Viewing data from:

HEMANGEOL

NDA

PROPRANOLOL HYDROCHLORIDE | N205410 | ETON PHARMACEUTICALS INC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2027

2028

Today

8338489

Oct. 16, 2028

8987262

Oct. 16, 2028

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

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Pierre Fabre Medicament SAS et al v. Rubicon Research Private Limited 1:2024cv00811	D. Del.	2024-07-12	Terminated 2026-01-15	—
Pierre Fabre Medicament SAS, et al. v. Annora Pharma Private Limited 1:2022cv01442	D. Del.	2022-11-02	Terminated 2024-11-25	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$457.32

Highest Price

$457.32

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
64370-0375-01HEMANGEOL 4.28MG/ML	$457.32	FSS	Pierre Fabre Pharmaceuticals, Inc.	09/26/2029

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

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

4 letters from Drugs@FDA

Date	Submission	Document
Jun 30, 2021	SUPPL -6	View Letter (PDF)
Apr 3, 2020	SUPPL -5	View Letter (PDF)
Dec 23, 2019	SUPPL -3	View Letter (PDF)
Mar 19, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 4.28MG/ML

RLD

2 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Mar 14, 2014

Patents (2) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8338489	Oct 16, 2028	—	—	—		—
8987262	Oct 16, 2028	—	—	—		—