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Gemcitabine hydrochloride for injection — Competitive Intelligence Brief

Gemcitabine hydrochloride for injection (Gemcitabine hydrochloride for injection) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Nucleoside analog; antimetabolite. Area: Oncology.

phase 3 Nucleoside analog; antimetabolite Ribonucleotide reductase; DNA synthesis Oncology Small molecule Live · refreshed every 30 min

Target snapshot

Gemcitabine hydrochloride for injection (Gemcitabine hydrochloride for injection) — Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.. Gemcitabine is a nucleoside analog that inhibits ribonucleotide reductase and gets incorporated into DNA, causing chain termination and cell death.

Comparator set (6 drugs)

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DrugGenericSponsorPhaseClassTargetApproval / PDUFA
Gemcitabine hydrochloride for injection TARGET Gemcitabine hydrochloride for injection Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. phase 3 Nucleoside analog; antimetabolite Ribonucleotide reductase; DNA synthesis
Cladribine Low Dose Cladribine Low Dose Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany phase 3 Purine nucleoside analog Ribonucleotide reductase; DNA synthesis
BICTEGRAVIR SODIUM BICTEGRAVIR SODIUM marketed Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] 2018-01-01
Biktarvy BICTEGRAVIR Gilead Sciences marketed Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] 2018-01-01
Pifeltro DORAVIRINE Merck & Co. marketed Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] 2018-01-01
Vemlidy TENOFOVIR ALAFENAMIDE Gilead Sciences marketed Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] 2015-01-01
Lonsurf TIPIRACIL Taiho Oncology Inc marketed Nucleoside Analog Antiviral [EPC] Thymidine phosphorylase 2015-01-01

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)

Sponsor landscape (Nucleoside analog; antimetabolite class)

  1. Assistance Publique - Hôpitaux de Paris · 1 drug in this class
  2. Astellas Pharma Global Development, Inc. · 1 drug in this class
  3. AstraZeneca · 1 drug in this class
  4. Celgene · 1 drug in this class
  5. Centre Hospitalier Universitaire Dijon · 1 drug in this class
  6. Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · 1 drug in this class
  7. Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · 1 drug in this class
  8. Eisai Inc. · 1 drug in this class
  9. Gruppo Italiano Malattie EMatologiche dell'Adulto · 1 drug in this class
  10. Jiangsu Simcere Pharmaceutical Co., Ltd. · 1 drug in this class

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Cite this brief

Drug Landscape (2026). Gemcitabine hydrochloride for injection — Competitive Intelligence Brief. https://druglandscape.com/ci/gemcitabine-hydrochloride-for-injection. Accessed 2026-05-16.

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