Targiniq is a drug owned by Purdue Pharma Lp. It is protected by 24 US drug patents filed from 2014 to 2018. Out of these, 5 drug patents are active and 19 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 30, 2025. Details of Targiniq's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US9073933 | Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone |
Mar, 2025
(8 months from now) | Active |
| US9522919 | Oxycodone compositions |
Mar, 2025
(8 months from now) | Active |
| US7683072 | Oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone |
Mar, 2025
(8 months from now) | Active |
| US7674800 | Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone |
Mar, 2025
(8 months from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8822487 | Opioid agonist/opioid antagonist/acetaminophen combinations |
Dec, 2018
(5 years ago) |
Expired
|
| US6696066 | Opioid agonist/antagonist combinations |
Dec, 2018
(5 years ago) |
Expired
|
| US9205082 | Opioid agonist/antagonist combinations |
Dec, 2018
(5 years ago) |
Expired
|
| US6277384 | Opioid agonist/antagonist combinations |
Dec, 2018
(5 years ago) |
Expired
|
| US8673355 | Opioid agonist/antagonist combinations |
Dec, 2018
(5 years ago) |
Expired
|
| US9474750 | Opioid agonist/opioid antagonist/acetaminophen combinations |
Dec, 2018
(5 years ago) |
Expired
|
| US9084729 | Abuse-resistant controlled-release opioid dosage form |
May, 2022
(2 years ago) |
Expired
|
| US9283216 | Abuse-resistant controlled-release opioid dosage form |
May, 2022
(2 years ago) |
Expired
|
| US9161937 | Abuse-resistant controlled-release opioid dosage form |
May, 2022
(2 years ago) |
Expired
|
| US9511066 | Abuse-resistant controlled-release opioid dosage form |
May, 2022
(2 years ago) |
Expired
|
| US8969369 | Abuse-resistant controlled-release opioid dosage form |
May, 2022
(2 years ago) |
Expired
|
| US9056051 | Abuse-resistant controlled-release opioid dosage form |
May, 2022
(2 years ago) |
Expired
|
| US9283221 | Abuse-resistant controlled-release opioid dosage form |
May, 2022
(2 years ago) |
Expired
|
| US9168252 | Abuse-resistant controlled-release opioid dosage form |
May, 2022
(2 years ago) |
Expired
|
| US9345701 | Abuse-resistant controlled-release opioid dosage form |
May, 2022
(2 years ago) |
Expired
|
| US9907793 | Pharmaceutical preparation containing oxycodone and naloxone |
Apr, 2023
(1 year, 3 months ago) |
Expired
|
| US9555000 | Pharmaceutical preparation containing oxycodone and naloxone |
Apr, 2023
(1 year, 3 months ago) |
Expired
|
| US8846090 | Matrix for sustained, invariant and independent release of active compounds |
Apr, 2023
(1 year, 3 months ago) |
Expired
|
| US8846091 | Matrix for sustained, invariant and independent release of active compounds |
Apr, 2023
(1 year, 3 months ago) |
Expired
|
| US7674799 | Oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone |
Mar, 2025
(8 months from now) | Active |
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 Targiniq's patents.
Latest Legal Activities on Targiniq's Patents
Given below is the list of recent legal activities going on the following patents of Targiniq.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Expire Patent | 01 Jul, 2024 | US9345701 |
| Expire Patent | 22 Apr, 2024 | US9283221 |
| Expire Patent | 22 Apr, 2024 | US9283216 |
| Maintenance Fee Reminder Mailed | 15 Jan, 2024 | US9345701 |
| Expire Patent | 04 Dec, 2023 | US9168252 |
| Expire Patent | 27 Nov, 2023 | US9161937 |
| Maintenance Fee Reminder Mailed | 06 Nov, 2023 | US9283216 |
| Maintenance Fee Reminder Mailed | 06 Nov, 2023 | US9283221 |
| Expire Patent | 28 Aug, 2023 | US9084729 |
| Expire Patent | 24 Jul, 2023 | US9056051 |
FDA has granted several exclusivities to Targiniq. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Targiniq, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Targiniq.
Exclusivity Information
Targiniq holds 1 exclusivities. All of its exclusivities have expired in 2017. Details of Targiniq's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Combination(NC) | Jul 23, 2017 |
Several oppositions have been filed on Targiniq'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 Targiniq's generic, the next section provides detailed information on ongoing and past EP oppositions related to Targiniq patents.
