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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 in its drug Faslodex on Apr 25, 2002. Another drug containing Fulvestrant is Fulvestrant. 17 different companies have introduced drugs containing Fulvestrant.


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
Faslodex US6774122 Formulation Jan 09, 2021

(Expired)

 Astrazeneca
Faslodex US6774122

(Pediatric)

 Formulation Jul 09, 2021

(Expired)

 Astrazeneca
Faslodex US7456160 Formulation Jan 09, 2021

(Expired)

 Astrazeneca
Faslodex US7456160

(Pediatric)

 Formulation Jul 09, 2021

(Expired)

 Astrazeneca
Faslodex US8329680 Formulation Jan 09, 2021

(Expired)

 Astrazeneca
Faslodex US8329680

(Pediatric)

 Formulation Jul 09, 2021

(Expired)

 Astrazeneca
Faslodex US8466139 Formulation Jan 09, 2021

(Expired)

 Astrazeneca
Faslodex US8466139

(Pediatric)

 Formulation Jul 09, 2021

(Expired)

 Astrazeneca
Fulvestrant US10188663 Fulvestrant formulations Feb 14, 2034 Fresenius Kabi Usa
Fulvestrant US9271990 Fulvestrant formulations May 17, 2034 Fresenius Kabi Usa
Fulvestrant US9833459 Fulvestrant formulations Feb 14, 2034 Fresenius Kabi Usa


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.

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

Event Date Patent/Publication
Patent litigations
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 29 Jan, 2019 US10188663
Recordation of Patent Grant Mailed 29 Jan, 2019 US10188663
Email Notification 10 Jan, 2019 US10188663
Issue Notification Mailed 09 Jan, 2019 US10188663
Application Is Considered Ready for Issue 20 Dec, 2018 US10188663
Dispatch to FDC 20 Dec, 2018 US10188663
Issue Fee Payment Verified 17 Dec, 2018 US10188663
Issue Fee Payment Received 17 Dec, 2018 US10188663



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Fulvestrant Generics

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.


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. 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


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


4. 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


5. 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


6. 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


7. 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


8. 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


9. 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


10. 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


11. 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


12. 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


13. 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


14. 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