Hysingla Er is a drug owned by Purdue Pharma Lp. It is protected by 42 US drug patents filed from 2014 to 2023. Out of these, 20 drug patents are active and 22 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 21, 2031. Details of Hysingla 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 focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8808740 | Encased tamper resistant controlled release dosage forms |
Dec, 2031
(7 years from now) | Active |
| US9872837 | Tamper resistant controlled release dosage forms |
Dec, 2031
(7 years from now) | Active |
| US9572779 | Encased tamper resistant controlled release dosage forms |
Dec, 2031
(7 years from now) | Active |
| US9750703 | Encased tamper resistant controlled release dosage forms |
Dec, 2031
(7 years from now) | Active |
| US9861584 | Tamper resistant controlled release dosage forms |
Dec, 2031
(7 years from now) | Active |
| US9095615 | Tamper resistant dosage forms |
Aug, 2027
(2 years from now) | Active |
| US9770416 | Tamper resistant dosage forms |
Aug, 2027
(2 years from now) | Active |
| US9763933 | Tamper resistant dosage forms |
Aug, 2027
(2 years from now) | Active |
| US9486412 | Tamper resistant dosage forms |
Aug, 2027
(2 years from now) | Active |
| US9084816 | Tamper resistant dosage forms |
Aug, 2027
(2 years from now) | Active |
| US11304908 | Tamper resistant dosage forms |
Aug, 2027
(2 years from now) | Active |
| US9775809 | Tamper resistant dosage forms |
Aug, 2027
(2 years from now) | Active |
| US9492389 | Tamper resistant dosage forms |
Aug, 2027
(2 years from now) | Active |
| US9486413 | Tamper resistant dosage forms |
Aug, 2027
(2 years from now) | Active |
| US9492391 | Tamper resistant dosage forms |
Aug, 2027
(2 years from now) | Active |
| US9492390 | Tamper resistant dosage forms |
Aug, 2027
(2 years from now) | Active |
| US11304909 | Tamper resistant dosage forms |
Aug, 2027
(2 years from now) | Active |
| US9095614 | Tamper resistant dosage forms |
Aug, 2027
(2 years from now) | Active |
| US9545380 | Tamper resistant dosage forms |
Aug, 2027
(2 years from now) | Active |
| US11844865 | Abuse-proofed oral dosage form |
Feb, 2025
(2 months from now) | Active |
| US10130591 | Abuse-proofed dosage form |
Nov, 2023
(11 months ago) |
Expired
|
| US8309060 | Abuse-proofed dosage form |
Nov, 2023
(11 months ago) |
Expired
|
| US9675610 | Abuse-proofed dosage form |
Jun, 2023
(1 year, 5 months ago) |
Expired
|
| US10369109 | Abuse-proofed dosage form |
Jun, 2023
(1 year, 5 months ago) |
Expired
|
| US8529948 | Pharmaceutical formulation containing gelling agent |
Aug, 2022
(2 years ago) |
Expired
|
| US8361499 | Controlled release hydrocodone formulations |
Oct, 2021
(3 years ago) |
Expired
|
| US8647667 | Controlled release hydrocodone formulations |
Oct, 2021
(3 years ago) |
Expired
|
| US8551520 | Controlled release hydrocodone |
Oct, 2021
(3 years ago) |
Expired
|
| US6733783 | Controlled release hydrocodone formulations |
Oct, 2021
(3 years ago) |
Expired
|
| US9517236 | Controlled release hydrocodone formulations |
Oct, 2020
(4 years ago) |
Expired
|
| US9198863 | Controlled release hydrocodone formulations |
Oct, 2020
(4 years ago) |
Expired
|
| US9023401 | Controlled release hydrocodone formulations |
Oct, 2020
(4 years ago) |
Expired
|
| US9669023 | Controlled release hydrocodone formulations |
Oct, 2020
(4 years ago) |
Expired
|
| US9289391 | Controlled release hydrocodone formulations |
Oct, 2020
(4 years ago) |
Expired
|
| US9669024 | Controlled release hydrocodone formulations |
Oct, 2020
(4 years ago) |
Expired
|
| US9205056 | Controlled release hydrocodone formulations |
Oct, 2020
(4 years ago) |
Expired
|
| US9572804 | Controlled release hydrocodone formulations |
Oct, 2020
(4 years ago) |
Expired
|
| US9060940 | Controlled release hydrocodone |
Oct, 2020
(4 years ago) |
Expired
|
| US9682077 | Methods of providing analgesia |
Oct, 2020
(4 years ago) |
Expired
|
| US9675611 | Methods of providing analgesia |
Oct, 2020
(4 years ago) |
Expired
|
| US9056052 | Controlled release hydrocodone formulations |
Oct, 2020
(4 years ago) |
Expired
|
| US6488963 | Hot-melt extrudable pharmaceutical formulation |
Jun, 2017
(7 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 Hysingla Er's patents.
