Fulvestrant Patent Expiration
Fulvestrant is used for treating hormone receptor positive metastatic breast cancer in postmenopausal women. It was first introduced by Astrazeneca Pharmaceuticals Lp
Fulvestrant Patents
Given below is the list of patents protecting Fulvestrant, 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 |
|---|---|---|---|---|
| Fulvestrant | US9271990 | Fulvestrant formulations | May 17, 2034 | Fresenius Kabi Usa |
| Fulvestrant | US10188663 | Fulvestrant formulations | Feb 14, 2034 | Fresenius Kabi Usa |
| Fulvestrant | US9833459 | Fulvestrant formulations | Feb 14, 2034 | Fresenius Kabi Usa |
| Faslodex |
US6774122 (Pediatric) | Formulation |
Jul 09, 2021
(Expired) | Astrazeneca |
| Faslodex |
US7456160 (Pediatric) | Formulation |
Jul 09, 2021
(Expired) | Astrazeneca |
| Faslodex |
US8329680 (Pediatric) | Formulation |
Jul 09, 2021
(Expired) | Astrazeneca |
| Faslodex |
US8466139 (Pediatric) | Formulation |
Jul 09, 2021
(Expired) | Astrazeneca |
| Faslodex | US6774122 | Formulation |
Jan 09, 2021
(Expired) | Astrazeneca |
| Faslodex | US7456160 | Formulation |
Jan 09, 2021
(Expired) | Astrazeneca |
| Faslodex | US8329680 | Formulation |
Jan 09, 2021
(Expired) | Astrazeneca |
| Faslodex | US8466139 | Formulation |
Jan 09, 2021
(Expired) | Astrazeneca |
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 Fulvestrant's patents.
Latest Legal Activities on Fulvestrant's Patents
Given below is the list recent legal activities going on the following patents of Fulvestrant.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 29 Jul, 2022 | US10188663 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 07 Jun, 2021 | US9833459 |
| Patent Issue Date Used in PTA Calculation Critical | 29 Jan, 2019 | US10188663 |
| Recordation of Patent Grant Mailed Critical | 29 Jan, 2019 | US10188663 |
| Email Notification Critical | 10 Jan, 2019 | US10188663 |
| Issue Notification Mailed Critical | 09 Jan, 2019 | US10188663 |
| Application Is Considered Ready for Issue Critical | 20 Dec, 2018 | US10188663 |
| Dispatch to FDC | 20 Dec, 2018 | US10188663 |
| Issue Fee Payment Verified Critical | 17 Dec, 2018 | US10188663 |
| Issue Fee Payment Received Critical | 17 Dec, 2018 | US10188663 |
Fulvestrant's Family Patents
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Fulvestrant Generic API Manufacturers
Several generic applications have been filed for Fulvestrant. The first generic version for Fulvestrant was by Amneal Eu Ltd and was approved on Mar 4, 2019. And the latest generic version is by Eugia Pharma Specialities Ltd and was approved on Jun 30, 2023.
Given below is the list of companies who have filed for Fulvestrant generic, along with the locations of their manufacturing plants worldwide.
1. ACCORD HLTHCARE
Accord Healthcare Inc has filed for 1 generic for Fulvestrant. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG/5ML (50MG/ML) | solution | Prescription | INTRAMUSCULAR | AO | Nov 17, 2020 |
2. ALEMBIC
Alembic Pharmaceuticals Ltd has filed for 1 generic for Fulvestrant. Given below are the details of the strengths of this generic introduced by Alembic.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG/5ML (50MG/ML) | solution | Prescription | INTRAMUSCULAR | AO | Dec 22, 2022 |
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 |
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3. AMNEAL
Amneal Eu Ltd has filed for 1 generic for Fulvestrant. Given below are the details of the strengths of this generic introduced by Amneal.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG/5ML (50MG/ML) | solution | Prescription | INTRAMUSCULAR | AO | Mar 4, 2019 |
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 |
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| India |
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4. APOTEX
Apotex Inc has filed for 1 generic for Fulvestrant. Given below are the details of the strengths of this generic introduced by Apotex.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG/5ML (50MG/ML) | solution | Discontinued | INTRAMUSCULAR | N/A | Jun 11, 2021 |
Manufacturing Plant Locations New
Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.
