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Last Updated: May 19, 2022

NOXAFIL Drug Patent Profile


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Which patents cover Noxafil, and when can generic versions of Noxafil launch?

Noxafil is a drug marketed by Merck Sharp Dohme, Schering, and Msd Merck Co. and is included in four NDAs. There are seven patents protecting this drug and three Paragraph IV challenges.

This drug has ninety-nine patent family members in twenty-seven countries.

The generic ingredient in NOXAFIL is posaconazole. There are twenty-one drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the posaconazole profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Noxafil

A generic version of NOXAFIL was approved as posaconazole by SINOTHERAPEUTICS INC on August 21st, 2019.

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Drug patent expirations by year for NOXAFIL
Drug Prices for NOXAFIL

See drug prices for NOXAFIL

Recent Clinical Trials for NOXAFIL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Milton S. Hershey Medical CenterEarly Phase 1
M.D. Anderson Cancer CenterPhase 1/Phase 2
Cidara Therapeutics Inc.Phase 3

See all NOXAFIL clinical trials

Pharmacology for NOXAFIL
Paragraph IV (Patent) Challenges for NOXAFIL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NOXAFIL Injection posaconazole 18 mg/mL, 16.7 mL vials 205596 1 2015-11-24
NOXAFIL Delayed-release Tablets posaconazole 100 mg 205053 1 2014-06-16
NOXAFIL Oral Suspension posaconazole 40 mg/mL 022003 1 2011-02-28

US Patents and Regulatory Information for NOXAFIL

NOXAFIL is protected by ten US patents and three FDA Regulatory Exclusivities.

Patents protecting NOXAFIL

Sulfoalkyl ether cyclodextrin compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Antifungal composition with enhanced bioavailability
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Sulfoalkyl ether cyclodextrin compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Posaconazole intravenous solution formulations stabilized by substituted .beta.-cyclodextrin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF INVASIVE ASPERGILLOSIS IN ADULTS AND PEDIATRIC PATIENTS 13 YEARS OF AGE AND OLDER

Posaconazole intravenous solution formulations stabilized by substituted .beta.-cyclodextrin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS

Posaconazole intravenous solution formulations stabilized by substituted .beta.-cyclodextrin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WHO ARE SEVERELY IMMUNOCOMPROMISED

Posaconazole intravenous solution formulations stabilized by substituted .beta.-cyclodextrin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF INVASIVE ASPERGILLOSIS IN ADULTS AND PEDIATRIC PATIENTS 13 YEARS OF AGE AND OLDER

Posaconazole intravenous solution formulations stabilized by substituted .beta.-cyclodextrin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WHO ARE SEVERELY IMMUNOCOMPROMISED

Alkylated cyclodextrin compositions and processes for preparing and using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Sulfoalkyl ether cyclodextrin compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting NOXAFIL

NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing

FOR THE TREATMENT OF INVASIVE ASPERGILLOSIS IN ADULTS AND PEDIATRIC PATIENTS 13 YEARS OF AGE AND OLDER
Exclusivity Expiration: See Plans and Pricing

FOR THE TREATMENT OF INVASIVE ASPERGILLOSIS IN PATIENTS 13 YEARS OF AGE AND OLDER
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme NOXAFIL posaconazole SOLUTION;INTRAVENOUS 205596-001 Mar 13, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Merck Sharp Dohme NOXAFIL posaconazole SOLUTION;INTRAVENOUS 205596-001 Mar 13, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Merck Sharp Dohme NOXAFIL posaconazole SOLUTION;INTRAVENOUS 205596-001 Mar 13, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for NOXAFIL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Schering NOXAFIL posaconazole SUSPENSION;ORAL 022003-001 Sep 15, 2006 See Plans and Pricing See Plans and Pricing
Schering NOXAFIL posaconazole SUSPENSION;ORAL 022003-001 Sep 15, 2006 See Plans and Pricing See Plans and Pricing
Schering NOXAFIL posaconazole SUSPENSION;ORAL 022003-001 Sep 15, 2006 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for NOXAFIL

See the table below for patents covering NOXAFIL around the world.

Country Patent Number Title Estimated Expiration
China 1161038 See Plans and Pricing
Brazil 112012033077 composição farmacêutica para administração intravenosa, método para tratar ou previnir uma infecção, e, kit See Plans and Pricing
Canada 2802929 FORMULATIONS D'UNE SOLUTION INTRAVEINEUSE DE POSACONAZOLE STABILISEES PAR UNE CYCLODEXTRINE BETA SUBSTITUEE (POSACONAZOLE INTRAVENOUS SOLUTION FORMULATIONS STABILIZED BY SUBSTITUTED BETA-CYCLODEXTRIN) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NOXAFIL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0736030 300219 Netherlands See Plans and Pricing 300219, 20141220, EXPIRES: 20191219
0736030 06C0009 France See Plans and Pricing PRODUCT NAME: POSACONAZOLE; REGISTRATION NO/DATE: EU/1/05/320/001 20051025
0736030 CA 2006 00002 Denmark See Plans and Pricing
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

Serving leading biopharmaceutical companies globally:

AstraZeneca
Boehringer Ingelheim
Merck
McKesson
Express Scripts
McKinsey

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 verification 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.