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. Other drugs containing Fulvestrant are Fulvestrant, Cligavyx. 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.

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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.

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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 8th Year, Large Entity 05 Jun, 2025 US9833459
Payment of Maintenance Fee, 8th Year, Large Entity 01 Sep, 2023 US9271990
Payment of Maintenance Fee, 4th Year, Large Entity 29 Jul, 2022 US10188663
Payment of Maintenance Fee, 4th Year, Large Entity 07 Jun, 2021 US9833459
Payment of Maintenance Fee, 4th Year, Large Entity 03 Sep, 2019 US9271990
Recordation of Patent Grant Mailed 29 Jan, 2019 US10188663
Patent Issue Date Used in PTA Calculation 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


Fulvestrant's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Fulvestrant:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy. AstraZeneca NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE3
To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer Genentech, Inc. NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE1
A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer Hoffmann-La Roche NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2, PHASE3
A Study Evaluating the Efficacy and Safety of Giredestrant Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acelERA Breast Cancer) Hoffmann-La Roche NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
Study for Participants Continuing From Pfizer-sponsored Palbociclib (a Study Medicine) Studies Pfizer NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
A Study to Learn About the Study Medicine (Called PF-07220060 in Combination With PF-07104091) In Participants With Breast Cancer and Solid Tumors Pfizer NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
[177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer Novartis Pharmaceuticals NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE1
BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors BeOne Medicines NA RECRUITING
(Sep 1, 2026)
PHASE1
The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study American Society of Clinical Oncology NA RECRUITING
(Sep 1, 2026)
PHASE3
Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) NA RECRUITING
(Sep 1, 2026)
PHASE1
A Study of Mirdametinib in Combination With Palbociclib in People With Liposarcoma Memorial Sloan Kettering Cancer Center NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors BeOne Medicines NA RECRUITING
(Sep 1, 2026)
PHASE1
To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer Hoffmann-La Roche NA RECRUITING
(Sep 1, 2026)
PHASE2
A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer Hoffmann-La Roche NA RECRUITING
(Sep 1, 2026)
PHASE2
Study of IEV407 as Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer Novartis Pharmaceuticals NA RECRUITING
(Sep 1, 2026)
PHASE1
A Study Evaluating the Safety of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With Advanced Breast Cancer (ABC) and Type 2 Diabetes Hoffmann-La Roche NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2
A Phase 2 Bridging Study of Elacestrant Monotherapy in Advanced or Metastatic Breast Cancer Stemline Therapeutics, Inc. NA RECRUITING
(Sep 1, 2026)
PHASE2
Alisertib With or Without Fulvestrant in Treating Patients With Locally Advanced or Metastatic, Endocrine-Resistant Breast Cancer Mayo Clinic NA COMPLETED
(Aug 1, 2026)
PHASE2
Palbociclib After CDK and Endocrine Therapy (PACE) Dana-Farber Cancer Institute NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Determinants of Resistance to Endocrine Therapy and a Cyclin-dependent Kinases 4 and 6 (CDK4/6) Inhibitor for HR+ MBC Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
AKT Inhibitor, Ipatasertib, With Endocrine and CDK 4/6 Inhibitor for Patients With Metastatic Breast Cancer (TAKTIC) Massachusetts General Hospital NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1
A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer AstraZeneca NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Phase 2a Study of ZW25 in Combination With Palbociclib Plus Fulvestrant Jazz Pharmaceuticals NA COMPLETED
(Aug 1, 2026)
PHASE2
Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations Seagen, a wholly owned subsidiary of Pfizer NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Phase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer Tvardi Therapeutics, Incorporated NA TERMINATED
(Aug 1, 2026)
PHASE1
Phase I Study of BEBT-209 in Women With Advanced Breast Cancer BeBetter Med Inc NA COMPLETED
(Aug 1, 2026)
PHASE1
Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and in Patients With Other Advanced Solid Tumors Novartis Pharmaceuticals NA RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors NiKang Therapeutics, Inc. NA RECRUITING
(Aug 1, 2026)
PHASE1
A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations Atavistik Bio, Inc NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1
JYP0035 Capsules Plus Fulvestrant in PIK3CA-Mutant HR+/HER2- Advanced Breast Cancer Chengdu JOYO pharma Co., Ltd. NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE3
A Study of LAE118 as Monotherapy and in Combination With Antitumor Agents in Advanced Solid Tumors Laekna Limited NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1
Durvalumab, With Olaparib and Fulvestrant in Advanced ER+, HER2- Breast Cancer Patients. UNICANCER NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
DNA-guided Second Line Adjuvant Therapy for High Residual Risk, Estrogen Receptor Positive, HER-2 Negative Breast Cancer (DARE) Criterium, Inc. NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Study of INCB123667 in Subjects With Advanced Solid Tumors Incyte Corporation NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE1
A Study of Lenvatinib, Pembrolizumab, and Fulvestrant in People With Breast Cancer Memorial Sloan Kettering Cancer Center NA RECRUITING
(Jul 1, 2026)
PHASE1, PHASE2
First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer OnKure, Inc. NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE1
Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib as Monotherapy or Combination Therapy. Taiho Oncology, Inc. NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2, PHASE3
A Trial of HRS-6209 in Combination With Fulvestrant, Letrozole, HRS-8080, or HRS-1358 in Breast Cancer Patients Jiangsu HengRui Medicine Co., Ltd. NA RECRUITING
(Jul 1, 2026)
PHASE1, PHASE2
Study of 68Ga-R10602 Radionetics Oncology NA COMPLETED
(Jul 1, 2026)
PHASE1
An Open-Label, Bayesian Adaptive Phase II Clinical Study in HR+/HER2- Advanced Breast Cancer After Progression on Standard Therapy Fudan University NA RECRUITING
(Jul 1, 2026)
PHASE2
Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors Novartis Pharmaceuticals NA RECRUITING
(Jul 1, 2026)
PHASE1, PHASE2
Clinical Trial Evaluating the Biological Activity of a New Drug Identified as Prifetrastat (PF-07248144), Combined With Fulvestrant for the Treatment of Patients With Hormone Receptor Positive (HR+) and HER2 Negative (HER2-) Breast Cancer Extended to Other Organs. UNICANCER NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2
Reversing InGuinal Hernia Trial: The Evaluation of Sex Hormones to Reverse Inguinal Hernias in Males Northwestern University NA RECRUITING
(Jul 1, 2026)
PHASE1
T-DXd Based Therapy Followed by Endocrine Therapy Plus Dual HER2 Blockade in First-line HER2+/ HR+ Metastatic Breast Cancer and Retreatment With T-DXd Daiichi Sankyo NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE3
Culmerciclib in HR+/HER2+ Advanced Breast Cancer Sun Yat-sen University NA RECRUITING
(Jul 1, 2026)
PHASE2
Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
A Study of Investigational Drug CFI-402257 in Patients With Advanced Solid Tumors University Health Network, Toronto NA COMPLETED
(Jun 1, 2026)
PHASE1
Cetuximab Plus Dalpicilib in Patients With HPV Negative, PD-1 Resistant R/M HNSCC Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University NA COMPLETED
(Jun 1, 2026)
PHASE2
BGB-43395 Alone or as Part of Combination Therapies in Chinese Participants With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors BeOne Medicines NA COMPLETED
(Jun 1, 2026)
PHASE1
A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors BeiGene NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE1
Nab-Sirolimus and Endocrine Therapy in Recurrent Low Grade Serous Ovarian Cancer (NARETO) University of Oklahoma NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors Ensem Therapeutics NA RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
