Epivir (3TC) — Competitive Intelligence Brief

Epivir (3TC) (Epivir (3TC)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Nucleoside reverse transcriptase inhibitor (NRTI). Area: Virology/Infectious Disease.

phase 3 Nucleoside reverse transcriptase inhibitor (NRTI) HIV reverse transcriptase; Hepatitis B virus polymerase Virology/Infectious Disease Small molecule

Target snapshot

Epivir (3TC) (Epivir (3TC)) — Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Epivir (lamivudine/3TC) is a nucleoside reverse transcriptase inhibitor that blocks HIV reverse transcriptase, preventing viral replication by terminating DNA chain elongation.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Epivir (3TC) TARGET	Epivir (3TC)	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	phase 3	Nucleoside reverse transcriptase inhibitor (NRTI)	HIV reverse transcriptase; Hepatitis B virus polymerase
Lamivudine Oral Solution	Lamivudine Oral Solution	ANRS, Emerging Infectious Diseases	marketed	Nucleoside reverse transcriptase inhibitor (NRTI)	HIV reverse transcriptase; Hepatitis B virus polymerase
Abacavir/Lamivudine	Abacavir/Lamivudine	GlaxoSmithKline	marketed	Nucleoside reverse transcriptase inhibitor (NRTI)	HIV reverse transcriptase
blank Baraclude tablets	blank Baraclude tablets	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	marketed	Nucleoside reverse transcriptase inhibitor (NRTI)	Hepatitis B virus reverse transcriptase / HBV polymerase
nucleoside reverse transcriptase inhibitors	nucleoside reverse transcriptase inhibitors	French National Agency for Research on AIDS and Viral Hepatitis	marketed	Nucleoside reverse transcriptase inhibitor (NRTI)	HIV reverse transcriptase
Once-daily ABC+3TC	Once-daily ABC+3TC	Medical Research Council	marketed	Nucleoside reverse transcriptase inhibitor (NRTI) combination	HIV reverse transcriptase
TAF/FTC FDC	TAF/FTC FDC	Janssen Scientific Affairs, LLC	marketed	Nucleoside reverse transcriptase inhibitor (NRTI) combination	HIV reverse transcriptase

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Nucleoside reverse transcriptase inhibitor (NRTI) class)

1. French National Agency for Research on AIDS and Viral Hepatitis · 3 drugs in this class
2. Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · 2 drugs in this class
3. ViiV Healthcare · 2 drugs in this class
4. Nanfang Hospital, Southern Medical University · 2 drugs in this class
5. Asan Medical Center · 1 drug in this class
6. Dong-A ST Co., Ltd. · 1 drug in this class
7. Bristol-Myers Squibb · 1 drug in this class
8. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · 1 drug in this class
9. Fu-Sheng Wang · 1 drug in this class
10. Avexa · 1 drug in this class