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Last Updated: April 19, 2021

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Propranolol hydrochloride - Generic Drug Details

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What are the generic drug sources for propranolol hydrochloride and what is the scope of freedom to operate?

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

Propranolol hydrochloride has sixty-one patent family members in thirty-two countries.

There are twenty-two drug master file entries for propranolol hydrochloride. Thirty-six suppliers are listed for this compound.

Summary for propranolol hydrochloride
International Patents:61
US Patents:3
Tradenames:6
Applicants:42
NDAs:126
Drug Master File Entries: 22
Suppliers / Packagers: 36
Bulk Api Vendors: 127
Clinical Trials: 283
Patent Applications: 5,655
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in propranolol hydrochloride?propranolol hydrochloride excipients list
DailyMed Link:propranolol hydrochloride at DailyMed
Recent Clinical Trials for propranolol hydrochloride

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

SponsorPhase
Christiana Care Health ServicesPhase 1
The New York Community TrustPhase 4
University of PittsburghPhase 1/Phase 2

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 NDA Submissiondate
INDERAL LA CAPSULE, EXTENDED RELEASE;ORAL propranolol hydrochloride 018553

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
Watson Labs PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride TABLET;ORAL 070140-001 Jul 30, 1985 DISCN No No   Start Trial   Start Trial   Start Trial
Actavis Elizabeth PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078494-002 Aug 10, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Roxane PROPRANOLOL HYDROCHLORIDE INTENSOL propranolol hydrochloride CONCENTRATE;ORAL 071388-001 May 15, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Superpharm PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride TABLET;ORAL 071517-001 Jun 8, 1988 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs Teva PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride TABLET;ORAL 070548-001 Jul 10, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
Sandoz PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride TABLET;ORAL 071687-001 Jul 5, 1988 DISCN No No   Start Trial   Start Trial   Start 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 Inc INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018553-003 Apr 19, 1983   Start Trial   Start Trial
Ani Pharms Inc INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018553-001 Apr 19, 1983   Start Trial   Start Trial
Wyeth Ayerst INDERAL propranolol hydrochloride SUSPENSION;ORAL 019536-001 Dec 12, 1986   Start Trial   Start Trial
Ani Pharms Inc INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018553-004 Mar 18, 1987   Start Trial   Start Trial
Ani Pharms Inc INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018553-002 Apr 19, 1983   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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.