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ADDYI

NDA

FLIBANSERIN | N022526 | SPROUT PHARMACEUTICALS INC

1 strength1 unique patent1 unique exclusivity

Patent Timeline

1 unique patent, 1 exclusivity by expiration date

Active (1)TodayExclusivity

2027

2028

2029

Today

May. 9, 2028

I-983

Dec. 13, 2028

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 Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

APICORE LLCFLIBANSERIN

DMF 353362020

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

Approval Letters

10 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG

RLD

1 patent1 exclusivity▴

TABLET;ORAL | Approved: Aug 18, 2015

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7151103	May 9, 2028	—	—	—		—

Code	Date	Status
I-983	Dec 13, 2028	Active