Viewing data from:

IDHIFA

NDA

ENASIDENIB MESYLATE | N209606 | BRISTOL MYERS SQUIBB

2 strengths6 unique patents0 unique exclusivities

Patent Timeline

6 unique patents by expiration date

Active (6)TodayIPRPTAB Challenge

2027

2028

2029

2030

2031

2032

2033

2034

2035

Today

Jan. 7, 2033

Sep. 16, 2034

Aug. 1, 2034

Aug. 1, 2034

Jan. 7, 2033

Jun. 21, 2030IPR

PTAB Proceedings

1 challenge on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2022-01423	10610125	IPR	Rigel Pharmaceuticals, Inc.	Terminated-Settled	2022-08-15	2023-01-06

Patent Reexaminations

1 reexamination on OB patents from USPTO Patent Center

90/015,127Ex ParteDenied

Patent: 10610125Filed: 2022-09-23

METHODS AND COMPOSITIONS FOR CELL-PROLIFERATION-RELATED DISORDERS

Recent Events

2022-09-26RXLITSRLitigation Search Conducted

Source: USPTO Patent Center. Ex parte and inter partes reexamination proceedings.

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Idhifa (2023)

Total Spending

$118.9M

Total Claims

3,608

Beneficiaries

813

Avg Cost/Unit

$1086.10

Spending Trend

$57.6M(2019)→$75.2M(2020)→$78.8M(2021)→$93.7M(2022)→$118.9M(2023)

YoY Change:+7.1%

5yr CAGR:+5.4%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Jan 17, 2025	SUPPL -7	View Letter (PDF)
Dec 22, 2023	SUPPL -6	View Letter (PDF)
Jul 27, 2021	SUPPL -5	View Letter (PDF)
Nov 27, 2020	SUPPL -4	View Letter (PDF)
Sep 30, 2019	SUPPL -2	View Letter (PDF)
Aug 2, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 50MG BASE

RLD

6 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 1, 2017

Patents (6)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9512107	Jan 7, 2033	—	Yes	Yes		—
9732062	Sep 16, 2034	—	Yes	—	—	—
9738625	Aug 1, 2034	—	Yes	—	—	—
10093654	Aug 1, 2034	—	Yes	Yes		—
10294215	Jan 7, 2033	—	—	Yes		—
10610125	Jun 21, 2030	—	—	—		—

#002 — EQ 100MG BASE

RLD

6 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 1, 2017