Dyloject is a drug owned by Javelin Pharmaceuticals Inc A Wholly Owned Sudsidiary Of Hospira Inc. It is protected by 2 US drug patents filed in 2015. Out of these, 1 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 22, 2027. Details of Dyloject'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). | |||
| US8946292 | Formulations of low dose diclofenac and beta-cyclodextrin |
Mar, 2027
(2 years from now) | Active |
| US6407079 | Pharmaceutical compositions containing drugs which are instable or sparingly soluble in water and methods for their preparation |
Jun, 2019
(5 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 Dyloject's patents.
Latest Legal Activities on Dyloject's Patents
Given below is the list of recent legal activities going on the following patents of Dyloject.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Jul, 2022 | US8946292 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 19 Jul, 2018 | US8946292 |
| Recordation of Patent Grant Mailed Critical | 03 Feb, 2015 | US8946292 |
| Patent Issue Date Used in PTA Calculation Critical | 03 Feb, 2015 | US8946292 |
| Email Notification Critical | 15 Jan, 2015 | US8946292 |
| Issue Notification Mailed Critical | 14 Jan, 2015 | US8946292 |
| Dispatch to FDC | 31 Dec, 2014 | US8946292 |
| Application Is Considered Ready for Issue Critical | 30 Dec, 2014 | US8946292 |
| Issue Fee Payment Verified Critical | 17 Dec, 2014 | US8946292 |
| Issue Fee Payment Received Critical | 17 Dec, 2014 | US8946292 |
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 Dyloject and ongoing litigations to help you estimate the early arrival of Dyloject generic.
Dyloject's Litigations
Dyloject been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 05, 2000, against patent number US6407079. The petitioner , challenged the validity of this patent, with PITHA V. MULLER as the respondent. Click below to track the latest information on how companies are challenging Dyloject's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6407079 | October, 2000 |
Decision
(05 Oct, 2000) | PITHA V. MULLER | |
FDA has granted some exclusivities to Dyloject. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Dyloject, 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 Dyloject.
Exclusivity Information
Dyloject holds 1 exclusivities. All of its exclusivities have expired in 2017. Details of Dyloject's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Dec 23, 2017 |
US patents provide insights into the exclusivity only within the United States, but Dyloject 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 Dyloject's family patents as well as insights into ongoing legal events on those patents.
Dyloject's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Dyloject's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 22, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Dyloject Generic API suppliers:
Diclofenac Sodium is the generic name for the brand Dyloject. 41 different companies have already filed for the generic of Dyloject, with Rubicon having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Dyloject's generic
How can I launch a generic of Dyloject before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Dyloject's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Dyloject'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 Dyloject -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 37.5 mg/mL, 1 mL single-dose vials | 15 Dec, 2015 | 1 | 18 Jun, 2019 | 22 Mar, 2027 | Eligible |
Alternative Brands for Dyloject
Dyloject which is used for pain management., has several other brand drugs using the same active ingredient (Diclofenac Sodium). 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 | |
|---|---|---|
| Falcon Pharms |
| |
| Fougera Pharms |
| |
| Horizon |
| |
| Nuvo Pharms Inc |
| |
| Pfizer |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Diclofenac Sodium, Dyloject's active ingredient. Check the complete list of approved generic manufacturers for Dyloject
About Dyloject
Dyloject is a drug owned by Javelin Pharmaceuticals Inc A Wholly Owned Sudsidiary Of Hospira Inc. It is used for pain management. Dyloject uses Diclofenac Sodium as an active ingredient. Dyloject was launched by Javelin Pharms Inc in 2014.
Approval Date:
Dyloject was approved by FDA for market use on 23 December, 2014.
Active Ingredient:
Dyloject uses Diclofenac Sodium as the active ingredient. Check out other Drugs and Companies using Diclofenac Sodium ingredient
Treatment:
Dyloject is used for pain management.
Dosage:
Dyloject is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 37.5MG/ML (37.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION | Discontinued | INTRAVENOUS |