ALPELISIB - Generic Drug Details
✉ Email this page to a colleague
What are the generic sources for alpelisib and what is the scope of freedom to operate?
Alpelisib
is the generic ingredient in two branded drugs marketed by Novartis and is included in three 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: | 3 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 73 |
Clinical Trials: | 66 |
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 |
---|---|
Novartis Pharmaceuticals | Phase 2/Phase 3 |
Dartmouth-Hitchcock Medical Center | Phase 2 |
University of Miami | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for ALPELISIB
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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Novartis | VIJOICE | alpelisib | TABLET;ORAL | 215039-003 | Apr 5, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Novartis | PIQRAY | alpelisib | TABLET;ORAL | 212526-003 | May 24, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Novartis | PIQRAY | alpelisib | TABLET;ORAL | 212526-003 | May 24, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Novartis | VIJOICE | alpelisib | TABLET;ORAL | 215039-003 | Apr 5, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Novartis | PIQRAY | alpelisib | TABLET;ORAL | 212526-001 | May 24, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
>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 |
---|---|---|---|
Eurasian Patent Organization | 018863 | ОРГАНИЧЕСКИЕ СОЕДИНЕНИЯ (ORGANIC COMPOUNDS) | ⤷ Sign Up |
Serbia | 54476 | DERIVATI 1-((5-HETEROARILTIAZOL-2-IL)AMINOKARBONIL)PIROLIDIN-2-KARBOKSAMIDA KAO INHIBITORI FOSFATIDILINOZITOL 3-KINAZE (PI3K) KORISNI U TRETMANU PROLIFERATIVNIH OBOLJENJA (1-((5-HETEROARYLTHIAZOL-2-YL)AMINOCARBONYL)PYRROLIDINE-2-CARBOXAMIDE DERIVATIVES AS PHOSPHATIDYLINOSITOL 3-KINASE (PI3K) INHIBITORS USEFUL IN THE TREATMENT OF PROLIFERATIVE DISEASES) | ⤷ Sign Up |
El Salvador | 2011003853 | COMPUESTOS ORGANICOS | ⤷ Sign Up |
Croatia | P20160014 | ⤷ Sign Up | |
Japan | 2012502080 | ⤷ Sign Up | |
Jordan | 3121 | مشتقات 1 - ((5-هيتيرورلثيازول-2-يل) أمينوكاربونيل) بيروليدين-2-كربوكساميد كمثبات الفوسفاتديلينوسيتول 3-كيناس (PI3K) مفيدة في علاج الأمراض التصاعدية (1-((5-HETEROARYLTHIAZOL-2-YL)AMINOCARBONYL)PYRROLIDINE-2-CARBOXAMIDE DERIVATIVES AS PHOSPHATIDYLINOSITOL 3-KINASE (PI3K) INHIBITORS USEFUL IN THE TREATMENT OF PROLIFERATIVE DISEASES) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ALPELISIB
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2331537 | 2020/048 | Ireland | ⤷ Sign Up | PRODUCT NAME: ALPELISIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/20/1455 20200728 |
2331537 | C202030063 | Spain | ⤷ Sign Up | 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 | LUC00186 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: ALPELISIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1455 20200728 |
2331537 | 301071 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ALPELISIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/20/1455 20200728 |
2331537 | C20200034 00362 | Estonia | ⤷ Sign Up | PRODUCT NAME: ALPELISIIB;REG NO/DATE: EU/1/20/1455 28.07.2020 |
2331537 | CR 2020 00054 | Denmark | ⤷ Sign Up | PRODUCT NAME: ALPELISIB ELLER ET FARMACEUTISK ACCEPTABELT SALT HERAF; NAT. REG. NO/DATE: EU/1/20/1455 20200728; FIRST REG. NO/DATE: CH 67359 20200324 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |