Dilaudid Patent Expiration

Dilaudid is a drug owned by Fresenius Kabi Usa Llc. It is protected by 3 US drug patents filed from 2013 to 2023. 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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6589960 Hydromorphone and hydrocodone compositions and methods for their synthesis
Nov, 2020

(3 years ago)

Expired
US9731082 Drug container
Apr, 2032

(7 years from now)

Active
US9248229 Packaging system for oxygen-sensitive drugs
Mar, 2034

(9 years from now)

Active

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

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

Dilaudid 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.

Family Patents

Coming Soon

Patent Strength Analyzer

Let us know if you're excited!

🤩🥱

Thank you for your response 🥳



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 Generics:

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




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.

Market Authorisation 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
2MG/ML INJECTABLE Prescription INJECTION
1MG/ML INJECTABLE Prescription INJECTION
4MG/ML INJECTABLE Discontinued INJECTION
0.5MG/0.5ML INJECTABLE Prescription INJECTION
0.2MG/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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6589960 Hydromorphone and hydrocodone compositions and methods for their synthesis
Nov, 2020

(3 years ago)

Expired

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

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


Family Patents

Coming Soon

Patent Strength Analyzer

Let us know if you're excited!

🤩🥱

Thank you for your response 🥳



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 Generics:

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




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 1992.

Market Authorisation Date:

Dilaudid was approved by FDA for market use on 07 December, 1992.

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
5MG/5ML SOLUTION Prescription ORAL
8MG TABLET Prescription ORAL
2MG TABLET Prescription ORAL
4MG TABLET Prescription ORAL