Viewing data from:

INNOPRAN XL

NDA

PROPRANOLOL HYDROCHLORIDE | N021438 | ANI PHARMACEUTICALS INC

2 strengths0 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 Innopran XL (2023)

Total Spending

$3.1M

Total Claims

711

Beneficiaries

187

Avg Cost/Unit

$73.96

Spending Trend

$3.0M(2019)→$3.0M(2020)→$3.2M(2021)→$3.1M(2022)→$3.1M(2023)

YoY Change:+0.9%

5yr CAGR:+5.9%

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

API Supply Chain7 active DMFs6 inactive

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

SIMS SRLPROPRANOLOL HYDROCHLORIDE

DMF 51391983

W R GRACE AND CO -CONNPROPRANOLOL HYDROCHLORIDE

DMF 58611985

IPCA LABORATORIES LTDPROPRANOLOL HYDROCHLORIDE USP

DMF 158492002

MANKIND PHARMA LTDPROPRANOLOL HYDROCHLORIDE USP

DMF 356352021

MACLEODS PHARMACEUTICALS LTDPROPRANOLOL HYDROCHLORIDE USP

DMF 397522024

ALIVUS LIFE SCIENCES LTDPROPRANOLOL HYDROCHLORIDE USP

DMF 397822024

RAKS PHARMA PVT LTDPROPRANOLOL HYDROCHLORIDE USP

DMF 423982025

LUSOCHIMICA SPAInactivePROPRANOLOL HYDROCHLORIDE USP XX, NF XV

DMF 49821983

UNIQUE PHARMACEUTICAL LABORATORIES A DIV OF JB CHEMICALS AND PHARMACEUTICALS LTDInactivePROPRANOLOL HYDROCHLORIDE (U.S.P.)

DMF 53251984

KOTHARI PHYTOCHEMICALS INTERNATIONALInactivePROPRANOLOL HYDROCHLORIDE

DMF 59371985

BOEHRINGER KNOLL LTDInactivePROPRANOLOL HYDROCHLORIDE

DMF 83091989

CYANAMID UK LTDInactivePROPRANOLOL HYDROCHLORIDE

DMF 93121991

LUPIN LTDInactivePROPRANOLOL HYDROCHLORIDE USP

DMF 332222018

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Dec 27, 2023	SUPPL -32	View Letter (PDF)
Aug 17, 2021	SUPPL -25	View Letter (PDF)
Nov 20, 2013	SUPPL -16	View Letter (PDF)
Dec 21, 2010	SUPPL -14	View Letter (PDF)
Dec 21, 2010	SUPPL -13	View Letter (PDF)
Jan 5, 2010	SUPPL -12	View Letter (PDF)
Jan 9, 2008	SUPPL -11	View Letter (PDF)
Oct 29, 2004	SUPPL -5	View Letter (PDF)
Apr 15, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 80MG

RLDBX

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Mar 12, 2003

No patent or exclusivity listings for this strength.

#002 — 120MG

RLDBX

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Mar 12, 2003