Letrozole Patent Expiration

Letrozole was first introduced by Novartis Pharmaceuticals Corp in its drug Femara on Jul 25, 1997. 19 different companies have introduced drugs containing Letrozole.


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Clinical Trials

Recent Clinical Trials on Letrozole:

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
Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer Novartis Pharmaceuticals NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
Neoadjuvant Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
GnRHa + Letrozole in Obese Progestin-insensitive Endometrial Cancer Patients Xiaojun Chen NA RECRUITING
(Sep 1, 2026)
PHASE2, PHASE3
Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer Olema Pharmaceuticals, Inc. NA RECRUITING
(Sep 1, 2026)
PHASE3
A Study to Compare the Steady-State Bioavailability of Injectable Letrozole SIE and Oral Letrozole in Post-Menopausal Women With Hormone Receptor Positive Early Breast Cancer Rovi Pharmaceuticals Laboratories NA RECRUITING
(Sep 1, 2026)
PHASE1
Tamoxifen Citrate or Letrozole With or Without Bevacizumab in Treating Women With Stage IIIB or Stage IV Breast Cancer National Cancer Institute (NCI) NA COMPLETED
(Aug 1, 2026)
PHASE3
A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer) Hoffmann-La Roche NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
A Phase 2 Single-Arm Open-Label Pilot Trial Evaluating Zanidatamab (ZW25) in Patients With Early Stage HER2/Neu Positive (HER2+) Breast Cancer (BC) M.D. Anderson Cancer Center NA RECRUITING
(Aug 1, 2026)
PHASE2
Letrozole and Misoprostol for Early Pregnancy Loss Management University of Pennsylvania NA COMPLETED
(Aug 1, 2026)
PHASE2
Second Trimester Abortion With Letrozole and Misoprostol Compared to Misoprostol Alone Sohag University NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Culmerciclib Combined With Letrozole and Dual HER2 Blockade as Neoadjuvant Therapy for HR+/HER2+ Breast Cancer Shengjing Hospital NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
Phase II Lenvatinib and Pembrolizumab in Endocrine Resistant Breast Cancer With Letrozole National Cancer Centre, Singapore NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Letrozole in Uterine Leiomyosarcoma GOG Foundation NA RECRUITING
(Jul 1, 2026)
PHASE2
Evaluation of the Pharmacokinetics, Safety, and Tolerability of IM Letrozole LEBE in Healthy Post-menopausal Women Rovi Pharmaceuticals Laboratories NA COMPLETED
(Jul 1, 2026)
PHASE1
A Study of Avutometinib, Defactinib, and Letrozole in People With Low-Grade Serous Ovarian Cancer Memorial Sloan Kettering Cancer Center NA RECRUITING
(Jul 1, 2026)
PHASE2
Palbociclib and Endocrine Therapy for LObular Breast Cancer Preoperative Study (PELOPS) Dana-Farber Cancer Institute NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
Fertility Preservation Using Tamoxifen and Letrozole in Estrogen Sensitive Tumors Trial University of California, San Francisco NA RECRUITING
(Jun 1, 2026)
PHASE3
Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole In Young Women With Early Endometrial Cancer Fudan University NA RECRUITING
(Jun 1, 2026)
PHASE2
A Study to Learn About the Study Medicine PF-07220060 Together With Letrozole Compared to Letrozole Alone in Women Post Menopause Pfizer NA COMPLETED
(Jun 1, 2026)
PHASE2
A Clinical Study of HRS-6209 Combined With Other Treatment Regimens in Patients With Breast Cancer Jiangsu HengRui Medicine Co., Ltd. NA RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
Inositol in Letrozol Resistant PCOS Women Kafrelsheikh University NA COMPLETED
(Jun 1, 2026)
PHASE2, PHASE3
Extended Letrozole Protocol Versus Letrozole Plus Inositol for Induction of Ovulation in Letrozole Resistant PCOS Women Eman Basuni Ebrahim Mowad NA COMPLETED
(Jun 1, 2026)
PHASE2
Comparative Evaluation of Letrozole, L-Carnitine, and Combination Therapy on Sperm Quality and ART Outcomes in Idiopathic Oligoasthenoteratozoospermia: A Three-Arm Randomized Trial Tehran University of Medical Sciences NA COMPLETED
(Jun 1, 2026)
PHASE2, PHASE3
Clinical Study of Local and Systemic Biological Impact of GLP1/GIP-Receptor Agonists in Patients With Breast Cancer: The CLARA Trial Universitaire Ziekenhuizen KU Leuven NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE2
Phase II Study of Neoadjuvant ArOMatase Inhibitor Therapy for ER+ Breast Cancer (NAOMI) Dartmouth-Hitchcock Medical Center NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
A Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Patients With Intermediate or High Risk Early Breast Cancer Shandong Suncadia Medicine Co., Ltd. NA RECRUITING
(May 1, 2026)
PHASE3
A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4] Pfizer NA COMPLETED
(Apr 1, 2026)
PHASE3
A Trial of Personalized Acupuncture, Fixed Acupuncture, Letrozole and Placebo on Live Birth in Women With PCOS Hongxia Ma NA COMPLETED
(Apr 1, 2026)
PHASE3
Chemotherapy-Free pCR-Guided Strategy With Trastuzumab-pertuzumab and T-DM1 in HER2-positive Early Breast Cancer MedSIR NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
NT-NOA - Novel Treatment of Some Men With Non-Obstructive Azoospermia Martin Blomberg Jensen NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2


Letrozole Generic API Manufacturers

Several generic applications have been filed for Letrozole. The first generic version for Letrozole was by Pharmobedient Consulting Llc and was approved on Dec 24, 2008. And the latest generic version is by Zydus Lifesciences Global Fze and was approved on Sep 14, 2026.

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