Pemazyre is a drug owned by Incyte Corp. It is protected by 4 US drug patents filed from 2020 to 2023 out of which none have expired yet. Pemazyre's patents have been open to challenges since 17 April, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 30, 2040. Details of Pemazyre'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. | |||
| US9611267 | Substituted tricyclic compounds as FGFR inhibitors |
Jan, 2035
(10 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). | |||
| US11628162 | Methods of treating cancer with an FGFR inhibitor |
Aug, 2040
(15 years from now) | Active |
| US11466004 | Solid forms of an FGFR inhibitor and processes for preparing the same |
May, 2039
(14 years from now) | Active |
| US10131667 | Substituted tricyclic compounds as FGFR inhibitors |
Jun, 2033
(8 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 Pemazyre's patents.
Latest Legal Activities on Pemazyre's Patents
Given below is the list of recent legal activities going on the following patents of Pemazyre.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| transaction for FDA Determination of Regulatory Review Period | 18 Jan, 2024 | US9611267 |
| transaction for FDA Determination of Regulatory Review Period | 18 Jan, 2024 | US10131667 |
| transaction for FDA Determination of Regulatory Review Period | 08 Dec, 2023 | US9611267 |
| transaction for FDA Determination of Regulatory Review Period | 08 Dec, 2023 | US10131667 |
| Email Notification Critical | 19 May, 2023 | US11628162 |
| Electronic Review Critical | 19 May, 2023 | US11628162 |
| Mail Miscellaneous Communication to Applicant | 18 May, 2023 | US11628162 |
| Miscellaneous Communication to Applicant - No Action Count | 18 May, 2023 | US11628162 |
| Mail Miscellaneous Communication to Applicant | 21 Apr, 2023 | US11628162 |
| Email Notification Critical | 21 Apr, 2023 | US11628162 |
FDA has granted several exclusivities to Pemazyre. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Pemazyre, 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 Pemazyre.
Exclusivity Information
Pemazyre holds 4 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Pemazyre's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 17, 2025 |
| New Indication(I-899) | Aug 26, 2025 |
| Orphan Drug Exclusivity(ODE-292) | Apr 17, 2027 |
| Orphan Drug Exclusivity(ODE-404) | Aug 26, 2029 |
US patents provide insights into the exclusivity only within the United States, but Pemazyre 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 Pemazyre's family patents as well as insights into ongoing legal events on those patents.
Pemazyre's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Pemazyre's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 30, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Pemazyre Generics:
There are no approved generic versions for Pemazyre as of now.
About Pemazyre
Pemazyre is a drug owned by Incyte Corp. It is used for treating cholangiocarcinoma and myeloid/lymphoid neoplasms with specific genetic rearrangements in patients who have not responded to previous treatments. Pemazyre uses Pemigatinib as an active ingredient. Pemazyre was launched by Incyte Corp in 2020.
Approval Date:
Pemazyre was approved by FDA for market use on 17 April, 2020.
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 Pemazyre is 17 April, 2020, its NCE-1 date is estimated to be 17 April, 2024.
Active Ingredient:
Pemazyre uses Pemigatinib as the active ingredient. Check out other Drugs and Companies using Pemigatinib ingredient
Treatment:
Pemazyre is used for treating cholangiocarcinoma and myeloid/lymphoid neoplasms with specific genetic rearrangements in patients who have not responded to previous treatments.
Dosage:
Pemazyre is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 13.5MG | TABLET | Prescription | ORAL |
| 4.5MG | TABLET | Prescription | ORAL |
| 9MG | TABLET | Prescription | ORAL |