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AROMASIN

NDA

EXEMESTANE | N020753 | PFIZER 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

184 trials from ClinicalTrials.gov — 2 recruiting, 11 active, 119 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
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
S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer NCT01674140	Phase 3	Active	SWOG Cancer Research Network	1,939	2013-09-12 → 2030-01
Pre-Operative Window of Adjuvant Endocrine Therapy to Inform RT Decisions in Older Women With Early-Stage Breast Cancer NCT04272801	Phase 2	Active	Shayna Showalter, MD	84	2020-04-07 → 2026-06-01
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
CONcurrent vs SEqueNTial Adjuvant Treatments in Early Breast Cancer NCT02918084	Phase 3	Active	IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy	1,000	2013-06 → 2028-06
Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial)NCT00310180	Phase 3	Active	National Cancer Institute (NCI)	10,273	2006-04-07 → 2030-09-30
A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread NCT02057133	Phase 1	Active	Eli Lilly and Company	198	2014-03-10 → 2026-12
Neoadjuvant Response-guided Treatment of Luminal B-type Tumors and Luminal A-type Tumors With Node Metastases NCT02603679	Phase 2	Active	Thomas Hatschek	181	2015-02 → 2031-12-31
Exemestane With or Without Entinostat in Treating Patients With Recurrent Hormone Receptor-Positive Breast Cancer That is Locally Advanced or Metastatic NCT02115282	Phase 3	Active	National Cancer Institute (NCI)	608	2014-03-29 → 2026-06-02
Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer NCT01272037	Phase 3	Active	National Cancer Institute (NCI)	5,018	2011-02-28 → 2027-01-08

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs (1 brand, 1 generic)

Highest NADAC/Unit

$38.98

per ea

Lowest NADAC/Unit

$0.6119

per ea

Brand NDCs

Generic NDCs

Avg Brand: $38.98

Avg Generic: $0.6119

98% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00009766304AROMASIN 25 MG TABLET	$38.98	EA	Brand	$0.6119	2026-01-01
59762285801EXEMESTANE 25 MG TABLET	$0.6119	EA	Generic	—	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 | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$4.15

Highest Price

$1167.96

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00009-7663-04AROMASIN TABLETS 25MG	$1167.96	FSS	Pfizer Inc.	06/30/2029
00009-7663-04AROMASIN TABLETS 25MG	$861.69	Big4	Pfizer Inc.	06/30/2029
59762-2858-01EXEMESTANE 25MG TAB	$47.87	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-2858-01EXEMESTANE 25MG TAB	$4.15	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027

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

Medicare Part D Spending

CMS annual spending data for Aromasin (2024)

Total Spending

$1.2M

Total Claims

646

Beneficiaries

116

Avg Cost/Unit

$36.85

Spending Trend

$2.5M(2019)→$2.4M(2020)→$1.8M(2021)→$1.3M(2022)→$1.4M(2023)→$1.2M(2024)

YoY Change:-4.6%

5yr CAGR:+1.0%

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

API Supply Chain10 active DMFs8 inactive

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

CURIA SPAIN SAUEXEMESTANE

DMF 178132004

SCINOPHARM TAIWAN LTDEXEMESTANE USP

DMF 211752007

CIPLA LTDEXEMESTANE USP

DMF 220992008

STERLING SPAEXEMESTANE

DMF 224392009

SYMBIOTICA SPECIALITY INGREDIENTS SDN BHDEXEMESTANE

DMF 252752011

SHANDONG ANHONG PHARMACEUTICAL CO LTDEXEMESTANE (NON-STERILE, API)

DMF 260612012

FARMABIOS SPAEXEMESTANE MICRONIZED USP

DMF 262912012

SUN PHARMACEUTICAL INDUSTRIES LTDEXEMESTANE USP

DMF 289602015

CORAL DRUGS PVT LTDEXEMESTANE

DMF 382472023

ZYDUS LIFESCIENCES LTDEXEMESTANE USP

DMF 392822023

PERRIGO API LTDInactiveEXEMESTANE

DMF 202192007

YANCHENG XINYI PHARM AND CHEM CO LTDInactiveEXEMESTANE (NON-STERILE, BULK FORM)

DMF 214412007

TRIFARMA SPAInactiveEXEMESTANE

DMF 223652008

ZYFINE DIV CADILA HEALTHCARE LTDInactiveEXEMESTANE

DMF 225782009

DR REDDYS LABORATORIES LTDInactiveEXEMESTANE

DMF 226452009

QILU PHARMACEUTICAL CO LTDInactiveEXEMESTANE (NON STERILE API)

DMF 235082010

MAC CHEM PRODUCTS INDIA PVT LTDInactiveEXEMESTANE

DMF 269112013

APOTEX PHARMACHEM INDIA PVT LTDInactiveEXEMESTANE

DMF 271672013

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

Approval Letters

15 letters from Drugs@FDA

Date	Submission	Document
Dec 18, 2024	SUPPL -25	View Letter (PDF)
Nov 18, 2021	SUPPL -22	View Letter (PDF)
May 21, 2018	SUPPL -20	View Letter (PDF)
Jul 26, 2016	SUPPL -18	View Letter (PDF)
May 6, 2014	SUPPL -15	View Letter (PDF)
May 6, 2014	SUPPL -16	View Letter (PDF)
Feb 20, 2013	SUPPL -14	View Letter (PDF)
Mar 28, 2011	SUPPL -12	View Letter (PDF)
Mar 28, 2011	SUPPL -9	View Letter (PDF)
Mar 28, 2011	SUPPL -11	View Letter (PDF)
Dec 30, 2008	SUPPL -7	View Letter (PDF)
Oct 11, 2005	SUPPL -6	View Letter (PDF)
Sep 29, 2004	SUPPL -5	View Letter (PDF)
Nov 25, 2003	SUPPL -3	View Letter (PDF)
Oct 21, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 25MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 21, 1999

No patent or exclusivity listings for this strength.