Study of ERW316 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors Novartis Pharmaceuticals NA WITHDRAWN
(Jun 1, 2026)
PHASE1, PHASE2
A Phase II Clinical Study of the Efficacy and Safety of Culmerciclib Rechallenge in HR-positive, HER2-negative Breast Cancer Patients With Resistance to First-line Endocrine Therapy. Fudan University NA RECRUITING
(Jun 1, 2026)
PHASE2
Efficacy and Safety of 500mg of Fulvestrant Beth Israel Deaconess Medical Center NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
Modular Study to Evaluate CT7001 Alone in Cancer Patients With Advanced Malignancies Carrick Therapeutics Limited NA COMPLETED
(May 1, 2026)
PHASE1, PHASE2
PF-07104091 as a Single Agent and in Combination Therapy Pfizer NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer Canadian Cancer Trials Group NA RECRUITING
(May 1, 2026)
PHASE2
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2) Celcuity Inc NA RECRUITING
(May 1, 2026)
PHASE3
A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors IDEAYA Biosciences NA RECRUITING
(May 1, 2026)
PHASE1
Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy for Early HR +/HER2- Breast Cancer: a Multicenter, Prospective Clinical Study Fujian Cancer Hospital NA RECRUITING
(May 1, 2026)
PHASE2
A Phase ll, Interventional, Single-arm Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib and Fulvestrant in Chinese Patients With PIK3CA-mutant, HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer. Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University NA NOT YET RECRUITING
(May 1, 2026)
PHASE2
A Phase II Study of Zongertinib Plus Fulvestrant in Participants With HR-positive/HER2-negative Advanced Breast Cancer Harboring HER2 Mutations. MedSIR NA NOT YET RECRUITING
(May 1, 2026)
PHASE2
Palbociclib and Letrozole or Fulvestrant in Treating Patients With Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer Alliance for Clinical Trials in Oncology NA COMPLETED
(Apr 1, 2026)
PHASE2
Phase 1/1b/2 Study of Oral PMD-026 in Patients With Metastatic Breast Cancer Phoenix Molecular Designs NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
Study of PF-07248144 in Advanced or Metastatic Solid Tumors Pfizer NA RECRUITING
(Apr 1, 2026)
PHASE2
A Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With Advanced Breast Cancer Chia Tai Tianqing Pharmaceutical Group Co., Ltd. NA COMPLETED
(Apr 1, 2026)
PHASE2
TQB3616 Capsules Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer in Clinical Trail Chia Tai Tianqing Pharmaceutical Group Co., Ltd. NA COMPLETED
(Apr 1, 2026)
PHASE3
A Study to Evaluate the Safety and Tolerability of TOS-358 in Women With HR+ HER2- Breast Cancer Totus Medicines NA RECRUITING
(Apr 1, 2026)
PHASE1
Evaluation of TQB3616 Capsules in a Phase II Clinical Trial for Recurrent/Metastatic Breast Cancer Chia Tai Tianqing Pharmaceutical Group Co., Ltd. NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Artificial Intelligence and Machine Learning to Guide CDK4/6 Inhibitor Rechallenge in Breast Cancer. University of California, San Diego NA RECRUITING
(Apr 1, 2026)
PHASE2
A Study of SH3765 Tablets in Combination With Fulvestrant in Patients With HR+/HER2- Advanced Breast Cancer. Nanjing Sanhome Pharmaceutical, Co., Ltd. NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE1
Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer Faeth Therapeutics NA RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
Ipatasertib + Pertuzumab +Trastuzumab in Advanced HER2+ PI3KCA-mutant Breast Cancer Patients SOLTI Breast Cancer Research Group NA COMPLETED
(Mar 1, 2026)
PHASE1
Phase II Study of Tazemetostat in Solid Tumors Harboring an ARID1A Mutation Prisma Health-Upstate NA TERMINATED
(Mar 1, 2026)
PHASE2
A Study of HRS-6208 in Combination With HRS-8080, or Fulvestrant, or Letrozole, With or Without HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer Shandong Suncadia Medicine Co., Ltd. NA RECRUITING
(Mar 1, 2026)
PHASE1, PHASE2
Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HLX97 (a KAT6A/B Inhibitor) in Patients With Advanced/Metastatic Solid Tumor Shanghai Henlius Biotech NA NOT YET RECRUITING
(Mar 1, 2026)
PHASE1


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.