Dilaudid is a drug owned by Fresenius Kabi Usa Llc. It is protected by 3 US drug patents filed from 2013 to 2018. Out of these, 2 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 12, 2034. Details of Dilaudid'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). | |||
| US9248229 | Packaging system for oxygen-sensitive drugs |
Mar, 2034
(9 years from now) | Active |
| US9731082 | Drug container |
Apr, 2032
(7 years from now) | Active |
| US6589960 | Hydromorphone and hydrocodone compositions and methods for their synthesis |
Nov, 2020
(4 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 Dilaudid's patents.
Latest Legal Activities on Dilaudid's Patents
Given below is the list of recent legal activities going on the following patents of Dilaudid.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 02 Aug, 2023 | US9248229 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 15 Feb, 2021 | US9731082 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 02 Aug, 2019 | US9248229 |
| Patent Issue Date Used in PTA Calculation Critical | 15 Aug, 2017 | US9731082 |
| Recordation of Patent Grant Mailed Critical | 15 Aug, 2017 | US9731082 |
| Email Notification Critical | 27 Jul, 2017 | US9731082 |
| Issue Notification Mailed Critical | 26 Jul, 2017 | US9731082 |
| Application Is Considered Ready for Issue Critical | 11 Jul, 2017 | US9731082 |
| Dispatch to FDC | 11 Jul, 2017 | US9731082 |
| Issue Fee Payment Received Critical | 10 Jul, 2017 | US9731082 |
US patents provide insights into the exclusivity only within the United States, but Dilaudid 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 Dilaudid's family patents as well as insights into ongoing legal events on those patents.
Dilaudid's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Dilaudid's generic launch date based on the expiry of its last outstanding patent is estimated to be Mar 12, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Dilaudid Generic API suppliers:
Hydromorphone Hydrochloride is the generic name for the brand Dilaudid. 17 different companies have already filed for the generic of Dilaudid, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Dilaudid's generic
How can I launch a generic of Dilaudid before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Dilaudid's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Dilaudid'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 Dilaudid -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg/5mL | 25 Feb, 2011 | 1 | 09 Nov, 2020 | Extinguished | |
| 10 mg/mL | 04 Nov, 2011 | 1 | Extinguished | ||
| 2 mg/mL | 22 Jun, 2011 | ||||
| 2 mg, 4 mg, and 8 mg | 05 Aug, 2013 | 1 | 13 May, 2016 | 09 Nov, 2020 | Deferred |
Alternative Brands for Dilaudid
There are several other brand drugs using the same active ingredient (Hydromorphone Hydrochloride) as Dilaudid. 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 |
| |
| Purdue Pharma Lp |
| |
| Specgx Llc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Hydromorphone Hydrochloride, Dilaudid's active ingredient. Check the complete list of approved generic manufacturers for Dilaudid
About Dilaudid
Dilaudid is a drug owned by Fresenius Kabi Usa Llc. Dilaudid uses Hydromorphone Hydrochloride as an active ingredient. Dilaudid was launched by Fresenius Kabi Usa in 2020.
Approval Date:
Dilaudid was approved by FDA for market use on 16 January, 2020.
Active Ingredient:
Dilaudid uses Hydromorphone Hydrochloride as the active ingredient. Check out other Drugs and Companies using Hydromorphone Hydrochloride ingredient
Dosage:
Dilaudid is available in injectable form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.5MG/0.5ML | INJECTABLE | Prescription | INJECTION |
| 1MG/ML | INJECTABLE | Prescription | INJECTION |
| 4MG/ML | INJECTABLE | Prescription | INJECTION |
| 0.2MG/ML | INJECTABLE | Prescription | INJECTION |
| 2MG/ML | INJECTABLE | Prescription | INJECTION |
Dilaudid is a drug owned by Rhodes Pharmaceuticals Lp. It is protected by 1 US drug patent 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 Dilaudid'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
|
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 Dilaudid's patents.
Latest Legal Activities on Dilaudid's Patents
Given below is the list of recent legal activities going on the following patents of Dilaudid.
| Activity | Date | Patent Number |
|---|---|---|
| | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 02 Aug, 2023 | US9248229 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 15 Feb, 2021 | US9731082 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 02 Aug, 2019 | US9248229 |
| Patent Issue Date Used in PTA Calculation Critical | 15 Aug, 2017 | US9731082 |
| Recordation of Patent Grant Mailed Critical | 15 Aug, 2017 | US9731082 |
| Email Notification Critical | 27 Jul, 2017 | US9731082 |
| Issue Notification Mailed Critical | 26 Jul, 2017 | US9731082 |
| Application Is Considered Ready for Issue Critical | 11 Jul, 2017 | US9731082 |
| Dispatch to FDC | 11 Jul, 2017 | US9731082 |
| Issue Fee Payment Received Critical | 10 Jul, 2017 | US9731082 |
US patents provide insights into the exclusivity only within the United States, but Dilaudid 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 Dilaudid's family patents as well as insights into ongoing legal events on those patents.
Dilaudid's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Dilaudid'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)
Dilaudid Generic API suppliers:
Hydromorphone Hydrochloride is the generic name for the brand Dilaudid. 17 different companies have already filed for the generic of Dilaudid, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Dilaudid's generic
How can I launch a generic of Dilaudid before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Dilaudid's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Dilaudid'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 Dilaudid -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg/5mL | 25 Feb, 2011 | 1 | 09 Nov, 2020 | Extinguished | |
| 10 mg/mL | 04 Nov, 2011 | 1 | Extinguished | ||
| 2 mg/mL | 22 Jun, 2011 | ||||
| 2 mg, 4 mg, and 8 mg | 05 Aug, 2013 | 1 | 13 May, 2016 | 09 Nov, 2020 | Deferred |
Alternative Brands for Dilaudid
There are several other brand drugs using the same active ingredient (Hydromorphone Hydrochloride) as Dilaudid. 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 |
| |
| Purdue Pharma Lp |
| |
| Specgx Llc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Hydromorphone Hydrochloride, Dilaudid's active ingredient. Check the complete list of approved generic manufacturers for Dilaudid
About Dilaudid
Dilaudid is a drug owned by Rhodes Pharmaceuticals Lp. Dilaudid uses Hydromorphone Hydrochloride as an active ingredient. Dilaudid was launched by Rhodes Pharms in 2007.
Approval Date:
Dilaudid was approved by FDA for market use on 09 November, 2007.
Active Ingredient:
Dilaudid uses Hydromorphone Hydrochloride as the active ingredient. Check out other Drugs and Companies using Hydromorphone Hydrochloride ingredient
Dosage:
Dilaudid is available in the following dosage forms - solution form for oral use, tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 4MG | TABLET | Prescription | ORAL |
| 2MG | TABLET | Prescription | ORAL |
| 8MG | TABLET | Prescription | ORAL |
| 5MG/5ML | SOLUTION | Prescription | ORAL |