Zydelig is a drug owned by Gilead Sciences Inc. It is protected by 13 US drug patents filed from 2014 to 2020. Out of these, 8 drug patents are active and 5 have expired. Zydelig's patents have been open to challenges since 23 July, 2018. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 02, 2033. Details of Zydelig's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US9469643 | Polymorphic forms of (S)-2-(1-(9H-purin-6-ylamino)propyl)-5-fluoro-3-phenylquinazolin-4(3H)-one |
Sep, 2033
(8 years from now) | Active |
| US8865730 | Polymorphic forms of (S)-2-(1-(9H-purin-6-ylamino)propyl)-5-fluoro-3-phenylquinazolin-4(3H)-one |
Mar, 2033
(8 years from now) | Active |
| US10730879 | Polymorphic forms of (S)-2-(1-(9H-purin-6-ylamino)propyl)-5-fluoro-3-phenylquinazolin-4(3H)-one |
Mar, 2033
(8 years from now) | Active |
| USRE44638 | Quinazolinones as inhibitors of human phosphatidylinositol 3-kinase delta |
Aug, 2025
(8 months from now) | Active |
| US8637533 | Inhibitors of human phosphatidylinositol 3-kinase delta |
Apr, 2021
(3 years ago) |
Expired
|
| US8138195 | Inhibitors of human phosphatidylinositol 3-kinase delta |
Apr, 2021
(3 years ago) |
Expired
|
| US6949535 | Inhibitors of human phosphatidyl-inositol 3-kinase delta |
Apr, 2021
(3 years ago) |
Expired
|
| US8492389 | Inhibitors of human phosphatidylinositol 3-kinase delta |
Apr, 2021
(3 years ago) |
Expired
|
| US6800620 | Inhibitors of human phosphatidylinositol 3-kinase delta |
Apr, 2021
(3 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9492449 | Therapies for hematologic malignancies |
Mar, 2030
(5 years from now) | Active |
| USRE44599 | Quinazolinones as inhibitors of human phosphatidylinositol 3-kinase delta |
Jul, 2025
(7 months from now) | Active |
| US8980901 | 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 |
May, 2025
(5 months from now) | Active |
| US9149477 | 5-fluoro-3-phenyl-2-[1-(9h-purin-6-ylamino)propyl]-3h-quinazolin-4-one as an inhibitor of human phosphatidylinositol 3-kinase delta |
May, 2025
(5 months from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Zydelig's patents.
Latest Legal Activities on Zydelig's Patents
Given below is the list of recent legal activities going on the following patents of Zydelig.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 01 May, 2024 | US9492449 |
| Expire Patent Critical | 22 Apr, 2024 | US8138195 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 03 Apr, 2024 | US9469643 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 17 Jan, 2024 | US10730879 |
| Maintenance Fee Reminder Mailed Critical | 06 Nov, 2023 | US8138195 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Mar, 2023 | US9149477 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 31 Aug, 2022 | US8980901 |
| Correspondence Address Change Critical | 26 Apr, 2022 | US10730879 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 06 Apr, 2022 | US8865730 |
| Expire Patent Critical | 07 Mar, 2022 | US8637533 |
FDA has granted several exclusivities to Zydelig. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zydelig, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Zydelig.
Exclusivity Information
Zydelig holds 4 exclusivities. All of its exclusivities have expired in 2021. Details of Zydelig's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 23, 2019 |
| Orphan Drug Exclusivity(ODE) | Jul 23, 2021 |
| Orphan Drug Exclusivity(ODE-70) | Jul 23, 2021 |
| Orphan Drug Exclusivity(ODE-71) | Jul 23, 2021 |
Several oppositions have been filed on Zydelig's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Zydelig's generic, the next section provides detailed information on ongoing and past EP oppositions related to Zydelig patents.
Zydelig's Oppositions Filed in EPO
Zydelig has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jun 28, 2017, by Stada Arzneimittel Ag. This opposition was filed on patent number EP05752122A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP05752122A | Jun, 2017 | STADA Arzneimittel AG | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Zydelig is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Zydelig's family patents as well as insights into ongoing legal events on those patents.
Zydelig's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zydelig's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 02, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zydelig Generics:
There are no approved generic versions for Zydelig as of now.
How can I launch a generic of Zydelig before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Zydelig's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Zydelig's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Zydelig -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 100 mg and 150 mg | 23 Mar, 2022 | 1 | 02 Sep, 2033 |
About Zydelig
Zydelig is a drug owned by Gilead Sciences Inc. It is used for disrupting leukocyte function, specifically for the treatment of CLL, FL, or SLL, and in combination with rituximab. Zydelig uses Idelalisib as an active ingredient. Zydelig was launched by Gilead Sciences Inc in 2014.
Approval Date:
Zydelig was approved by FDA for market use on 23 July, 2014.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Zydelig is 23 July, 2014, its NCE-1 date is estimated to be 23 July, 2018.
Active Ingredient:
Zydelig uses Idelalisib as the active ingredient. Check out other Drugs and Companies using Idelalisib ingredient
Treatment:
Zydelig is used for disrupting leukocyte function, specifically for the treatment of CLL, FL, or SLL, and in combination with rituximab.
Dosage:
Zydelig is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 150MG | TABLET | Prescription | ORAL |
| 100MG | TABLET | Prescription | ORAL |