Latest Legal Activities on Hysingla Er's Patents
Given below is the list of recent legal activities going on the following patents of Hysingla Er.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed Critical | 01 Jul, 2024 | US8309060 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Jun, 2024 | US9545380 |
| Expire Patent Critical | 29 Apr, 2024 | US9289391 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 18 Apr, 2024 | US9492390 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 18 Apr, 2024 | US9486413 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 18 Apr, 2024 | US9492391 |
| Expire Patent Critical | 15 Jan, 2024 | US9205056 (Litigated) |
| Expire Patent Critical | 08 Jan, 2024 | US9198863 (Litigated) |
| Email Notification Critical | 20 Dec, 2023 | US11844865 |
| Mail Patent eGrant Notification | 19 Dec, 2023 | US11844865 |
Several oppositions have been filed on Hysingla 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 Hysingla Er's generic, the next section provides detailed information on ongoing and past EP oppositions related to Hysingla Er patents.
Hysingla Er's Oppositions Filed in EPO
Hysingla 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 |
| 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 Hysingla 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 Hysingla Er's family patents as well as insights into ongoing legal events on those patents.
Hysingla Er's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Hysingla Er's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 21, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Hysingla Er Generic API suppliers:
Hydrocodone Bitartrate is the generic name for the brand Hysingla Er. 1 company has already filed for the generic of Hysingla Er. Check out the entire list of companies who have already received approval for Hysingla Er's generic
How can I launch a generic of Hysingla Er before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Hysingla Er's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Hysingla Er'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 Hysingla Er -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 20 mg, 60 mg, and 120 mg | 15 Apr, 2015 | 1 | 01 Mar, 2021 | 21 Dec, 2031 | Deferred |
| 30 mg, 40 mg, 80 mg, and 100 mg | 08 May, 2015 | 1 | 01 Mar, 2021 | 21 Dec, 2031 | Deferred |
Alternative Brands for Hysingla Er
Hysingla Er which is used for managing severe chronic pain when other treatment options are insufficient., has several other brand drugs in the same treatment category and using the same active ingredient (Hydrocodone Bitartrate). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||||||
|---|---|---|---|---|---|---|---|---|
| Bdsi |
| |||||||
| Collegium Pharm Inc |
| |||||||
| Purdue Pharma Lp |
| |||||||
| Zyla |
| |||||||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Hydrocodone Bitartrate. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Abbvie |
| |
| Recro Gainesville |
| |
| Sovereign Pharms |
| |
| Teva Branded Pharm |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Hydrocodone Bitartrate, Hysingla Er's active ingredient. Check the complete list of approved generic manufacturers for Hysingla Er
About Hysingla Er
Hysingla Er is a drug owned by Purdue Pharma Lp. It is used for managing severe chronic pain when other treatment options are insufficient. Hysingla Er uses Hydrocodone Bitartrate as an active ingredient. Hysingla Er was launched by Purdue Pharma Lp in 2014.
Approval Date:
Hysingla Er was approved by FDA for market use on 20 November, 2014.
Active Ingredient:
Hysingla Er uses Hydrocodone Bitartrate as the active ingredient. Check out other Drugs and Companies using Hydrocodone Bitartrate ingredient
Treatment:
Hysingla Er is used for managing severe chronic pain when other treatment options are insufficient.
Dosage:
Hysingla 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 | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 100MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 20MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 30MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 80MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 120MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 60MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |