Viewing data from:

ARIMIDEX

NDA

ANASTROZOLE | N020541 | ANI PHARMACEUTICALS INC

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

210 trials from ClinicalTrials.gov — 1 recruiting, 20 active, 125 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III Breast Cancer Undergoing Surgery NCT01953588	Phase 3	Active	Alliance for Clinical Trials in Oncology	1,473	2014-02-27 → 2027-04-01
Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer NCT02947685	Phase 3	Active	Alliance Foundation Trials, LLC.	518	2017-06-21 → 2026-07-31
ExclUsive endocRine Therapy Or Radiation theraPy for Women Aged ≥70 Years Early Stage Breast Cancer NCT04134598	Phase 3	Active	Azienda Ospedaliero-Universitaria Careggi	926	2021-02-08 → 2030-03-31
Endocrine Therapy With Abemaciclib or Chemotherapy as Initial Metastatic Treatment in ER+/HER2- Breast Cancer NCT04158362	Phase 3	Active	UNICANCER	180	2020-06-11 → 2028-06
A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer NCT02246621	Phase 3	Active	Eli Lilly and Company	493	2014-11-06 → 2026-12
Study of AZD9833 Alone or in Combination in Women With Advanced Breast Cancer.NCT03616587	Phase 1	Active	AstraZeneca	396	2018-10-11 → 2027-06-24
Endocrine Therapy Plus CDK4/6 in First or Second Line for Hormone (SONIA) Receptor Positive Advanced Breast Cancer NCT03425838	Phase 3	Active	Borstkanker Onderzoek Groep	1,050	2017-11-09 → 2028-12
PD 0332991 and Anastrozole for Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer NCT01723774	Phase 2	Active	Washington University School of Medicine	84	2013-04-10 → 2026-08-24
Trial of Anastrozole and Palbociclib in Metastatic HER2-Negative Breast Cancer NCT02942355	Phase 2	Active	Wake Forest University Health Sciences	40	2016-12-07 → 2028-06-30
A Study to Evaluate Genetic Predictors of Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS)NCT01824836	N/A	Active	ECOG-ACRIN Cancer Research Group	1,046	2013-06-11 → 2026-12

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$52.57

per ea

Lowest NADAC/Unit

$52.57

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
62559067030ARIMIDEX 1 MG TABLET	$52.57	EA	Brand	$0.1374	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$988.02

Highest Price

$1607.76

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
62559-0670-30ANASTROZOLE 1MG TAB,30	$1607.76	FSS	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0670-30ANASTROZOLE 1MG TAB,30	$988.02	Big4	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Arimidex (2024)

Total Spending

$3.5M

Total Claims

1,348

Beneficiaries

279

Avg Cost/Unit

$50.35

Spending Trend

$5.9M(2019)→$5.6M(2020)→$5.0M(2021)→$4.3M(2022)→$4.0M(2023)→$3.5M(2024)

YoY Change:-3.1%

5yr CAGR:+1.9%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain13 active DMFs12 inactive

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

SCINOPHARM TAIWAN LTDANASTROZOLE USP

DMF 183352005

TAPI NL BVANASTROZOLE

DMF 190342005

NATCO PHARMA LTDANASTROZOLE

DMF 196872006

CIPLA LTDANASTROZOLE USP

DMF 197482008

DR REDDYS LABORATORIES LTDANASTROZOLE USP

DMF 201412007

FORMOSA LABORATORIES INCANASTROZOLE

DMF 202822007

EXCELLA GMBH AND CO KGANASTROZOLE

DMF 203382007

SUN PHARMACEUTICAL INDUSTRIES LTDANASTROZOLE USP

DMF 219012008

HETERO LABS LTDANASTROZOLE USP

DMF 222312008

APOTEX INCANASTROZOLE USP

DMF 233262009

SYNTHIMED LABS PRIVATE LTDANASTROZOLE USP

DMF 253082011

SHILPA PHARMA LIFESCIENCES LTDANASTROZOLE USP

DMF 296542015

WANYANG HENGSHUI PHARMACEUTICAL CO LTDANASTROZOLE

DMF 403052024

ALCAMI WISCONSIN CORPInactiveANASTROZOLE

DMF 190252005

TAI HENG INDUSTRY CO LTDInactiveANASTROZOLE

DMF 194962006

WAVELENGTH ENTERPRISES LTDInactiveANASTROZOLE

DMF 198082006

USV LTDInactiveANASTROZOLE

DMF 204692007

FRESENIUS KABI ONCOLOGY LTDInactiveANASTROZOLE

DMF 206602007

CADILA HEALTHCARE LTDInactiveANASTROZOLE

DMF 223232008

SHILPA MEDICARE LTDInactiveANASTROZOLE

DMF 231232009

EMCURE PHARMACEUTICALS LTDInactiveANASTROZOLE USP

DMF 254842011

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveANASTROZOLE USP

DMF 258972012

SICHUAN XIELI PHARMACEUTICAL CO LTDInactiveANASTROZOLE

DMF 262022012

MAC CHEM PRODUCTS INDIA PVT LTDInactiveANASTROZOLE USP

DMF 265812012

ASYMCHEM LABORATORIES TIANJIN CO LTDInactiveANASTROZOLE

DMF 277502013

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

Approval Letters

14 letters from Drugs@FDA

Date	Submission	Document
Dec 18, 2024	SUPPL -36	View Letter (PDF)
Dec 20, 2018	SUPPL -31	View Letter (PDF)
May 6, 2014	SUPPL -29	View Letter (PDF)
May 7, 2013	SUPPL -27	View Letter (PDF)
Apr 20, 2011	SUPPL -26	View Letter (PDF)
May 6, 2009	SUPPL -24	View Letter (PDF)
May 6, 2009	SUPPL -25	View Letter (PDF)
Dec 18, 2008	SUPPL -20	View Letter (PDF)
Dec 18, 2008	SUPPL -23	View Letter (PDF)
Sep 22, 2005	SUPPL -16	View Letter (PDF)
Sep 3, 2004	SUPPL -15	View Letter (PDF)
Oct 7, 2002	SUPPL -5	View Letter (PDF)
Sep 5, 2002	SUPPL -10	View Letter (PDF)
Sep 1, 2000	SUPPL -6	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 27, 1995

No patent or exclusivity listings for this strength.