Opana Er is a drug owned by Endo Operations Ltd. It is protected by 7 US drug patents filed from 2013 to 2021. Out of these, 2 drug patents are active and 5 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 22, 2029. Details of Opana Er's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8871779 | Process for preparing morphinan-6-one products with low levels of α,β-unsaturated ketone compounds |
Nov, 2029
(5 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8808737 | Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment |
Jun, 2027
(2 years from now) | Active |
| US8329216 | Oxymorphone controlled release formulations |
Feb, 2023
(1 year, 9 months ago) |
Expired
|
| US7276250 | Sustained release formulations of oxymorphone |
Feb, 2023
(1 year, 9 months ago) |
Expired
|
| US8309112 | Coatings for implantable medical devices comprising hydrophilic substances and methods for fabricating the same |
Feb, 2023
(1 year, 9 months ago) |
Expired
|
| US5958456 | Controlled release formulation (albuterol) |
Sep, 2013
(11 years ago) |
Expired
|
| US5662933 | Controlled release formulation (albuterol) |
Sep, 2013
(11 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 Opana Er's patents.
Latest Legal Activities on Opana Er's Patents
Given below is the list of recent legal activities going on the following patents of Opana Er.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 08 Jul, 2024 | US8192722 |
| Maintenance Fee Reminder Mailed Critical | 01 Jul, 2024 | US8309060 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 10 May, 2024 | US8329216 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 11 Apr, 2024 | US8309122 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 22 Jan, 2024 | US8192722 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 02 Aug, 2023 | US8114383 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 31 May, 2023 | US8075872 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Mar, 2022 | US8871779 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Jan, 2022 | US8808737 (Litigated) |
| Expire Patent Critical | 21 Dec, 2020 | US8309112 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Opana Er and ongoing litigations to help you estimate the early arrival of Opana Er generic.
Opana Er's Litigations
Opana Er been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Aug 22, 2014, against patent number US8329216. The petitioner Amneal Pharmaceuticals, LLC, challenged the validity of this patent, with Endo Pharmaceuticals, Inc. as the respondent. Click below to track the latest information on how companies are challenging Opana Er's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8329216 | January, 2014 |
FWD Entered
(22 Jul, 2015) | Endo Pharmaceuticals, Inc. | Amneal Pharmaceuticals, LLC |
| US8329216 | August, 2014 |
FWD Entered
(22 Jul, 2015) | Endo Pharmaceuticals, Inc. | Amneal Pharmaceuticals, LLC |
Several oppositions have been filed on Opana Er's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Opana Er's generic, the next section provides detailed information on ongoing and past EP oppositions related to Opana Er patents.
Opana Er's Oppositions Filed in EPO
Opana Er has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Aug 10, 2010, by Straus, Alexander. This opposition was filed on patent number EP07751984A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP07751984A | Aug, 2010 | Straus, Alexander | Revoked |
US patents provide insights into the exclusivity only within the United States, but Opana Er 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 Opana Er's family patents as well as insights into ongoing legal events on those patents.
Opana Er's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Opana Er's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 22, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Opana Er Generic API suppliers:
Oxymorphone Hydrochloride is the generic name for the brand Opana Er. 11 different companies have already filed for the generic of Opana Er, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Opana Er's generic
About Opana Er
Opana Er is a drug owned by Endo Operations Ltd. It is used for managing moderate to severe pain. Opana Er uses Oxymorphone Hydrochloride as an active ingredient. Opana Er was launched by Endo Operations in 2006.
Approval Date:
Opana Er was approved by FDA for market use on 22 June, 2006.
Active Ingredient:
Opana Er uses Oxymorphone Hydrochloride as the active ingredient. Check out other Drugs and Companies using Oxymorphone Hydrochloride ingredient
Treatment:
Opana Er is used for managing moderate to severe pain.
Dosage:
Opana Er is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
Opana Er is a drug owned by Endo Pharmaceuticals Inc. It is protected by 9 US drug patents filed from 2013 to 2014. Out of these, 4 drug patents are active and 5 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 22, 2029. Details of Opana Er's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8871779 | Process for preparing morphinan-6-one products with low levels of α,β-unsaturated ketone compounds |
Nov, 2029
(5 years from now) | Active |
| US7851482 | Method for making analgesics |
Jul, 2029
(4 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8808737 | Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment |
Jun, 2027
(2 years from now) | Active |
| US8192722 | Abuse-proof dosage form |
Sep, 2025
(9 months from now) | Active |
| US8114383 | Abuse-proofed dosage form |
Aug, 2024
(3 months ago) |
Expired
|
| US8309060 | Abuse-proofed dosage form |
Nov, 2023
(1 year, 3 days ago) |
Expired
|
| US8075872 | Abuse-proofed dosage form |
Nov, 2023
(1 year, 3 days ago) |
Expired
|
| US8329216 | Oxymorphone controlled release formulations |
Feb, 2023
(1 year, 9 months ago) |
Expired
|
| US8309122 | Oxymorphone controlled release formulations |
Feb, 2023
(1 year, 9 months 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 Opana Er's patents.
