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: | 64 |
Clinical Trials: | 59 |
Patent Applications: | 2,519 |
What excipients (inactive ingredients) are in alpelisib? | alpelisib excipients list |
DailyMed Link: | alpelisib at DailyMed |
Recent Clinical Trials for alpelisib
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Breast Cancer Research Foundation | Phase 2 |
Hoffmann-La Roche | Phase 3 |
Stemline Therapeutics, Inc. | Phase 1/Phase 2 |
US Patents and Regulatory Information for alpelisib
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 |
---|---|---|---|
Hungary | S2000044 | See Plans and Pricing | |
Hungary | E025884 | See Plans and Pricing | |
Ukraine | 104147 | ПРОИЗВОДНАЯ ПИРРОЛИДИНДИКАРБОНОВОЙ КИСЛОТЫ И ЕЕ ПРИМЕНЕНИЕ В ЛЕЧЕНИИ ПРОЛИФЕРАТИВНЫХ ЗАБОЛЕВАНИЙ;ПОХІДНА ПІРОЛІДИНДИКАРБОНОВОЇ КИСЛОТИ ТА ЇЇ ЗАСТОСУВАННЯ У ЛІКУВАННІ ПРОЛІФЕРАТИВНИХ ЗАХВОРЮВАНЬ (PYRROLIDINE DICARBOXYLIC ACID DERIVATIVE AND USE THEREOF IN THE TREATMENT OF PROLIFERATIVE DISEASES) | See Plans and Pricing |
Tunisia | 2011000053 | ORGANIC COMPOUNDS | See Plans and Pricing |
South Korea | 101290844 | See Plans and Pricing | |
Croatia | P20160014 | See Plans and Pricing | |
South Korea | 20110038737 | ORGANIC COMPOUNDS | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for alpelisib
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2331537 | 132020000000155 | Italy | See Plans and Pricing | PRODUCT NAME: ALPELISIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE.(PIQRAY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1455, 20200728 |
2331537 | PA2020534 | Lithuania | See Plans and Pricing | PRODUCT NAME: ALPELISIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1455 20200727 |
2331537 | 20C1055 | France | See Plans and Pricing | EPRODUCT NAME: ALPELISIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, REGISTRATION NO/DATE: EU/1/20/1455 20200728 |
2331537 | 2090050-2 | Sweden | See Plans and Pricing | PRODUCT NAME: ALPELISIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/20/1455 20200728 |
2331537 | LUC00186 | Luxembourg | See Plans and Pricing | PRODUCT NAME: ALPELISIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1455 20200728 |
2331537 | C202030063 | Spain | See Plans and Pricing | PRODUCT NAME: ALPELISIP O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/20/1455; DATE OF AUTHORISATION: 20200727; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1455; DATE OF FIRST AUTHORISATION IN EEA: 20200727 |
2331537 | C20200034 00362 | Estonia | See Plans and Pricing | PRODUCT NAME: ALPELISIIB;REG NO/DATE: EU/1/20/1455 28.07.2020 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |