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BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
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Serving leading biopharmaceutical companies globally:

Cerilliant
Deloitte
Chinese Patent Office
Healthtrust
Fuji
Teva
Novartis
Harvard Business School
Daiichi Sankyo
Accenture

Generated: November 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022315

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NDA 022315 describes OZURDEX, which is a drug marketed by Allergan and is included in one NDA. It is available from one supplier. There are fourteen patents protecting this drug. Additional details are available on the OZURDEX profile page.

The generic ingredient in OZURDEX is dexamethasone. There are thirty-nine drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the dexamethasone profile page.

Summary for 022315

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:14
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Inflammatory Bowel Disease Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 022315

Medical Subject Heading (MeSH) Categories for 022315

Suppliers and Packaging for NDA: 022315

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OZURDEX
dexamethasone
IMPLANT;INTRAVITREAL 022315 NDA Allergan, Inc. 0023-3348 0023-3348-07 1 POUCH in 1 CARTON (0023-3348-07) > 1 IMPLANT in 1 POUCH
OZURDEX
dexamethasone
IMPLANT;INTRAVITREAL 022315 NDA Allergan, Inc. 0023-3348 0023-3348-08 1 POUCH in 1 CARTON (0023-3348-08) > 1 IMPLANT in 1 POUCH

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:IMPLANT;INTRAVITREALStrength0.7MG
Approval Date:Jun 17, 2009TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 29, 2017
Regulatory Exclusivity Use:INDICATED FOR THE TREATMENT OF DIABETIC MACULAR EDEMA IN PATIENTS WHO ARE PSEUDOPHAKIC OR ARE PHAKIC AND SCHEDULED FOR CATARACT SURGERY
Regulatory Exclusivity Expiration:Sep 24, 2017
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Patent:► SubscribePatent Expiration:Oct 20, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF MACULAR EDEMA


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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Covington
Novartis
QuintilesIMS
Chubb
US Department of Justice
Julphar
Healthtrust
Chinese Patent Office
Mallinckrodt

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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