Probuphine is a drug owned by Reacx Pharmaceuticals Inc. It is protected by 1 US drug patent filed in 2016 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 25, 2024. Details of Probuphine'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7736665 | Implantable polymeric device for sustained release of buprenorphine |
Apr, 2024
(3 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 Probuphine's patents.
Latest Legal Activities on Probuphine's Patents
Given below is the list of recent legal activities going on the following patents of Probuphine.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Yr, Small Entity | 01 Dec, 2021 | US7736665 |
| Email Notification | 24 Aug, 2018 | US7736665 |
| Change in Power of Attorney (May Include Associate POA) | 22 Aug, 2018 | US7736665 |
| Correspondence Address Change | 21 Aug, 2018 | US7736665 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 13 Nov, 2017 | US7736665 |
| Post Issue Communication - Certificate of Correction | 09 Mar, 2017 | US7736665 |
| Post Issue Communication - Certificate of Correction | 07 Mar, 2017 | US7736665 |
| Email Notification | 09 Jan, 2015 | US7736665 |
| Change in Power of Attorney (May Include Associate POA) | 09 Jan, 2015 | US7736665 |
| Correspondence Address Change | 08 Jan, 2015 | US7736665 |
FDA has granted several exclusivities to Probuphine. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Probuphine, 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 Probuphine.
Exclusivity Information
Probuphine holds 1 exclusivities. All of its exclusivities have expired in 2019. Details of Probuphine's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | May 26, 2019 |
US patents provide insights into the exclusivity only within the United States, but Probuphine 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 Probuphine's family patents as well as insights into ongoing legal events on those patents.
Probuphine's family patents
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Generic Launch
Generic Release Date:
Probuphine's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 25, 2024 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Probuphine Generics:
Buprenorphine Hydrochloride is the generic name for the brand Probuphine. 12 different companies have already filed for the generic of Probuphine, with Alvogen having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Probuphine's generic
About Probuphine
Probuphine is a drug owned by Reacx Pharmaceuticals Inc. It is used for managing opioid dependence. Probuphine uses Buprenorphine Hydrochloride as an active ingredient. Probuphine was launched by Reacx Pharms in 2016.
Market Authorisation Date:
Probuphine was approved by FDA for market use on 26 May, 2016.
Active Ingredient:
Probuphine uses Buprenorphine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Buprenorphine Hydrochloride ingredient
Treatment:
Probuphine is used for managing opioid dependence.
Dosage:
Probuphine is available in implant form for implantation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 80MG BASE/IMPLANT | IMPLANT | Discontinued | IMPLANTATION |