| Miscellaneous Incoming Letter | 25 Jun, 2021 | US11103490 |
FDA has granted several exclusivities to Cleviprex. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Cleviprex, 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 Cleviprex.
Exclusivity Information
Cleviprex holds 1 exclusivities. All of its exclusivities have expired in 2013. Details of Cleviprex's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 01, 2013 |
Several oppositions have been filed on Cleviprex'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 Cleviprex's generic, the next section provides detailed information on ongoing and past EP oppositions related to Cleviprex patents.
Cleviprex's Oppositions Filed in EPO
Cleviprex has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Dec 23, 2015, by Fresenius Kabi Deutschland Gmbh. This opposition was filed on patent number EP11833207A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP11833207A | Dec, 2015 | Fresenius Kabi Deutschland GmbH | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Cleviprex 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 Cleviprex's family patents as well as insights into ongoing legal events on those patents.
Cleviprex's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Cleviprex's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 10, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Cleviprex Generics:
There are no approved generic versions for Cleviprex as of now.
How can I launch a generic of Cleviprex before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Cleviprex's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Cleviprex'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 Cleviprex -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 25 mg/50 mL and 50 mg/100 mL | 02 Jul, 2019 | 1 | 10 Oct, 2031 |
About Cleviprex
Cleviprex is a drug owned by Chiesi Usa Inc. It is used for lowering blood pressure when oral therapy is not feasible or not desirable. Cleviprex uses Clevidipine as an active ingredient. Cleviprex was launched by Chiesi in 2008.
Approval Date:
Cleviprex was approved by FDA for market use on 01 August, 2008.
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 Cleviprex is 01 August, 2008, its NCE-1 date is estimated to be 01 August, 2012.
Active Ingredient:
Cleviprex uses Clevidipine as the active ingredient. Check out other Drugs and Companies using Clevidipine ingredient
Treatment:
Cleviprex is used for lowering blood pressure when oral therapy is not feasible or not desirable.
Dosage:
Cleviprex is available in emulsion form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 50MG/100ML (0.5MG/ML) | EMULSION | Prescription | INTRAVENOUS |
| 125MG/250ML (0.5MG/ML) | EMULSION | Discontinued | INTRAVENOUS |
| 25MG/50ML (0.5MG/ML) | EMULSION | Prescription | INTRAVENOUS |