Question 1

Is there a generic for Doravirine; islatravir?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Doravirine; islatravir. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Doravirine; islatravir?

Accepted Answer

IDVYNSO (NDA 216964, MSD) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Doravirine; islatravir?

Accepted Answer

The Orange Book lists 2 patents against Doravirine; islatravir products, with the earliest listed expiry in 2027. 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 Doravirine; islatravir have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Doravirine; islatravir. 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 Doravirine; islatravir are approved?

Accepted Answer

Doravirine; islatravir is approved in the following dosage form: tablet.

Patent	Expires	In	Type
7339053	May 31, 2027	in 1 yr	Substance
8486975	Aug 30, 2032	in 6 yr 3 mo	SubstanceProductU-4527

Doravirine; islatravir

Brand (NDA) products · tablet

Marketing exclusivity (1)

Listed patents (2)

Doravirine; islatravir — frequently asked questions

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