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XENICAL

NDA

ORLISTAT | N020766 | CHEPLAPHARM ARZNEIMITTEL GMBH

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 Xenical (2023)

Total Spending

$283K

Total Claims

225

Beneficiaries

Avg Cost/Unit

$8.08

Spending Trend

$770K(2019)→$738K(2020)→$703K(2021)→$666K(2022)→$283K(2023)

YoY Change:+3.2%

5yr CAGR:+1.7%

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

API Supply Chain9 active DMFs4 inactive

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

FORMOSA LABORATORIES INCORLISTAT USP

DMF 239782010

CHONGQING ZEIN PHARMACEUTICAL CO LTDORLISTAT

DMF 248852011

ARGUS PHARMACEUTICALS LTDORLISTAT

DMF 264552012

MURLI KRISHNA PHARMA PVT LTDORLISTAT PELLETS 50.0% W/W

DMF 276242013

SHANDONG NEW TIME PHARMACEUTICAL CO LTDORLISTAT

DMF 299142015

MURLI KRISHNA PHARMA PVT LTDORLISTAT PELLETS 50.0% W/W

DMF 307802016

SUN PHARMACEUTICAL INDUSTRIES LTDORLISTAT USP

DMF 323382018

DIVIS LABORATORIES LTDORLISTAT

DMF 358842021

BIOCON LTDORLISTAT USP

DMF 380962023

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveORLISTAT

DMF 221102008

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveORLISTAT (NON-STERILE BULK)

DMF 223572008

BIOCON LTDInactiveORLISTAT

DMF 261012012

HISUN PHARMACEUTICAL HANGZHOU CO LTDInactiveORLISTAT USP

DMF 273122013

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

Approval Letters

14 letters from Drugs@FDA

Date	Submission	Document
Nov 18, 2022	SUPPL -38	View Letter (PDF)
Aug 15, 2016	SUPPL -36	View Letter (PDF)
Aug 11, 2015	SUPPL -35	View Letter (PDF)
Oct 18, 2013	SUPPL -33	View Letter (PDF)
Jan 25, 2012	SUPPL -29	View Letter (PDF)
Dec 22, 2010	SUPPL -30	View Letter (PDF)
May 25, 2010	SUPPL -28	View Letter (PDF)
Feb 18, 2009	SUPPL -26	View Letter (PDF)
Jan 12, 2007	SUPPL -22	View Letter (PDF)
Sep 8, 2005	SUPPL -21	View Letter (PDF)
Oct 29, 2004	SUPPL -19	View Letter (PDF)
Jul 14, 2004	SUPPL -20	View Letter (PDF)
Dec 19, 2003	SUPPL -18	View Letter (PDF)
Apr 26, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 120MG

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Apr 23, 1999

No patent or exclusivity listings for this strength.