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NOXAFIL Drug Profile
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 eight patents protecting this drug and three Paragraph IV challenges.
The generic ingredient in NOXAFIL is posaconazole. There are nineteen 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 NOXAFIL
| US Patents: | 8 |
| Applicants: | 2 |
| NDAs: | 3 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 63 |
| Clinical Trials: | 15 |
| Patent Applications: | 35 |
| 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 |
Generic Entry Opportunity Date for NOXAFIL
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NOXAFIL
| Ingredient-type | Azoles |
| Drug Class | Azole Antifungal |
Synonyms for NOXAFIL
| 1-((1S,2S)-1-Ethyl-2-hydroxypropyl)-4-{4-[4-(4-{[(5S,3R)-5-(2,4-difluorophenyl)-5-(1,2,4-triazolylmethyl)oxolan-3-yl]methoxy}phenyl)piperazinyl]phenyl}-1,2,4-triazolin-5-one |
| 171228-49-2 |
| 177571-33-4 |
| 2,5-anhydro-1,3,4-trideoxy-2-(2,4-difluorophenyl)-4-({4-[4-(4-{1-[(2S,3S)-2-hydroxypentan-3-yl]-5-oxo-1,5-dihydro-4H-1,2,4-triazol-4-yl}phenyl)piperazin-1-yl]phenoxy}methyl)-1-(1H-1,2,4-triazol-1-yl)-D-threo-pentitol |
| 228P492 |
| 3H-1,2,4-Triazol-3-one, 4-(4-(4-(4-((5-(2,4-difluorophenyl)tetrahydro-5-(1H-1,2,4-triazol-1-ylmethyl)-3-furanyl)methoxy)phenyl)-1-piperazinyl)phenyl)-2-(1-ethyl-2-hydroxypropyl)-2,4-dihydro-, (3R-(3alpha(1S*,2S*),5alpha))- |
| 4-(4-(4-(4-(((3R,5R)-5-((1H-1,2,4-triazol-1-yl)methyl)-5-(2,4-difluorophenyl)-tetrahydrofuran-3-yl)methoxy)phenyl)piperazin-1-yl)phenyl)-2-((2S,3S)-2-hydroxypentan-3-yl)-2H-1,2,4-triazol-3(4H)-one |
| 4-(4-(4-(4-(((3R,5R)-5-((1H-1,2,4-TRIAZOL-1-YL)METHYL)-5-(2,4-DIFLUOROPHENYL)TETRAHYDROFURAN-3-YL)METHOXY)PHENYL)PIPERAZIN-1-YL)PHENYL)-1-((2S,3S)-2-HYDROXYPENTAN-3-YL)-1H-1,2,4-TRIAZOL-5(4H)-ONE |
| 4-(4-(4-(4-(((3R,5R)-5-(3,4-difluorophenyl)-5-(1H-1,2,4-triazol-1-yl)tetrahydrofuran-3-yl)methoxy)phenyl)piperazin-1-yl)phenyl)-1-((2S,3S)-2-hydroxypentan-3-yl)-1H-1,2,4-triazol-5(4H)-one |
| 4-(4-(4-(4-(((5R)-5-((1H-1,2,4-triazol-1-yl)methyl)-5-(2,4-difluorophenyl)-tetrahydrofuran-3-yl)methoxy)phenyl)piperazin-1-yl)phenyl)-2-((2S,3S)-2-hydroxypentan-3-yl)-2H-1,2,4-triazol-3(4H)-one |
| 4-(p-(4-(p-(((3R,5R)-5-(2,4-Difluorophenyl)tetrahydro-5-(1H-1,2,4-triazol-1-ylmethyl)-3-furyl)methoxy)phenyl)-1-piperazinyl)phenyl)-1-((1S,2S)-1-ethyl-2-hydroxypropyl)-delta(sup 2)-1,2,4-triazolin-5-one |
| 4-[4-(4-{4-[(R)-5-(2,4-difluoro-phenyl)-5-(4,5-dihydro-[1,2,4]triazol-1-ylmethyl)-tetrahydro-furan-3-ylmethoxy]-phenyl}-piperazin-1-yl)-phenyl]-2-((1S,2S)-1-ethyl-2-hydroxy-propyl)-2,4-dihydro-[1,2,4]triazol-3-one |
| 4-[4-[4-[4-[[(3R,5R)-5-(2,4-difluorophenyl)-5-(1,2,4-triazol-1-ylmethyl)oxolan-3-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2-[(2S,3S)-2-hydroxypentan-3-yl]-1,2,4-triazol-3-one |
| 4-[4-[4-[4-[[(3R,5R)-5-(2,4-difluorophenyl)-5-(1,2,4-triazol-1-ylmethyl)tetrahydrofuran-3-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2-[(1S,2S)-1-ethyl-2-hydroxy-propyl]-1,2,4-triazol-3-one |
| 4-{4-[4-(4-{[(3R,5R)-5-(2,4-difluorophenyl)-5-(1,2,4-triazol-1-ylmethyl)oxolan-3-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-2-[(2S,3S)-2-hydroxypentan-3-yl]-1,2,4-triazol-3-one |
