Question 1

Is there a generic for Dolutegravir sodium; lamivudine?

Accepted Answer

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

Question 2

What is the reference-listed drug for Dolutegravir sodium; lamivudine?

Accepted Answer

DOVATO (NDA 211994, VIIV HLTHCARE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Dolutegravir sodium; lamivudine?

Accepted Answer

The Orange Book lists 5 patents against Dolutegravir sodium; lamivudine 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 Dolutegravir sodium; lamivudine have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Dolutegravir sodium; lamivudine. 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 Dolutegravir sodium; lamivudine are approved?

Accepted Answer

Dolutegravir sodium; lamivudine is approved in the following dosage form: tablet.

Patent	Expires	In	Type
8129385	Oct 05, 2027	in 1 yr 4 mo	SubstanceProduct
8129385*PED	Apr 05, 2028	in 1 yr 10 mo
9242986	Dec 08, 2029	in 3 yr 6 mo	SubstanceProduct
9242986*PED	Jun 08, 2030	in 4 yr
11234985	Jan 24, 2031	in 4 yr 8 mo	ProductU-257

Dolutegravir sodium; lamivudine

Brand (NDA) products · tablet

Marketing exclusivity (1)

Listed patents (5)

Dolutegravir sodium; lamivudine — frequently asked questions

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.