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AFINITOR Drug Profile
When do Afinitor patents expire, and what generic alternatives are available?
Afinitor is a drug marketed by Novartis and Novartis Pharm and is included in two NDAs. There are eight patents protecting this drug and three Paragraph IV challenges.
The generic ingredient in AFINITOR is everolimus. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the everolimus profile page.
Summary for AFINITOR
Pharmacology for AFINITOR
| Drug Class | Kinase Inhibitor mTOR Inhibitor Immunosuppressant |
| Mechanism of Action | Protein Kinase Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors Cytochrome P450 2D6 Inhibitors mTOR Inhibitors |
| Physiological Effect | Decreased Immunologic Activity |
Medical Subject Heading (MeSH) Categories for AFINITOR
Synonyms for AFINITOR
| (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-Dihydroxy-12-((1R)-2-((1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl)-1-methylethyl)-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo( |
| (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,35R)-1,18-dihydroxy-12-{(2R)-1-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]propan-2-yl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1. |
| (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hexadecahydro-9,27-dihydroxy-3-((1R)-2-((1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl)-1-methylethyl)-10,21-dimet |
| (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-3-{(2R)-1-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]propan-2-yl}-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-9,10,12,13,14,21,22,23,24,25,26,2 |
| 1245613-55-1 |
| 159351-69-6 |
| 351E696 |
| 40-O-(2-hydroxyethyl)-rapamycin |
| 42-O-(2-Hydroxyethyl)rapamycin |
| 9HW64Q8G6G |
| Afinitor Disperz |
| AKOS015850977 |
| AS-16971 |
| AT-22180 |
| BDBM50088378 |
| BRD-K13514097-001-01-2 |
| C53H83NO14 |
| CAS-159351-69-6 |
| Certican |
| CHEBI:68478 |
| CHEMBL1908360 |
| CS-0064 |
| DB01590 |
| dihydroxy-[(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxy-cyclohexyl]-1-methyl-ethyl]-dimethoxy-hexamethyl-[?]pentone |
| DSSTox_CID_20599 |
| DSSTox_GSID_40599 |
| DSSTox_RID_79508 |
| DTXSID0040599 |
| Everolimus |
| Everolimus - RAD001 |
| Everolimus (INN) |
| Everolimus [USAN:INN:BAN] |
| Everolimus [USAN] |
| Everolimus solution, 1.0 mg/mL in acetonitrile, ampule of 1 mL, certified reference material |
| Everolimus, analytical standard |
| everolimusum |
| HSDB 8255 |
| HY-10218 |
| LS-143292 |
| MolPort-003-847-342 |
| NCGC00167512-01 |
| NSC733504 |
| NVP-RAD-001 |
| PubChem20048 |
| Q-101413 |
| RAD |
| RAD 001 |
| RAD-001 |
| RAD-001C |
| RAD001 |
| Rapamycin, 42-O-(2-hydroxyethyl)- |
| RL02051 |
| SCHEMBL4378 |
| SDZ-RAD |
| Tox21_112510 |
| UNII-9HW64Q8G6G |
| V2036 |
| Votubia |
| XIENCE V |
| Zortress |
US Patents and Regulatory Information for AFINITOR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-003 | Aug 29, 2012 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-004 | Mar 30, 2012 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-004 | Mar 30, 2012 | RX | Yes | No | ➤ 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 AFINITOR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-002 | Mar 30, 2009 | ➤ Sign Up | ➤ Sign Up |
| Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-003 | Jul 9, 2010 | ➤ Sign Up | ➤ Sign Up |
| Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-004 | Mar 30, 2012 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for AFINITOR
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets for Oral Suspension | 2 mg, 3 mg and 5 mg | ➤ Subscribe | ➤ Sign Up |
| ➤ Subscribe | Tablets | 2.5 mg, 5 mg, and 7.5 mg | ➤ Subscribe | ➤ Sign Up |
| ➤ Subscribe | Tablets | 10 mg | ➤ Subscribe | ➤ Sign Up |
International Patents for AFINITOR
Supplementary Protection Certificates for AFINITOR
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| /2016 | Austria | ➤ Sign Up | PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090805 |
| 0663916/01 | Switzerland | ➤ Sign Up | PRODUCT NAME: EVEROLIMUS; REGISTRATION NUMBER/DATE: SWISSMEDIC 56238 21.04.2005 |
| 320 | Luxembourg | ➤ Sign Up | PRODUCT NAME: TRAITEMENT DE TUMEURS SOLIDES RENALES AVEC UN DERIVE DE LA RAPAMYCINE |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
