Question 1

Is there a generic for Ombitasvir; paritaprevir; ritonavir?

Accepted Answer

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

Question 2

What is the reference-listed drug for Ombitasvir; paritaprevir; ritonavir?

Accepted Answer

TECHNIVIE (NDA 207931, ABBVIE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Ombitasvir; paritaprevir; ritonavir?

Accepted Answer

The Orange Book lists 7 patents against Ombitasvir; paritaprevir; ritonavir products, with the earliest listed expiry in 2029. 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

What dosage forms of Ombitasvir; paritaprevir; ritonavir are approved?

Accepted Answer

Ombitasvir; paritaprevir; ritonavir is approved in the following dosage form: tablet.

Patent	Expires	In	Type
8642538	Sep 10, 2029	in 3 yr 3 mo	SubstanceProductU-1638
9006387	Jun 10, 2030	in 4 yr	U-1687
9044480	Apr 10, 2031	in 4 yr 11 mo	U-1638
8420596	Apr 10, 2031	in 4 yr 11 mo	SubstanceProduct
8686026	Jun 09, 2031	in 5 yr 1 mo	Product
8420596*PED	Oct 10, 2031	in 5 yr 5 mo
8691938	Apr 13, 2032	in 5 yr 11 mo	SubstanceProduct

Ombitasvir; paritaprevir; ritonavir

Brand (NDA) products · tablet

Listed patents (7)

Ombitasvir; paritaprevir; ritonavir — frequently asked questions

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