Viewing data from:

EVISTA

NDA

RALOXIFENE HYDROCHLORIDE | N020815 | ELI LILLY AND CO

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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Evista (2023)

Total Spending

$1.2M

Total Claims

2,802

Beneficiaries

625

Avg Cost/Unit

$6.63

Spending Trend

$2.3M(2019)→$2.0M(2020)→$1.6M(2021)→$1.3M(2022)→$1.2M(2023)

YoY Change:+1.1%

5yr CAGR:+0.8%

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

API Supply Chain13 active DMFs6 inactive

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

ERREGIERRE SPARALOXIFENE HYDROCHLORIDE

DMF 159322002

DR REDDYS LABORATORIES LTDRALOXIFENE HYDROCHLORIDE USP

DMF 161432002

AARTI DRUGS LTDRALOXIFENE HYDROCHLORIDE USP

DMF 216502008

GLOCHEM INDUSTRIES PRIVATE LTDRALOXIFENE HYDROCHLORIDE

DMF 216822008

CAMBREX PROFARMACO MILANO SRLRALOXIFENE HYDROCHLORIDE

DMF 229272009

HETERO DRUGS LTDRALOXIFENE HYDROCHLORIDE USP

DMF 252812011

APITORIA PHARMA PRIVATE LTDRALOXIFENE HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE)

DMF 256502012

CADILA PHARMACEUTICALS LTDRALOXIFENE HYDROCHLORIDE USP

DMF 270642013

TAPI NL BVRALOXIFENE HYDROCHLORIDE

DMF 279692014

OLON SPARALOXIFENE HYDROCHLORIDE

DMF 297212015

AURORE LIFE SCIENCES PRIVATE LTDRALOXIFENE HYDROCHLORIDE USP

DMF 364452021

MEDILUX LABORATORIES PVT LTDRALOXIFENE HYDROCHLORIDE USP

DMF 391752023

ALIVUS LIFE SCIENCES LTDRALOXIFENE HYDROCHLORIDE USP

DMF 416112025

EXCELLA GMBHInactiveRALOXIFENE HYDROCHLORIDE

DMF 174152004

CIPLA LTDInactiveRALOXIFENE HYDROCHLORIDE

DMF 201632007

TEVA PHARMACEUTICALS INDUSTRIES LTDInactiveRALOXIFENE HYDROCHLORIDE BULK DRUG SUBSTANCE

DMF 213272008

APOTEX PHARMACHEM INDIA PVT LTDInactiveRALOXIFENE HYDROCHLORIDE USP

DMF 245892011

SICHUAN XIELI PHARMACEUTICAL CO LTDInactiveRALOXIFENE HYDROCHLORIDE

DMF 264922012

CIPLA LTDInactiveRALOXIFENE HYDROCHLORIDE USP

DMF 328982018

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Jul 6, 2018	SUPPL -34	View Letter (PDF)
Sep 25, 2007	SUPPL -25	View Letter (PDF)
Jul 24, 2007	SUPPL -18	View Letter (PDF)
Sep 30, 1999	SUPPL -3	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 60MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 9, 1997

No patent or exclusivity listings for this strength.