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TARGRETIN

NDA

BEXAROTENE | N021055 | BAUSCH HEALTH IRELAND LTD

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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Bexarotene* (2023)

Total Spending

$50.9M

Total Claims

5,794

Beneficiaries

893

Avg Cost/Unit

$92.97

Spending Trend

$61.3M(2019)→$30.0M(2019)→$55.0M(2020)→$24.1M(2020)→$45.1M(2021)→$15.7M(2021)→$13.4M(2022)→$46.7M(2022)→$50.9M(2023)→$5.9M(2023)

YoY Change:-18.9%

5yr CAGR:-12.1%

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

API Supply Chain7 active DMFs1 inactive

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

APICORE US LLCBEXAROTENE

DMF 236312010

REFARMED CHEMICALS LTDBEXAROTENE

DMF 255422011

HETERO LABS LTDBEXAROTENE

DMF 289442014

MSN LABORATORIES PRIVATE LTDBEXAROTENE [ROUTE CODE BX]

DMF 300772016

TIANJIN WEIJIE PHARMACEUTICAL CO LTDBEXAROTENE

DMF 315802017

EMCURE PHARMACEUTICALS LTDBEXAROTENE

DMF 319792017

SHANDONG ANHONG PHARMACEUTICAL CO LTDBEXAROTENE

DMF 424892025

USV LTDInactiveBEXAROTENE

DMF 235452010

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Jul 30, 2015	SUPPL -10	View Letter (PDF)
Jan 9, 2012	SUPPL -8	View Letter (PDF)
May 19, 2011	SUPPL -6	View Letter (PDF)
May 29, 2003	SUPPL -3	View Letter (PDF)
May 29, 2003	SUPPL -2	View Letter (PDF)
Dec 29, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 75MG

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Dec 29, 1999

No patent or exclusivity listings for this strength.