Docetaxel Patent Expiration

Docetaxel is used for the treatment of hormone-refractory metastatic prostate cancer, non-small cell lung cancer, and operable node-positive breast cancer. It was first introduced by Sanofi Aventis Us Llc in its drug Taxotere on May 14, 1996. Other drugs containing Docetaxel are Docefrez, Docivyx, Docetaxel. 24 different companies have introduced drugs containing Docetaxel.


Docetaxel Patents

Given below is the list of patents protecting Docetaxel, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Docetaxel US10842770 Non-aqueous taxane pro-emulsion formulations and methods of making and using the same Aug 07, 2031 Shilpa
Docetaxel US8940786 Non-aqueous taxane nanodispersion formulations and methods of using the same Sep 30, 2033 Shilpa
Docetaxel US9308195 Non-aqueous taxane formulations and methods of using the same Sep 30, 2033 Shilpa
Docetaxel US9763880 Non-aqueous taxane formulations and methods of using the same Sep 30, 2033 Shilpa
Docivyx US10398785 Pharmaceutical compositions containing taxane-cyclodextrin complexes, method of making and methods of use Mar 14, 2036 Avyxa Holdings
Taxotere US5438072 Taxoid-based compositions Nov 22, 2013

(Expired)

Sanofi Aventis Us
Taxotere US5438072

(Pediatric)

Taxoid-based compositions May 22, 2014

(Expired)

Sanofi Aventis Us
Taxotere US5698582 Compositions containing taxane derivatives Jul 03, 2012

(Expired)

Sanofi Aventis Us
Taxotere US5698582

(Pediatric)

Compositions containing taxane derivatives Jan 03, 2013

(Expired)

Sanofi Aventis Us
Taxotere US5714512 Compositions containing taxane derivatives Jul 03, 2012

(Expired)

Sanofi Aventis Us
Taxotere US5714512

(Pediatric)

Compositions containing taxane derivatives Jan 03, 2013

(Expired)

Sanofi Aventis Us
Taxotere US5750561 Compositions containing taxane derivatives Jul 03, 2012

(Expired)

Sanofi Aventis Us
Taxotere US5750561

(Pediatric)

Compositions containing taxane derivatives Jan 03, 2013

(Expired)

Sanofi Aventis Us


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.

Given below is the list recent legal activities going on the following patents of Docetaxel.

Event Date Patent/Publication
Patent litigations
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 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



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Docetaxel Generics

Several generic applications have been filed for Docetaxel. The first generic version for Docetaxel was by Dr Reddys Laboratories Ltd and was approved on Nov 5, 2014. And the latest generic version is by Acic Pharmaceuticals Inc and was approved on Feb 28, 2024.

Given below is the list of companies who have filed for Docetaxel generic.


1. DR REDDYS

Dr Reddys Laboratories Ltd has filed for 2 different strengths of generic version for Docetaxel. Given below are the details of the strengths of this generic introduced by Dr Reddys.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG/ML (20MG/ML) injectable Prescription INJECTION AP Nov 5, 2014
80MG/4ML (20MG/ML) injectable Prescription INJECTION AP Nov 5, 2014


2. TEVA PHARMS USA

Teva Pharmaceuticals Usa has filed for 2 different strengths of generic version for Docetaxel. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
80MG/4ML (20MG/ML) injectable Discontinued INJECTION N/A Sep 16, 2015
20MG/ML (20MG/ML) injectable Discontinued INJECTION N/A Sep 16, 2015


3. AMNEAL

Amneal Eu Ltd has filed for 3 different strengths of generic version for Docetaxel. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG/ML (20MG/ML) injectable Prescription INJECTION AP Jan 19, 2018
160MG/8ML (20MG/ML) injectable Prescription INJECTION AP Jan 19, 2018
80MG/4ML (20MG/ML) injectable Prescription INJECTION AP Jan 19, 2018


4. MYLAN LABS LTD

Mylan Laboratories Ltd has filed for 4 different strengths of generic version for Docetaxel. Given below are the details of the strengths of this generic introduced by Mylan Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
160MG/16ML (10MG/ML) injectable Prescription INJECTION AP Apr 30, 2018
20MG/2ML (10MG/ML) injectable Prescription INJECTION AP Jul 2, 2018
80MG/8ML (10MG/ML) injectable Prescription INJECTION AP Jul 6, 2018
160MG/8ML (20MG/ML) injectable Prescription INJECTION AP Apr 1, 2019


5. HIKMA

Hikma Farmaceutica Portugal Sa has filed for 2 different strengths of generic version for Docetaxel. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG/ML (20MG/ML) injectable Prescription INJECTION AP Jan 14, 2021
80MG/4ML (20MG/ML) injectable Prescription INJECTION AP Jan 14, 2021


6. GLAND PHARMA LTD

Gland Pharma Ltd has filed for 3 different strengths of generic version for Docetaxel. Given below are the details of the strengths of this generic introduced by Gland Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG/2ML (10MG/ML) injectable Prescription INJECTION AP Jul 1, 2021
80MG/8ML (10MG/ML) injectable Prescription INJECTION AP Jul 1, 2021
160MG/16ML (10MG/ML) injectable Prescription INJECTION AP Jul 1, 2021


7. NORVIUM BIOSCIENCE

Norvium Bioscience Llc has filed for 2 different strengths of generic version for Docetaxel. Given below are the details of the strengths of this generic introduced by Norvium Bioscience.

