Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Moodys
Dow
Medtronic
AstraZeneca
Colorcon

Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205053

See Plans and Pricing

« Back to Dashboard

NDA 205053 describes NOXAFIL, which is a drug marketed by Merck Sharp Dohme and Schering and is included in three NDAs. It is available from two suppliers. There are eight 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 twenty-one drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the posaconazole profile page.
Summary for 205053
Tradename:NOXAFIL
Applicant:Merck Sharp Dohme
Ingredient:posaconazole
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 205053
Suppliers and Packaging for NDA: 205053
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NOXAFIL posaconazole TABLET, DELAYED RELEASE;ORAL 205053 NDA Merck Sharp & Dohme Corp. 0085-4324 0085-4324-02 60 TABLET, COATED in 1 BOTTLE (0085-4324-02)
NOXAFIL posaconazole TABLET, DELAYED RELEASE;ORAL 205053 NDA AUTHORIZED GENERIC Par Pharmaceutical Inc. 0254-2045 0254-2045-02 60 TABLET, COATED in 1 BOTTLE (0254-2045-02)
Paragraph IV (Patent) Challenges for 205053
Tradename Dosage Ingredient NDA Submissiondate
NOXAFIL TABLET, DELAYED RELEASE;ORAL posaconazole 205053 2014-06-16

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength100MG
Approval Date:Nov 25, 2013TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Jul 19, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS

Expired US Patents for NDA 205053

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme NOXAFIL posaconazole TABLET, DELAYED RELEASE;ORAL 205053-001 Nov 25, 2013   Start Trial   Start Trial
Merck Sharp Dohme NOXAFIL posaconazole TABLET, DELAYED RELEASE;ORAL 205053-001 Nov 25, 2013   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Express Scripts
Colorcon
Johnson and Johnson
McKinsey
Dow

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.