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Last Updated: June 7, 2020

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ZYDELIG Drug Profile


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US ANDA Litigation and Generic Entry Outlook for Zydelig

Zydelig was eligible for patent challenges on July 23, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 2, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Drug patent expirations by year for ZYDELIG
Drug Prices for ZYDELIG

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Generic Entry Opportunity Date for ZYDELIG
Generic Entry Date for ZYDELIG*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Pharmacology for ZYDELIG

US Patents and Regulatory Information for ZYDELIG

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 205858-002 Jul 23, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-002 Jul 23, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-001 Jul 23, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-002 Jul 23, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ZYDELIG

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1761540 122017000008 Germany   Start Trial PRODUCT NAME: LDELALISIB ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/938 20140918
1761540 300867 Netherlands   Start Trial PRODUCT NAME: IDELALISIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/14/938 20140919
1761540 C01761540/01 Switzerland   Start Trial PRODUCT NAME: IDELALISIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65291 22.01.2015
1761540 1790006-9 Sweden   Start Trial PRODUCT NAME: IDELALISIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/14/938 20140919
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Merck
Boehringer Ingelheim
Colorcon
McKinsey
Dow

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.