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
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 |
---|---|---|---|---|
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.
Latest 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 |
---|---|---|
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
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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 Feb 28, 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 | ||||||||||||||
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India |
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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 |
---|---|---|---|---|---|
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 |
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 | ||||||||||||||||
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United States |
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India |
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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 |
---|---|---|---|---|---|
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 |
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 |
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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. 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 |
8. HERITAGE
Heritage Pharmaceuticals Inc Dba Avet 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 Heritage.
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 |
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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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United States |
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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 | ||||||||
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United States |
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Portugal |
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Jordan |
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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. 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 |
---|---|---|---|---|---|
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 |
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 | ||||||||||
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United States |
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India |
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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 |
---|---|---|---|---|---|
80MG/4ML (20MG/ML) | injectable | Discontinued | INJECTION | N/A | Sep 16, 2015 |
20MG/ML (20MG/ML) | injectable | Discontinued | INJECTION | N/A | Sep 16, 2015 |