Viewing data from:

ZYDELIG

NDA

IDELALISIB | N205858 | GILEAD SCIENCES INC

2 strengths4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents by expiration date

Active (4)Today

2027

2028

2029

2030

2031

2032

2033

2034

Today

Mar. 5, 2033

Sep. 2, 2033

Mar. 11, 2030

Mar. 5, 2033

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Gilead Sciences, Inc. et al v. Natco Pharma Limited 1:2022cv00852	D. Del.	2022-06-23	Terminated 2023-08-22	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

50 trials from ClinicalTrials.gov, 2 active, 20 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL NCT02970318	Phase 3	Active	Acerta Pharma BV	310	2017-02-02 → 2027-10-01
ACY-1215 in Combination With BCR Pathway Inhibitors in Relapsed CLL NCT02787369	Phase 1	Active	Dana-Farber Cancer Institute	3	2016-05 → 2027-04
Expanded Access for Idelalisib in Combination With Rituximab in Chronic Lymphocytic Leukemia NCT02136511	—	APPROVED_FOR_MARKETING	Gilead Sciences	—	—
Personalized Kinase Inhibitor Therapy Combined With Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia NCT02779283	Phase 1	Completed	OHSU Knight Cancer Institute	7	2016-01-13 → 2018-09-20
A Study of Idelalisib (GS1101, CAL101) + Ofatumumab in Previously Untreated CLL/SLL NCT02135133	Phase 2	Completed	Dana-Farber Cancer Institute	27	2014-06 → 2020-10-06
Safety and Efficacy of Idelalisib in Relapsed or Refractory Hodgkin Lymphoma NCT01393106	Phase 2	Completed	Gilead Sciences	25	2011-09 → 2014-08
Study to Evaluate Safety and Preliminary Efficacy of Tafasitamab With Idelalisib or Venetoclax in R/R CLL/SLL Patients Pretreated With BTKi NCT02639910	Phase 2	Completed	MorphoSys AG	24	2016-11 → 2021-12
Efficacy and Safety Study of Idelalisib in Participants With Indolent B-Cell Non-Hodgkin Lymphomas NCT01282424	Phase 2	Completed	Gilead Sciences	125	2011-03-18 → 2018-05-16
Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela )NCT01569295	Phase 3	Completed	Gilead Sciences	416	2012-06-15 → 2019-06-10
Efficacity of Idelalisib and Obinutuzumab in Patient With Relapsed Refractory Waldenstrom's Macroglobulinemia NCT02962401	Phase 2	Completed	French Innovative Leukemia Organisation	50	2017-03-07 → 2023-04-13

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$9492.71

Highest Price

$9492.71

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
61958-1701-01ZYDELIG 100MG TAB	$9492.71	FSS	Gilead Sciences, Inc.	09/29/2026
61958-1701-01ZYDELIG 100MG TAB	$9492.71	Big4	Gilead Sciences, Inc.	09/29/2026
61958-1702-01ZYDELIG 150MGTAB	$9492.71	FSS	Gilead Sciences, Inc.	09/29/2026
61958-1702-01ZYDELIG 150MGTAB	$9492.71	Big4	Gilead Sciences, Inc.	09/29/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Zydelig (2024)

Total Spending

$4.4M

Total Claims

325

Beneficiaries

Avg Cost/Unit

$226.93

Spending Trend

$37.5M(2019)→$25.6M(2020)→$20.3M(2021)→$15.1M(2022)→$8.1M(2023)→$4.4M(2024)

YoY Change:-3.7%

5yr CAGR:+3.7%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain2 active DMFs1 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

ZHEJIANG LEPU PHARMACEUTICAL CO LTDIDELALISIB NON-STERILE BULK DRUG SUBSTANCES

DMF 325192018

NATCO PHARMA LTDIDELALISIB

DMF 363712021

LUPIN LTDInactiveIDELALISIB

DMF 324342018

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

13 letters from Drugs@FDA

Date	Submission	Document
Jul 7, 2022	SUPPL -18	View Letter (PDF)
Mar 11, 2022	SUPPL -17	View Letter (PDF)
Feb 22, 2022	SUPPL -16	View Letter (PDF)
Oct 21, 2020	SUPPL -14	View Letter (PDF)
Jan 30, 2019	SUPPL -13	View Letter (PDF)
Mar 28, 2018	SUPPL -12	View Letter (PDF)
Feb 8, 2018	SUPPL -10	View Letter (PDF)
Feb 8, 2018	SUPPL -11	View Letter (PDF)
Jan 30, 2018	SUPPL -9	View Letter (PDF)
Dec 1, 2017	SUPPL -7	View Letter (PDF)
Jan 5, 2017	SUPPL -5	View Letter (PDF)
Sep 22, 2016	SUPPL -4	View Letter (PDF)
Jul 24, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 100MG

RLDAB

4 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 23, 2014

Patents (4) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8865730	Mar 5, 2033	—	Yes	Yes		—
9469643	Sep 2, 2033	—	Yes	—	—	—
9492449	Mar 11, 2030	—	—	—		—
10730879	Mar 5, 2033	—	Yes	Yes	—	—

#002 — 150MG

RLDAB

4 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 23, 2014