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RIZAFILM

NDA

RIZATRIPTAN BENZOATE | N205394 | GENSCO LABORATORIES LLC DBA GENSCO PHARMA

2 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

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2033

2034

Today

9301948

Jul. 30, 2034

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 Chain19 active DMFs3 inactive

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

CIPLA LTDRIZATRIPTAN BENZOATE USP

DMF 180212005

MATRIX PHARMACORP PRIVATE LTDRIZATRIPTAN BENZOATE USP

DMF 190982006

DR REDDYS LABORATORIES LTDRIZATRIPTAN BENZOATE USP

DMF 191792006

NATCO PHARMA LTDRIZATRIPTAN BENZOATE

DMF 207812007

ALIVUS LIFE SCIENCES LTDRIZATRIPTAN BENZOATE USP

DMF 226762009

NATCO PHARMA LTDRIZATRIPTAN BENZOATE (ROUTE - 2; PRODUCT CODE: RTB)

DMF 227632009

SMS PHARMACEUTICALS LTDRIZATRIPTAN BENZOATE

DMF 230662009

SUN PHARMACEUTICAL INDUSTRIES LTDRIZATRIPTAN BENZOATE USP

DMF 235812010

ZHEJIANG SUPOR PHARMACEUTICALS CO LTDRIZATRIPTAN BENZOATE

DMF 235982010

APITORIA PHARMA PRIVATE LTDRIZATRIPTAN BENZOATE USP (NON-STERILE DRUG SUBSTANCE)

DMF 238142010

JUBILANT PHARMOVA LTDRIZATRIPTAN BENZOATE USP

DMF 240542010

UNIMARK REMEDIES LTDRIZATRIPTAN BENZOATE

DMF 241772010

MACLEODS PHARMACEUTICALS LTDRIZATRIPTAN BENZOATE

DMF 245522011

ALKEM LABORATORIES LTDRIZATRIPTAN BENZOATE USP

DMF 248842011

INKE SARIZATRIPTAN BENZOATE

DMF 256232011

EMCURE PHARMACEUTICALS LTDRIZATRIPTAN BENZOATE USP

DMF 257642012

HETERO DRUGS LTDRIZATRIPTAN BENZOATE USP

DMF 260172012

UNICHEM LABORATORIES LTDRIZATRIPTAN BENZOATE USP

DMF 279912014

SYN-TECH CHEM AND PHARM CO LTDRIZATRIPTAN BENZOATE USP

DMF 286342014

CIPLA LTDInactiveRIZATRIPTAN BENZOATE

DMF 176332004

APOTEX PHARMACHEM INDIA PVT LTDInactiveRIZATRIPTAN BENZOATE USP

DMF 240612010

ALP PHARM BEIJING CO LTDInactiveRIZATRIPTAN BENZOATE

DMF 252292011

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Mar 2, 2026	SUPPL -5	View Letter (PDF)
Jan 30, 2026	SUPPL -7	View Letter (PDF)
Dec 12, 2023	SUPPL -2	View Letter (PDF)
Apr 17, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 10MG BASE

RLD

1 patent0 exclusivities▴

FILM;ORAL | Approved: Apr 14, 2023

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9301948	Jul 30, 2034	—	Yes	Yes	—	—

#002 — EQ 5MG BASE

RLD

0 patents0 exclusivities▾

FILM;ORAL | Approved: Feb 26, 2026