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. Jesduvroq's patents will be open to challenges from 01 February, 2027. 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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US11117871 | Crystalline forms of GSK1278863, preparation method and pharmaceutical use thereof |
Mar, 2038
(13 years from now) | Active |
| US8324208 | Prolyl hydroxylase inhibitors |
Dec, 2028
(4 years from now) | Active |
| US11643397 | Prolyl hydroxylase inhibitors |
Jun, 2027
(2 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). | |||
| US11649217 | Crystalline forms of GSK1278863, preparation method and pharmaceutical use thereof |
Mar, 2038
(13 years from now) | Active |
| US8815884 | Prolyl hydroxylase inhibitors |
Jun, 2027
(2 years from now) | Active |
| US8557834 | Prolyl hydroxylase inhibitors |
Jun, 2027
(2 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.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| 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 Critical | 16 May, 2023 | US11649217 |
| Recordation of Patent eGrant | 16 May, 2023 | US11649217 |
| Electronic Review Critical | 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 Critical | 16 May, 2023 | US11649217 |
| Recordation of Patent Grant Mailed Critical | 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
Explore Our Curated Drug Screens
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.
Alternative Brands for Jesduvroq
Jesduvroq which is used for managing anemia associated with chronic kidney disease., has several other brand drugs in the same treatment category . 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 | ||||
|---|---|---|---|---|---|---|
| Takeda Pharms Usa |
| |||||
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.
Approval Date:
Jesduvroq was approved by FDA for market use on 01 February, 2023.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. 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 |
|---|---|---|---|
| 1MG | TABLET | Discontinued | ORAL |
| 8MG | TABLET | Discontinued | ORAL |
| 6MG | TABLET | Discontinued | ORAL |
| 4MG | TABLET | Discontinued | ORAL |
| 2MG | TABLET | Discontinued | ORAL |