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NOXAFIL Drug 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 and Schering and is included in three NDAs. There are seven patents protecting this drug and three Paragraph IV challenges.
This drug has eighty-nine patent family members in twenty-one countries.
The generic ingredient in NOXAFIL is posaconazole. There are twenty-one drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the posaconazole profile page.
US ANDA 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: | 89 |
| US Patents: | 7 |
| Applicants: | 2 |
| NDAs: | 3 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 79 |
| Clinical Trials: | 19 |
| Patent Applications: | 39 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for NOXAFIL |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NOXAFIL |
| DailyMed Link: | NOXAFIL at DailyMed |
Recent Clinical Trials for NOXAFIL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Cidara Therapeutics Inc. | Phase 3 |
| Novartis Pharmaceuticals | Phase 1/Phase 2 |
| Hospices Civils de Lyon | N/A |
Pharmacology for NOXAFIL
| Drug Class | Azole Antifungal |
Paragraph IV (Patent) Challenges for NOXAFIL
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| NOXAFIL | SOLUTION;INTRAVENOUS | posaconazole | 205596 | 2015-11-24 |
| NOXAFIL | TABLET, DELAYED RELEASE;ORAL | posaconazole | 205053 | 2014-06-16 |
| NOXAFIL | SUSPENSION;ORAL | posaconazole | 022003 | 2011-02-28 |
US Patents and Regulatory Information for NOXAFIL
| 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 | Start Trial | Start Trial | Y | Start Trial | |||
| Schering | NOXAFIL | posaconazole | SUSPENSION;ORAL | 022003-001 | Sep 15, 2006 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Merck Sharp Dohme | NOXAFIL | posaconazole | SOLUTION;INTRAVENOUS | 205596-001 | Mar 13, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Merck Sharp Dohme | NOXAFIL | posaconazole | TABLET, DELAYED RELEASE;ORAL | 205053-001 | Nov 25, 2013 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Merck Sharp Dohme | NOXAFIL | posaconazole | SOLUTION;INTRAVENOUS | 205596-001 | Mar 13, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Merck Sharp Dohme | NOXAFIL | posaconazole | SOLUTION;INTRAVENOUS | 205596-001 | Mar 13, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Merck Sharp Dohme | NOXAFIL | posaconazole | SOLUTION;INTRAVENOUS | 205596-001 | Mar 13, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >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 |
|---|---|---|---|---|---|---|---|
| Merck Sharp Dohme | NOXAFIL | posaconazole | SOLUTION;INTRAVENOUS | 205596-001 | Mar 13, 2014 | Start Trial | Start Trial |
| Schering | NOXAFIL | posaconazole | SUSPENSION;ORAL | 022003-001 | Sep 15, 2006 | Start Trial | Start Trial |
| Schering | NOXAFIL | posaconazole | SUSPENSION;ORAL | 022003-001 | Sep 15, 2006 | Start Trial | Start Trial |
| Schering | NOXAFIL | posaconazole | SUSPENSION;ORAL | 022003-001 | Sep 15, 2006 | Start Trial | Start Trial |
| Merck Sharp Dohme | NOXAFIL | posaconazole | TABLET, DELAYED RELEASE;ORAL | 205053-001 | Nov 25, 2013 | Start Trial | Start Trial |
| Merck Sharp Dohme | NOXAFIL | posaconazole | SOLUTION;INTRAVENOUS | 205596-001 | Mar 13, 2014 | 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 |
International Patents for NOXAFIL
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 4923144 | Start Trial |
| Mexico | 2012015168 | Start Trial |
| Australia | 2016210707 | Start Trial |
| New Zealand | 309281 | Start Trial |
| Mexico | 346901 | Start Trial |
| Japan | 2016166368 | Start Trial |
| Australia | 1512795 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for NOXAFIL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0736030 | 300219 | Netherlands | Start Trial | 300219, 20141220, EXPIRES: 20191219 |
| 0736030 | CA 2006 00002 | Denmark | Start Trial | |
| 0736030 | SPC/GB06/007 | United Kingdom | Start Trial | PRODUCT NAME: POSACONAZOLE, OPTIONALLY IN THE FORM OF AN ESTER OR PHARMACEUTICALLY ACCEPTABLE SALT.; REGISTERED: UK EU/1/05/320/001 20051025; UK EU/1/05/321/001 20051025 |
| 0736030 | 8/2006 | Austria | Start Trial | PRODUCT NAME: POSACONAZOL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER ESTERS; REGISTRATION NO/DATE: EU/1/05/320/001 EU/1/05/321/001 20051025 |
| 0736030 | C00736030/01 | Switzerland | Start Trial | FORMER OWNER: SCHERING CORPORATION, US |
| 0736030 | C300219 | Netherlands | Start Trial | PRODUCT NAME: POSACONAZOLUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ESTER EN/OF ZOUT; REGISTRATION NO/DATE: EU/1/05/320/001EU/1/05/321/001 2005251025 |
| 0736030 | 06C0009 | France | Start Trial | PRODUCT NAME: POSACONAZOLE; REGISTRATION NO/DATE: EU/1/05/320/001 20051025 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
