Palladone Patent Expiration

Palladone is a drug owned by Purdue Pharma Lp. It is protected by 6 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 09, 2020. Details of Palladone'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).
US6589960 Hydromorphone and hydrocodone compositions and methods for their synthesis
Nov, 2020

(4 years ago)

Expired
US6335033 Melt-extrusion multiparticulates
Nov, 2014

(10 years ago)

Expired
US6706281 Melt-extrusion multiparticulates
Nov, 2014

(10 years ago)

Expired
US6743442 Melt-extruded orally administrable opioid formulations
Nov, 2014

(10 years ago)

Expired
US5958452 Extruded orally administrable opioid formulations
Nov, 2014

(10 years ago)

Expired
US5965161 Extruded multi-particulates
Nov, 2014

(10 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 Palladone's patents.

Given below is the list of recent legal activities going on the following patents of Palladone.

Activity Date Patent Number
Patent litigations
Expire Patent 24 Jun, 2016 US6743442
Expire Patent 08 Apr, 2016 US6706281
Post Issue Communication - Certificate of Correction 04 Aug, 2004 US6706281
Patent Issue Date Used in PTA Calculation 01 Jun, 2004 US6743442
Recordation of Patent Grant Mailed 01 Jun, 2004 US6743442
Issue Notification Mailed 13 May, 2004 US6743442
Receipt into Pubs 29 Mar, 2004 US6743442
Application Is Considered Ready for Issue 25 Mar, 2004 US6743442
Receipt into Pubs 18 Mar, 2004 US6743442
Mail Examiner's Amendment 17 Mar, 2004 US6743442

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US patents provide insights into the exclusivity only within the United States, but Palladone 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 Palladone's family patents as well as insights into ongoing legal events on those patents.

Palladone's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Palladone's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 09, 2020 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Palladone Generic API suppliers:

Hydromorphone Hydrochloride is the generic name for the brand Palladone. 17 different companies have already filed for the generic of Palladone, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Palladone's generic

Alternative Brands for Palladone

Palladone which is used for managing persistent, moderate to severe pain in patients requiring continuous, around-the-clock analgesia with a high potency opioid for an extended period of time., has several other brand drugs using the same active ingredient (Hydromorphone 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
Fresenius Kabi Usa
Dilaudid
Dilaudid-hp
Rhodes Pharms
Dilaudid
Specgx Llc
Exalgo


Apart from brand drugs containing the same ingredient, some generics have also been filed for Hydromorphone Hydrochloride, Palladone's active ingredient. Check the complete list of approved generic manufacturers for Palladone





About Palladone

Palladone is a drug owned by Purdue Pharma Lp. It is used for managing persistent, moderate to severe pain in patients requiring continuous, around-the-clock analgesia with a high potency opioid for an extended period of time. Palladone uses Hydromorphone Hydrochloride as an active ingredient. Palladone was launched by Purdue Pharma Lp in 2004.

Approval Date:

Palladone was approved by FDA for market use on 24 September, 2004.

Active Ingredient:

Palladone uses Hydromorphone Hydrochloride as the active ingredient. Check out other Drugs and Companies using Hydromorphone Hydrochloride ingredient

Treatment:

Palladone is used for managing persistent, moderate to severe pain in patients requiring continuous, around-the-clock analgesia with a high potency opioid for an extended period of time.

Dosage:

Palladone is available in capsule, extended release form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
12MG CAPSULE, EXTENDED RELEASE Discontinued ORAL
24MG CAPSULE, EXTENDED RELEASE Discontinued ORAL
32MG CAPSULE, EXTENDED RELEASE Discontinued ORAL
16MG CAPSULE, EXTENDED RELEASE Discontinued ORAL