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Propranolol hydrochloride - Generic Drug Details

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

This ingredient has forty-seven patent family members in twenty-eight countries.

There are twenty-one drug master file entries for propranolol hydrochloride. Fifty-four suppliers are listed for this compound.

Summary for Generic Name: propranolol hydrochloride

Tradenames:6
Patents:2
Applicants:38
NDAs:135
Drug Master File Entries: see list21
Suppliers / Packaging: see list54
Therapeutic Class:Antimigraine Agents
Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: propranolol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz
PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride
TABLET;ORAL072197-001Jul 5, 1988DISCNNo► subscribe► subscribe
Inwood Labs
PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL072499-001Apr 11, 1989DISCNNo► subscribe► subscribe
Mylan
PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride
TABLET;ORAL070213-004Nov 19, 1985RXNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: propranolol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Wyeth Ayerst
INDERAL
propranolol hydrochloride
SUSPENSION;ORAL019536-001Dec 12, 19864,600,708► subscribe
Ani Pharms Inc
INDERAL LA
propranolol hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL018553-004Mar 18, 19874,138,475► subscribe
Ani Pharms Inc
INDERAL LA
propranolol hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL018553-003Apr 19, 19834,138,475► subscribe
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Non-Orange Book Patents for Generic Ingredient: propranolol hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,987,262Use of a beta blocker for the manufacture of a medicament for the treatment of hemangiomas► subscribe
9,358,214Timed, sustained release systems for propranolol► subscribe
9,040,086Timed, sustained release systems for propranolol► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: propranolol hydrochloride

Country Document Number Estimated Expiration
Colombia6270209► subscribe
Russian Federation2010112816► subscribe
European Patent Office1432411► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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 verifification 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.

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