Viewing data from:

DOPTELET SPRINKLE

NDA

AVATROMBOPAG MALEATE | N219696 | AKARX INC

1 strength1 unique patent2 unique exclusivities

Patent Timeline

1 unique patent, 2 exclusivities by expiration date

Active (1)TodayExclusivity

2027

2028

2029

2030

2031

2032

Today

7638536

Jul. 28, 2027

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

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

1 letter from Drugs@FDA

Date	Submission	Document
Jul 25, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 10MG BASE

RLD

1 patent2 exclusivities▴

GRANULE;ORAL | Approved: Jul 24, 2025

Patents (1)

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

Exclusivities (2)

Code	Date	Status
NP	Jul 24, 2028	Active
ODE-548	Jul 24, 2032	Active

Change History (1)

Recent changes detected for this application.

ADDED7/1/2026

Akarx Inc added orphan drug exclusivity to Doptelet Sprinkle (avatrombopag maleate) for indication ODE-548, providing seven years of regulatory exclusivity from approval.

New: New record