Strength Dosage Form Availability Application Pathway TE code Launch Date
80MG/4ML (20MG/ML) injectable Discontinued INJECTION N/A May 11, 2023
20MG/ML (20MG/ML) injectable Discontinued INJECTION N/A May 11, 2023


8. SHILPA

Shilpa Medicare Ltd has filed for 3 different strengths of generic version for Docetaxel. Given below are the details of the strengths of this generic introduced by Shilpa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
80MG/4ML (20MG/ML) injectable Prescription INJECTION AP May 16, 2019
20MG/ML (20MG/ML) injectable Prescription INJECTION AP May 16, 2019
160MG/8ML (20MG/ML) injectable Prescription INJECTION AP May 16, 2019


9. HENGRUI PHARMA

Jiangsu Hengrui Pharmaceuticals Co Ltd has filed for 4 different strengths of generic version for Docetaxel. Given below are the details of the strengths of this generic introduced by Hengrui Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG/ML injectable Discontinued INJECTION N/A Feb 15, 2017
160MG/8ML (20MG/ML) injectable Prescription INJECTION AP Aug 9, 2017
20MG/ML (20MG/ML) injectable Prescription INJECTION AP Aug 9, 2017
80MG/4ML (20MG/ML) injectable Prescription INJECTION AP Aug 9, 2017


10. MEITHEAL

Meitheal Pharmaceuticals Inc has filed for 3 different strengths of generic version for Docetaxel. Given below are the details of the strengths of this generic introduced by Meitheal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG/2ML (10MG/ML) injectable Prescription INJECTION AP Aug 24, 2018
160MG/16ML (10MG/ML) injectable Prescription INJECTION AP Aug 24, 2018
80MG/8ML (10MG/ML) injectable Prescription INJECTION AP Aug 24, 2018


11. EUGIA PHARMA

Eugia Pharma Specialities Ltd has filed for 3 different strengths of generic version for Docetaxel. Given below are the details of the strengths of this generic introduced by Eugia Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
80MG/8ML (10MG/ML) injectable Prescription INJECTION AP Jun 25, 2021
160MG/16ML (10MG/ML) injectable Prescription INJECTION AP Jun 25, 2021
20MG/2ML (10MG/ML) injectable Prescription INJECTION AP Jun 25, 2021


12. NOVAST LABS

Novast Laboratories Inc has filed for 3 different strengths of generic version for Docetaxel. Given below are the details of the strengths of this generic introduced by Novast Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG/2ML (10MG/ML) injectable Discontinued INJECTION N/A Aug 31, 2017
80MG/8ML (10MG/ML) injectable Prescription INJECTION AP Aug 31, 2017
160MG/16ML (10MG/ML) injectable Prescription INJECTION AP Aug 31, 2017


13. ACIC PHARMS

Acic Pharmaceuticals Inc has filed for 2 different strengths of generic version for Docetaxel. Given below are the details of the strengths of this generic introduced by Acic Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
80MG/4ML (20MG/ML) injectable Prescription INJECTION AP Feb 28, 2024
20MG/ML (20MG/ML) injectable Prescription INJECTION AP Feb 28, 2024


14. DFB ONCOLOGY LTD

Dfb Oncology Ltd has filed for 3 different strengths of generic version for Docetaxel. Given below are the details of the strengths of this generic introduced by Dfb Oncology Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
80MG/4ML (20MG/ML) injectable Discontinued INJECTION N/A Jan 20, 2017
200MG/10ML (20MG/ML) injectable Discontinued INJECTION N/A Jan 20, 2017
20MG/ML (20MG/ML) injectable Discontinued INJECTION N/A Jan 20, 2017


15. ALEMBIC

Alembic Pharmaceuticals Ltd has filed for 3 different strengths of generic version for Docetaxel. Given below are the details of the strengths of this generic introduced by Alembic.

Strength Dosage Form Availability Application Pathway TE code Launch Date
80MG/8ML (10MG/ML) injectable Prescription INJECTION AP Feb 28, 2023
160MG/16ML (10MG/ML) injectable Prescription INJECTION AP Feb 28, 2023
20MG/2ML (10MG/ML) injectable Prescription INJECTION AP Feb 28, 2023