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 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: | 60 |
| 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 |
| The Methodist Hospital Research Institute | 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 | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
| Novartis | PIQRAY | alpelisib | TABLET;ORAL | 212526-001 | May 24, 2019 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
| Novartis | VIJOICE | alpelisib | TABLET;ORAL | 215039-001 | Apr 5, 2022 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
| Novartis | VIJOICE | alpelisib | TABLET;ORAL | 215039-003 | Apr 5, 2022 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Novartis | PIQRAY | alpelisib | TABLET;ORAL | 212526-003 | May 24, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
| Novartis | VIJOICE | alpelisib | TABLET;ORAL | 215039-002 | Apr 5, 2022 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
| >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 |
|---|---|---|---|
| Japan | 5486601 | 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 |
| San Marino | AP201100019 | Composti organici. | See Plans and Pricing |
| World Intellectual Property Organization (WIPO) | 2010029082 | See Plans and Pricing | |
| Croatia | P20160014 | See Plans and Pricing | |
| Taiwan | I453206 | 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 | 122020000073 | Germany | See Plans and Pricing | PRODUCT NAME: ALPELISIB ODER EIN PHARMAZEUTISCH ZULAESSIGES SALZ DAVON; NAT. REGISTRATION NO/DATE: EU/1/20/1455 20200727; FIRST REGISTRATION: SCHWEIZ 67359 20200324 |
| 2331537 | 301071 | Netherlands | See Plans and Pricing | PRODUCT NAME: ALPELISIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/20/1455 20200728 |
| 2331537 | 2020/048 | Ireland | See Plans and Pricing | PRODUCT NAME: ALPELISIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/20/1455 20200728 |
| 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 | 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 | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
