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EXKIVITY

NDA

MOBOCERTINIB SUCCINATE | N215310 | TAKEDA PHARMACEUTICALS USA INC

1 strength2 unique patents2 unique exclusivities

Patent Timeline

2 unique patents, 2 exclusivities by expiration date

Active (2)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

Today

9796712

May. 13, 2035

10227342

May. 13, 2035

NCE

Sep. 15, 2026

ODE-374

Sep. 15, 2028

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

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 Exkivity (2023)

Total Spending

$10.3M

Total Claims

449

Beneficiaries

120

Avg Cost/Unit

$228.46

Spending Trend

$1.2M(2021)→$9.4M(2022)→$10.3M(2023)

YoY Change:+6.4%

5yr CAGR:+3.3%

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Sep 18, 2023	SUPPL -3	View Letter (PDF)
Mar 3, 2023	SUPPL -2	View Letter (PDF)
Sep 17, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 40MG BASE

RLD

2 patents2 exclusivities▴

CAPSULE;ORAL | Approved: Sep 15, 2021

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9796712	May 13, 2035	—	Yes	Yes	—	—
10227342	May 13, 2035	—	Yes	Yes		—

Exclusivities (2)

Code	Date	Status
NCE	Sep 15, 2026	< 1 year
ODE-374	Sep 15, 2028	Active