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AFINITOR DISPERZ Drug Profile
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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 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. Five suppliers are listed 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 |
| Suppliers / Packagers: | 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 |
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 |
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 | 203985-001 | 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 | 203985-002 | 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 |
|---|---|---|
| Austria | 310519 | Start Trial |
| Cyprus | 1117164 | Start Trial |
| Canada | 2458455 | Start Trial |
| Portugal | 3342411 | Start Trial |
| Germany | 69322282 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for AFINITOR DISPERZ
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2269603 | 122015000094 | Germany | Start Trial | PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001 20120723 |
| 3342411 | 2020C/504 | Belgium | Start Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), FUSION |
| 0663916 | 04C0012 | France | Start Trial | PRODUCT NAME: EVEROLIMUS; NAT. REGISTRATION NO/DATE: NL 29433 20040415; FIRST REGISTRATION: SE - 18693 20030718 |
| 0663916 | SPC001/2010 | Ireland | Start Trial | SPC001/2010: 20101001, EXPIRES: 20180717 |
| 2269604 | 122016000094 | Germany | Start Trial | PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