Latest Legal Activities on Opana Er's Patents
Given below is the list of recent legal activities going on the following patents of Opana Er.
| Activity | Date | Patent Number |
|---|---|---|
| | ||
| Expire Patent Critical | 08 Jul, 2024 | US8192722 |
| Maintenance Fee Reminder Mailed Critical | 01 Jul, 2024 | US8309060 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 10 May, 2024 | US8329216 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 11 Apr, 2024 | US8309122 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 22 Jan, 2024 | US8192722 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 02 Aug, 2023 | US8114383 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 31 May, 2023 | US8075872 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Mar, 2022 | US8871779 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Jan, 2022 | US8808737 (Litigated) |
| Expire Patent Critical | 21 Dec, 2020 | US8309112 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Opana Er and ongoing litigations to help you estimate the early arrival of Opana Er generic.
Opana Er's Litigations
Opana Er been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jul 20, 2009, against patent number US8309122. The petitioner , challenged the validity of this patent, with Huai-Hung Kao et al as the respondent. Click below to track the latest information on how companies are challenging Opana Er's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
| | ||||
| US8329216 | January, 2014 |
FWD Entered
(22 Jul, 2015) | Endo Pharmaceuticals, Inc. | Amneal Pharmaceuticals, LLC |
| US8329216 | August, 2014 |
FWD Entered
(22 Jul, 2015) | Endo Pharmaceuticals, Inc. | Amneal Pharmaceuticals, LLC |
| US7851482 | November, 2013 |
Terminated-Settled
(22 Jan, 2015) | Endo Pharmaceuticals Inc. | Amneal Pharmaceuticals, LLC |
| US8309122 | January, 2014 |
Terminated-Denied
(25 Jul, 2014) | Endo Pharmaceuticals, Inc. | Amneal Pharmaceuticals, LLC |
| US7851482 | December, 2013 |
Decision
(19 Dec, 2013) | Jen-Sen Dung et al | |
| US8309122 | July, 2009 |
Decision
(09 Aug, 2012) | Huai-Hung Kao et al | |
Several oppositions have been filed on Opana Er's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Opana Er's generic, the next section provides detailed information on ongoing and past EP oppositions related to Opana Er patents.
Opana Er's Oppositions Filed in EPO
Opana Er has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Dec 14, 2007, by Purdue Pharma Lp. This opposition was filed on patent number EP04763834A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP06706682A | Dec, 2017 | G. L. Pharma GmbH | Revoked |
| EP07751984A | Aug, 2010 | Straus, Alexander | Revoked |
| EP2005006983W | Oct, 2009 | Sanofi-Aventis Deutschland GmbH | Patent maintained as amended |
| EP2005006983W | Oct, 2009 | Ypsomed AG | Patent maintained as amended |
| EP04763833A | Mar, 2008 | Purdue Pharma LP | Opposition rejected |
| EP04763834A | Dec, 2007 | Purdue Pharma LP | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Opana Er 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 Opana Er's family patents as well as insights into ongoing legal events on those patents.
Opana Er's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Opana Er's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 22, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Opana Er Generic API suppliers:
Oxymorphone Hydrochloride is the generic name for the brand Opana Er. 11 different companies have already filed for the generic of Opana Er, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Opana Er's generic
About Opana Er
Opana Er is a drug owned by Endo Pharmaceuticals Inc. It is used for managing moderate to severe pain. Opana Er uses Oxymorphone Hydrochloride as an active ingredient. Opana Er was launched by Endo Pharms in 2011.
Approval Date:
Opana Er was approved by FDA for market use on 09 December, 2011.
Active Ingredient:
Opana Er uses Oxymorphone Hydrochloride as the active ingredient. Check out other Drugs and Companies using Oxymorphone Hydrochloride ingredient
Treatment:
Opana Er is used for managing moderate to severe pain.
Dosage:
Opana Er is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 30MG | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 5MG | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 40MG | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 15MG | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 20MG | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 7.5MG | TABLET, EXTENDED RELEASE | Discontinued | ORAL |