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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Baxter
Express Scripts
Queensland Health
Mallinckrodt
Fish and Richardson
Argus Health
Dow
Harvard Business School
UBS

Generated: July 23, 2017

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Propranolol hydrochloride - Generic Drug Details

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

Propranolol hydrochloride
is the generic ingredient in six branded drugs marketed by Inwood Labs, Sandoz Inc, Rp Scherer, Frontida Biopharm, Duramed Pharms Barr, Pierre Fabre Derma, Upsher-smith Labs, 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, Ani Pharms Inc, Warner Chilcott, Watson Labs, Watson Labs Teva, Ipca Labs Ltd, Sandoz, Hikma Farmaceutica, Ivax Sub Teva Pharms, Nortec Dev Assoc, Interpharm, Impax Labs Inc, West-ward Pharms Int, Morton Grove, Par Pharm, Athenex Inc, and Actavis Elizabeth, and is included in one hundred and thirty-five NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for Generic Name: propranolol hydrochloride

Tradenames:6
Patents:3
Applicants:40
NDAs:135
Drug Master File Entries: see list21
Suppliers / Packagers: see list55
Bulk Api Vendors: see list80
Clinical Trials: see list2,426
Patent Applications: see list4,499
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:propranolol hydrochloride at DailyMed

Pharmacology for Ingredient: propranolol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ivax Sub Teva Pharms
PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride
TABLET;ORAL072067-001Jul 29, 1988DISCNNoNo► Subscribe► Subscribe
Actavis Elizabeth
PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL078494-003Aug 10, 2007ABRXNoNo► Subscribe► Subscribe
Superpharm
PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride
TABLET;ORAL071515-001Jun 8, 1988DISCNNoNo► Subscribe► Subscribe
Sandoz
PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride
TABLET;ORAL070665-001Jun 13, 1986DISCNNoNo► Subscribe► Subscribe
Duramed Pharms Barr
PROPRANOLOL HYDROCHLORIDE
propranolol hydrochloride
TABLET;ORAL070309-001Oct 1, 1986DISCNNoNo► 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
Ani Pharms Inc
INDERAL LA
propranolol hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL018553-001Apr 19, 19834,138,475► Subscribe
Wyeth Ayerst
INDERAL
propranolol hydrochloride
SUSPENSION;ORAL019536-001Dec 12, 19864,600,708► Subscribe
Ani Pharms Inc
INDERAL LA
propranolol hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL018553-002Apr 19, 19834,138,475► Subscribe
Ani Pharms Inc
INDERAL LA
propranolol hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL018553-003Apr 19, 19834,138,475► Subscribe
Ani Pharms Inc
INDERAL LA
propranolol hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL018553-004Mar 18, 19874,138,475► 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
9,040,086Timed, sustained release systems for propranolol► Subscribe
9,358,214Timed, sustained release systems for propranolol► Subscribe
9,173,858Use of a beta blocker for the manufacture of a medicament for the treatment of hemangiomas► 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
MexicoPA04003234► Subscribe
CroatiaP20110659► Subscribe
Germany08838691► Subscribe
Tunisia2010000170► Subscribe
Spain2368299► 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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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Cantor Fitzgerald
Covington
Dow
Moodys
Boehringer Ingelheim
McKesson
Colorcon
UBS
Novartis

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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