Viewing data from:

Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.

RILPIVIRINE HYDROCHLORIDE

ANDA

Tentative Approval

RILPIVIRINE HYDROCHLORIDE | A219788 | LAURUS

API Supply Chain10 active DMFs1 inactive

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

JANSSEN PHARMACEUTICA NVRILPIVIRINE HYDROCHLORIDE (R314585) DRUG SUBSTANCE

DMF 238242010

MATRIX PHARMACORP PRIVATE LTDRILPIVIRINE HYDROCHLORIDE

DMF 272532013

HETERO DRUGS LTDRILPIVIRINE HYDROCHLORIDE

DMF 293012015

LAURUS LABS LTDRILPIVIRINE HYDROCHLORIDE

DMF 298412015

MSN PHARMACHEM PRIVATE LTDRILPIVIRINE HYDROCHLORIDE [ROUTE CODE RC]

DMF 304232016

CIPLA LTDRILPIVIRINE HYDROCHLORIDE

DMF 307732017

REYOUNG CORPORATIONRILPIVIRINE HYDROCHLORIDE

DMF 374792022

CIPLA LTDRILPIVIRINE

DMF 379402023

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDRILPIVIRINE HYDROCHLORIDE

DMF 395522024

MSN PHARMACHEM PRIVATE LTDRILPIVIRINE

DMF 397292024

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDInactiveRILPIVIRINE HYDROCHLORIDE

DMF 263052012

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

Products (1)

#001 — EQ 25MG BASE

▴

TABLET;ORAL | Approved: 2026-07-10 00:00:00

No patent or exclusivity listings for this strength.