Question 1

Is there a generic for Sofosbuvir?

Accepted Answer

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

Question 2

What is the reference-listed drug for Sofosbuvir?

Accepted Answer

SOVALDI (NDA 212480, GILEAD SCIENCES INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Sofosbuvir?

Accepted Answer

The Orange Book lists 18 patents against Sofosbuvir products, with the earliest listed expiry in 2028. 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 Sofosbuvir have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 4 marketing-exclusivity periods for Sofosbuvir. 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 Sofosbuvir are approved?

Accepted Answer

Sofosbuvir is approved in the following dosage forms: pellets, tablet.

Product	Applicant	Application	TE	Approved
SOVALDIRLD×2	GILEAD SCIENCES INC	NDA 212480	—	Aug 28, 2019
SOVALDIRLD×2	GILEAD SCIENCES INC	NDA 204671	—	Aug 28, 2019

Patent	Expires	In	Type
8334270	Mar 21, 2028	in 1 yr 9 mo	SubstanceProductU-1470
8580765	Mar 21, 2028	in 1 yr 9 mo	SubstanceProductU-1470
9085573	Mar 21, 2028	in 1 yr 9 mo	SubstanceProductU-1470
8334270*PED	Sep 21, 2028	in 2 yr 4 mo
8580765*PED	Sep 21, 2028	in 2 yr 4 mo
9085573*PED	Sep 21, 2028	in 2 yr 4 mo
7964580	Mar 26, 2029	in 2 yr 10 mo	SubstanceProductU-1470
8633309	Mar 26, 2029	in 2 yr 10 mo	SubstanceProductU-1470
8889159	Mar 26, 2029	in 2 yr 10 mo	ProductU-1470
9549941	Mar 26, 2029	in 2 yr 10 mo	U-1958
7964580*PED	Sep 26, 2029	in 3 yr 4 mo
8633309*PED	Sep 26, 2029	in 3 yr 4 mo
8889159*PED	Sep 26, 2029	in 3 yr 4 mo
9549941*PED	Sep 26, 2029	in 3 yr 4 mo
9284342	Sep 13, 2030	in 4 yr 4 mo	SubstanceProductU-1470
8618076	Dec 11, 2030	in 4 yr 7 mo	SubstanceProductU-1470
9284342*PED	Mar 13, 2031	in 4 yr 10 mo
8618076*PED	Jun 11, 2031	in 5 yr 1 mo

Sofosbuvir

Brand (NDA) products · pellets, tablet

Generic (ANDA) products (1)

Marketing exclusivity (4)

Listed patents (18)

Sofosbuvir — frequently asked questions

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