DrugPatentWatch Database Preview
Everolimus - Generic Drug Details
» See Plans and Pricing
What are the generic drug sources for everolimus and what is the scope of patent protection?
Everolimus
is the generic ingredient in four branded drugs marketed by Novartis Pharm, Mylan, Novartis, Hikma, Par Pharm, and Teva Pharms Usa, and is included in nine NDAs. There are seven patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Everolimus has three hundred and ninety-seven patent family members in forty-eight countries.
There are twelve drug master file entries for everolimus. There is one tentative approval for this compound.
Summary for everolimus
International Patents: | 397 |
US Patents: | 7 |
Tradenames: | 4 |
Applicants: | 6 |
NDAs: | 9 |
Drug Master File Entries: | 12 |
Bulk Api Vendors: | 34 |
Clinical Trials: | 720 |
Patent Applications: | 5,697 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for everolimus |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for everolimus |
DailyMed Link: | everolimus at DailyMed |
Recent Clinical Trials for everolimus
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Fondazione per la Medicina Personalizzata | Phase 2 |
National Cancer Institute, France | Phase 2 |
King Chulalongkorn Memorial Hospital | N/A |
Generic filers with tentative approvals for EVEROLIMUS
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 7.5MG | TABLET;ORAL |
Start Trial | Start Trial | 5MG | TABLET;ORAL |
Start Trial | Start Trial | 2.5MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Medical Subject Heading (MeSH) Categories for everolimus
Paragraph IV (Patent) Challenges for EVEROLIMUS
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
AFINITOR DISPERZ | TABLET, FOR SUSPENSION;ORAL | everolimus | 203985 | 2016-12-30 |
AFINITOR | TABLET;ORAL | everolimus | 022334 | 2014-12-10 |
AFINITOR | TABLET;ORAL | everolimus | 022334 | 2014-06-18 |
ZORTRESS | TABLET;ORAL | everolimus | 021560 | 2013-09-30 |
US Patents and Regulatory Information for everolimus
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan | EVEROLIMUS | everolimus | TABLET, FOR SUSPENSION;ORAL | 210130-001 | Apr 19, 2019 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-003 | Jul 9, 2010 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
Novartis Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-002 | Aug 29, 2012 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-003 | Jul 9, 2010 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
Hikma | EVEROLIMUS | everolimus | TABLET;ORAL | 207486-002 | Jun 8, 2020 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Mylan | EVEROLIMUS | everolimus | TABLET;ORAL | 212936-001 | Jun 8, 2020 | AB | RX | No | No | Start Trial | Start Trial | 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 everolimus
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | ZORTRESS | everolimus | TABLET;ORAL | 021560-003 | Apr 20, 2010 | Start Trial | Start Trial |
Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-001 | Mar 30, 2009 | Start Trial | Start Trial |
Novartis | ZORTRESS | everolimus | TABLET;ORAL | 021560-001 | Apr 20, 2010 | Start Trial | Start Trial |
Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-002 | Mar 30, 2009 | Start Trial | Start Trial |
Novartis | ZORTRESS | everolimus | TABLET;ORAL | 021560-001 | Apr 20, 2010 | Start Trial | Start Trial |
Novartis Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-002 | Aug 29, 2012 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for everolimus
Country | Patent Number | Estimated Expiration |
---|---|---|
Italy | 1319701 | Start Trial |
Israel | 202155 | Start Trial |
United Kingdom | 0601082 | Start Trial |
Cyprus | 1117164 | Start Trial |
Norway | 20121113 | Start Trial |
Hong Kong | 1141239 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for everolimus
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2269604 | PA2016035 | Lithuania | Start Trial | PRODUCT NAME: EVEROLIMUZAS; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803 |
3143995 | 2019C/528 | Belgium | Start Trial | 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 |
0663916 | 2010/001 | Ireland | Start Trial | PRODUCT NAME: EVEROLIMUS; NAT REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803; FIRST REGISTRATION NO/DATE: 18960 018691 18962 18693 18694 18695. 20030718 |
2269604 | 93320 | Luxembourg | Start Trial | PRODUCT NAME: EVEROLIMUS OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/09/538-001-006 - AFINITOR - EVEROLIMUS |
0663916 | C300154 | Netherlands | Start Trial | PRODUCT NAME: EVEROLIMUSUM; NAT. REGISTRATION NO/DATE: RVG 30041RVG 30042RVG 30043RVG 30044RVG 30045RVG 30046 2004100610; FIRST REGISTRATION: 186901869118692186931869418695 2003180718 |
3143995 | LUC00122 | Luxembourg | Start Trial | PRODUCT NAME: EVEROLIMUS OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/09/538/001, 003, 004, 006-010 20160530 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |