Alpelisib - Generic Drug Details
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What are the generic drug 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 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
*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 | 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 | 215039-001 | Apr 5, 2022 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 |
|---|---|---|---|
| Tunisia | 2011000053 | ORGANIC COMPOUNDS | ⤷ Sign Up |
| Chile | 2011000504 | Compuestos derivados de piridin-4-il-tiazol-2il-amida 2-amida-pirrolidin-1,2-dicarboxilico, inhibidores de quinasa de fosfatidil-inositol-3; composicion farmaceutica que comprende a uno de los compuestos; y uso de los compuestos en la preparacion de un medicamento para el tratamiento del cancer. | ⤷ Sign Up |
| Portugal | 2331537 | ⤷ 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 | SPC/GB20/059 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ALPELISIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 67359 20200324; UK EU/1/20/1455(FOR NI) 20200728; UK FURTHER MA ON IPSUM 20200728 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