| 4-{4-[4-(4-{[(3r,5r)-5-(2,4-difluorophenyl)-5-(1h-1,2,4-triazol-1-ylmethyl)tetrahydrofuran-3-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-2-[(1s,2s)-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3h-1,2,4-triazol-3-one |
| 6TK1G07BHZ |
| AB0015409 |
| AB01274762_02 |
| AB01274762-01 |
| AC-1350 |
| AC1LAHLQ |
| ACN-040495 |
| AK-72814 |
| AKOS005145917 |
| BC677686 |
| BDBM50181473 |
| C37H42F2N8O4 |
| CHEBI:64355 |
| CHEMBL1397 |
| CP0094 |
| CS-0998 |
| CTK6B1621 |
| D-threo-Pentitol, 2,5-anhydro-1,3,4-trideoxy-2-C-(2,4-difluorophenyl)-4-((4-(4-(4-(1-((1S,2S)-1-etyl-2-hydroxypropyl)-1,5-dihydro-5-oxo-4H-1,2,4-triazol-4-yl)phenyl)-1-piperazinyl)phenoxy)methyl)-1-(1H-1,2,4-triazol-1-yl)- |
| D02555 |
| DB01263 |
| FT-0657137 |
| HE073055 |
| HE317797 |
| HSDB 7421 |
| HY-17373 |
| KS-00000GY1 |
| KS-1413 |
| M842 |
| MFCD00941162 |
| MMV688774 |
| MolPort-006-666-426 |
| Noxafil (TN) |
| P-7020 |
| P2477 |
| pasaconazole |
| PB30668 |
| posaconazol |
| Posaconazole |
| Posaconazole (JAN/USAN/INN) |
| Posaconazole [USAN:INN:BAN] |
| Posaconazole in combination with MGCD290 |
| Posaconazole SP |
| Posaconazole, Antibiotic for Culture Media Use Only |
| Posaconazole, VETRANAL(TM), analytical standard |
| Posconazole |
| Q-4359 |
| RAGOYPUPXAKGKH-XAKZXMRKSA-N |
| RL02201 |
| RTR-007528 |
| s1257 |
| SC-23857 |
| Sch 56592 |
| SCH-56592 |
| SCH56592 |
| SCHEMBL991747 |
| Schering 56592 |
| Spriafil |
| ST24042909 |
| TR-007528 |
| UNII-6TK1G07BHZ |
| ZINC3938482 |
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 | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Schering | NOXAFIL | posaconazole | SUSPENSION;ORAL | 022003-001 | Sep 15, 2006 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Merck Sharp Dohme | NOXAFIL | posaconazole | SOLUTION;INTRAVENOUS | 205596-001 | Mar 13, 2014 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| 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 | TABLET, DELAYED RELEASE;ORAL | 205053-001 | Nov 25, 2013 | ➤ Sign Up | ➤ Sign Up |
| Merck Sharp Dohme | NOXAFIL | posaconazole | SOLUTION;INTRAVENOUS | 205596-001 | Mar 13, 2014 | ➤ Sign Up | ➤ Sign Up |
| Schering | NOXAFIL | posaconazole | SUSPENSION;ORAL | 022003-001 | Sep 15, 2006 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for NOXAFIL
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Injection | 18 mg/mL, 16.7 mL vials | ➤ Subscribe | ➤ Sign Up |
| ➤ Subscribe | Delayed-release Tablets | 100 mg | ➤ Subscribe | ➤ Sign Up |
| ➤ Subscribe | Oral Suspension | 40 mg/mL | ➤ Subscribe | ➤ Sign Up |
International Patents for NOXAFIL
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Mexico | 2014010323 | ➤ Sign Up |
| Australia | 2016210707 | ➤ Sign Up |
| Germany | 122006000004 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for NOXAFIL
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 0219 | Netherlands | ➤ Sign Up | 300219, 20141220, EXPIRES: 20191219 |
| 00219 | Netherlands | ➤ Sign Up | 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 |
| C0009 | France | ➤ Sign Up | PRODUCT NAME: POSACONAZOLE; REGISTRATION NO/DATE: EU/1/05/320/001 20051025 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
