Question 1

Is there a generic for Dordaviprone hydrochloride?

Accepted Answer

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

Question 2

What is the reference-listed drug for Dordaviprone hydrochloride?

Accepted Answer

MODEYSO (NDA 219876, CHIMERIX) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Dordaviprone hydrochloride?

Accepted Answer

The Orange Book lists 7 patents against Dordaviprone hydrochloride products, with the earliest listed expiry in 2032. 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 Dordaviprone hydrochloride have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Dordaviprone 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 Dordaviprone hydrochloride are approved?

Accepted Answer

Dordaviprone hydrochloride is approved in the following dosage form: capsule.

Patent	Expires	In	Type
9629842	Apr 30, 2032	in 5 yr 11 mo	U-4254
RE46290	Apr 30, 2032	in 5 yr 11 mo	U-4254
9265765	Jul 26, 2034	in 8 yr 3 mo	Product
11976068	Mar 01, 2036	in 9 yr 10 mo	Product
12102639	Jan 30, 2037	in 10 yr 9 mo	U-4254
10369154	Jan 30, 2037	in 10 yr 9 mo	U-4254
10172862	Jan 30, 2037	in 10 yr 9 mo	U-4254

Dordaviprone hydrochloride

Brand (NDA) products · capsule

Marketing exclusivity (2)

Listed patents (7)

Dordaviprone hydrochloride — frequently asked questions

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