Cardene In 4.8% Dextrose In Plastic Container Patent Expiration

Cardene In 4.8% Dextrose 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 4.8% Dextrose 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
US7659291 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
US8455524 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 4.8% Dextrose In Plastic Container's patents.

Given below is the list of recent legal activities going on the following patents of Cardene In 4.8% Dextrose In Plastic Container.

Activity Date Patent Number
Patent litigations
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 10 Jan, 2023 US11547758
Recordation of Patent Grant Mailed 10 Jan, 2023 US11547758
Email Notification 22 Dec, 2022 US11547758
Issue Notification Mailed 21 Dec, 2022 US11547758
Application Is Considered Ready for Issue 12 Dec, 2022 US11547758
Dispatch to FDC 12 Dec, 2022 US11547758
Issue Fee Payment Verified 08 Dec, 2022 US11547758
Issue Fee Payment Received 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 4.8% Dextrose In Plastic Container and ongoing litigations to help you estimate the early arrival of Cardene In 4.8% Dextrose In Plastic Container generic.

Cardene In 4.8% Dextrose In Plastic Container's Litigations

Cardene In 4.8% Dextrose 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 4.8% Dextrose In Plastic Container's patents.

Last updated on December 10, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
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.

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US patents provide insights into the exclusivity only within the United States, but Cardene In 4.8% Dextrose 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 4.8% Dextrose In Plastic Container's family patents as well as insights into ongoing legal events on those patents.

Cardene In 4.8% Dextrose In Plastic Container's Family Patents

Cardene In 4.8% Dextrose In Plastic Container has patent protection in a total of 10 countries. It's US patent count contributes only to 47.2% of its total global patent coverage. 6 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Cardene In 4.8% Dextrose In Plastic Container.

Family Patents

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Generic Launch

Generic Release Date:

Cardene In 4.8% Dextrose 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 4.8% Dextrose In Plastic Container Generic API suppliers:

Nicardipine Hydrochloride is the generic name for the brand Cardene In 4.8% Dextrose In Plastic Container. 18 different companies have already filed for the generic of Cardene In 4.8% Dextrose 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 4.8% Dextrose In Plastic Container's generic

How can I launch a generic of Cardene In 4.8% Dextrose In Plastic Container before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Cardene In 4.8% Dextrose 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 4.8% Dextrose 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 4.8% Dextrose 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 4.8% Dextrose In Plastic Container

Cardene In 4.8% Dextrose In Plastic Container which is used for lowering 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
Cardene In 5.0% Dextrose In Plastic Container

(uses Nicardipine Hydrochloride)

used for treating acute elevations of blood pressure in humans.
Cardene In 0.83% Sodium Chloride In Plastic Container

(uses Nicardipine Hydrochloride)

used for treating acute elevations of blood pressure in human subjects.
Cardene In 0.86% Sodium Chloride In Plastic Container

(uses Nicardipine Hydrochloride)

Used for treating acute elevations of blood pressure in human subjects.

Apart from brand drugs containing the same ingredient, some generics have also been filed for Nicardipine Hydrochloride, Cardene In 4.8% Dextrose In Plastic Container's active ingredient. Check the complete list of approved generic manufacturers for Cardene In 4.8% Dextrose In Plastic Container





About Cardene In 4.8% Dextrose In Plastic Container

Cardene In 4.8% Dextrose In Plastic Container is a drug owned by Chiesi Usa Inc. It is used for lowering acute elevations of blood pressure in human subjects. Cardene In 4.8% Dextrose In Plastic Container uses Nicardipine Hydrochloride as an active ingredient. Cardene In 4.8% Dextrose In Plastic Container was launched by Chiesi in 1992.

Approval Date:

Cardene In 4.8% Dextrose In Plastic Container was approved by FDA for market use on 30 January, 1992.

Active Ingredient:

Cardene In 4.8% Dextrose In Plastic Container uses Nicardipine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Nicardipine Hydrochloride ingredient

Treatment:

Cardene In 4.8% Dextrose In Plastic Container is used for lowering acute elevations of blood pressure in human subjects.

Dosage:

Cardene In 4.8% Dextrose In Plastic Container is available in injectable form for intravenous use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
20MG/200ML (0.1MG/ML) INJECTABLE Prescription INTRAVENOUS