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BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Chinese Patent Office
Fuji
QuintilesIMS
Argus Health
Chubb
Baxter
Novartis
Cantor Fitzgerald
Teva

Generated: November 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077317

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NDA 077317 describes ISRADIPINE, which is a drug marketed by Watson Labs Teva, Mylan Pharms Inc, and Elite Labs Inc, and is included in three NDAs. It is available from five suppliers. Additional details are available on the ISRADIPINE profile page.

The generic ingredient in ISRADIPINE is isradipine. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the isradipine profile page.

Summary for 077317

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 077317

Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists

Medical Subject Heading (MeSH) Categories for 077317

Suppliers and Packaging for NDA: 077317

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISRADIPINE
isradipine
CAPSULE;ORAL 077317 ANDA Actavis Pharma, Inc. 16252-539 16252-539-01 100 CAPSULE in 1 BOTTLE (16252-539-01)
ISRADIPINE
isradipine
CAPSULE;ORAL 077317 ANDA Actavis Pharma, Inc. 16252-540 16252-540-01 100 CAPSULE in 1 BOTTLE (16252-540-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2.5MG
Approval Date:Jan 5, 2006TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Jan 5, 2006TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Fuji
Harvard Business School
Cantor Fitzgerald
Cipla
Queensland Health
QuintilesIMS
UBS
Federal Trade Commission
Cerilliant
Medtronic

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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