Question 1

Is there a generic for Rilpivirine hydrochloride?

Accepted Answer

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Rilpivirine hydrochloride, referencing the brand EDURANT PED. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

What is the reference-listed drug for Rilpivirine hydrochloride?

Accepted Answer

EDURANT PED (NDA 219016, JANSSEN PRODS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Rilpivirine hydrochloride?

Accepted Answer

The Orange Book lists 1 patent against Rilpivirine hydrochloride products, with the earliest listed expiry in 2037. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Rilpivirine hydrochloride have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 4 marketing-exclusivity periods for Rilpivirine hydrochloride. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Rilpivirine hydrochloride are approved?

Accepted Answer

Rilpivirine hydrochloride is approved in the following dosage forms: tablet, tablet, for suspension.

Product	Applicant	Application	TE	Approved
EDURANT PEDRLD	JANSSEN PRODS	NDA 219016	—	Mar 15, 2024
EDURANTRLD	JANSSEN PRODS	NDA 202022	AB	May 20, 2011

Rilpivirine hydrochloride

Brand (NDA) products · tablet, tablet, for suspension

Generic (ANDA) products (1)

Marketing exclusivity (4)

Listed patents (1)

Rilpivirine hydrochloride — frequently asked questions

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