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DARUNAVIR

ANDA

DARUNAVIR | A212493 | AMNEAL EU LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: PREZISTA(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
JANSSEN PRODUCTS, L.P. et al v. AMNEAL PHARMACEUTICALS, LLC et al 2:2018cv17585 3 patentsANDA 212493darunavir	D.N.J.	2018-12-26	Terminated 2019-05-02	—

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

API Supply Chain25 active DMFs8 inactive

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

JANSSEN PHARMACEUTICA NVDARUNAVIR (R319064) DRUG SUBSTANCE

DMF 188252005

CIPLA LTDDARUNAVIR

DMF 236602011

CIPLA LTDDARUNAVIR HYDRATE

DMF 236612010

CIPLA LTDDARUNAVIR ETHANOLATE

DMF 236622010

HETERO LABS LTDDARUNAVIR AMORPHOUS

DMF 238542010

MATRIX PHARMACORP PRIVATE LTDDARUNAVIR

DMF 238732010

HETERO LABS LTDDARUNAVIR ETHANOLATE

DMF 279972014

MICRO LABS LTDDARUNAVIR ETHANOLATE

DMF 291572015

MSN LIFE SCIENCES PRIVATE LTDDARUNAVIR ETHANOLATE

DMF 305892016

MATRIX PHARMACORP PRIVATE LTDDARUNAVIR (PROCESS-II)

DMF 305962016

MATRIX PHARMACORP PRIVATE LTDDARUNAVIR ETHANOLATE

DMF 307352016

RAKS PHARMA PVT LTDDARUNAVIR

DMF 308032016

MSN LIFE SCIENCES PRIVATE LTDDARUNAVIR (AMORPHOUS)

DMF 308822016

HETERO LABS LTDDARUNAVIR ETHANOLATE (PROCESS-II)

DMF 310112016

LAURUS LABS LTDDARUNAVIR

DMF 311982017

APITORIA PHARMA PRIVATE LTDDARUNAVIR PROPYLENE GLYCOLATE

DMF 313582017

LUPIN MANUFACTURING SOLUTIONS LTDDARUNAVIR ETHANOLATE (PROCESS-B)

DMF 314982017

PORTON PHARMA SOLUTIONS LTDDARUNAVIR ETHANOLATE

DMF 337982019

ZYDUS LIFESCIENCES LTDDARUNAVIR

DMF 338952019

INNOVARE LABS PRIVATE LTDDARUNAVIR

DMF 355082021

HETERO LABS LTDDARUNAVIR AMORPHOUS (PROCESS-II)

DMF 358342021

CHROMO LABORATORIES INDIA PRIVATE LTDDARUNAVIR ETHANOLATE

DMF 369762024

ARENE LIFE SCIENCES PRIVATE LTDDARUNAVIR ETHANOLATE

DMF 379162023

LAURUS LABS LTDDARUNAVIR ETHANOLATE

DMF 389802024

CIPLA LTDDARUNAVIR HYDRATE (PROCESS II)

DMF 408262025

LUPIN LTDInactiveDARUNAVIR ETHANOLATE

DMF 238502011

MSN PHARMACHEM PRIVATE LTDInactiveDARUNAVIR [ROUTE CODE - "DI"]

DMF 270382013

MSN PHARMACHEM PRIVATE LTDInactiveDARUNAVIR ETHANOLATE [ROUTE CODE - DN]

DMF 274212013

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTDInactiveDARUNAVIR

DMF 274362013

LUPIN LTDInactiveDARUNAVIR N-PROPANOLATE

DMF 291182015

LUPIN LTDInactiveDARUNAVIR (AMORPHOUS)

DMF 294552015

CIPLA LTDInactiveDARUNAVIR HYDRATE (PROCESS II)

DMF 302862016

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTDInactiveDARUNAVIR

DMF 314942017

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

Products (2)

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#001 — 600MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 8, 2023

No patent or exclusivity listings for this strength.

#002 — 800MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 8, 2023