| Country | City | Firm Name | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| Canada |
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| India |
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5. CHIA TAI TIANQING
Chia Tai Tianqing Pharmaceutical Group Co Ltd has filed for 1 generic for Fulvestrant. Given below are the details of the strengths of this generic introduced by Chia Tai Tianqing.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG/5ML (50MG/ML) | solution | Prescription | INTRAMUSCULAR | AO | Feb 7, 2020 |
Manufacturing Plant Locations New
Chia Tai Tianqing's manufacturing plants are situated in 1 country - China. Given below are the details of these plant locations as well as the firm names of Chia Tai Tianqing as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| China |
| |||
6. DR REDDYS
Dr Reddys Laboratories Ltd has filed for 1 generic for Fulvestrant. 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 |
|---|---|---|---|---|---|
| 250MG/5ML (50MG/ML) | solution | Prescription | INTRAMUSCULAR | AO | Aug 7, 2020 |
7. EUGIA PHARMA
Eugia Pharma Specialities Ltd has filed for 1 generic for Fulvestrant. 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 |
|---|---|---|---|---|---|
| 250MG/5ML (50MG/ML) | solution | Prescription | INTRAMUSCULAR | AO | Jun 30, 2023 |
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 |
| |||||||
8. GLENMARK PHARMS INC
Glenmark Pharmaceuticals Inc Usa has filed for 1 generic for Fulvestrant. Given below are the details of the strengths of this generic introduced by Glenmark Pharms Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG/5ML (50MG/ML) | solution | Prescription | INTRAMUSCULAR | AO | Aug 22, 2019 |
9. HBT LABS INC
Hbt Labs Inc has filed for 1 generic for Fulvestrant. Given below are the details of the strengths of this generic introduced by Hbt Labs Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG/5ML (50MG/ML) | solution | Prescription | INTRAMUSCULAR | AO | Nov 21, 2019 |
10. JIANGSU HANSOH PHARM
Jiangsu Hansoh Pharmaceutical Group Co Ltd has filed for 1 generic for Fulvestrant. Given below are the details of the strengths of this generic introduced by Jiangsu Hansoh Pharm.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG/5ML (50MG/ML) | solution | Prescription | INTRAMUSCULAR | AO | Feb 10, 2022 |
Manufacturing Plant Locations New
Jiangsu Hansoh Pharm's manufacturing plants are situated in 1 country - China. Given below are the details of these plant locations as well as the firm names of Jiangsu Hansoh Pharm as present at those locations.
| Country | City | Firm Name | ||||
|---|---|---|---|---|---|---|
| China |
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11. SAGENT PHARMS INC
Sagent Pharmaceuticals Inc has filed for 1 generic for Fulvestrant. Given below are the details of the strengths of this generic introduced by Sagent Pharms Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG/5ML (50MG/ML) | solution | Prescription | INTRAMUSCULAR | AO | Aug 22, 2019 |
12. SANDOZ
Sandoz Inc has filed for 1 generic for Fulvestrant. Given below are the details of the strengths of this generic introduced by Sandoz.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG/5ML (50MG/ML) | solution | Prescription | INTRAMUSCULAR | AO | May 14, 2019 |
Manufacturing Plant Locations New
Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.
| Country | City | Firm Name | ||||
|---|---|---|---|---|---|---|
| Austria |
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| United States |
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| Spain |
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| India |
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13. XIROMED
Xiromed Pharma Espana Sl has filed for 1 generic for Fulvestrant. Given below are the details of the strengths of this generic introduced by Xiromed.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG/5ML (50MG/ML) | solution | Prescription | INTRAMUSCULAR | AO | Aug 13, 2021 |
Manufacturing Plant Locations New
Xiromed'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 Xiromed as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| United States |
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14. ZYDUS PHARMS
Zydus Pharmaceuticals Usa Inc has filed for 1 generic for Fulvestrant. Given below are the details of the strengths of this generic introduced by Zydus Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG/5ML (50MG/ML) | solution | Prescription | INTRAMUSCULAR | AO | Jul 29, 2021 |