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.
Summary for NOXAFIL
| International Patents: | 99 |
| US Patents: | 7 |
| Applicants: | 3 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 88 |
| Clinical Trials: | 24 |
| Patent Applications: | 2,620 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for NOXAFIL |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NOXAFIL |
| What excipients (inactive ingredients) are in NOXAFIL? | NOXAFIL excipients list |
| DailyMed Link: | NOXAFIL at DailyMed |
Recent Clinical Trials for NOXAFIL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Milton S. Hershey Medical Center | Early Phase 1 |
| M.D. Anderson Cancer Center | Phase 1/Phase 2 |
| Cidara Therapeutics Inc. | Phase 3 |
Pharmacology for NOXAFIL
| Drug Class | Azole Antifungal |
Anatomical Therapeutic Chemical (ATC) Classes 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
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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.
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