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AVANAFIL

ANDA

AVANAFIL | A209266 | HETERO LABS LTD UNIT V

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: STENDRA(TE code: AB)

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).

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.

Products (3)

Sort:

#001 — 50MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 14, 2024

No patent or exclusivity listings for this strength.

#002 — 100MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 14, 2024

#003 — 200MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 14, 2024