Cardene In 0.83% Sodium Chloride In Plastic Container is a drug owned by Chiesi Usa Inc. It is protected by 6 US drug patents filed from 2013 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 26, 2027. Details of Cardene In 0.83% Sodium Chloride In Plastic Container'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). | |||
| US9364564 | Pre-mixed, ready-to-use pharmaceutical compositions |
Dec, 2027
(3 years from now) | Active |
| US7612102 | Pre-mixed, ready-to-use pharmaceutical compositions |
Dec, 2027
(3 years from now) | Active |
| US8455524 | Methods of treatment with pre-mixed, ready-to-use pharmaceutical compositions |
Apr, 2027
(2 years from now) | Active |
| US10758616 | Pre-mixed, ready-to-use pharmaceutical compositions |
Apr, 2027
(2 years from now) | Active |
| US7659291 | Methods of treatment with pre-mixed, ready-to-use pharmaceutical compositions |
Apr, 2027
(2 years from now) | Active |
| US11547758 | Pre-mixed, ready-to-use pharmaceutical compositions |
Apr, 2027
(2 years 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 Cardene In 0.83% Sodium Chloride In Plastic Container's patents.
Latest Legal Activities on Cardene In 0.83% Sodium Chloride In Plastic Container's Patents
Given below is the list of recent legal activities going on the following patents of Cardene In 0.83% Sodium Chloride In Plastic Container.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 01 Mar, 2024 | US10758616 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 14 Dec, 2023 | US9364564 |
| Patent Issue Date Used in PTA Calculation Critical | 10 Jan, 2023 | US11547758 |
| Recordation of Patent Grant Mailed Critical | 10 Jan, 2023 | US11547758 |
| Email Notification Critical | 22 Dec, 2022 | US11547758 |
| Issue Notification Mailed Critical | 21 Dec, 2022 | US11547758 |
| Application Is Considered Ready for Issue Critical | 12 Dec, 2022 | US11547758 |
| Dispatch to FDC | 12 Dec, 2022 | US11547758 |
| Issue Fee Payment Verified Critical | 08 Dec, 2022 | US11547758 |
| Issue Fee Payment Received Critical | 08 Dec, 2022 | US11547758 |
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 Cardene In 0.83% Sodium Chloride In Plastic Container and ongoing litigations to help you estimate the early arrival of Cardene In 0.83% Sodium Chloride In Plastic Container generic.
Cardene In 0.83% Sodium Chloride In Plastic Container's Litigations
Cardene In 0.83% Sodium Chloride In Plastic Container been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 01, 2014, against patent number US8455524. The petitioner Sandoz Inc., challenged the validity of this patent, with EKR Therapeutics, LLC as the respondent. Click below to track the latest information on how companies are challenging Cardene In 0.83% Sodium Chloride In Plastic Container's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US7612102 | October, 2014 |
Terminated-Denied
(24 Apr, 2015) | EKR Therapeutics, LLC | Sandoz Inc. |
| US7659291 | October, 2014 |
Terminated-Denied
(24 Apr, 2015) | EKR Therapeutics, LLC | Sandoz Inc. |
| US8455524 | October, 2014 |
Terminated-Denied
(24 Apr, 2015) | EKR Therapeutics, LLC | Sandoz Inc. |
US patents provide insights into the exclusivity only within the United States, but Cardene In 0.83% Sodium Chloride In Plastic Container 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 Cardene In 0.83% Sodium Chloride In Plastic Container's family patents as well as insights into ongoing legal events on those patents.
Cardene In 0.83% Sodium Chloride In Plastic Container's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Cardene In 0.83% Sodium Chloride In Plastic Container's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 26, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Cardene In 0.83% Sodium Chloride In Plastic Container Generic API suppliers:
Nicardipine Hydrochloride is the generic name for the brand Cardene In 0.83% Sodium Chloride In Plastic Container. 18 different companies have already filed for the generic of Cardene In 0.83% Sodium Chloride In Plastic Container, with Ani Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Cardene In 0.83% Sodium Chloride In Plastic Container's generic
How can I launch a generic of Cardene In 0.83% Sodium Chloride In Plastic Container before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Cardene In 0.83% Sodium Chloride In Plastic Container's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Cardene In 0.83% Sodium Chloride In Plastic Container'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 Cardene In 0.83% Sodium Chloride In Plastic Container -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2.5 mg/mL, 10 mL Ampoules | 27 Dec, 2006 | 1 | |||
| 0.1 mg/mL, 200 mL 0.2mg/mL, 200 mL | 09 Jan, 2013 | 1 | 26 Dec, 2027 |
Alternative Brands for Cardene In 0.83% Sodium Chloride In Plastic Container
Cardene In 0.83% Sodium Chloride In Plastic Container which is used for treating acute elevations of blood pressure in human subjects., has several other brand drugs in the same treatment category and using the same active ingredient (Nicardipine Hydrochloride). 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 | ||||||
|---|---|---|---|---|---|---|---|---|
| Chiesi |
| |||||||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Nicardipine Hydrochloride, Cardene In 0.83% Sodium Chloride In Plastic Container's active ingredient. Check the complete list of approved generic manufacturers for Cardene In 0.83% Sodium Chloride In Plastic Container
About Cardene In 0.83% Sodium Chloride In Plastic Container
Cardene In 0.83% Sodium Chloride In Plastic Container is a drug owned by Chiesi Usa Inc. It is used for treating acute elevations of blood pressure in human subjects. Cardene In 0.83% Sodium Chloride In Plastic Container uses Nicardipine Hydrochloride as an active ingredient. Cardene In 0.83% Sodium Chloride In Plastic Container was launched by Chiesi in 1992.
Approval Date:
Cardene In 0.83% Sodium Chloride In Plastic Container was approved by FDA for market use on 30 January, 1992.
Active Ingredient:
Cardene In 0.83% Sodium Chloride In Plastic Container uses Nicardipine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Nicardipine Hydrochloride ingredient
Treatment:
Cardene In 0.83% Sodium Chloride In Plastic Container is used for treating acute elevations of blood pressure in human subjects.
Dosage:
Cardene In 0.83% Sodium Chloride In Plastic Container is available in injectable form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 40MG/200ML (0.2MG/ML) | INJECTABLE | Prescription | INTRAVENOUS |