Viewing data from:

STENDRA

NDA

AVANAFIL | N202276 | VIVUS LLC

3 strengths0 unique patents0 unique exclusivities

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
VIVUS, INC. et al v. HETERO USA, INC. et al 2:2016cv04560 2 patentsANDA 209266avanafil	D.N.J.	2016-07-27	Terminated 2017-01-09	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain7 active DMFs

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

VIVUS LLCAVANAFIL

DMF 248492011

MSN LABORATORIES PRIVATE LTDAVANAFIL [ROUTE CODE "AV"]

DMF 280952014

SANOFI CHIMIEAVANAFIL

DMF 287322014

ZAKLADY FARMACEUTYCZNE POLPHARMA SAAVANAFIL

DMF 296892015

HONOUR LAB LTDAVANAFIL

DMF 300242015

REYOUNG CORPORATIONAVANAFIL

DMF 361752021

RAKSHIT PHARMACEUTICALS LTDAVANAFIL

DMF 425492025

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

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Oct 19, 2022	SUPPL -20	View Letter (PDF)
Aug 7, 2018	SUPPL -18	View Letter (PDF)
Oct 12, 2017	SUPPL -17	View Letter (PDF)
Aug 29, 2017	SUPPL -16	View Letter (PDF)
Sep 17, 2015	SUPPL -13	View Letter (PDF)
May 19, 2015	SUPPL -10	View Letter (PDF)
Sep 18, 2014	SUPPL -5	View Letter (PDF)
Apr 30, 2014	SUPPL -6	View Letter (PDF)
Nov 6, 2012	SUPPL -1	View Letter (PDF)
Apr 27, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 50MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 27, 2012

No patent or exclusivity listings for this strength.

#002 — 100MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 27, 2012

#003 — 200MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 27, 2012