IDELALISIB - Generic Drug Details
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What are the generic drug sources for idelalisib and what is the scope of freedom to operate?
Idelalisib
is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Idelalisib has one hundred and eleven patent family members in forty countries.
There are two drug master file entries for idelalisib. One supplier is listed for this compound.
Summary for IDELALISIB
International Patents: | 111 |
US Patents: | 8 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 106 |
Clinical Trials: | 61 |
Patent Applications: | 2,356 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in IDELALISIB? | IDELALISIB excipients list |
DailyMed Link: | IDELALISIB at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for IDELALISIB
Generic Entry Date for IDELALISIB*:
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 IDELALISIB
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Oslo University Hospital | Phase 2 |
ADC Therapeutics S.A. | Phase 2 |
Loxo Oncology, Inc. | Phase 3 |
Pharmacology for IDELALISIB
Drug Class | Kinase Inhibitor |
Mechanism of Action | Cytochrome P450 3A Inhibitors Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for IDELALISIB
Paragraph IV (Patent) Challenges for IDELALISIB
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ZYDELIG | Tablets | idelalisib | 100 mg and 150 mg | 205858 | 1 | 2022-03-23 |
US Patents and Regulatory Information for IDELALISIB
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Gilead Sciences Inc | ZYDELIG | idelalisib | TABLET;ORAL | 205858-001 | Jul 23, 2014 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Gilead Sciences Inc | ZYDELIG | idelalisib | TABLET;ORAL | 205858-001 | Jul 23, 2014 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Gilead Sciences Inc | ZYDELIG | idelalisib | TABLET;ORAL | 205858-002 | Jul 23, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Gilead Sciences Inc | ZYDELIG | idelalisib | TABLET;ORAL | 205858-002 | Jul 23, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Gilead Sciences Inc | ZYDELIG | idelalisib | TABLET;ORAL | 205858-001 | Jul 23, 2014 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Gilead Sciences Inc | ZYDELIG | idelalisib | TABLET;ORAL | 205858-001 | Jul 23, 2014 | 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 |
Expired US Patents for IDELALISIB
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Gilead Sciences Inc | ZYDELIG | idelalisib | TABLET;ORAL | 205858-002 | Jul 23, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Gilead Sciences Inc | ZYDELIG | idelalisib | TABLET;ORAL | 205858-002 | Jul 23, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Gilead Sciences Inc | ZYDELIG | idelalisib | TABLET;ORAL | 205858-001 | Jul 23, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Gilead Sciences Inc | ZYDELIG | idelalisib | TABLET;ORAL | 205858-002 | Jul 23, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Gilead Sciences Inc | ZYDELIG | idelalisib | TABLET;ORAL | 205858-001 | Jul 23, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Gilead Sciences Inc | ZYDELIG | idelalisib | TABLET;ORAL | 205858-002 | Jul 23, 2014 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for IDELALISIB
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Gilead Sciences Ireland UC | Zydelig | idelalisib | EMEA/H/C/003843 Zydelig is indicated in combination with an anti‑CD20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL):who have received at least one prior therapy, oras first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies.Zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment. |
Authorised | no | no | no | 2014-09-18 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for IDELALISIB
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Lithuania | 2612862 | ⤷ Sign Up | |
Australia | 2009313878 | Therapies for hematologic malignancies | ⤷ Sign Up |
Slovenia | 2612862 | ⤷ Sign Up | |
Japan | 2007537291 | ⤷ Sign Up | |
Singapore | 11201405446P | POLYMORPHIC FORMS OF (S)-2-(1-(9H-PURIN-6-YLAMINO)PROPYL)-5-FLUORO-3-PHENYLQUINAZOLIN-4(3H)-ONE | ⤷ Sign Up |
Australia | 2009230739 | Quinazolinones as Inhibitors of Human Phosphatidylinositol 3-Kinase Delta | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for IDELALISIB
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1761540 | 132017000031007 | Italy | ⤷ Sign Up | PRODUCT NAME: IDELALISIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ZYDELIG); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/938, 20140919 |
1761540 | 1790006-9 | Sweden | ⤷ Sign Up | PRODUCT NAME: IDELALISIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/14/938 20140919 |
1761540 | 300867 | Netherlands | ⤷ Sign Up | PRODUCT NAME: IDELALISIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/14/938 20140919 |
1761540 | SPC/GB17/024 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: IDELALISIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/14/938/001-002 20140919; UK PLGB 11972/0031 20140919; UK PLGB 11972/0032 20140919 |
1761540 | 2017/006 | Ireland | ⤷ Sign Up | PRODUCT NAME: IDELALISIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/14/938 20140918 |
1761540 | 122017000008 | Germany | ⤷ Sign Up | PRODUCT NAME: LDELALISIB ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/938 20140918 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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