DrugPatentWatch Database Preview
AFINITOR DISPERZ Drug Profile
When do Afinitor Disperz patents expire, and when can generic versions of Afinitor Disperz launch?
Afinitor Disperz is a drug marketed by Novartis Pharm and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.
This drug has three hundred and twenty-six patent family members in forty-five countries.
The generic ingredient in AFINITOR DISPERZ 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 DISPERZ
| International Patents: | 326 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 29 |
| Patent Applications: | 6,144 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for AFINITOR DISPERZ |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AFINITOR DISPERZ |
| DailyMed Link: | AFINITOR DISPERZ at DailyMed |
Recent Litigation for AFINITOR DISPERZ
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Point.360, a California Corporation | 2017-10-10 |
| Novartis Pharmaceuticals Corporation v. Teva Pharmaceuticals USA, Inc. | 2017-06-30 |
| Novartis Pharmaceuticals Corporation v. Teva Pharmaceuticals USA, Inc. | 2017-04-07 |
See all AFINITOR DISPERZ litigation
PTAB Litigation
| Petitioner | Date |
|---|---|
| Breckenridge Pharmaceutical, Inc. | 2016-05-26 |
| Roxane Laboratories, Inc. | 2016-05-26 |
| Par Pharmaceutical, Inc. | 2016-05-17 |
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 |
Synonyms for AFINITOR DISPERZ
| 1245613-55-1 |
| 159351-69-6 |
| 351E696 |
| 40-O-(2-hydroxyethyl)-rapamycin |
| 42-O-(2-Hydroxyethyl)rapamycin |
| 9HW64Q8G6G |
| Afinitor |
| AK323674 |
| 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 [USAN:INN:BAN] |
| Everolimus [USAN] |
| Everolimus solution, 1.0 mg/mL in acetonitrile, ampule of 1 mL, certified reference material |
| Everolimus, analytical standard |
| Everolimus; RAD001; SDZ-RAD |
| everolimusum |
| EX-A2057 |
| GTPL5889 |
| HKVAMNSJSFKALM-GKUWKFKPSA-N |
| 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 |
| ZINC169677008 |
| 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 | Start Trial for $ | Start Trial for $ | Y | Start Trial for $ | |||
| Novartis Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-003 | Aug 29, 2012 | RX | Yes | Yes | Start Trial for $ | Start Trial for $ | Start Trial for $ | ||||
| Novartis Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-002 | Aug 29, 2012 | RX | Yes | No | Start Trial for $ | Start Trial for $ | Y | Start Trial for $ | |||
| Novartis Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-001 | Aug 29, 2012 | RX | Yes | No | Start Trial for $ | Start Trial for $ | Y | Start Trial for $ | |||
| Novartis Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-002 | Aug 29, 2012 | RX | Yes | No | Start Trial for $ | Start Trial for $ | Start Trial for $ | ||||
| Novartis Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-002 | Aug 29, 2012 | RX | Yes | No | Start Trial for $ | Start Trial for $ | Y | Start Trial for $ | |||
| Novartis Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-003 | Aug 29, 2012 | RX | Yes | Yes | Start Trial for $ | Start Trial for $ | Y | Start Trial for $ | |||
| >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 | 203985-003 | Aug 29, 2012 | Start Trial for $ | Start Trial for $ |
| Novartis Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-001 | Aug 29, 2012 | Start Trial for $ | Start Trial for $ |
| Novartis Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-002 | Aug 29, 2012 | Start Trial for $ | Start Trial for $ |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for AFINITOR DISPERZ
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets for Oral Suspension | 2 mg, 3 mg and 5 mg | ➤ Subscribe | Start Trial for $ |
International Patents for AFINITOR DISPERZ
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Austria | 365051 | Start Trial for $ |
| Norway | 20161348 | Start Trial for $ |
| Czech Republic | 20032209 | Start Trial for $ |
| Japan | 6310970 | Start Trial for $ |
| Norway | 332698 | Start Trial for $ |
| Canada | 2651609 | Start Trial for $ |
| South Korea | 20050095906 | Start Trial for $ |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for AFINITOR DISPERZ
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3143995 | 2019C/528 | Belgium | Start Trial for $ | PRODUCT NAME: EVEROLIMUS OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/09/538/001, 003, 004, 006-010 (C(2016)3286) 20160530 |
| 2269603 | CA 2015 00058 | Denmark | Start Trial for $ | PRODUCT NAME: EVEROLIMUS ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/09/538/001-008 (K(2012)5347) 20120725 |
| 3143995 | PA2019511 | Lithuania | Start Trial for $ | PRODUCT NAME: EVEROLIMUZAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/09/538/001, 003, 004, 006-010 20160526 |
| 3143995 | CA 2019 00031 | Denmark | Start Trial for $ | PRODUCT NAME: EVEROLIMUS ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/09/538, C(2016)3286 20160530 |
| 0663916 | SZ 14/2004 | Austria | Start Trial for $ | PRODUCT NAME: EVEROLIMUS (40-0-(2-HYDROXY)ETYHL RAPAMYCIN) |
| 0663916 | 300154 | Netherlands | Start Trial for $ | PRODUCT NAME: EVEROLIMUSUM; NATIONAL REGISTRATION NO/DATE: RVG 30041 20040610; FIRST REGISTRATION: SE 18690 20030718 |
| 0663916 | C00663916/01 | Switzerland | Start Trial for $ | PRODUCT NAME: EVEROLIMUS; REGISTRATION NUMBER/DATE: SWISSMEDIC 56238 21.04.2005 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
