Gemcitabine Injectable Product — Competitive Intelligence Brief

Gemcitabine Injectable Product (Gemcitabine Injectable Product) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Nucleoside analog antimetabolite. Area: Oncology.

marketed Nucleoside analog antimetabolite Ribonucleotide reductase; DNA incorporation Oncology Small molecule

Target snapshot

Gemcitabine Injectable Product (Gemcitabine Injectable Product) — Henan Cancer Hospital. Gemcitabine is a nucleoside analog that inhibits ribonucleotide reductase and gets incorporated into DNA, causing chain termination and cell death.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Gemcitabine Injectable Product TARGET	Gemcitabine Injectable Product	Henan Cancer Hospital	marketed	Nucleoside analog antimetabolite	Ribonucleotide reductase; DNA incorporation
Gemzar	Gemcitabine Hydrochloride	Accord Hlthcare	marketed	Nucleoside metabolic inhibitor	Ribonucleotide reductase; DNA incorporation	1996-01-01
Cladribine Tablets	Cladribine Tablets	Keith Edwards, M.D.	marketed	Purine nucleoside analog	Ribonucleotide reductase; DNA incorporation
Gemcitabine monotherapy	Gemcitabine monotherapy	AstraZeneca	phase 3	Nucleoside analog; antimetabolite	Ribonucleotide reductase; DNA incorporation
Gemcitabine Hydrochloride Injection	Gemcitabine Hydrochloride Injection	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	phase 3	Nucleoside analog; antimetabolite	Ribonucleotide reductase; DNA incorporation
Cladribine Pill	Cladribine Pill	Haukeland University Hospital	phase 3	Purine nucleoside analog	Ribonucleotide reductase; DNA incorporation
standard dose ARA-C	standard dose ARA-C	National Research Center for Hematology, Russia	marketed	Nucleoside analog antimetabolite	DNA polymerase; ribonucleotide reductase

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)

• 2030-06-28 — Gemzar · 12403086 · Formulation · US
• 2032-04-15 — Gemzar · 8679094 · Formulation · US
• 2033-07-01 — Gemzar · 9241948 · Formulation · US
• 2034-08-19 — Gemzar · 10729823 · Formulation · US
• 2034-08-19 — Gemzar · 12447241 · Formulation · US

Sponsor landscape (Nucleoside analog antimetabolite class)

1. Henan Cancer Hospital · 1 drug in this class
2. Intergroupe Francophone de Cancerologie Thoracique · 1 drug in this class
3. International Extranodal Lymphoma Study Group (IELSG) · 1 drug in this class
4. National Research Center for Hematology, Russia · 1 drug in this class
5. University of California, San Diego · 1 drug in this class
6. University of Rochester · 1 drug in this class
7. University of Ulm · 1 drug in this class