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

208 trials from ClinicalTrials.gov — 3 recruiting, 2 active, 111 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Modafinil and Cognitive Function in POTS NCT01988883	Early Phase 1	Active	Vanderbilt University Medical Center	20	2014-10 → 2026-12
Treatment of Orthostatic Intolerance NCT00262470	Phase 1/2	Active	Satish R. Raj	150	1997-04 → 2029-12
Colorectal Metastasis Prevention International Trial 2 NCT03919461	Phase 2	Recruiting	Assaf-Harofeh Medical Center	200	2019-02-28 → 2027-02-28
Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity NCT03083431	Phase 2	Recruiting	University of Zurich	276	2022-09-22 → 2029-12-31
Crossover Study of Propranolol vs Ivabradine in POTS NCT04186286	Phase 2	Recruiting	University of Calgary	20	2021-02-01 → 2026-12-31
Effect of Medical Treatment and Prognosis of Postural Orthostatic Tachycardia Syndrome (POTS)NCT02171988	Phase 4	Completed	Seoul National University Hospital	150	2014-03 → 2016-12
Propranolol and Botulinum Toxin for Essential Vocal Tremor NCT02111369	Phase 4	Completed	Emory University	18	2014-05 → 2014-11
Study of Human Non-Shivering Thermogenesis and Basal Metabolic Rate NCT01950520	Phase 2	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	47	2014-02-07 → 2024-06-11
Study of Propranolol to Decrease Gene Expression of Stress-Mediated Beta-Adrenergic Pathways in HCT Recipients NCT02420223	Phase 2	Completed	Medical College of Wisconsin	25	2015-07-17 → 2020-02
The Safety and Efficiency of Propranolol as an Initial Treatment for Pediatric Hemangioma NCT01908972	Phase 4	Completed	Seoul National University Hospital	34	2013-06 → 2015-05

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 4 NDCs

Highest NADAC/Unit

$69.29

per ea

Lowest NADAC/Unit

$68.71

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
62559059130INNOPRAN XL 120 MG CAPSULE	$69.29	EA	Brand	—	2025-09-17
62559060130INDERAL XL 120 MG CAPSULE	$69.29	EA	Brand	—	2025-09-17
62559059030INNOPRAN XL 80 MG CAPSULE	$68.71	EA	Brand	—	2026-06-17
62559060030INDERAL XL 80 MG CAPSULE	$68.71	EA	Brand	—	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 | 8 NDCs (4 FSS, 4 Big4)

Lowest Price

$1553.69

Highest Price

$2151.16

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
62559-0590-30INNOPRAN XL 80MG CAP	$2151.16	FSS	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0590-30INNOPRAN XL 80MG CAP	$1555.55	Big4	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0591-30INNOPRAN XL 120MG CAP	$2151.16	FSS	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0591-30INNOPRAN XL 120MG CAP	$1553.69	Big4	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0600-30INDERAL XL 80MG CAP	$2151.16	FSS	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0600-30INDERAL XL 80MG CAP	$1558.18	Big4	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0601-30INDERAL XL 120MG CAP	$2151.16	FSS	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0601-30INDERAL XL 120MG CAP	$1564.83	Big4	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027

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

Medicare Part D Spending

CMS annual spending data for Innopran XL (2024)

Total Spending

$2.7M

Total Claims

584

Beneficiaries

170

Avg Cost/Unit

$70.91

Spending Trend

$3.0M(2019)→$3.0M(2020)→$3.2M(2021)→$3.1M(2022)→$3.1M(2023)→$2.7M(2024)

YoY Change:-4.1%

5yr CAGR:+2.6%

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

API Supply Chain7 active DMFs7 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

MTM CHEMICALS INCInactivePROPRANOLOL HYDROCHLORIDE,BULK

DMF 61021985

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