Fruzaqla is a drug owned by Takeda Pharmaceuticals Usa Inc. It is protected by 4 US drug patents filed in 2023 out of which none have expired yet. Fruzaqla's patents will be open to challenges from 09 November, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 07, 2035. Details of Fruzaqla'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. | |||
| US10519142 | Crystalline forms of 6-((6,7-dimethoxyquinazolin-4-yl)oxy)-N,2-dimethylbenzofuran-3-carboxamide |
Sep, 2035
(10 years from now) | Active |
| US7829574 | Substituted quinazoline compounds and their use in treating angiogenesis-related diseases |
May, 2028
(3 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). | |||
| US11046674 | Crystalline forms of 6-((6,7-dimethoxyquinazolin-4-yl)oxy)-N,2-dimethylbenzofuran-3-carboxamide |
Sep, 2035
(10 years from now) | Active |
| US8212033 | Use of substituted quinazoline compounds in treating angiogenesis-related diseases |
May, 2028
(3 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 Fruzaqla's patents.
Latest Legal Activities on Fruzaqla's Patents
Given below is the list of recent legal activities going on the following patents of Fruzaqla.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Second letter to regulating agency to determine regulatory review period | 26 Apr, 2024 | US7829574 |
| Second letter to regulating agency to determine regulatory review period | 26 Apr, 2024 | US10519142 |
| Second letter to regulating agency to determine regulatory review period | 26 Apr, 2024 | US8212033 |
| Second letter to regulating agency to determine regulatory review period | 26 Apr, 2024 | US11046674 |
| Letter from FDA or Dept of Agriculture re PTE application | 17 Apr, 2024 | US11046674 |
| Letter from FDA or Dept of Agriculture re PTE application | 17 Apr, 2024 | US8212033 |
| Letter from FDA or Dept of Agriculture re PTE application | 17 Apr, 2024 | US10519142 |
| Letter from FDA or Dept of Agriculture re PTE application | 17 Apr, 2024 | US7829574 |
| Initial letter Re: PTE Application to regulating agency | 08 Jan, 2024 | US10519142 |
| Initial letter Re: PTE Application to regulating agency | 08 Jan, 2024 | US7829574 |
FDA has granted several exclusivities to Fruzaqla. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Fruzaqla, 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 Fruzaqla.
Exclusivity Information
Fruzaqla holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Fruzaqla's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 08, 2028 |
US patents provide insights into the exclusivity only within the United States, but Fruzaqla 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 Fruzaqla's family patents as well as insights into ongoing legal events on those patents.
Fruzaqla's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Fruzaqla's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 07, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Fruzaqla Generics:
There are no approved generic versions for Fruzaqla as of now.
About Fruzaqla
Fruzaqla is a drug owned by Takeda Pharmaceuticals Usa Inc. It is used for the treatment of metastatic colorectal cancer that is resistant to multiple chemotherapies and targeted therapies. Fruzaqla uses Fruquintinib as an active ingredient. Fruzaqla was launched by Takeda Pharms Usa in 2023.
Approval Date:
Fruzaqla was approved by FDA for market use on 08 November, 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 Fruzaqla is 08 November, 2023, its NCE-1 date is estimated to be 09 November, 2027.
Active Ingredient:
Fruzaqla uses Fruquintinib as the active ingredient. Check out other Drugs and Companies using Fruquintinib ingredient
Treatment:
Fruzaqla is used for the treatment of metastatic colorectal cancer that is resistant to multiple chemotherapies and targeted therapies.
Dosage:
Fruzaqla is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1MG | CAPSULE | Prescription | ORAL |
| 5MG | CAPSULE | Prescription | ORAL |