Dilaudid-hp Patent Expiration

Dilaudid-hp 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-hp'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

(3 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-hp's patents.

Given below is the list of recent legal activities going on the following patents of Dilaudid-hp.

Activity Date Patent Number
Patent litigations
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 15 Aug, 2017 US9731082
Recordation of Patent Grant Mailed 15 Aug, 2017 US9731082
Email Notification 27 Jul, 2017 US9731082
Issue Notification Mailed 26 Jul, 2017 US9731082
Application Is Considered Ready for Issue 11 Jul, 2017 US9731082
Dispatch to FDC 11 Jul, 2017 US9731082
Issue Fee Payment Received 10 Jul, 2017 US9731082

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

Dilaudid-hp's Family Patents

Dilaudid-hp has patent protection in a total of 13 countries. It's US patent count contributes only to 32.3% of its total global patent coverage. 3 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 Dilaudid-hp.

Family Patents

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Generic Launch

Generic Release Date:

Dilaudid-hp'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-hp Generics:

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

How can I launch a generic of Dilaudid-hp before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Dilaudid-hp's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Dilaudid-hp'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-hp -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
10 mg/mL 04 Nov, 2011 1 Extinguished
2 mg/mL 22 Jun, 2011

Alternative Brands for Dilaudid-hp

There are several other brand drugs using the same active ingredient (Hydromorphone Hydrochloride) as Dilaudid-hp. 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
Purdue Pharma Lp
Palladone
Rhodes Pharms
Dilaudid
Specgx Llc
Exalgo


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





About Dilaudid-hp

Dilaudid-Hp is a drug owned by Fresenius Kabi Usa Llc. Dilaudid-Hp uses Hydromorphone Hydrochloride as an active ingredient. Dilaudid-Hp was launched by Fresenius Kabi Usa in 2009.

Approval Date:

Dilaudid-hp was approved by FDA for market use on 30 April, 2009.

Active Ingredient:

Dilaudid-hp uses Hydromorphone Hydrochloride as the active ingredient. Check out other Drugs and Companies using Hydromorphone Hydrochloride ingredient

Dosage:

Dilaudid-hp is available in injectable form for injection use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
250MG/VIAL INJECTABLE Discontinued INJECTION
10MG/ML INJECTABLE Discontinued INJECTION