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AFINITOR DISPERZ Drug Profile
Which patents cover Afinitor Disperz, and when can generic versions of Afinitor Disperz launch?
This drug has two hundred and eighty-eight patent family members in forty-five countries.
The generic ingredient in AFINITOR DISPERZ is everolimus. There are eleven 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 DISPERZ
| International Patents: | 288 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 21 |
| Clinical Trials: | 31 |
| Patent Applications: | 5,311 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | AFINITOR DISPERZ at DailyMed |
Pharmacology for AFINITOR DISPERZ
| 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 DISPERZ
Synonyms for AFINITOR DISPERZ
| (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 |
| 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 DISPERZ
| 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 | 203985-001 | Aug 29, 2012 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Novartis Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-002 | Aug 29, 2012 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Novartis Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-001 | Aug 29, 2012 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Novartis Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-003 | Aug 29, 2012 | 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 AFINITOR DISPERZ
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-001 | Aug 29, 2012 | ➤ Sign Up | ➤ Sign Up |
| Novartis Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-002 | Aug 29, 2012 | ➤ Sign Up | ➤ Sign Up |
| Novartis Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-003 | Aug 29, 2012 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for AFINITOR DISPERZ
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Tablets for Oral Suspension | 2 mg, 3 mg and 5 mg | ➤ Subscribe | 2016-12-30 |
Non-Orange Book US Patents for AFINITOR DISPERZ
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 |
|---|---|---|
| 8,436,010 | Treatment of solid tumors with rapamycin derivatives | ➤ Sign Up |
| 6,852,729 | Macrolides | ➤ Sign Up |
| 7,572,804 | Macrolides | ➤ Sign Up |
| 6,440,990 | O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for AFINITOR DISPERZ
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Russian Federation | 2243769 | ➤ Sign Up |
| Hong Kong | 1067036 | ➤ Sign Up |
| Russian Federation | 2325906 | ➤ Sign Up |
| Norway | 20150413 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for AFINITOR DISPERZ
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2016000094 | Germany | ➤ Sign Up | PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803 |
| C0012 | France | ➤ Sign Up | PRODUCT NAME: EVEROLIMUS; NAT. REGISTRATION NO/DATE: NL 29433 20040415; FIRST REGISTRATION: SE - 18693 20030718 |
| 0769 | Netherlands | ➤ Sign Up | PRODUCT NAME: EVEROLIMUS, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/09/538/001-008(C(2012)5347) 20120725 |
| 2004000033 | Germany | ➤ Sign Up | PRODUCT NAME: EVEROLIMUS; NAT. REGISTRATION NO/DATE: 58387.00.00 58387.00.01 58387.01.00 58387.01.01 58387.02.00 58387.03.00 20040204 FIRST REGISTRATION: SCHWEDEN 18690 18691 18692 18693 18694 18695 20030718 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
