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Last Updated: October 26, 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 patent protection?

Propranolol hydrochloride is the generic ingredient in six branded drugs marketed by Ani Pharms, 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 Pharms, 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. Forty-two 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
Finished Product Suppliers / Packagers: 42
Raw Ingredient (Bulk) Api Vendors: 130
Clinical Trials: 290
Patent Applications: 5,841
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
Rennes University HospitalPhase 2
University Hospital, ToulousePhase 3
Hospital Israelita Albert EinsteinPhase 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 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 070380-001 Mar 19, 1987 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Upsher Smith Labs PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078311-001 Mar 6, 2009 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Innogenix PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride TABLET;ORAL 070322-004 Oct 22, 1985 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Purepac Pharm PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride TABLET;ORAL 070757-001 Nov 3, 1986 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Interpharm PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride TABLET;ORAL 071371-001 May 5, 1987 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Inwood Labs PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 072500-001 Apr 11, 1989 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Duramed Pharms Barr PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride TABLET;ORAL 070310-001 Sep 9, 1985 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 ⤷  Free Forever Trial ⤷  Free Forever Trial
Wyeth Ayerst INDERAL propranolol hydrochloride SUSPENSION;ORAL 019536-001 Dec 12, 1986 ⤷  Free Forever Trial ⤷  Free Forever Trial
Ani Pharms INNOPRAN XL propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021438-001 Mar 12, 2003 ⤷  Free Forever Trial ⤷  Free Forever Trial
Ani Pharms INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018553-003 Apr 19, 1983 ⤷  Free Forever Trial ⤷  Free Forever Trial
Ani Pharms INNOPRAN XL propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021438-002 Mar 12, 2003 ⤷  Free Forever Trial ⤷  Free Forever Trial
Ani Pharms INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018553-002 Apr 19, 1983 ⤷  Free Forever Trial ⤷  Free Forever Trial
Ani Pharms INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018553-001 Apr 19, 1983 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for propranolol hydrochloride

Country Patent Number Estimated Expiration
Germany 08838691 ⤷  Free Forever Trial
European Patent Office 2233135 ⤷  Free Forever Trial
Portugal 2187878 ⤷  Free Forever Trial
Colombia 6270209 ⤷  Free Forever Trial
Cyprus 1113597 ⤷  Free Forever Trial
Chile 2008003083 ⤷  Free Forever Trial
South Korea 20040084890 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Dow
Mallinckrodt
Harvard Business School
Express Scripts
Boehringer Ingelheim

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