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SESQUIENT

NDA

FOSPHENYTOIN SODIUM | N210864 | LUPIN INC

2 strengths5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Active (5)Today

2027

2028

2029

2030

2031

2032

2033

Today

Mar. 13, 2029

Mar. 13, 2029

Mar. 13, 2029

Feb. 27, 2033

Mar. 13, 2029

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 Chain5 active DMFs5 inactive

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

SHANGHAI ZIYUAN PHARMACEUTICAL CO LTDFOSPHENYTOIN SODIUM USP

DMF 173332004

SUN PHARMACEUTICAL INDUSTRIES LTDFOSPHENYTOIN SODIUM USP

DMF 194552006

GUANG'AN KINGDAY PHARMA AND CHEM CO LTDFOSPHENYTOIN SODIUM USP

DMF 328162018

GLAND PHARMA LTDFOSPHENYTOIN SODIUM

DMF 337562019

CHEMWERTH INCFOSPHENYTOIN SODIUM USP

DMF 375652023

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPAInactiveFOSPHENYTOIN SODIUM API

DMF 168992003

DIVIS LABORATORIES LTDInactiveFOSPHENYTOIN SODIUM USP

DMF 188062005

CILAG AGInactiveFOSPHENYTOIN SODIUM DRUG SUBSTANCE (ACTIVE PHARMACEUTICAL INGREDIENT)

DMF 189542005

DR REDDYS LABORATORIES LTDInactiveFOSPHENYTOIN SODIUM

DMF 205112007

TRIFARMA SPAInactiveFOSPHENYTOIN SODIUM

DMF 209702007

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 9, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 100MG PHENYTOIN NA/2ML (EQ 50MG PHENYTOIN NA/ML)

RLD

5 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Nov 5, 2020

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7635773	Mar 13, 2029	—	—	Yes	—	—
8410077	Mar 13, 2029	—	—	Yes	—	—
9200088	Mar 13, 2029	—	—	Yes	—	—
9493582	Feb 27, 2033	—	—	Yes	—	—
9750822	Mar 13, 2029	—	—	Yes	—	—

#002 — EQ 500MG PHENYTOIN NA/10ML (EQ 50MG PHENYTOIN NA/ML)

RLD

5 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Nov 5, 2020