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Last Updated: March 29, 2024

PROPRANOLOL HYDROCHLORIDE - Generic Drug Details


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What are the generic sources for propranolol hydrochloride and what is the scope of patent protection?

Propranolol hydrochloride is the generic ingredient in six branded drugs marketed by Ani Pharms, Actavis Elizabeth, Adare Pharms Inc, Amta, Inwood Labs, Lupin Ltd, Mylan, Nortec Dev Assoc, Upsher Smith Labs, Zydus Pharms Usa Inc, Roxane, Baxter Hlthcare Corp, Chartwell Injectable, Fosun Pharma, Fresenius Kabi Usa, Hikma Farmaceutica, Smith And Nephew, Solopak, Pierre Fabre Derma, Hikma, Pai Holdings Pharm, Wyeth Ayerst, Wyeth Pharms, Chartwell Rx, Dava Pharms Inc, Duramed Pharms Barr, Impax Labs Inc, Innogenix, Interpharm, Ipca Labs Ltd, Ivax Sub Teva Pharms, Lederle, Northstar Hlthcare, Purepac Pharm, Sandoz, Schering, Strides Pharma, Superpharm, Teva, Vintage Pharms, Warner Chilcott, Watson Labs, and Watson Labs Teva, and is included in one hundred and twenty-six NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Propranolol hydrochloride has forty-seven patent family members in thirty-one countries.

There are ten drug master file entries for propranolol hydrochloride. Thirty-nine suppliers are listed for this compound.

Recent Clinical Trials for PROPRANOLOL HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
AIDS Malignancy ConsortiumPhase 2
Unity Health TorontoN/A
University of New MexicoPhase 4

See all PROPRANOLOL HYDROCHLORIDE clinical trials

Pharmacology for PROPRANOLOL HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for PROPRANOLOL HYDROCHLORIDE
Paragraph IV (Patent) Challenges for PROPRANOLOL HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
HEMANGEOL Oral Solution propranolol hydrochloride 4.28 mg/mL 205410 1 2022-07-21

US Patents and Regulatory Information for PROPRANOLOL HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Adare Pharms Inc PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078703-004 Jul 15, 2011 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Nortec Dev Assoc PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078065-003 Jan 26, 2007 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride TABLET;ORAL 071098-001 Oct 6, 1986 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Inwood Labs PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 072499-001 Apr 11, 1989 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Superpharm PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride TABLET;ORAL 071518-001 Jun 8, 1988 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for PROPRANOLOL HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ani Pharms INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018553-004 Mar 18, 1987 ⤷  Try a Trial ⤷  Try a Trial
Ani Pharms INNOPRAN XL propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021438-002 Mar 12, 2003 ⤷  Try a Trial ⤷  Try a Trial
Ani Pharms INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018553-002 Apr 19, 1983 ⤷  Try a Trial ⤷  Try a Trial
Ani Pharms INNOPRAN XL propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021438-001 Mar 12, 2003 ⤷  Try a Trial ⤷  Try a Trial
Ani Pharms INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018553-001 Apr 19, 1983 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for PROPRANOLOL HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
Cyprus 1113597 ⤷  Try a Trial
South Korea 101562627 ⤷  Try a Trial
European Patent Office 2187878 UTILISATION D'UN BÊTA-BLOQUANT POUR LA FABRICATION D'UN MÉDICAMENT POUR LE TRAITEMENT DES HÉMANGIOMES (USE OF A BETA BLOCKER FOR THE MANUFACTURE OF A MEDICAMENT FOR THE TREATMENT OF HEMANGIOMAS) ⤷  Try a Trial
Hong Kong 1148940 USE OF A BETA BLOCKER FOR THE MANUFACTURE OF A MEDICAMENT FOR THE TREATMENT OF HEMANGIOMAS ⤷  Try a Trial
China 103169971 Use of beta blocker for the manufacture of a medicament for the treatment of hemangiomas ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.