AFINITOR Drug Patent Profile
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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 five patents protecting this drug and two Paragraph IV challenges.
This drug has two hundred and twenty-nine patent family members in thirty-one countries.
The generic ingredient in AFINITOR is everolimus. There are twelve drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the everolimus profile page.
DrugPatentWatch® 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: | 229 |
US Patents: | 4 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 37 |
Clinical Trials: | 175 |
Patent Applications: | 4,445 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for AFINITOR |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AFINITOR |
What excipients (inactive ingredients) are in AFINITOR? | AFINITOR excipients list |
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 |
The Lilabean Foundation for Pediatric Brain Cancer Research | Phase 1 |
Pediatric Brain Tumor Foundation | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for AFINITOR
Paragraph IV (Patent) Challenges for AFINITOR
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
AFINITOR | Tablets | everolimus | 2.5 mg, 5 mg, and 7.5 mg | 022334 | 1 | 2014-12-10 |
AFINITOR | Tablets | everolimus | 10 mg | 022334 | 1 | 2014-06-18 |
US Patents and Regulatory Information for AFINITOR
AFINITOR is protected by one US patents and one FDA Regulatory Exclusivity.
Patents protecting AFINITOR
Neuroendocrine tumor treatment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PATIENTS WITH PROGESSIVE NEUROENDOCRINE TUMORS OF PANCREATIC ORIGIN (PNET) THAT ARE UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC
FDA Regulatory Exclusivity protecting AFINITOR
TREATMENT OF ADULT PATIENTS WITH PROGRESSIVE, WELL-DIFFERENTIATED, NON-FUNCTIONAL, NEUROENDOCRINE TUMORS (NET) OF GASTROINTESTINAL (GI) OR LUNG ORIGIN, (EXCLUDING PANCREATIC) WITH UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC DISEASE
Exclusivity Expiration: See Plans and Pricing
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 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
Novartis Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-003 | Aug 29, 2012 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-003 | Jul 9, 2010 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-002 | Mar 30, 2009 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
Novartis Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-002 | Aug 29, 2012 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
>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 | See Plans and Pricing | See Plans and Pricing |
Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-003 | Jul 9, 2010 | See Plans and Pricing | See Plans and Pricing |
Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-003 | Jul 9, 2010 | See Plans and Pricing | See Plans and Pricing |
Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-001 | Mar 30, 2009 | See Plans and Pricing | See Plans and Pricing |
Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-004 | Mar 30, 2012 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AFINITOR
See the table below for patents covering AFINITOR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hong Kong | 1198946 | See Plans and Pricing | |
Japan | 2014177469 | CANCER TREATMENT | See Plans and Pricing |
Poland | 191933 | See Plans and Pricing | |
United Kingdom | 0523658 | See Plans and Pricing | |
Lithuania | 3342411 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AFINITOR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3143995 | 122019000051 | Germany | See Plans and Pricing | 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 |
3143995 | PA2019511 | Lithuania | See Plans and Pricing | PRODUCT NAME: EVEROLIMUZAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/09/538/001, 003, 004, 006-010 20160526 |
0663916 | CA 2004 00020 | Denmark | See Plans and Pricing | PRODUCT NAME: EVEROLIMUS |
3351246 | 122019000102 | Germany | See Plans and Pricing | PRODUCT NAME: EVEROLIMUS; REGISTRATION NO/DATE: EU/1/09/538/001-008 20120723 |
2269603 | 300769 | Netherlands | See Plans and Pricing | PRODUCT NAME: EVEROLIMUS, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/09/001, 003, 004 EN 006-010 (C(2012)5347) 20120725 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |