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
(5 years ago) |
Expired
|
| US6335033 | Melt-extrusion multiparticulates |
Nov, 2014
(11 years ago) |
Expired
|
| US6706281 | Melt-extrusion multiparticulates |
Nov, 2014
(11 years ago) |
Expired
|
| US6743442 | Melt-extruded orally administrable opioid formulations |
Nov, 2014
(11 years ago) |
Expired
|
| US5958452 | Extruded orally administrable opioid formulations |
Nov, 2014
(11 years ago) |
Expired
|
| US5965161 | Extruded multi-particulates |
Nov, 2014
(11 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.
Latest 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 |
|---|---|---|
| ||
| Expire Patent
Critical | 24 Jun, 2016 | US6743442 |
| Expire Patent
Critical | 08 Apr, 2016 | US6706281 |
| Post Issue Communication - Certificate of Correction | 04 Aug, 2004 | US6706281 |
| Patent Issue Date Used in PTA Calculation
Critical | 01 Jun, 2004 | US6743442 |
| Recordation of Patent Grant Mailed
Critical | 01 Jun, 2004 | US6743442 |
| Issue Notification Mailed
Critical | 13 May, 2004 | US6743442 |
| Receipt into Pubs | 29 Mar, 2004 | US6743442 |
| Application Is Considered Ready for Issue
Critical | 25 Mar, 2004 | US6743442 |
| Receipt into Pubs | 18 Mar, 2004 | US6743442 |
| Mail Examiner's Amendment | 17 Mar, 2004 | US6743442 |
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
Explore Our Curated Drug Screens
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 |
| ||
| Rhodes Pharms |
| ||
| Specgx Llc |
|
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 |
