Diprivan is a drug owned by Fresenius Kabi Usa Llc. It is protected by 10 US drug patents filed in 2013 out of which all 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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8476010 | Propofol formulations with non-reactive container closures |
Dec, 2024
(1 year, 10 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US8476010 (Pediatric) | Propofol formulations with non-reactive container closures |
Jun, 2025
(1 year, 4 months ago) |
Expired
|
|
US5714520 (Pediatric) | Propofol compostion containing edetate |
Sep, 2015
(11 years ago) |
Expired
|
|
US5731356 (Pediatric) | Pharmaceutical compositions of propofol and edetate |
Sep, 2015
(11 years ago) |
Expired
|
|
US5908869 (Pediatric) | Propofol compositions containing edetate |
Sep, 2015
(11 years ago) |
Expired
|
|
US5731355 (Pediatric) | Pharmaceutical compositions of propofol and edetate |
Sep, 2015
(11 years ago) |
Expired
|
| US5908869 | Propofol compositions containing edetate |
Mar, 2015
(11 years ago) |
Expired
|
| US5714520 | Propofol compostion containing edetate |
Mar, 2015
(11 years ago) |
Expired
|
| US5731355 | Pharmaceutical compositions of propofol and edetate |
Mar, 2015
(11 years ago) |
Expired
|
| US5731356 | Pharmaceutical compositions of propofol and edetate |
Mar, 2015
(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 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.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent | 04 Aug, 2025 | US8476010 (Litigated) |
| Maintenance Fee Reminder Mailed | 17 Feb, 2025 | US8476010 (Litigated) |
| 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
Critical | 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) |
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 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. et al., challenged the validity 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 |
Final Written Decision
(07 Jun, 2017) | Fresenius Kabi USA, LLC | Bass, J Kyle et al. |
| US8476010 | February, 2015 |
Institution Denied
(02 Apr, 2015) | Fresenius Kabi USA, LLC | Dr. Reddy's Laboratories, Inc. et al. |
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
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Diprivan:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
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 Generic API suppliers:
Propofol is the generic name for the brand Diprivan. 12 different companies have already filed for the generic of Diprivan, with Amneal 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 | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| None |
Alternative Brands for Diprivan
Diprivan which is used for preventing microbial growth, administering over a longer period, and inducing anesthesia., has several other brand drugs using the same active ingredient (Propofol). 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 | |
|---|---|---|
| Eisai Inc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Propofol, Diprivan's active ingredient. Check the complete list of approved generic manufacturers for Diprivan
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 in 1989.
Approval 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 |