Hydromorphone Hydrochloride Patent Expiration

Hydromorphone Hydrochloride was first introduced by Fresenius Kabi Usa Llc in its drug Dilaudid-Hp on Jan 11, 1984. Other drugs containing Hydromorphone Hydrochloride are Palladone, Exalgo, Dilaudid, Hydromorphone Hydrochloride. 20 different companies have introduced drugs containing Hydromorphone Hydrochloride.


Hydromorphone Hydrochloride Patents

Given below is the list of patents protecting Hydromorphone Hydrochloride, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Dilaudid US6589960 Hydromorphone and hydrocodone compositions and methods for their synthesis Nov 09, 2020

(Expired)

Fresenius Kabi Usa
Dilaudid US6589960 Hydromorphone and hydrocodone compositions and methods for their synthesis Nov 09, 2020

(Expired)

Rhodes Pharms
Dilaudid US9248229 Packaging system for oxygen-sensitive drugs Mar 12, 2034 Fresenius Kabi Usa
Dilaudid US9731082 Drug container Apr 23, 2032 Fresenius Kabi Usa
Dilaudid-hp US6589960 Hydromorphone and hydrocodone compositions and methods for their synthesis Nov 09, 2020

(Expired)

Fresenius Kabi Usa
Dilaudid-hp US9248229 Packaging system for oxygen-sensitive drugs Mar 12, 2034 Fresenius Kabi Usa
Dilaudid-hp US9731082 Drug container Apr 23, 2032 Fresenius Kabi Usa
Exalgo US5702725 Hydromorphone therapy Jul 07, 2014

(Expired)

Specgx Llc
Exalgo US5914131 Hydromorphone therapy Jul 07, 2014

(Expired)

Specgx Llc
Palladone US5958452 Extruded orally administrable opioid formulations Nov 04, 2014

(Expired)

Purdue Pharma Lp
Palladone US5965161 Extruded multi-particulates Nov 04, 2014

(Expired)

Purdue Pharma Lp
Palladone US6335033 Melt-extrusion multiparticulates Nov 04, 2014

(Expired)

Purdue Pharma Lp
Palladone US6589960 Hydromorphone and hydrocodone compositions and methods for their synthesis Nov 09, 2020

(Expired)

Purdue Pharma Lp
Palladone US6706281 Melt-extrusion multiparticulates Nov 04, 2014

(Expired)

Purdue Pharma Lp
Palladone US6743442 Melt-extruded orally administrable opioid formulations Nov 04, 2014

(Expired)

Purdue Pharma Lp


Coming Soon

Patent Strength Analyzer

Will this be useful for you?

YesNo

Thank you for your response 🥳

Hydromorphone Hydrochloride Generics

Several generic applications have been filed for Hydromorphone Hydrochloride. The first generic version for Hydromorphone Hydrochloride was by Watson Laboratories Inc and was approved on Aug 23, 1995. And the latest generic version is by Hikma Pharmaceuticals Usa Inc and was approved on Feb 9, 2024.

Given below is the list of companies who have filed for Hydromorphone Hydrochloride generic.


1. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 7 different strengths of generic version for Hydromorphone Hydrochloride. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
8MG tablet Discontinued ORAL N/A Jul 29, 1998
5MG/5ML solution Prescription ORAL AA Jul 29, 1998
4MG tablet Discontinued ORAL N/A May 29, 2009
2MG/ML injectable Prescription INJECTION AP Feb 9, 2024
0.5MG/0.5ML injectable Prescription INJECTION AP Feb 9, 2024
0.2MG/ML injectable Prescription INJECTION AP Feb 9, 2024
1MG/ML injectable Prescription INJECTION AP Feb 9, 2024


2. SPECGX LLC

Specgx Llc has filed for 3 different strengths of generic version for Hydromorphone Hydrochloride. Given below are the details of the strengths of this generic introduced by Specgx Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
8MG tablet Prescription ORAL AB Dec 23, 2004
4MG tablet Prescription ORAL AB Sep 19, 2007
2MG tablet Prescription ORAL AB Sep 19, 2007


3. NESHER PHARMS

Nesher Pharmaceuticals Usa Llc has filed for 3 different strengths of generic version for Hydromorphone Hydrochloride. Given below are the details of the strengths of this generic introduced by Nesher Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2MG tablet Discontinued ORAL N/A Nov 9, 2005
4MG tablet Discontinued ORAL N/A Nov 9, 2005
8MG tablet Discontinued ORAL N/A Nov 9, 2005


4. OSMOTICA PHARM US

Osmotica Pharmaceutical Us Llc has filed for 4 different strengths of generic version for Hydromorphone Hydrochloride. Given below are the details of the strengths of this generic introduced by Osmotica Pharm Us.

