Alpelisib - Generic Drug Details
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What are the generic sources for alpelisib and what is the scope of patent protection?
Alpelisib
is the generic ingredient in two branded drugs marketed by Novartis and is included in two NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Alpelisib has fifty-eight patent family members in forty-eight countries.
One supplier is listed for this compound.
Summary for alpelisib
International Patents: | 58 |
US Patents: | 2 |
Tradenames: | 2 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 73 |
Clinical Trials: | 63 |
Patent Applications: | 2,670 |
What excipients (inactive ingredients) are in alpelisib? | alpelisib excipients list |
DailyMed Link: | alpelisib at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for alpelisib
Generic Entry Dates for alpelisib*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
Generic Entry Dates for alpelisib*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for alpelisib
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Miami | Phase 2 |
Columbia University | Phase 1 |
Breast Cancer Research Foundation | Phase 2 |
US Patents and Regulatory Information for alpelisib
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | VIJOICE | alpelisib | TABLET;ORAL | 215039-003 | Apr 5, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Novartis | PIQRAY | alpelisib | TABLET;ORAL | 212526-002 | May 24, 2019 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Novartis | VIJOICE | alpelisib | TABLET;ORAL | 215039-003 | Apr 5, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Novartis | PIQRAY | alpelisib | TABLET;ORAL | 212526-001 | May 24, 2019 | 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 |
EU/EMA Drug Approvals for alpelisib
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Novartis Europharm Limited | Piqray | alpelisib | EMEA/H/C/004804 Piqray is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy (see section 5.1). |
Authorised | no | no | no | 2020-07-27 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for alpelisib
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Honduras | 2011000699 | EL COMPUESTO (S)-1-({4-METIL-5-[2-(2,2,2-TRIFLUORO-1,1-DIMETIL-ETIL)-PIRIDIN-4-IL]-TIAZOL-2-IL}-AMIDA) DE 2-AMIDA DEL ACIDO PIRROLIDIN-1,2-DICARBOXILICO EN FORMA LIBRE O DE SAL Y COMPOSICIONES Y COMPOSICION FARMACEUTICA QUE LO CONTIENE. | ⤷ Try a Trial |
Peru | 20110796 | (S)-1-({4-METIL-5-[2-(2,2,2-TRIFLUORO-1,1-DIMETIL-ETIL)-PIRIDIN-4-IL]-TIAZOL-2-IL}-AMIDA) DE 2-AMIDA DEL ACIDO PIRROLIDIN-1,2-DICARBOXILICO COMO INHIBIDOR DE LA CINASA DE FOSFATIDILINOSITOL (PI3K) | ⤷ Try a Trial |
Georgia, Republic of | P20135991 | 2-CARBOXAMIDE-PYRROLIDINE-AMIDE UREA DERIVATIVES SUBSTITUTED WITH PYRIMIDINE-4-YL, AND USAGE THEREAT TREATMENT OF DISEASES CAUSED BY PHOSPHATIDYL INOSITOL 3-KINASE | ⤷ Try a Trial |
Denmark | 2331537 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for alpelisib
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2331537 | 2020C/547 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ALPELISIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1455 20200728 |
2331537 | LUC00186 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: ALPELISIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1455 20200728 |
2331537 | 301071 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ALPELISIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/20/1455 20200728 |
2331537 | PA2020534 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ALPELISIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1455 20200727 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |