AFINITOR DISPERZ Drug Patent 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 two patents protecting this drug and one Paragraph IV challenge.
This drug has two hundred and twenty-nine patent family members in thirty-five countries.
The generic ingredient in AFINITOR DISPERZ is everolimus. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the everolimus profile page.
DrugPatentWatch® 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: | 229 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 41 |
Clinical Trials: | 1 |
Patent Applications: | 3,805 |
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 | Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors mTOR Inhibitors |
Physiological Effect | Decreased Immunologic Activity |
Anatomical Therapeutic Chemical (ATC) Classes for AFINITOR DISPERZ
Paragraph IV (Patent) Challenges for AFINITOR DISPERZ
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
AFINITOR DISPERZ | Tablets for Oral Suspension | everolimus | 2 mg, 3 mg and 5 mg | 203985 | 1 | 2016-12-30 |
US Patents and Regulatory Information for AFINITOR DISPERZ
AFINITOR DISPERZ is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting AFINITOR DISPERZ
FOR THE ADJUNCTIVE TREATMENT OF ADULT AND PEDIATRIC PATIENTS AGED 2 YEARS AND OLDER WITH TUBEROUS SCLEROSIS COMPLEX (TSC)-ASSOCIATED PARTIAL-ONSET SEIZURES
Exclusivity Expiration: ⤷ Try a Trial
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 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Novartis Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-003 | Aug 29, 2012 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Novartis Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-002 | Aug 29, 2012 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Novartis Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-003 | Aug 29, 2012 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Novartis Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-001 | Aug 29, 2012 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Novartis Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-001 | Aug 29, 2012 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Novartis Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-002 | Aug 29, 2012 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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
EU/EMA Drug Approvals for AFINITOR DISPERZ
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Novartis Europharm Limited | Afinitor | everolimus | EMEA/H/C/001038 Hormone-receptor-positive advanced breast cancerAfinitor is indicated for the treatment of hormone-receptor-positive, HER2/neu-negative advanced breast cancer, in combination with exemestane, in post-menopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.Neuroendocrine tumours of pancreatic originAfinitor is indicated for the treatment of unresectable or metastatic, well or moderately differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease.Neuroendocrine tumours of gastrointestinal or lung originAfinitor is indicated for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease.Renal-cell carcinomaAfinitor is indicated for the treatment of patients with advanced renal-cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy. |
Authorised | no | no | no | 2009-08-02 | |
Novartis Europharm Limited | Votubia | everolimus | EMEA/H/C/002311 Renal angiomyolipoma associated with tuberous sclerosis complex (TSC), , Votubia is indicated for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumour size or presence of aneurysm, or presence of multiple or bilateral tumours) but who do not require immediate surgery., , The evidence is based on analysis of change in sum of angiomyolipoma volume., , Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC), , Votubia is indicated for the treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not amenable to surgery., , The evidence is based on analysis of change in SEGA volume. Further clinical benefit, such as improvement in disease‑related symptoms, has not been demonstrated., |
Authorised | no | no | yes | 2011-09-02 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for AFINITOR DISPERZ
See the table below for patents covering AFINITOR DISPERZ around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 0839028 | DISPERSIONS SOLIDES DE RAPAMYCINE (SOLID DISPERSIONS OF RAPAMYCIN) | ⤷ Try a Trial |
Lithuania | PA2019521 | ⤷ Try a Trial | |
Japan | 5522901 | ⤷ Try a Trial | |
Austria | 310519 | ⤷ Try a Trial | |
Japan | 2018168188 | 癌の処置 (CANCER TREATMENT) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 03028705 | ⤷ Try a Trial | |
Poland | 324502 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AFINITOR DISPERZ
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0663916 | C300154 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: EVEROLIMUSUM; NAT. REGISTRATION NO/DATE: RVG 30041RVG 30042RVG 30043RVG 30044RVG 30045RVG 30046 2004100610; FIRST REGISTRATION: 186901869118692186931869418695 2003180718 |
2269604 | PA2016035 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: EVEROLIMUZAS; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803 |
3143995 | 34/2019 | Austria | ⤷ Try a Trial | PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538 IDF DER ENTSCHEIDUNG DER KOMMISSION C (2016) 3286 (MITTEILUNG) 20160530 |
2269603 | 300769 | Netherlands | ⤷ Try a Trial | 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 |
3143995 | 300992 | Netherlands | ⤷ Try a Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE |
0663916 | CA 2004 00020 | Denmark | ⤷ Try a Trial | PRODUCT NAME: EVEROLIMUS |
3143995 | PA2019511 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: EVEROLIMUZAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/09/538/001, 003, 004, 006-010 20160526 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |