Jesduvroq is a drug owned by Glaxosmithkline Intellectual Property No 2 Ltd England. It is protected by 6 US drug patents filed in 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 13, 2038. Details of Jesduvroq'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. | |||
| US11643397 | Prolyl hydroxylase inhibitors |
Jun, 2027
(2 years from now) | Active |
| US8324208 | Prolyl hydroxylase inhibitors |
Dec, 2028
(4 years from now) | Active |
| US11117871 | Crystalline forms of GSK1278863, preparation method and pharmaceutical use thereof |
Mar, 2038
(13 years 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). | |||
| US8815884 | Prolyl hydroxylase inhibitors |
Jun, 2027
(2 years from now) | Active |
| US8557834 | Prolyl hydroxylase inhibitors |
Jun, 2027
(2 years from now) | Active |
| US11649217 | Crystalline forms of GSK1278863, preparation method and pharmaceutical use thereof |
Mar, 2038
(13 years 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 Jesduvroq's patents.
Latest Legal Activities on Jesduvroq's Patents
Given below is the list of recent legal activities going on the following patents of Jesduvroq.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Second letter to regulating agency to determine regulatory review period | 26 Apr, 2024 | US8324208 |
| Letter from FDA or Dept of Agriculture re PTE application | 30 Jan, 2024 | US8324208 |
| Initial letter Re: PTE Application to regulating agency | 22 Jun, 2023 | US8324208 |
| Email Notification | 16 May, 2023 | US11649217 |
| Recordation of Patent eGrant | 16 May, 2023 | US11649217 |
| Electronic Review | 16 May, 2023 | US11649217 |
| Patent eGrant Notification | 16 May, 2023 | US11649217 |
| Mail Patent eGrant Notification | 16 May, 2023 | US11649217 |
| Patent Issue Date Used in PTA Calculation | 16 May, 2023 | US11649217 |
| Recordation of Patent Grant Mailed | 16 May, 2023 | US11649217 |
FDA has granted several exclusivities to Jesduvroq. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Jesduvroq, 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 Jesduvroq.
Exclusivity Information
Jesduvroq holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Jesduvroq's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Feb 01, 2028 |
US patents provide insights into the exclusivity only within the United States, but Jesduvroq 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 Jesduvroq's family patents as well as insights into ongoing legal events on those patents.
Jesduvroq's family patents
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Generic Launch
Generic Release Date:
Jesduvroq's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 13, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Jesduvroq Generics:
There are no approved generic versions for Jesduvroq as of now.
About Jesduvroq
Jesduvroq is a drug owned by Glaxosmithkline Intellectual Property No 2 Ltd England. It is used for managing anemia associated with chronic kidney disease. Jesduvroq uses Daprodustat as an active ingredient. Jesduvroq was launched by Glaxosmithkline in 2023.
Market Authorisation Date:
Jesduvroq was approved by FDA for market use on 01 February, 2023.
NCE-1 date:
NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Jesduvroq is 01 February, 2023, its NCE-1 date is estimated to be 01 February, 2027
Active Ingredient:
Jesduvroq uses Daprodustat as the active ingredient. Check out other Drugs and Companies using Daprodustat ingredient
Treatment:
Jesduvroq is used for managing anemia associated with chronic kidney disease.
Dosage:
Jesduvroq is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 4MG | TABLET | Discontinued | ORAL |
| 8MG | TABLET | Discontinued | ORAL |
| 6MG | TABLET | Discontinued | ORAL |
| 2MG | TABLET | Discontinued | ORAL |
| 1MG | TABLET | Discontinued | ORAL |