Hydromorphone Hydrochloride Patent Expiration
Hydromorphone Hydrochloride was first introduced by Fresenius Kabi Usa Llc
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
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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 |
| |||
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.
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| Mexico |
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| Singapore |
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| United States |
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| Philippines |
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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 |
| |||||
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 |
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| Portugal |
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| Jordan |
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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 |
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| United States |
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| Dominican Republic (the) |
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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 |
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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 |
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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. 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 |
12. 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 |
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 |
| |||
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 |
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| Mexico |
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| India |
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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 |
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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 |