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AFINITOR Drug Profile
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When do Afinitor patents expire, and when can generic versions of Afinitor launch?
This drug has two hundred and eighty-five patent family members in forty-seven countries.
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
| International Patents: | 285 |
| US Patents: | 7 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 22 |
| Clinical Trials: | 149 |
| Patent Applications: | 4,607 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AFINITOR |
| DailyMed Link: | AFINITOR at DailyMed |
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 | |||
| Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-002 | Mar 30, 2009 | 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 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 |
| Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-001 | Mar 30, 2009 | ➤ 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 |
Non-Orange Book US Patents for AFINITOR
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 |
|---|---|---|
| 6,440,990 | O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants | ➤ Sign Up |
| 6,852,729 | Macrolides | ➤ Sign Up |
| 7,572,804 | Macrolides | ➤ Sign Up |
| 8,877,771 | Treatment of solid tumors with rapamycin derivatives | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for AFINITOR
Supplementary Protection Certificates for AFINITOR
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2015 00058 | Denmark | ➤ Sign Up | PRODUCT NAME: EVEROLIMUS ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/09/538/001-008 (K(2012)5347) 20120725 |
| 2016035 | Lithuania | ➤ Sign Up | PRODUCT NAME: EVEROLIMUZAS; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803 |
| C/GB10/003 | United Kingdom | ➤ Sign Up | PRODUCT NAME: EVEROLIMUS; REGISTERED: SE SE 18690-18695 20030718; UK EU/1/09/538/001 20090803; UK EU/1/09/538/002 20090803; UK EU/1/09/538/003 20090803; UK EU/1/09/538/004 20090803; UK EU/1/09/538/005 20090803; UK EU/1/09/538/006 20090803 |
| 0663916/01 | Switzerland | ➤ Sign Up | PRODUCT NAME: EVEROLIMUS; REGISTRATION NUMBER/DATE: SWISSMEDIC 56238 21.04.2005 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
