Precedex is a drug owned by Hospira Inc. It is protected by 17 US drug patents filed from 2013 to 2018. Out of these, 13 drug patents are active and 4 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 04, 2032. Details of Precedex'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). | |||
|
US8338470 (Pediatric) | Dexmedetomidine premix formulation |
Jul, 2032
(7 years from now) | Active |
|
US8455527 (Pediatric) | Methods of treatment using a dexmedetomidine premix formulation |
Jul, 2032
(7 years from now) | Active |
|
US8242158 (Pediatric) | Dexmedetomidine premix formulation |
Jul, 2032
(7 years from now) | Active |
|
US8648106 (Pediatric) | Dexmedetomidine premix formulation |
Jul, 2032
(7 years from now) | Active |
|
US9616049 (Pediatric) | Dexmedetomidine premix formulation |
Jul, 2032
(7 years from now) | Active |
|
US9320712 (Pediatric) | Dexmedetomidine premix formulation |
Jul, 2032
(7 years from now) | Active |
| US9320712 | Dexmedetomidine premix formulation |
Jan, 2032
(6 years from now) | Active |
| US8648106 | Dexmedetomidine premix formulation |
Jan, 2032
(6 years from now) | Active |
| US9616049 | Dexmedetomidine premix formulation |
Jan, 2032
(6 years from now) | Active |
| US8455527 | Methods of treatment using a dexmedetomidine premix formulation |
Jan, 2032
(6 years from now) | Active |
| US8242158 | Dexmedetomidine premix formulation |
Jan, 2032
(6 years from now) | Active |
| US10016396 | Dexmedetomidine premix formulation |
Jan, 2032
(6 years from now) | Active |
| US8338470 | Dexmedetomidine premix formulation |
Jan, 2032
(6 years from now) | Active |
|
US6716867 (Pediatric) | Use of dexmedetomidine for ICU sedation |
Oct, 2019
(5 years ago) |
Expired
|
| US6716867 | Use of dexmedetomidine for ICU sedation |
Mar, 2019
(6 years ago) |
Expired
|
|
US4910214 (Pediatric) | Optical isomer of an imidazole derivative medetomidine as an alpha-2-receptor agonist |
Jan, 2014
(11 years ago) |
Expired
|
| US4910214 | Optical isomer of an imidazole derivative medetomidine as an alpha-2-receptor agonist |
Jul, 2013
(11 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 Precedex's patents.
Latest Legal Activities on Precedex's Patents
Given below is the list of recent legal activities going on the following patents of Precedex.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 10 May, 2024 | US8338470 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 11 Jan, 2024 | US8242158 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 14 Sep, 2023 | US9320712 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 09 Dec, 2021 | US10016396 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 15 Jul, 2021 | US8648106 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Sep, 2020 | US8455527 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 15 Sep, 2020 | US9616049 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 May, 2020 | US8338470 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Jan, 2020 | US8242158 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 16 Sep, 2019 | US9320712 |
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 Precedex and ongoing litigations to help you estimate the early arrival of Precedex generic.
Precedex's Litigations
Precedex been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Aug 11, 2016, against patent number US8648106. The petitioner Amneal Pharmaceuticals LLC, challenged the validity of this patent, with Hospira, Inc. as the respondent. Click below to track the latest information on how companies are challenging Precedex's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8242158 | March, 2017 |
Terminated-Denied
(06 Sep, 2017) | Hospira, Inc. | Fresenius Kabi USA, LLC |
| US8338470 | March, 2017 |
Terminated-Denied
(06 Sep, 2017) | Hospira, Inc. | Fresenius Kabi USA, LLC |
| US8455527 | March, 2017 |
Terminated-Denied
(06 Sep, 2017) | Hospira, Inc. | Fresenius Kabi USA, LLC |
| US8338470 | August, 2016 |
Terminated-Settled
(26 May, 2017) | Hospira, Inc. | Amneal Pharmaceuticals LLC |
| US8242158 | August, 2016 |
Terminated-Settled
(19 May, 2017) | Hospira, Inc. | Amneal Pharmaceuticals LLC |
| US8455527 | August, 2016 |
Terminated-Settled
(19 May, 2017) | Hospira, Inc. | Amneal Pharmaceuticals LLC |
| US8648106 | August, 2016 |
Terminated-Denied
(03 Feb, 2017) | Hospira, Inc. | Amneal Pharmaceuticals LLC |
FDA has granted some exclusivities to Precedex. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Precedex, 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 Precedex.
Exclusivity Information
Precedex holds 4 exclusivities out of which 3 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Precedex's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-577) | Oct 17, 2011 |
| M(M-61) | Jun 17, 2016 |
| Pediatric Exclusivity(PED) | Dec 17, 2016 |
| New Patient Population(NPP) | Dec 16, 2025 |
Several oppositions have been filed on Precedex'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 Precedex's generic, the next section provides detailed information on ongoing and past EP oppositions related to Precedex patents.
Precedex's Oppositions Filed in EPO
Precedex has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jan 09, 2019, by Fresenius Kabi Deutschland Gmbh. This opposition was filed on patent number EP12823234A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP12823234A | Jan, 2019 | Fresenius Kabi Deutschland GmbH | Revoked |
US patents provide insights into the exclusivity only within the United States, but Precedex 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 Precedex's family patents as well as insights into ongoing legal events on those patents.
Precedex's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Precedex's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 04, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Precedex Generic API suppliers:
Dexmedetomidine Hydrochloride is the generic name for the brand Precedex. 24 different companies have already filed for the generic of Precedex, with Hengrui Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Precedex's generic
How can I launch a generic of Precedex before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Precedex's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Precedex'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 Precedex -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 100 mcg/mL | 08 Apr, 2009 | 1 | 14 Jun, 2016 | 31 Mar, 2019 | Eligible |
| 4 mcg/mL, 50 mL and 100 mL vials | 26 Dec, 2013 | 1 | 30 Jan, 2020 | 04 Jan, 2032 | Extinguished |
| 4 mcg/mL, 20 mL vials | 30 Sep, 2015 | 1 | 29 Nov, 2018 | 04 Jan, 2032 | Eligible |
Alternative Brands for Precedex
Precedex which is used for sedating patients in the Intensive Care Unit and during surgical procedures., has several other brand drugs using the same active ingredient (Dexmedetomidine Hydrochloride). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Bioxcel |
| |
| Hq Spclt Pharma |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Dexmedetomidine Hydrochloride, Precedex's active ingredient. Check the complete list of approved generic manufacturers for Precedex
About Precedex
Precedex is a drug owned by Hospira Inc. It is used for sedating patients in the Intensive Care Unit and during surgical procedures. Precedex uses Dexmedetomidine Hydrochloride as an active ingredient. Precedex was launched by Hospira in 2020.
Approval Date:
Precedex was approved by FDA for market use on 31 January, 2020.
Active Ingredient:
Precedex uses Dexmedetomidine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Dexmedetomidine Hydrochloride ingredient
Treatment:
Precedex is used for sedating patients in the Intensive Care Unit and during surgical procedures.
Dosage:
Precedex is available in injectable form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE | Prescription | INJECTION |
| EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE | Prescription | INJECTION |
| EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE | Prescription | INJECTION |
| EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | INJECTABLE | Prescription | INJECTION |