Gemzar — Competitive Intelligence Brief

Gemzar (gemcitabine) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Nucleoside Metabolic Inhibitor. Area: Oncology.

marketed Nucleoside Metabolic Inhibitor DNA polymerase (alpha/delta/epsilon) Oncology

Target snapshot

Gemzar (gemcitabine) — Accord Hlthcare. Gemzar works by mimicking a building block of DNA, tricking cancer cells into incorporating it into their DNA and then stopping the replication process.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Gemzar TARGET	gemcitabine	Accord Hlthcare	marketed	Nucleoside Metabolic Inhibitor	DNA polymerase (alpha/delta/epsilon)	1996-01-01
Inqovi	Inqovi	Otsuka	marketed	Nucleoside Metabolic Inhibitor [EPC]	Cytidine deaminase	2020-01-01
CEDAZURIDINE	CEDAZURIDINE		marketed	Nucleoside Metabolic Inhibitor [EPC]	DNA methyltransferase	2020-01-01
Dacogen	decitabine	Sun Pharma	marketed	Nucleoside Metabolic Inhibitor [EPC]	DNA (cytosine-5)-methyltransferase 1	2006-01-01
Arranon	NELARABINE	Novartis	marketed	Nucleoside Metabolic Inhibitor [EPC]		2005-01-01
Clolar	CLOFARABINE	Sanofi	marketed	Nucleoside Metabolic Inhibitor [EPC]	Ribonucleoside-diphosphate reductase large subunit	2004-01-01
AZACITIDINE	AZACITIDINE		marketed	Nucleoside Metabolic Inhibitor [EPC]		2004-01-01

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)

• 2028-10-16 — Inqovi · 8618075 · US
• 2028-10-16 — Inqovi · 9567363 · US
• 2030-08-22 — Inqovi · 8268800 · US

Sponsor landscape (Nucleoside Metabolic Inhibitor class)

1. · 2 drugs in this class
2. Accord Hlthcare · 1 drug in this class
3. Nihon Schering K.K. · 1 drug in this class
4. Spectrum Pharms · 1 drug in this class