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Serving 500+ biopharmaceutical companies globally:

Queensland Health
Cerilliant
McKesson
Teva
Fish and Richardson
Moodys
Fuji
Colorcon
Novartis
US Army

Generated: June 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022003

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NDA 022003 describes NOXAFIL, which is a drug marketed by Schering and Merck Sharp Dohme and is included in three NDAs. It is available from one supplier. There are seven patents protecting this drug and three Paragraph IV challenges. Additional details are available on the NOXAFIL profile page.

The generic ingredient in NOXAFIL is posaconazole. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the posaconazole profile page.

Summary for NDA: 022003

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for NDA: 022003

Ingredient-typeAzoles

Suppliers and Packaging for NDA: 022003

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NOXAFIL
posaconazole
SUSPENSION;ORAL 022003 NDA Merck Sharp & Dohme Corp. 0085-1328 0085-1328-01 1 BOTTLE, GLASS in 1 CARTON (0085-1328-01) > 105 mL in 1 BOTTLE, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength40MG/ML
Approval Date:Sep 15, 2006TE:RLD:Yes
Patent:8,263,600Patent Expiration:Apr 1, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:5,661,151Patent Expiration:Jul 19, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS AND TREATMENT OF OROPHARYNGEAL CANDIDAIASIS
Patent:6,958,337Patent Expiration:Oct 5, 2018Product Flag?YSubstance Flag?YDelist Request?
Patented Use:PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS AND TREATMENT OF OROPHARYNGEAL CANDIDAIASIS

Expired Orange Book Patents for NDA: 022003

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Schering
NOXAFIL
posaconazole
SUSPENSION;ORAL022003-001Sep 15, 20065,703,079► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
Farmers Insurance
Moodys
Boehringer Ingelheim
Queensland Health
Cipla
US Department of Justice
Harvard Business School
Deloitte
Citi

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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