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ZUPLENZ

NDA

ONDANSETRON | N022524 | AQUESTIVE THERAPEUTICS INC

2 strengths2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2027

2028

2029

2030

Today

8580830

Nov. 23, 2029

9095577

Jul. 13, 2030

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 Chain10 active DMFs3 inactive

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

TEVA PHARMACEUTICAL INDUSTRIES LTDONDANSETRON HCL DIHYDRATE

DMF 156422001

CIPLA LTDONDANSETRON HCL USP

DMF 157242001

CAMBREX CHARLES CITY INCONDANSETRON HCL

DMF 157522001

INKE SAONDANSETRON BASE

DMF 161722002

DR REDDYS LABORATORIES LTDONDANSETRON

DMF 163202003

TAPI NL BVONDANSETRON BASE

DMF 166442003

SUN PHARMACEUTICAL INDUSTRIES LTDONDANSETRON USP

DMF 179802005

HIKAL LTDONDANSETRON USP

DMF 188292005

HIKMA PHARMACEUTICALSONDANSETRON HYDROCHLORIDE, USP

DMF 221812008

IPCA LABORATORIES LTDONDANSETRON USP

DMF 237582010

CHEMSOURCE CORPInactiveONDANSETRON HCL

DMF 157832001

QILU PHARMACEUTICAL CO LTDInactiveONDANSETRON

DMF 197622006

CADILA PHARMACEUTICALS LTDInactiveOndansetron

DMF 210272007

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Aug 9, 2021	SUPPL -7	View Letter (PDF)
Sep 23, 2014	SUPPL -3	View Letter (PDF)
Oct 31, 2013	SUPPL -2	View Letter (PDF)
Jul 27, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 4MG

RLD

2 patents0 exclusivities▴

FILM;ORAL | Approved: Jul 2, 2010

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8580830	Nov 23, 2029	—	—	Yes	—	—
9095577	Jul 13, 2030	—	—	Yes	—	—

#002 — 8MG

RLD

2 patents0 exclusivities▾

FILM;ORAL | Approved: Jul 2, 2010