Docetaxel is a drug owned by Shilpa Medicare Ltd. It is protected by 4 US drug patents filed from 2015 to 2021 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 30, 2033. Details of Docetaxel'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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9308195 | Non-aqueous taxane formulations and methods of using the same |
Sep, 2033
(8 years from now) | Active |
| US8940786 | Non-aqueous taxane nanodispersion formulations and methods of using the same |
Sep, 2033
(8 years from now) | Active |
| US9763880 | Non-aqueous taxane formulations and methods of using the same |
Sep, 2033
(8 years from now) | Active |
| US10842770 | Non-aqueous taxane pro-emulsion formulations and methods of making and using the same |
Aug, 2031
(6 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 Docetaxel's patents.
Latest Legal Activities on Docetaxel's Patents
Given below is the list of recent legal activities going on the following patents of Docetaxel.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 08 May, 2024 | US10842770 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 27 Sep, 2023 | US9308195 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Jul, 2022 | US8940786 |
| Post Issue Communication - Certificate of Correction | 18 May, 2021 | US10842770 |
| Email Notification Critical | 13 May, 2021 | US10842770 |
| Mail Pet Dec Routed to Certificate of Corrections Branch | 12 May, 2021 | US10842770 |
| Mail-Record a Petition Decision of Granted for Patent Term Adjustment after Issue | 12 May, 2021 | US10842770 |
| Record a Petition Decision of Granted for Patent Term Adjustment after Issue | 11 May, 2021 | US10842770 |
| Pet Dec Routed to Certificate of Corrections Branch | 11 May, 2021 | US10842770 |
| Adjustment of PTA Calculation by PTO | 11 May, 2021 | US10842770 |
US patents provide insights into the exclusivity only within the United States, but Docetaxel 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 Docetaxel's family patents as well as insights into ongoing legal events on those patents.
Docetaxel's Family Patents
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Generic Launch
Generic Release Date:
Docetaxel's generic launch date based on the expiry of its last outstanding patent is estimated to be Sep 30, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Docetaxel Generic API suppliers:
Docetaxel is the generic name for the brand Docetaxel. 15 different companies have already filed for the generic of Docetaxel, with Hengrui Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Docetaxel's generic
Alternative Brands for Docetaxel
Docetaxel which is used for the treatment of hormone-refractory metastatic prostate cancer, non-small cell lung cancer, and operable node-positive breast cancer., has several other brand drugs using the same active ingredient (Docetaxel). 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.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Docetaxel, Docetaxel's active ingredient. Check the complete list of approved generic manufacturers for Docetaxel
About Docetaxel
Docetaxel is a drug owned by Shilpa Medicare Ltd. It is used for the treatment of hormone-refractory metastatic prostate cancer, non-small cell lung cancer, and operable node-positive breast cancer. Docetaxel uses Docetaxel as an active ingredient. Docetaxel was launched by Shilpa in 2015.
Approval Date:
Docetaxel was approved by FDA for market use on 22 December, 2015.
Active Ingredient:
Docetaxel uses Docetaxel as the active ingredient. Check out other Drugs and Companies using Docetaxel ingredient
Treatment:
Docetaxel is used for the treatment of hormone-refractory metastatic prostate cancer, non-small cell lung cancer, and operable node-positive breast cancer.
Dosage:
Docetaxel is available in injectable form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 160MG/8ML (20MG/ML) | INJECTABLE | Prescription | INJECTION |
| 80MG/4ML (20MG/ML) | INJECTABLE | Prescription | INJECTION |
| 20MG/ML (20MG/ML) | INJECTABLE | Prescription | INJECTION |