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R-GENE 10

NDA

ARGININE HYDROCHLORIDE | N016931 | PHARMACIA AND UPJOHN CO

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

4 trials from ClinicalTrials.gov — 4 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Phase I Clinical Study of LNF2105 in Patients With Advanced Solid Tumors NCT07661797	Phase 1	Not Yet Recruiting	Shandong New Time Pharmaceutical Co., LTD	294	2026-06 → 2028-08
Daily Amino Acid Supplementation for People With Parkinson's Disease NCT07115563	N/A	Recruiting	Cristina Colon-Semenza	30	2025-10-31 → 2027-11
AZD3470 as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Haematologic Malignancies.NCT06137144	Phase 1/2	Recruiting	AstraZeneca	161	2024-01-23 → 2029-05-03
A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors NCT07277413	Phase 1	Recruiting	IDEAYA Biosciences	260	2026-03-04 → 2028-04-30

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

ORCHID PHARMA LTDARGININE (STERILE BULK)

DMF 188432005

ACS DOBFAR SPAARGININE (STERILE BULK)

DMF 229182009

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jan 26, 2010	SUPPL -31	View Letter (PDF)
Aug 15, 2003	SUPPL -28	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10GM/100ML

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.