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CYANOKIT

NDA

HYDROXOCOBALAMIN | N022041 | BTG INTERNATIONAL INC

2 strengths0 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
Vitamin B12 Absorption Study NCT07665671	Phase 4	Not Yet Recruiting	RDC Clinical Pty Ltd	12	2026-07 → 2026-12
Dietary Macronutrients and Gut Microbiota, Inflammation, and Metabolic Markers NCT07672691	N/A	Recruiting	The Jerzy Kukuczka Academy of Physical Education in Katowice	200	2024-09-02 → 2028-12-30
Clinical and Laboratory Study of Methylmalonic Acidemia NCT00078078	—	Recruiting	National Human Genome Research Institute (NHGRI)	2,275	2004-06-07
Immun4Cure Cohort of Autoimmune Diseases NCT07515638	—	Recruiting	University Hospital, Montpellier	500	2026-06-23 → 2034-06-23

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

API Supply Chain5 active DMFs1 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

EUROAPI FRANCEHYDROXOCOBALAMIN ACETATE PH.EUR.,JP,PYROGEN-FREE

DMF 161522002

EUROAPI FRANCEHYDROXOCOBALAMIN

DMF 182162005

HEBEI HUARONG PHARMACEUTICAL CO LTDHYDROXOCOBALAMIN ACETATE

DMF 272292013

SUPRIYA LIFESCIENCE LTDHYDROXOCOBALAMIN USP

DMF 371682022

HEBEI HUARONG PHARMACEUTICAL CO LTDHYDROXOCOBALAMIN ACETATE

DMF 386382023

HOECHST MARION ROUSSEL SAInactiveHYDROXOCOBALAMIN BASE

DMF 91001991

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

Approval Letters

6 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 5GM/VIAL (5GM/KIT)

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Apr 8, 2011

No patent or exclusivity listings for this strength.

#002 — 2.5GM/VIAL (5GM/KIT)

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Dec 15, 2006