Question 1

Is there a generic for Cobicistat?

Accepted Answer

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

Question 2

What is the reference-listed drug for Cobicistat?

Accepted Answer

TYBOST (NDA 203094, 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 Cobicistat?

Accepted Answer

The Orange Book lists 4 patents against Cobicistat 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

Does Cobicistat have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Cobicistat. 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 Cobicistat are approved?

Accepted Answer

Cobicistat is approved in the following dosage form: tablet.

Patent	Expires	In	Type
8148374	Sep 03, 2029	in 3 yr 3 mo	SubstanceProductU-1279
8148374*PED	Mar 03, 2030	in 3 yr 9 mo
10039718	Oct 06, 2032	in 6 yr 5 mo	Product
10039718*PED	Apr 06, 2033	in 6 yr 11 mo

Cobicistat

Brand (NDA) products · tablet

Generic (ANDA) products (1)

Marketing exclusivity (1)

Listed patents (4)

Cobicistat — frequently asked questions

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