Doribax is a drug owned by Shionogi Inc. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Doribax's patents have been open to challenges since 13 October, 2011. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 30, 2021. Details of Doribax'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). | |||
| US8247402 | Crystal form of pyrrolidylthiocarbapenem derivative |
Mar, 2021
(3 years ago) |
Expired
|
| US5317016 | Pyrrolidylthiocarbapenem derivative |
Jun, 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 Doribax's patents.
Latest Legal Activities on Doribax's Patents
Given below is the list of recent legal activities going on the following patents of Doribax.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed Critical | 08 Apr, 2024 | US8247402 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 06 Feb, 2020 | US8247402 (Litigated) |
| Post Issue Communication - Certificate of Correction | 29 May, 2013 | US8247402 (Litigated) |
| Case Docketed to Examiner in GAU Critical | 07 May, 2013 | US8247402 (Litigated) |
| Post Issue Communication - Certificate of Correction | 01 May, 2013 | US8247402 (Litigated) |
| Post Issue Communication - Certificate of Correction | 07 Mar, 2013 | US8247402 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 21 Aug, 2012 | US8247402 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 21 Aug, 2012 | US8247402 (Litigated) |
| Email Notification Critical | 02 Aug, 2012 | US8247402 (Litigated) |
| Issue Notification Mailed Critical | 01 Aug, 2012 | US8247402 (Litigated) |
FDA has granted several exclusivities to Doribax. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Doribax, 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 Doribax.
Exclusivity Information
Doribax holds 1 exclusivities. All of its exclusivities have expired in 2012. Details of Doribax's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 12, 2012 |
US patents provide insights into the exclusivity only within the United States, but Doribax 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 Doribax's family patents as well as insights into ongoing legal events on those patents.
Doribax's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Doribax's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 30, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Doribax Generics:
There are no approved generic versions for Doribax as of now.
How can I launch a generic of Doribax before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Doribax's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Doribax'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 Doribax -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 250 mg/vial and 500 mg/vial | 12 Oct, 2011 | 1 | 05 Jun, 2015 | Extinguished |
Alternative Brands for Doribax
Doribax which is used for treating bacterial infections., has several other brand drugs in the same treatment category . 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 | Treatment Area | ||||
|---|---|---|---|---|---|---|
| Abbvie |
| |||||
| Baxter Hlthcare Corp |
| |||||
| Cubist Pharms Llc |
| |||||
| Cumberland |
| |||||
| Lg Chem Ltd |
| |||||
| Pfizer |
| |||||
| Pf Prism Cv |
| |||||
| Rempex |
| |||||
| Wyeth Pharms |
| |||||
| Xellia Pharms Aps |
| |||||
About Doribax
Doribax is a drug owned by Shionogi Inc. It is used for treating bacterial infections. Doribax uses Doripenem as an active ingredient. Doribax was launched by Shionogi Inc in 2010.
Approval Date:
Doribax was approved by FDA for market use on 05 October, 2010.
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 Doribax is 05 October, 2010, its NCE-1 date is estimated to be 13 October, 2011.
Active Ingredient:
Doribax uses Doripenem as the active ingredient. Check out other Drugs and Companies using Doripenem ingredient
Treatment:
Doribax is used for treating bacterial infections.
Dosage:
Doribax is available in injectable form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE | Discontinued | INTRAVENOUS |
| 250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE | Discontinued | INTRAVENOUS |