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INDERAL

NDA

PROPRANOLOL HYDROCHLORIDE | N019536 | WYETH AYERST LABORATORIES

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Attachment 1 - FDA Orange Book page for INDERAL (propranolol) Tablets RE Suit... FDA-2023-P-4320 · 8 docket documents Lachman Consultant Services, Inc. filed a petition regarding the suitability of INDERAL (propranolol) tablets, as documented in the FDA Orange Book. The petition addresses regulatory considerations related to the approved drug product listing and its Orange Book designation.	Suitability	2023-10-03	Denied	Lachman Consultant Services, Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

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.

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.

Products (1)

#001 — 10MG/ML

0 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Dec 12, 1986

No patent or exclusivity listings for this strength.