Targiniq's oppositions filed in EPO
Targiniq has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 30, 2009, by Hexal Ag. This opposition was filed on patent number EP03720425A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP11177518A | Feb, 2018 | Zentiva, k.s. | Revoked |
| EP11177516A | Feb, 2018 | Zentiva, k.s. | Revoked |
| EP11177516A | Feb, 2018 | Teva Pharmaceutical Industries Ltd | Revoked |
| EP11177518A | Feb, 2018 | Teva Pharmaceutical Industries Ltd | Revoked |
| EP11177516A | Feb, 2018 | Intas Pharmaceuticals Ltd. | Revoked |
| EP11177518A | Feb, 2018 | Intas Pharmaceuticals Ltd. | Revoked |
| EP11177518A | Jan, 2018 | STADA Arzneimittel AG | Revoked |
| EP11177516A | Jan, 2018 | STADA Arzneimittel AG | Revoked |
| EP11177518A | Nov, 2017 | G. L. Pharma GmbH | Revoked |
| EP11177516A | Nov, 2017 | G. L. Pharma GmbH | Revoked |
| EP11177516A | Nov, 2017 | Ethypharm | Revoked |
| EP11177518A | Nov, 2017 | Ethypharm | Revoked |
| EP11177520A | Aug, 2017 | Ethypharm | Revoked |
| EP11177520A | Aug, 2017 | Intas Pharmaceuticals Ltd. | Revoked |
| EP11177520A | Aug, 2017 | Teva Pharmaceutical Industries Ltd | Revoked |
| EP11177520A | Aug, 2017 | G. L. Pharma GmbH | Revoked |
| EP11177516A | Jul, 2017 | Acino Pharma AG | Revoked |
| EP11177518A | Jul, 2017 | Acino Pharma AG | Revoked |
| EP11177520A | Jun, 2017 | STADA Arzneimittel AG | Revoked |
| EP11177516A | Jun, 2017 | KRKA, d.d., Novo mesto | Revoked |
| EP11177518A | Jun, 2017 | Krka, d.d., Novo mesto | Revoked |
| EP11177516A | May, 2017 | Glenmark Pharmaceuticals Europe Ltd | Revoked |
| EP11177518A | May, 2017 | Glenmark Pharmaceuticals Europe Ltd | Revoked |
| EP11177520A | May, 2017 | Glenmark Pharmaceuticals Europe Ltd | Revoked |
| EP11177518A | May, 2017 | Hexal AG / Sandoz International GmbH | Revoked |
| EP11177518A | May, 2017 | Develco Pharma Schweiz AG | Revoked |
| EP11177516A | May, 2017 | Develco Pharma Schweiz AG | Revoked |
| EP11177516A | May, 2017 | Hexal AG / Sandoz International GmbH | Revoked |
| EP11177520A | May, 2017 | Hexal AG / Sandoz International GmbH | Revoked |
| EP11177520A | Apr, 2017 | Acino Supply AG | Revoked |
| EP11177520A | Apr, 2017 | KRKA, d.d., Novo mesto | Revoked |
| EP11177520A | Mar, 2017 | Develco Pharma Schweiz AG | Revoked |
| EP11186168A | Oct, 2016 | James Poole Limited | Opposition rejected |
| EP03720424A | Mar, 2016 | STADA Arzneimittel AG | Revoked |
| EP03720424A | Mar, 2016 | KRKA, d.d., Novo mesto | Revoked |
| EP03720424A | Mar, 2016 | FRKelly | Revoked |
| EP03720424A | Mar, 2016 | Zentiva k.s. | Revoked |
| EP03720424A | Mar, 2016 | Develco Pharma Schweiz AG | Revoked |
| EP03720424A | Mar, 2016 | ETHYPHARM | Revoked |
| EP03720424A | Mar, 2016 | G. L. Pharma GmbH | Revoked |
| EP03720424A | Mar, 2016 | Hexal AG / Sandoz International GmbH | Revoked |
| EP03720424A | Feb, 2016 | Teva Pharmaceutical Industries Ltd | Revoked |
| EP03720424A | Feb, 2016 | Acino Pharma AG | Revoked |
| EP03720424A | Dec, 2015 | Actavis Group PTC ehf | Revoked |
| EP10011792A | Oct, 2015 | Setna, Rohan P. | Granted and Under Opposition |
| EP10011792A | Oct, 2015 | Hoffmann Eitle | Granted and Under Opposition |
| EP10011792A | Oct, 2015 | James Poole Limited | Granted and Under Opposition |
| EP10011792A | Oct, 2015 | Acino Pharma AG | Granted and Under Opposition |
| EP05730345A | Dec, 2011 | Actavis group PTC ehf | Patent maintained as amended |
| EP05730345A | Dec, 2011 | Acino Pharma AG | Patent maintained as amended |
| EP05730345A | Dec, 2011 | Elend, Almut Susanne | Patent maintained as amended |
| EP03720425A | Sep, 2009 | Hexal AG | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Targiniq 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 Targiniq's family patents as well as insights into ongoing legal events on those patents.
Targiniq's family patents
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Generic Launch
Generic Release Date:
Targiniq's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 30, 2025 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Targiniq Generics:
There are no approved generic versions for Targiniq as of now.
About Targiniq
Targiniq is a drug owned by Purdue Pharma Lp. It is used for managing severe chronic pain when alternative treatment options are inadequate, requiring daily, around-the-clock, long-term opioid treatment. Targiniq uses Naloxone Hydrochloride; Oxycodone Hydrochloride as an active ingredient. Targiniq was launched by Purdue Pharma Lp in 2014.
Market Authorisation Date:
Targiniq was approved by FDA for market use on 23 July, 2014.
Active Ingredient:
Targiniq uses Naloxone Hydrochloride; Oxycodone Hydrochloride as the active ingredient. Check out other Drugs and Companies using Naloxone Hydrochloride; Oxycodone Hydrochloride ingredient
Treatment:
Targiniq is used for managing severe chronic pain when alternative treatment options are inadequate, requiring daily, around-the-clock, long-term opioid treatment.
Dosage:
Targiniq is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG;10MG | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 10MG;20MG | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 20MG;40MG | TABLET, EXTENDED RELEASE | Discontinued | ORAL |