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AFINITOR Drug Profile
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» See Plans and PricingWhen 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.
This drug has three hundred and forty patent family members in forty-seven countries.
The generic ingredient in AFINITOR is everolimus. There are twelve drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the everolimus profile page.
US ANDA Litigation and Generic Entry Outlook for Afinitor
A generic version of AFINITOR was approved as everolimus by HIKMA on April 12th, 2018.
Summary for AFINITOR
| International Patents: | 340 |
| US Patents: | 7 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 29 |
| Clinical Trials: | 157 |
| Patent Applications: | 6,254 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for AFINITOR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AFINITOR |
| DailyMed Link: | AFINITOR at DailyMed |
Recent Clinical Trials for AFINITOR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| M.D. Anderson Cancer Center | Early Phase 1 |
| Uppsala University Hospital | Phase 2 |
| Merck Sharp & Dohme Corp. | Phase 3 |
Recent Litigation for AFINITOR
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Novartis Pharmaceuticals Corporation v. Mylan Pharmaceuticals Inc. | 2019-06-05 |
| Point.360, a California Corporation | 2017-10-10 |
| Novartis Pharmaceuticals Corporation v. Teva Pharmaceuticals USA, Inc. | 2017-06-30 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Hikma Pharmaceuticals PLC | 2018-01-17 |
| Breckenridge Pharmaceutial, Inc. | 2017-06-12 |
| 2017-03-13 |
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 |
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-dime |
| (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, |
| 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 |
| BRD-K13514097-001-05-3 |
| 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 (RAD001) |
| Everolimus [USAN:INN:BAN] |
| Everolimus [USAN] |
| Everolimus solution, 1.0 mg/ml in acetonitrile |
| Everolimus solution, 1.0 mg/mL in acetonitrile, ampule of 1 mL, certified reference material |
| Everolimus, analytical standard |
| Everolimus; RAD001; SDZ-RAD |
| Everolimus(RAD001) |
| everolimusum |
| EX-A2057 |
| GTPL5889 |
| HKVAMNSJSFKALM-GKUWKFKPSA-N |
| HSDB 8255 |
| HY-10218 |
| LS-143292 |
| NCGC00167512-01 |
| NSC733504 |
| NVP-RAD-001 |
| NVP-RAD001 |
| PubChem20048 |
| Q-101413 |
| Q421052 |
| RAD |
| RAD 001 |
| RAD 666 |
| RAD-001 |
| RAD-001C |
| RAD-666 |
| RAD001 |
| Rapamycin, 42-O-(2-hydroxyethyl)- |
| SCHEMBL4378 |
| SDZ-RAD |
| SDZRAD |
| Tox21_112510 |
| UNII-9HW64Q8G6G |
| V2036 |
| Votubia |
| XIENCE V |
| ZINC169677008 |
| Zortress |
Paragraph IV (Patent) Challenges for AFINITOR
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| AFINITOR | TABLET;ORAL | everolimus | 022334 | 2014-12-10 |
| AFINITOR | TABLET;ORAL | everolimus | 022334 | 2014-06-18 |
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 | AFINITOR | everolimus | TABLET;ORAL | 022334-002 | Mar 30, 2009 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-004 | Mar 30, 2012 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Novartis Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-001 | Aug 29, 2012 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Novartis Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-003 | Aug 29, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >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 | 022334-004 | Mar 30, 2012 | Start Trial | Start Trial |
| Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-003 | Jul 9, 2010 | Start Trial | Start Trial |
| Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-002 | Mar 30, 2009 | Start Trial | Start Trial |
| Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-004 | Mar 30, 2012 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AFINITOR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Finland | 951678 | Start Trial |
| Netherlands | 300154 | Start Trial |
| Russian Federation | 2018127821 | Start Trial |
| Cyprus | 2603 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for AFINITOR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3143995 | 122019000051 | Germany | Start Trial | PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001 EU/1/09/538/003 EU/1/09/538/004 EU/1/09/538/006 EU/1/09/538/007 EU/1/09/538/008 EU/1/09/538/009 EU/1/09/538/010 20160526 |
| 3342411 | CA 2020 00007 | Denmark | Start Trial | PRODUCT NAME: EVEROLIMUS; REG. NO/DATE: EU/1/09/538 (K(2011)6162) 20110830 |
| 0663916 | SZ 14/2004 | Austria | Start Trial | PRODUCT NAME: EVEROLIMUS (40-0-(2-HYDROXY)ETYHL RAPAMYCIN) |
| 2269604 | 62/2016 | Austria | Start Trial | PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090805 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
