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FDA Orange Book · active-ingredient family

Raltegravir potassium

Raltegravir potassium is approved as 3 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ISENTRESS · NDA 205786

3

Brand (NDA)

2

Generics (ANDA)

7

Listed patents

0

Exclusivity periods

Brand (NDA) products · powder, tablet, tablet, chewable

ProductApplicantApplicationTEApproved
ISENTRESSRLDMSD SUB MERCKNDA 205786—Dec 20, 2013
ISENTRESSRLD×2MSD SUB MERCKNDA 203045—Dec 21, 2011
ISENTRESSRLD×2MSD SUB MERCKNDA 022145—Oct 12, 2007

Generic (ANDA) products (2)

ProductApplicantApplicationTEApproved
RALTEGRAVIR POTASSIUMLUPINANDA 217990ABMay 06, 2025
RALTEGRAVIR POTASSIUMHETERO LABS LTD IIIANDA 203540—Dec 19, 2024

Listed patents (7)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8852632Jan 28, 2028in 1 yr 8 mo
SubstanceProductU-257
7754731Mar 11, 2029in 2 yr 9 mo
SubstanceProductU-257
7754731*PEDSep 11, 2029in 3 yr 3 mo
8771733Jun 02, 2030in 4 yr
SubstanceProductU-257
9649311Oct 21, 2030in 4 yr 5 mo
Product
9649311*PEDApr 21, 2031in 4 yr 11 mo
10772888Mar 30, 2032in 5 yr 10 mo
U-1663

Raltegravir potassium — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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