Strength Dosage Form Availability Application Pathway TE code Launch Date
12MG tablet, extended release Prescription ORAL AB Jul 7, 2016
32MG

(reference standard)

tablet, extended release Prescription ORAL AB Jul 7, 2016
16MG tablet, extended release Prescription ORAL AB Jul 7, 2016
8MG tablet, extended release Prescription ORAL AB Jul 7, 2016


5. ASCENT PHARMS INC

Ascent Pharmaceuticals Inc has filed for 7 different strengths of generic version for Hydromorphone Hydrochloride. Given below are the details of the strengths of this generic introduced by Ascent Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG/5ML solution Prescription ORAL AA Oct 27, 2017
8MG tablet, extended release Prescription ORAL AB Sep 23, 2020
4MG tablet Prescription ORAL AB Jan 17, 2018
2MG tablet Prescription ORAL AB Jan 17, 2018
16MG tablet, extended release Prescription ORAL AB Sep 23, 2020
12MG tablet, extended release Prescription ORAL AB Sep 23, 2020
32MG tablet, extended release Prescription ORAL AB Sep 23, 2020


6. BARR

Barr Laboratories Inc has filed for 1 generic for Hydromorphone Hydrochloride. Given below are the details of the strengths of this generic introduced by Barr.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG/ML injectable Discontinued INJECTION N/A Apr 25, 2003


7. NOSTRUM LABS INC

Nostrum Laboratories Inc has filed for 1 generic for Hydromorphone Hydrochloride. Given below are the details of the strengths of this generic introduced by Nostrum Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
8MG tablet Discontinued ORAL N/A Oct 18, 2005


8. AUROLIFE PHARMA LLC

Aurolife Pharma Llc has filed for 3 different strengths of generic version for Hydromorphone Hydrochloride. Given below are the details of the strengths of this generic introduced by Aurolife Pharma Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
4MG tablet Prescription ORAL AB May 13, 2016
8MG tablet Prescription ORAL AB May 13, 2016
2MG tablet Prescription ORAL AB May 13, 2016


9. PADAGIS US

Padagis Us Llc has filed for 4 different strengths of generic version for Hydromorphone Hydrochloride. Given below are the details of the strengths of this generic introduced by Padagis Us.

Strength Dosage Form Availability Application Pathway TE code Launch Date
12MG tablet, extended release Prescription ORAL AB Apr 6, 2015
16MG tablet, extended release Prescription ORAL AB Apr 6, 2015
8MG tablet, extended release Prescription ORAL AB Apr 6, 2015
32MG tablet, extended release Prescription ORAL AB Sep 20, 2017


10. GENUS

Genus Lifesciences Inc has filed for 4 different strengths of generic version for Hydromorphone Hydrochloride. Given below are the details of the strengths of this generic introduced by Genus.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2MG tablet Discontinued ORAL N/A Dec 9, 2009
8MG tablet Discontinued ORAL N/A Dec 9, 2009
4MG tablet Discontinued ORAL N/A Dec 9, 2009
5MG/5ML solution Discontinued ORAL N/A Apr 22, 2020


11. ACTAVIS LABS FL INC

Actavis Laboratories Fl Inc has filed for 4 different strengths of generic version for Hydromorphone Hydrochloride. Given below are the details of the strengths of this generic introduced by Actavis Labs Fl Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
16MG tablet, extended release Discontinued ORAL N/A May 12, 2014
8MG tablet, extended release Discontinued ORAL N/A May 12, 2014
12MG tablet, extended release Discontinued ORAL N/A May 12, 2014
32MG tablet, extended release Discontinued ORAL N/A Jun 30, 2016


12. MALLINCKRODT INC

Mallinckrodt Inc has filed for 2 different strengths of generic version for Hydromorphone Hydrochloride. Given below are the details of the strengths of this generic introduced by Mallinckrodt Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
4MG tablet Prescription ORAL AB Sep 19, 2007
2MG tablet Prescription ORAL AB Sep 19, 2007


13. HOSPIRA INC

Hospira Inc has filed for 1 generic for Hydromorphone Hydrochloride. Given below are the details of the strengths of this generic introduced by Hospira Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG/ML injectable Prescription INJECTION AP Jun 17, 2008


14. LANNETT

Lannett Holdings Inc has filed for 2 different strengths of generic version for Hydromorphone Hydrochloride. Given below are the details of the strengths of this generic introduced by Lannett.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2MG tablet Prescription ORAL AB Dec 9, 2009
4MG tablet Prescription ORAL AB Dec 9, 2009


15. WATSON LABS

Watson Laboratories Inc has filed for 1 generic for Hydromorphone Hydrochloride. Given below are the details of the strengths of this generic introduced by Watson Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG/ML injectable Discontinued INJECTION N/A Aug 23, 1995


16. RISING

Rising Pharma Holdings Inc has filed for 1 generic for Hydromorphone Hydrochloride. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG/ML injectable Prescription INJECTION AP Apr 14, 2010


17. HOSPIRA

Hospira Inc has filed for 1 generic for Hydromorphone Hydrochloride. Given below are the details of the strengths of this generic introduced by Hospira.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG/ML injectable Discontinued INJECTION N/A Jun 19, 1997