ZYDELIG Drug Patent Profile
✉ Email this page to a colleague
When do Zydelig patents expire, and when can generic versions of Zydelig launch?
Zydelig is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and eleven patent family members in forty countries.
The generic ingredient in ZYDELIG is idelalisib. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the idelalisib profile page.
DrugPatentWatch® 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.
There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
Summary for ZYDELIG
| International Patents: | 111 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 106 |
| Clinical Trials: | 13 |
| Patent Applications: | 1,009 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ZYDELIG |
| What excipients (inactive ingredients) are in ZYDELIG? | ZYDELIG excipients list |
| DailyMed Link: | ZYDELIG at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ZYDELIG
*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 ZYDELIG
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Loxo Oncology, Inc. | Phase 3 |
| Prospect Creek Foundation | Phase 1 |
| Oregon Health and Science University | Phase 1 |
Pharmacology for ZYDELIG
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Cytochrome P450 3A Inhibitors Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for ZYDELIG
Paragraph IV (Patent) Challenges for ZYDELIG
| 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 ZYDELIG
ZYDELIG is protected by nine US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZYDELIG is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting ZYDELIG
Polymorphic forms of (S)-2-(1-(9H-purin-6-ylamino)propyl)-5-fluoro-3-phenylquinazolin-4(3H)-on- e
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Polymorphic forms of (S)-2-(1-(9H-purin-6-ylamino)propyl)-5-fluoro-3-phenylquinazolin-4(3H)-on- e
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CLL, FL, OR SLL
5-fluoro-3-phenyl-2[1-(9H-purin-6-ylamino)propyl]-3H-quinazolin-4-one and 6-fluoro-3-phenyl-2-[1-(9H-purin-6-ylamino)ethyl]-3H-quinazolin-4-one as inhibitors of human phosphatidylinositol 3-kinase delta
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CLL, FL, OR SLL
5-fluoro-3-phenyl-2-[1-(9h-purin-6-ylamino)propyl]-3h-quinazolin-4-one as an inhibitor of human phosphatidylinositol 3-kinase delta
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: INHIBITION ON PI3K KINASE
Polymorphic forms of (S)-2-(1-(9H-purin-6-ylamino)propyl)-5-fluoro-3-phenylquinazolin-4(3H)-on- e
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Therapies for hematologic malignancies
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: IN COMBINATION WITH RITUXIMAB, FOR THE TREATMENT OF PATIENTS WITH RELAPSED CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
Quinazolinones as inhibitors of human phosphatidylinositol 3-kinase delta
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: FOR THE TREATMENT OF PATIENTS WITH RELAPSED FOLLICULAR B-CELL NON-HODGKIN LYMPHOMA OR [RELAPSED] SMALL LYMPHOCYTIC LYMPHOMA
Quinazolinones as inhibitors of human phosphatidylinositol 3-kinase delta
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CLL, FL, OR SLL
Quinazolinones as inhibitors of human phosphatidylinositol 3-kinase delta
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| 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 | Y | Y | ⤷ Sign Up | ||
| Gilead Sciences Inc | ZYDELIG | idelalisib | TABLET;ORAL | 205858-002 | Jul 23, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 | ||
| Gilead Sciences Inc | ZYDELIG | idelalisib | TABLET;ORAL | 205858-002 | Jul 23, 2014 | RX | Yes | Yes | ⤷ 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 |
Expired US Patents for ZYDELIG
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Gilead Sciences Inc | ZYDELIG | idelalisib | TABLET;ORAL | 205858-001 | 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 | 205858-001 | 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 ZYDELIG
| 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 ZYDELIG
When does loss-of-exclusivity occur for ZYDELIG?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 0253
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 13203620
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2014021935
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 64305
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 14002358
Estimated Expiration: ⤷ Sign Up
China
Patent: 4334560
Estimated Expiration: ⤷ Sign Up
Patent: 6146506
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 71131
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 140460
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 14020478
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 5407
Estimated Expiration: ⤷ Sign Up
Patent: 1491473
Estimated Expiration: ⤷ Sign Up
Patent: 1690461
Estimated Expiration: ⤷ Sign Up
Patent: 1691327
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 34241
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 06345
Estimated Expiration: ⤷ Sign Up
India
Patent: 05DEN2014
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 15509537
Estimated Expiration: ⤷ Sign Up
Patent: 16104823
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 14010656
Estimated Expiration: ⤷ Sign Up
Moldova, Republic of
Patent: 140100
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 379
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 9684
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 141792
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 014501920
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 34241
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 34241
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201405446P
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 34241
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1405870
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 140133590
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 48273
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 1350486
Estimated Expiration: ⤷ Sign Up
Uruguay
Patent: 656
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering ZYDELIG around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 5566701 | ⤷ Sign Up | |
| Costa Rica | 20140460 | FORMAS POLIMÓRFICAS DE (S)-2-(1-(9H-PURIN-6-ILAMINO)PROPIL)-5-FLUORO-3-FENILQUINAZOLIN-4(3H)-ONA | ⤷ Sign Up |
| Denmark | 1939203 | ⤷ Sign Up | |
| Australia | 2001255667 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ZYDELIG
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1761540 | 2017/006 | Ireland | ⤷ Sign Up | PRODUCT NAME: IDELALISIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/14/938 20140918 |
| 1761540 | 269 7-2017 | Slovakia | ⤷ Sign Up | PRODUCT NAME: IDELALISIB VO VSETKYCH FORMACH CHRANENYCH ZA- KLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/938 20140919 |
| 1761540 | C01761540/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: IDELALISIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65291 22.01.2015 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - HIPAA-ready chat for life sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
