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AFINITOR DISPERZ Drug Profile
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Which patents cover Afinitor Disperz, 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 forty-nine 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. Additional details are available on the everolimus profile page.
US ANDA Litigation and Generic Entry Outlook for Afinitor Disperz
A generic version of AFINITOR DISPERZ was approved as everolimus by HIKMA on April 12th, 2018.
Summary for AFINITOR DISPERZ
| International Patents: | 349 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 34 |
| Clinical Trials: | 1 |
| Patent Applications: | 4,188 |
| 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 Clinical Trials for AFINITOR DISPERZ
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Merck Sharp & Dohme Corp. | Phase 3 |
Paragraph IV (Patent) Challenges for AFINITOR DISPERZ
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| AFINITOR DISPERZ | TABLET, FOR SUSPENSION;ORAL | everolimus | 203985 | 2016-12-30 |
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 | 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 | 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 Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-001 | Aug 29, 2012 | RX | Yes | No | Start Trial | Start Trial | Y | 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 | ||||
| >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 | 203985-002 | Aug 29, 2012 | Start Trial | Start Trial |
| Novartis Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-001 | Aug 29, 2012 | Start Trial | Start Trial |
| Novartis Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-002 | Aug 29, 2012 | Start Trial | Start Trial |
| Novartis Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-003 | Aug 29, 2012 | Start Trial | Start Trial |
| Novartis Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-003 | Aug 29, 2012 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AFINITOR DISPERZ
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | H11509223 | Start Trial |
| Canada | 2458455 | Start Trial |
| Mexico | 368013 | Start Trial |
| Slovenia | 1281400 | Start Trial |
| Slovenia | 1432408 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for AFINITOR DISPERZ
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
