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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 Docivyx, Beizray, Docetaxel, Docefrez. 25 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
Beizray US11419842 Neutral pH compositions of Docetaxel and human serum albumin May 16, 2036 Zhuhai
Beizray US12090134 Neutral pH compositions of docetaxel and human serum albumin May 16, 2036 Zhuhai
Beizray US12090135 Neutral pH compositions of docetaxel and human serum albumin May 16, 2036 Zhuhai
Docivyx US10398785 Pharmaceutical compositions containing taxane-cyclodextrin complexes, method of making and methods of use Mar 14, 2036 Avyxa Holdings
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
Docetaxel US10842770 Non-aqueous taxane pro-emulsion formulations and methods of making and using the same Aug 07, 2031 Shilpa
Taxotere US5438072

(Pediatric)

 Taxoid-based compositions May 22, 2014

(Expired)

 Sanofi Aventis Us
Taxotere US5438072 Taxoid-based compositions Nov 22, 2013

(Expired)

 Sanofi Aventis Us
Taxotere US5698582

(Pediatric)

 Compositions containing taxane derivatives Jan 03, 2013

(Expired)

 Sanofi Aventis Us
Taxotere US5714512

(Pediatric)

 Compositions containing taxane derivatives Jan 03, 2013

(Expired)

 Sanofi Aventis Us
Taxotere US5750561

(Pediatric)

 Compositions containing taxane derivatives Jan 03, 2013

(Expired)

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

(Expired)

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

(Expired)

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

(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.

Activity Date Patent Number
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
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


Docetaxel's Family Patents

Family Patents

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Docetaxel Generic API Manufacturers

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 Heritage Pharmaceuticals Inc Dba Avet Pharmaceuticals Inc and was approved on Nov 26, 2024.

Given below is the list of companies who have filed for Docetaxel generic, along with the locations of their manufacturing plants worldwide.


1. 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


Manufacturing Plant Locations
New

Alembic's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Alembic as present at those locations.

Country City Firm Name
India
Vadodara Alembic Pharmaceuticals Ltd (API Division, Karakhadi)
Vadodara Alembic Pharmaceuticals, Ltd
Vadodara Alembic Pharmaceuticals Ltd
Panchmahal Alembic Pharmaceuticals Limited (Units I and II)
Panelav Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Limited
Panchmahal Alembic Pharmaceuticals Limited





2. 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
160MG/8ML (20MG/ML)

injectable Prescription INJECTION AP Jan 19, 2018
80MG/4ML (20MG/ML)

injectable Prescription INJECTION AP Jan 19, 2018
20MG/ML (20MG/ML)

injectable Prescription INJECTION AP Jan 19, 2018


Manufacturing Plant Locations
New

Amneal's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Amneal as present at those locations.

Country City Firm Name
United States
Brookhaven Amneal Pharmaceuticals of New York, LLC
Piscataway Amneal Pharmaceuticals, LLC
East Hanover Amneal Pharmaceuticals LLC
Paterson Amneal Pharmaceuticals, Llc
Hauppauge Amneal Pharmaceuticals of New York, LLC
Branchburg Amneal Pharmaceuticals, LLC
Glasgow Amneal Pharmaceuticals LLC
Bridgewater Amneal Complex Products Research LLC
India
Tal Bavla, Ahmedabad Amneal Pharmaceuticals Pvt. Ltd.
Hyderabad Amneal Oncology Private Limited
Matoda Amneal Pharmaceuticals Private Ltd.
Ahmedabad Amneal Pharmaceuticals Private Ltd.





3. 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
200MG/10ML (20MG/ML)

injectable Discontinued INJECTION N/A Jan 20, 2017
80MG/4ML (20MG/ML)

injectable Discontinued INJECTION N/A Jan 20, 2017
20MG/ML (20MG/ML)

injectable Discontinued INJECTION N/A Jan 20, 2017





4. 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





5. 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


Manufacturing Plant Locations
New

Eugia Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Eugia Pharma as present at those locations.

Country City Firm Name
India
Medchal-Malkajgiri District EUGIA Pharma Specialities Limited
Pashamylaram Eugia Pharma Specialities Limited
Riico Industrial Area EUGIA Pharma Specialities Limited





6. GLAND

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.

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


Manufacturing Plant Locations
New

Gland's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Gland as present at those locations.

Country City Firm Name
India
Hyderabad Gland Pharma Limited
Hyderabad Gland Pharma Limited, Units I+II Pashamylaram Site
Aurangabad Gland Chemical Private Limited
Malur Gland Chemicals Pvt Ltd.
Sriperumbudur Gland Chemical Private Limited
Visakhapatnam Gland Pharma Limited
Parawada, Visakhapatnam Gland Pharma Limited





7. 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
80MG/4ML (20MG/ML)

injectable Prescription INJECTION AP Aug 9, 2017
20MG/ML (20MG/ML)

injectable Prescription INJECTION AP Aug 9, 2017





8. HERITAGE

Heritage Pharmaceuticals Inc Dba Avet 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 Heritage.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG/ML (20MG/ML)

injectable Prescription INJECTION AP Feb 28, 2024
80MG/4ML (20MG/ML)

injectable Prescription INJECTION AP Feb 28, 2024
160MG/8ML (20MG/ML)

injectable Prescription INJECTION AP Nov 26, 2024


Manufacturing Plant Locations
New

Heritage's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Heritage as present at those locations.

Country City Firm Name
United States
De Graff Heritage Cooperative Inc
Canfield Heritage Cooperative
Vanlue Heritage Cooperative
Morgantown Heritage Animal Hospital
Chino Heritage #2
London Heritage Cooperative Inc.
Mc Cutchenville Heritage Cooperative, Inc
Springfield Heritage Cooperative, Inc
Kenton Heritage Cooperative
Beloit Heritage Cooperative
Lisbon Heritage Cooperative, Inc.
Van Nuys Heritage Candy Company, Inc.
Plain City Heritage Cooperative Inc.
Cairo Heritage Cooperative
Woodsfield Heritage Cooperative
Richwood Heritage Cooperative, Inc
Caldwell Heritage Country Store-Heritage Cooperative
New Philadelphia Heritage Cooperative
Ada Heritage Cooperative Inc
London Heritage Cooperative, Inc
Minneapolis Heritage Deli Provisions, LLC
Waterford Heritage Cooperative
Fletcher Heritage Cooperative Inc
Upper Sandusky Heritage Cooperative
Alger Heritage Cooperative
South Burlington Heritage Aviation
West Mansfield Heritage Cooperative Inc.
Fort Scott Heritage Acres Farm
West Liberty Heritage Cooperative, Inc
Dola Heritage Cooperative Inc
Urbana Heritage Cooperative Inc
Middlebury Heritage Acres
Sacramento Heritage Baking Company Inc.





9. 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


Manufacturing Plant Locations
New

Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.

Country City Firm Name
United States
Cherry Hill Hikma Pharmaceuticals USA Inc.
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Eatontown Hikma Pharmaceuticals USA, Inc.
Dayton Hikma Injectables USA Inc
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





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
80MG/8ML (10MG/ML)

injectable Prescription INJECTION AP Aug 24, 2018
160MG/16ML (10MG/ML)

injectable Prescription INJECTION AP Aug 24, 2018





11. 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





12. 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





13. 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





14. 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
20MG/ML (20MG/ML)

injectable Prescription INJECTION AP May 16, 2019
80MG/4ML (20MG/ML)

injectable Prescription INJECTION AP May 16, 2019
160MG/8ML (20MG/ML)

injectable Prescription INJECTION AP May 16, 2019


Manufacturing Plant Locations
New

Shilpa's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Shilpa as present at those locations.

Country City Firm Name
United States
Minneapolis Shilpa Gupta
India
Hyderbad Shilpa Medicare Limited
Polepally, Jadcherla Shilpa Medicare Limited
Bengaluru Shilpa Medicare Limited
Chicksugur, Raichur Shilpa Pharma Lifesciences Limited
Hyderabad Shilpa Medicare Limited





15. 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
20MG/ML (20MG/ML)

injectable Discontinued INJECTION N/A Sep 16, 2015
80MG/4ML (20MG/ML)

injectable Discontinued INJECTION N/A Sep 16, 2015