ALPELISIB - Generic Drug Details
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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
*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 | 215039-002 | Apr 5, 2022 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Novartis | PIQRAY | alpelisib | TABLET;ORAL | 212526-002 | May 24, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Novartis | VIJOICE | alpelisib | GRANULES;ORAL | 218466-001 | Apr 24, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Novartis | PIQRAY | alpelisib | TABLET;ORAL | 212526-002 | 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 |
|---|---|---|---|
| Denmark | 2331537 | ⤷ Sign Up | |
| Malaysia | 151556 | ORGANIC COMPOUNDS | ⤷ Sign Up |
| 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. | ⤷ Sign Up |
| Uruguay | 32096 | DERIVADOS DE 2-CARBOXAMIDA - CICLOAMINO - UREA ESPECÌFICOS, SUS SALES FARMACÈUTICAMENTE ACEPTABLES, COMPOSICIONES CONTENIÈNDOLOS, PRO-FARMACOS DE LOS MISMOS, PROCESOS PARA SU PRODUCIÒN Y APLICACIONES | ⤷ 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 | 122020000073 | Germany | ⤷ Sign Up | PRODUCT NAME: ALPELISIB ODER EIN PHARMAZEUTISCH ZULAESSIGES SALZ DAVON; NAT. REGISTRATION NO/DATE: EU/1/20/1455 20200727; FIRST REGISTRATION: SCHWEIZ 67359 20200324 |
| 2331537 | C02331537/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: ALPELISIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67359 24.03.2020 |
| 2331537 | 132020000000155 | Italy | ⤷ Sign Up | PRODUCT NAME: ALPELISIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE.(PIQRAY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1455, 20200728 |
| 2331537 | 2020037 | Norway | ⤷ Sign Up | PRODUCT NAME: ALPELISIB ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV; REG. NO/DATE: EU/1/20/1455 20200810 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
