Viewing data from:

DOPTELET

NDA

AVATROMBOPAG MALEATE | N210238 | AKARX INC

1 strength1 unique patent3 unique exclusivities

Patent Timeline

1 unique patent, 3 exclusivities by expiration date

Active (1)TodayExclusivity

2027

2028

2029

2030

2031

2032

Today

7638536

Jul. 28, 2027

ODE-246

Jun. 26, 2026

I-974

Jul. 24, 2028

ODE-548

Jul. 24, 2032

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 Doptelet (2023)

Total Spending

$96.0M

Total Claims

7,220

Beneficiaries

1,609

Avg Cost/Unit

$406.25

Spending Trend

$8.2M(2019)→$18.9M(2020)→$34.7M(2021)→$60.6M(2022)→$96.0M(2023)

YoY Change:+8.6%

5yr CAGR:-4.3%

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

API Supply Chain9 active DMFs

8 active API suppliers hold Drug Master Files for this ingredient.

APICHEM LABORATORIES PRIVATE LTDAVATROMBOPAG MALEATE

DMF 357842021

REYOUNG CORPORATIONAVATROMBOPAG MALEATE

DMF 384912023

STHREE CHEMICALS PRIVATE LTDAVATROMBOPAG MALEATE

DMF 406972024

BIOPHORE INDIA PHARMACEUTICALS PVT LTDAVATROMBOPAG MALEATE

DMF 410152024

ZHEJIANG AUSUN PHARMACEUTICAL CO LTDAVATROMBOPAG MALEATE POLYMORPHIC FORM B

DMF 418032025

GRANULES INDIA LTDAVATROMBOPAG MALEATE

DMF 418722025

ZHEJIANG AUSUN PHARMACEUTICAL CO LTDAVATROMBOPAG MALEATE POLYMORPHIC FORM C

DMF 419212025

HONOUR LAB LTDAVATROMBOPAG MALEATE

DMF 430912025

MATRIX PHARMACORP PRIVATE LTDAVATROMBOPAG MALEATE

DMF 434232025

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Jul 25, 2025	SUPPL -10	View Letter (PDF)
Jul 22, 2024	SUPPL -9	View Letter (PDF)
Oct 19, 2021	SUPPL -6	View Letter (PDF)
Aug 24, 2020	SUPPL -4	View Letter (PDF)
Jun 20, 2019	SUPPL -1	View Letter (PDF)
May 24, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 20MG BASE

RLD

1 patent3 exclusivities▴

TABLET;ORAL | Approved: May 21, 2018

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7638536	Jul 28, 2027	—	Yes	Yes	—	—

Exclusivities (3)

Code	Date	Status
I-974	Jul 24, 2028	Active
ODE-246	Jun 26, 2026	Expired
ODE-548	Jul 24, 2032	Active

Change History (1)

Recent changes detected for this application.

ADDED7/1/2026

DOPTELET (avatrombopag maleate) received orphan drug exclusivity designation, providing seven years of regulatory exclusivity protection from the date of approval.

New: New record