Diprivan is a drug owned by Fresenius Kabi Usa Llc. It is protected by 10 US drug patents filed in 2013. Out of these, 2 drug patents are active and 8 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 01, 2025. Details of Diprivan'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. | |||
| US8476010 | Propofol formulations with non-reactive container closures |
Dec, 2024
(4 months from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US5908869 | Propofol compositions containing edetate |
Mar, 2015
(9 years ago) |
Expired
|
| US5714520 | Propofol compostion containing edetate |
Mar, 2015
(9 years ago) |
Expired
|
| US5731356 | Pharmaceutical compositions of propofol and edetate |
Mar, 2015
(9 years ago) |
Expired
|
| US5731355 | Pharmaceutical compositions of propofol and edetate |
Mar, 2015
(9 years ago) |
Expired
|
|
US5731356 (Pediatric) | Pharmaceutical compositions of propofol and edetate |
Sep, 2015
(8 years ago) |
Expired
|
|
US5731355 (Pediatric) | Pharmaceutical compositions of propofol and edetate |
Sep, 2015
(8 years ago) |
Expired
|
|
US5714520 (Pediatric) | Propofol compostion containing edetate |
Sep, 2015
(8 years ago) |
Expired
|
|
US5908869 (Pediatric) | Propofol compositions containing edetate |
Sep, 2015
(8 years ago) |
Expired
|
|
US8476010 (Pediatric) | Propofol formulations with non-reactive container closures |
Jun, 2025
(10 months 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 Diprivan's patents.
Latest Legal Activities on Diprivan's Patents
Given below is the list of recent legal activities going on the following patents of Diprivan.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 04 Jan, 2021 | US8476010 (Litigated) |
| Review Certificate Mailed | 16 Jan, 2020 | US8476010 (Litigated) |
| Review Certificate | 27 Nov, 2019 | US8476010 (Litigated) |
| Termination or Final Written Decision | 07 Jun, 2017 | US8476010 (Litigated) |
| Request for Trial Granted | 08 Jun, 2016 | US8476010 (Litigated) |
| Petition Requesting Trial | 10 Dec, 2015 | US8476010 (Litigated) |
| Post Issue Communication - Certificate of Correction | 12 May, 2015 | US8476010 (Litigated) |
| Termination or Final Written Decision | 02 Apr, 2015 | US8476010 (Litigated) |
| Petition Requesting Trial | 06 Feb, 2015 | US8476010 (Litigated) |
| Mail-Petition Decision - Dismissed | 28 Oct, 2014 | US8476010 (Litigated) |
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 Diprivan and ongoing litigations to help you estimate the early arrival of Diprivan generic.
Diprivan's Litigations
Diprivan has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Feb 06, 2015, against patent number US8476010. The petitioner Dr. Reddy's Laboratories, Inc., challenged the validity or infringement of this patent, with Fresenius Kabi USA, LLC as the respondent. Click below to track the latest information on how companies are challenging Diprivan's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8476010 | November, 2015 | FWD Entered | Fresenius Kabi USA, LLC | J Kyle Bass |
| US8476010 | February, 2015 | Terminated-Denied | Fresenius Kabi USA, LLC | Dr. Reddy's Laboratories, Inc. |
US patents provide insights into the exclusivity only within the United States, but Diprivan 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 Diprivan's family patents as well as insights into ongoing legal events on those patents.
Diprivan's family patents
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Generic Launch
Generic Release Date:
Diprivan's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 01, 2025 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Diprivan Generics:
Propofol is the generic name for the brand Diprivan. 9 different companies have already filed for the generic of Diprivan, with Aspiro having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Diprivan's generic
How can I launch a generic of Diprivan before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Diprivan's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Diprivan'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 Diprivan -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg/mL ; 20 mL, 50 mL and 100 mL vials and 20 mL syringe |
About Diprivan
Diprivan is a drug owned by Fresenius Kabi Usa Llc. It is used for preventing microbial growth, administering over a longer period, and inducing anesthesia. Diprivan uses Propofol as an active ingredient. Diprivan was launched by Fresenius Kabi Usa in 1989.
Market Authorisation Date:
Diprivan was approved by FDA for market use on 02 October, 1989.
Active Ingredient:
Diprivan uses Propofol as the active ingredient. Check out other Drugs and Companies using Propofol ingredient
Treatment:
Diprivan is used for preventing microbial growth, administering over a longer period, and inducing anesthesia.
Dosage:
Diprivan is available in injectable form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG/ML | INJECTABLE | Prescription | INJECTION |