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

(Expired)

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

(Expired)

 Purdue Pharma Lp
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 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
Exalgo US5702725 Hydromorphone therapy Jul 07, 2014

(Expired)

 Specgx Llc
Exalgo US5914131 Hydromorphone therapy Jul 07, 2014

(Expired)

 Specgx Llc



Hydromorphone Hydrochloride's Family Patents

Family Patents

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Hydromorphone Hydrochloride Generic API Manufacturers

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 Osmotica Pharmaceutical Us Llc and was approved on Oct 30, 2024.

Given below is the list of companies who have filed for Hydromorphone Hydrochloride generic, along with the locations of their manufacturing plants worldwide.


1. 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





2. 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
2MG

tablet Prescription ORAL AB Jan 17, 2018
4MG

tablet Prescription ORAL AB Jan 17, 2018
12MG

tablet, extended release Prescription ORAL AB Sep 23, 2020
16MG

tablet, extended release Prescription ORAL AB Sep 23, 2020
32MG

tablet, extended release Prescription ORAL AB Sep 23, 2020





3. 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


Manufacturing Plant Locations
New

Aurolife Pharma Llc's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Aurolife Pharma Llc as present at those locations.

Country City Firm Name
United States
Durham Aurolife Pharma LLC





4. 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


Manufacturing Plant Locations
New

Barr's manufacturing plants are situated in 4 countries - Mexico, Singapore, United States, Philippines. Given below are the details of these plant locations as well as the firm names of Barr as present at those locations.

Country City Firm Name
Mexico
Aldama Barra La Coma, S. De R.L
Singapore
Singapore Barramundi Asia Pte Ltd
United States
Davie Barrier Technologies LLC
Lake Barrington Barrington Ventures, Ltd
Lee Barrington Coffee Roasting Company, Inc.
Somerset Barrett Distribution Centers Inc
Madison Barriques Holding Company, LLC
Franklin Barrett Distribution Centers, Inc.
Barrett Barrett Farm Supply, Inc.
Paso Robles Barreto Cellars
Belvidere Barred Woods, LLC
Forest Barr Laboratories Inc.
Greenwood Barr Enterprises, Inc.
Machipongo Barrier Island Seafood
Harrison Barrington Chemical Corporation
Arecibo Barreto Dairy, Inc.
Memphis Barrett Distribution Centers
Swartz Creek Barrett Donut Mixes, Inc..
Randolph Barrett Farm
Hereford Barrett and Crofoot, LLP
Curtis Bay Barrett Distribution Center
Dillon Barretts Minerals Inc
Hereford Barrett and Crofoot Feedyard, West
Brainerd Barrett Ag Service, Inc.
Live Oak Barrington Dairy Farm
Englewood Barrett E. Cowan, MD
Buffalo Barrel and Brine Inc
Montezuma Barrington Dairies
Newton Barrett Technology, LLC
Commerce Barreras Meat Co
Philippines
Bulacan Barrio Fiesta Manufacturing Corporation





5. GENUS LIFESCIENCES

Genus Life Sciences 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 Lifesciences.

Strength Dosage Form Availability Application Pathway TE code Launch Date
8MG

tablet Discontinued ORAL N/A Dec 9, 2009
2MG

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


Manufacturing Plant Locations
New

Genus Lifesciences's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Genus Lifesciences as present at those locations.

Country City Firm Name
United States
Allentown GENUS LIFESCIENCES INC
Allentown Genus Lifesciences Inc.





6. 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
5MG/5ML

solution Prescription ORAL AA Jul 29, 1998
8MG

tablet Discontinued ORAL N/A 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


Manufacturing Plant Locations
New

Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.

Country City Firm Name
United States
Dayton Hikma Injectables USA Inc
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Cherry Hill Hikma Pharmaceuticals USA Inc.
Eatontown Hikma Pharmaceuticals USA, Inc.
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





7. 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


Manufacturing Plant Locations
New

Hospira's manufacturing plants are situated in 3 countries - Australia, United States, Dominican Republic (the). Given below are the details of these plant locations as well as the firm names of Hospira as present at those locations.

Country City Firm Name
Australia
Mulgrave Hospira Australia Pty Ltd.
United States
Rocky Mount Hospira, Inc.
Pleasant Prairie Hospira Worldwide, LLC d.b.a. Hospira, a Pfizer-owned Company
Mcpherson Hospira, Inc., A Pfizer Company
Lake Forest Hospira Inc
Morgan Hill Hospira Inc
Clayton Hospira, Inc.
Dominican Republic (the)
Haina, San Cristobal Hospira, Ltd.





8. 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


Manufacturing Plant Locations
New

Hospira Inc's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Hospira Inc as present at those locations.

Country City Firm Name
United States
Lake Forest Hospira Inc
Morgan Hill Hospira Inc





9. 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


Manufacturing Plant Locations
New

Lannett's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Lannett as present at those locations.

Country City Firm Name
United States
Seymour Lannett Company Inc.
Philadelphia Lannett Company, Inc.





10. 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





11. MPP PHARMA

Mpp Pharma Llc has filed for 1 generic for Hydromorphone Hydrochloride. Given below are the details of the strengths of this generic introduced by Mpp Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
8MG

tablet Discontinued ORAL N/A Oct 18, 2005





12. 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
8MG

tablet Discontinued ORAL N/A Nov 9, 2005
4MG

tablet Discontinued ORAL N/A Nov 9, 2005





13. OSMOTICA PHARM US

Osmotica Pharmaceutical Us Llc has filed for 5 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
8MG

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
12MG

tablet, extended release Prescription ORAL AB Jul 7, 2016
24MG

tablet, extended release Prescription ORAL N/A Oct 30, 2024





14. 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
8MG

tablet, extended release Prescription ORAL AB Apr 6, 2015
16MG

tablet, extended release Prescription ORAL AB Apr 6, 2015
12MG

tablet, extended release Prescription ORAL AB Apr 6, 2015
32MG

tablet, extended release Prescription ORAL AB Sep 20, 2017


Manufacturing Plant Locations
New

Padagis Us's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Padagis Us as present at those locations.

Country City Firm Name
United States
Minneapolis Padagis US LLC





15. 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


Manufacturing Plant Locations
New

Rising's manufacturing plants are situated in 3 countries - United States, Mexico, India. Given below are the details of these plant locations as well as the firm names of Rising as present at those locations.

Country City Firm Name
United States
Saddle Brook Rising Pharmaceuticals, Inc.
Rising Sun Rising Sun Veterinary Clinic
Flagstaff Rising High Enterprises, LLC (DBA RisingHy)
East Brunswick Rising Pharma Holding, Inc.
Fort Bragg Rising Tide Sea Vegetables
Phoenix Rising Sun Farms Inc
Decatur Rising Pharma Holdings, Inc
Mount Morris Rising Creek Bakery LLC
Livingston Risingsun Iodine Products Corp.
Mexico
Pueblo San Clemente RISING FARMS SAPI DE CV
India
Ahmedabad Rising Retina Clinic





16. 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


Manufacturing Plant Locations
New

Specgx Llc's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Specgx Llc as present at those locations.

Country City Firm Name
United States
Greenville SpecGx LLC
Saint Louis SpecGx LLC
Raleigh SpecGx LLC





17. 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