Pralatrexate injection — Competitive Intelligence Brief

Pralatrexate injection (Pralatrexate injection) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Antifolate antimetabolite. Area: Oncology.

phase 3 Antifolate antimetabolite Dihydrofolate reductase (DHFR), folate receptor, reduced folate carrier Oncology Small molecule

Target snapshot

Pralatrexate injection (Pralatrexate injection) — Mundipharma K.K.. Pralatrexate is a folate analog that inhibits dihydrofolate reductase and other folate-dependent enzymes, disrupting DNA synthesis and cell division in rapidly dividing cells.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Pralatrexate injection TARGET	Pralatrexate injection	Mundipharma K.K.	phase 3	Antifolate antimetabolite	Dihydrofolate reductase (DHFR), folate receptor, reduced folate carrier
Intrathecal injection of pemetrexed	Intrathecal injection of pemetrexed	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	marketed	Antifolate antimetabolite	Thymidylate synthase, dihydrofolate reductase, glycinamide ribonucleotide formyltransferase
Pemetrexed + oral folinic acid rescue	Pemetrexed + oral folinic acid rescue	Radboud University Medical Center	marketed	Antifolate antimetabolite	Thymidylate synthase, dihydrofolate reductase, glycinamide ribonucleotide formyltransferase
Anlotinib plus Pemetrexed	Anlotinib plus Pemetrexed	Henan Provincial People's Hospital	marketed	Multi-target tyrosine kinase inhibitor plus antifolate antimetabolite	VEGFR, FGFR, RET, c-Kit (anlotinib); thymidylate synthase, DHFR, GARFT (pemetrexed)
Erlotinib, Pemetrexed	Erlotinib, Pemetrexed	Hunan Province Tumor Hospital	marketed	EGFR tyrosine kinase inhibitor + antifolate antimetabolite	EGFR; thymidylate synthase and folate-dependent enzymes
Pemetrexed+carboplatin/Cisplatin	Pemetrexed+carboplatin/Cisplatin	Suzhou Puhe Pharmaceutical Technology Co., LTD	phase 3	Antifolate antimetabolite + platinum-based chemotherapy combination	Thymidylate synthase, dihydrofolate reductase, glycinamide ribonucleotide formyltransferase; DNA (platinum agents)
Pemetrexed disodium f Injection	Pemetrexed disodium f Injection	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	phase 3	Antifolate antimetabolite	Thymidylate synthase, dihydrofolate reductase, glycinamide ribonucleotide formyltransferase

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 (Antifolate antimetabolite class)

1. Allist Pharmaceuticals, Inc. · 1 drug in this class
2. Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · 1 drug in this class
3. Mundipharma K.K. · 1 drug in this class
4. Radboud University Medical Center · 1 drug in this class
5. Shanghai Miracogen Inc. · 1 drug in this class
6. The First Affiliated Hospital with Nanjing Medical University · 1 drug in this class
7. Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · 1 drug in this class