Ofirmev is a drug owned by Mallinckrodt Hosp Products Ip Ltd. It is protected by 11 US drug patents filed from 2013 to 2019. Out of these, 7 drug patents are active and 4 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 11, 2032. Details of Ofirmev'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). | |||
|
US9399012 (Pediatric) | Reduced dose intravenous acetaminophen |
Mar, 2032
(7 years from now) | Active |
| US9399012 | Reduced dose intravenous acetaminophen |
Sep, 2031
(6 years from now) | Active |
|
US9987238 (Pediatric) | Reduced dose intravenous acetaminophen |
May, 2029
(4 years from now) | Active |
|
US9610265 (Pediatric) | Reduced dose intravenous acetaminophen |
May, 2029
(4 years from now) | Active |
| US10383834 | Reduced dose intravenous acetaminophen |
Nov, 2028
(3 years from now) | Active |
| US9987238 | Reduced dose intravenous acetaminophen |
Nov, 2028
(3 years from now) | Active |
| US9610265 | Reduced dose intravenous acetaminophen |
Nov, 2028
(3 years from now) | Active |
|
US6992218 (Pediatric) | Method for obtaining aqueous formulations of oxidation-sensitive active principles |
Dec, 2021
(2 years ago) |
Expired
|
| US6992218 | Method for obtaining aqueous formulations of oxidation-sensitive active principles |
Jun, 2021
(3 years ago) |
Expired
|
|
US6028222 (Pediatric) | Stable liquid paracetamol compositions, and method for preparing same |
Feb, 2018
(6 years ago) |
Expired
|
| US6028222 | Stable liquid paracetamol compositions, and method for preparing same |
Aug, 2017
(7 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 Ofirmev's patents.
Latest Legal Activities on Ofirmev's Patents
Given below is the list of recent legal activities going on the following patents of Ofirmev.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 26 Jan, 2024 | US9399012 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Feb, 2023 | US10383834 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 06 Dec, 2021 | US9987238 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 30 Sep, 2020 | US9610265 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 27 Jan, 2020 | US9399012 |
| Recordation of Patent Grant Mailed Critical | 20 Aug, 2019 | US10383834 |
| Patent Issue Date Used in PTA Calculation Critical | 20 Aug, 2019 | US10383834 |
| Email Notification Critical | 01 Aug, 2019 | US10383834 |
| Issue Notification Mailed Critical | 31 Jul, 2019 | US10383834 |
| Dispatch to FDC | 22 Jul, 2019 | US10383834 |
FDA has granted several exclusivities to Ofirmev. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Ofirmev, 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 Ofirmev.
Exclusivity Information
Ofirmev holds 3 exclusivities. All of its exclusivities have expired in 2020. Details of Ofirmev's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Nov 02, 2013 |
| M(M-196) | Jan 27, 2020 |
| Pediatric Exclusivity(PED) | Jul 27, 2020 |
US patents provide insights into the exclusivity only within the United States, but Ofirmev 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 Ofirmev's family patents as well as insights into ongoing legal events on those patents.
Ofirmev's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ofirmev's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 11, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ofirmev Generic API suppliers:
Acetaminophen is the generic name for the brand Ofirmev. 20 different companies have already filed for the generic of Ofirmev, with Cosette having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Ofirmev's generic
How can I launch a generic of Ofirmev before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Ofirmev's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Ofirmev'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 Ofirmev -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1000 mg/100 mL (10 mg/mL) | 07 Apr, 2011 | 1 | 06 Jun, 2021 | Extinguished |
Alternative Brands for Ofirmev
Ofirmev which is used for managing mild to severe pain in conjunction with opioid analgesics., has several other brand drugs using the same active ingredient (Acetaminophen). 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 | ||
|---|---|---|---|
| Aft Pharms Us |
| ||
| Fresenius Kabi Usa |
| ||
| Haleon Us Holdings |
| ||
| Hikma |
| ||
| Mallinckrodt Inc |
| ||
| Zevra Therap |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Acetaminophen, Ofirmev's active ingredient. Check the complete list of approved generic manufacturers for Ofirmev
About Ofirmev
Ofirmev is a drug owned by Mallinckrodt Hosp Products Ip Ltd. It is used for managing mild to severe pain in conjunction with opioid analgesics. Ofirmev uses Acetaminophen as an active ingredient. Ofirmev was launched by Mallinckrodt Hosp in 2010.
Approval Date:
Ofirmev was approved by FDA for market use on 02 November, 2010.
Active Ingredient:
Ofirmev uses Acetaminophen as the active ingredient. Check out other Drugs and Companies using Acetaminophen ingredient
Treatment:
Ofirmev is used for managing mild to severe pain in conjunction with opioid analgesics.
Dosage:
Ofirmev is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION | Discontinued | INTRAVENOUS |