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NOXAFIL Drug Profile
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When do Noxafil patents expire, and what generic alternatives are available?
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.
This drug has one hundred and thirty-five patent family members in thirty-four countries.
The generic ingredient in NOXAFIL is posaconazole. There are eighteen 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
| International Patents: | 135 |
| 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;IV (INFUSION) | 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;IV (INFUSION) | 205596-001 | Mar 13, 2014 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | 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;IV (INFUSION) | 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 |
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Expired US Patents for NOXAFIL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Merck Sharp Dohme | NOXAFIL | posaconazole | SOLUTION;IV (INFUSION) | 205596-001 | Mar 13, 2014 | ➤ Sign Up | ➤ Sign Up |
| Merck Sharp Dohme | NOXAFIL | posaconazole | TABLET, DELAYED RELEASE;ORAL | 205053-001 | Nov 25, 2013 | ➤ 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 |
Non-Orange Book US Patents for NOXAFIL
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 9,200,088 | Sulfoalkyl ether cyclodextrin compositions | ➤ Sign Up |
| 5,693,626 | Tetrahydrofuran antifungals | ➤ Sign Up |
| 5,714,490 | Tetrahydrofuran antifungals | ➤ Sign Up |
| 5,703,236 | Tetrahydrofuran antifungals | ➤ Sign Up |
| 7,635,773 | Sulfoalkyl ether cyclodextrin compositions | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for NOXAFIL
| Country | Document Number | Estimated Expiration |
|---|---|---|
| New Zealand | 309281 | ➤ Sign Up |
| Australia | 2006200354 | ➤ Sign Up |
| China | 105288650 | ➤ Sign Up |
| Argentina | 033096 | ➤ Sign Up |
| Japan | H09500658 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for NOXAFIL
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2006 | Austria | ➤ Sign Up | 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 |
| 2006 00002 | Denmark | ➤ Sign Up | |
| 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 |
| C003/2006 | Ireland | ➤ Sign Up | SPC003/2006: 20061023, EXPIRES: 20191219 |
| 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 |
