Viewing data from:

FEMARA

NDA

LETROZOLE | N020726 | NOVARTIS PHARMACEUTICALS CORP

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

10 trials from ClinicalTrials.gov — 9 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Skipping Hormone Therapy in Low-Risk Early Breast Cancer NCT07661927	Phase 2	Not Yet Recruiting	UNICANCER	700	2026-06-15 → 2033-06-15
Roll-Over Study of Alpelisib (BYL719) for Continued Access and Long-Term Safety.NCT07679269	Phase 2	Not Yet Recruiting	Novartis Pharmaceuticals	51	2027-01-01 → 2031-07-25
Non-interventional Study to Assess the Effectiveness and Safety of Ribociclib in the Adjuvant Therapy of Hormone Receptor Positive (HR+) HER2-negative Stage II and III Breast Cancer in Real Clinical Practice in Russia NCT06930859	—	Recruiting	Novartis Pharmaceuticals	2,766	2025-12-03 → 2032-12-31
A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors NCT07029399	Phase 1	Recruiting	NiKang Therapeutics, Inc.	361	2025-03-25 → 2027-12-31
A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer NCT06790693	Phase 3	Recruiting	Hoffmann-La Roche	450	2025-04-09 → 2032-05-30
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 NCT07288359	Phase 1/2	Recruiting	Novartis Pharmaceuticals	205	2025-12-29 → 2031-05-09
A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer NCT07054190	Phase 2	Recruiting	Hoffmann-La Roche	60	2025-09-09 → 2027-09-28
Study of IEV407 as Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer NCT07604571	Phase 1	Recruiting	Novartis Pharmaceuticals	194	2026-05-28 → 2032-06-08
Reversing InGuinal Hernia Trial: The Evaluation of Sex Hormones to Reverse Inguinal Hernias in Males NCT07604272	Phase 1	Recruiting	Northwestern University	30	2026-07-01 → 2028-06
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 NCT07570966	Phase 1/2	Withdrawn	Novartis Pharmaceuticals	—	2026-06-30 → 2031-08-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Femara (2023)

Total Spending

$1.5M

Total Claims

1,045

Beneficiaries

209

Avg Cost/Unit

$25.48

Spending Trend

$2.4M(2019)→$2.4M(2020)→$2.0M(2021)→$1.6M(2022)→$1.5M(2023)

YoY Change:+10.8%

5yr CAGR:+2.5%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain13 active DMFs12 inactive

11 active API suppliers hold Drug Master Files for this ingredient.

NATCO PHARMA LTDLETROZOLE

DMF 183882005

SCINOPHARM TAIWAN LTDLETROZOLE

DMF 191392006

CIPLA LTDLETROZOLE USP

DMF 201752008

TAPI NL BVLETROZOLE USP NON-STERILE BULK DRUG SUBSTANCE

DMF 205662007

DR REDDYS LABORATORIES LTDLETROZOLE

DMF 210362007

TAPI NL BVLETROZOLE

DMF 211822007

SYNTHIMED LABS PRIVATE LTDLETROZOLE USP

DMF 220932008

SUN PHARMACEUTICAL INDUSTRIES LTDLETROZOLE USP

DMF 226322009

NATCO PHARMA LTDLETROZOLE (LER)

DMF 228122009

HETERO LABS LTDLETROZOLE USP

DMF 248862011

SHILPA PHARMA LIFESCIENCES LTDLETROZOLE USP

DMF 274892013

WANYANG HENGSHUI PHARMACEUTICAL CO LTDLETROZOLE

DMF 394232024

ZYDUS LIFESCIENCES LTDLETROZOLE USP

DMF 407462024

OLON SPAInactiveLETROZOLE DRUG SUBSTANCE

DMF 196222006

SANMAR SPECIALITY CHEMICALS LTDInactiveLETROZOLE USP

DMF 200202006

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveLETROZOLE USP

DMF 203562007

TAI HENG INDUSTRY CO LTDInactiveLETROZOLE USP

DMF 207612007

FRESENIUS KABI ONCOLOGY LTDInactiveLETROZOLE

DMF 211912008

CADILA HEALTHCARE LTDInactiveLETROZOLE USP

DMF 214622008

USV PRIVATE LTDInactiveLETROZOLE USP

DMF 222392008

MYLAN LABORATORIES LTDInactiveLETROZOLE USP

DMF 234112009

JIANGSU HENGRUI PHARMACEUTICALS CO LTDInactiveLETROZOLE USP NON-STERILE BULK DRUG SUBSTANCE

DMF 238312010

APOTEX PHARMACHEM INDIA PVT LTDInactiveLETROZOLE USP

DMF 250692011

SICHUAN XIELI PHARMACEUTICAL CO LTDInactiveLETROZOLE

DMF 262522012

MAC CHEM PRODUCTS INDIA PVT LTDInactiveLETROZOLE USP

DMF 265502012

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

18 letters from Drugs@FDA

Date	Submission	Document
Dec 18, 2024	SUPPL -43	View Letter (PDF)
Apr 6, 2018	SUPPL -35	View Letter (PDF)
Jul 17, 2017	SUPPL -33	View Letter (PDF)
Jan 17, 2014	SUPPL -27	View Letter (PDF)
Jan 3, 2012	SUPPL -24	View Letter (PDF)
Jun 29, 2010	SUPPL -19	View Letter (PDF)
May 6, 2010	SUPPL -20	View Letter (PDF)
Mar 8, 2010	SUPPL -15	View Letter (PDF)
Mar 8, 2010	SUPPL -16	View Letter (PDF)
Jul 17, 2009	SUPPL -18	View Letter (PDF)
Aug 13, 2008	SUPPL -17	View Letter (PDF)
Apr 20, 2007	SUPPL -14	View Letter (PDF)
Jun 27, 2006	SUPPL -13	View Letter (PDF)
Jan 6, 2006	SUPPL -12	View Letter (PDF)
Jan 26, 2005	SUPPL -11	View Letter (PDF)
Jun 4, 2004	SUPPL -8	View Letter (PDF)
Mar 10, 2003	SUPPL -5	View Letter (PDF)
Jan 10, 2001	SUPPL -6	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2.5MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 25, 1997

No patent or exclusivity listings for this strength.