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BERUBIGEN

NDA

CYANOCOBALAMIN | N006798 | 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

3 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Robert Van Osdel FDA-2024-P-4293 · 6 docket documents Robert van Osdel filed a citizen petition requesting that the FDA determine whether NASCOBAL (Cyanocobalamin, USP) Nasal Spray 0.5 mg/spray was discontinued due to safety or effectiveness concerns.	Other	2024-09-11	Granted	Robert Van Osdel
Citizen Petition from Foley & Lardner LLP FDA-2017-P-6136 · 5 docket documents Foley & Lardner LLP filed this citizen petition requesting that the FDA designate ANDA A080737, Cyanocobalamin Injection 1 mg/mL by Luitpold Pharmaceutical Inc., as an additional reference listed drug in the Orange Book to enable future ANDA applicants to file applications citing this product as the	505(q)	2017-10-12	Granted	Foley & Lardner LLP
Citizen Petition from JR Rapoza Associates, Inc. FDA-2016-P-1676 · 7 docket documents JR Rapoza Associates, Inc. filed this citizen petition on behalf of a client requesting that the FDA Commissioner determine that Cyanocobalamin Injection 1000 mcg/ml in a 10 ml multi-dose vial under ANDA A080557 was withdrawn from the marketplace for reasons other than safety and efficacy, to permit	505(q)	2016-06-17	Granted	JR Rapoza Associates, Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

20 trials from ClinicalTrials.gov, 15 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Oral Cyanocobalamin (Eligen B12) Bioavailability Study NCT01311739	N/A	Completed	Emisphere Technologies, Inc.	20	2008-05 → 2008-06
Study of Pralatrexate in Female Patients With Previously-treated Breast Cancer NCT01118624	Phase 2	Completed	Acrotech Biopharma Inc.	22	2010-03 → 2012-07
Study of Pralatrexate to Treat Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma NCT00998946	Phase 2	Completed	Spectrum Pharmaceuticals, Inc	29	2009-09 → 2012-08
Randomized Study of Folic Acid Therapy for Hyperhomocysteinemia in Patients With End Stage Renal Disease Receiving Hemodialysis NCT00004495	N/A	Completed	Georgetown University	84	1999-06 → 2000-09
The Effect of Phentermine and B12 on Weight Loss Among Obese Patients NCT01719185	Early Phase 1	Completed	Dr. Michael Lang	22	2012-09 → 2013-04
VITRO-Trial. B Vitamins and the Secondary Prevention of Venous Thrombosis NCT00314990	N/A	Completed	Radboud University Medical Center	620	1996-01 → 2003-01
Vitamin Therapy for Prevention of Stroke NCT00004734	Phase 3	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	—	1996-09 → 2004-02
Effectiveness of Dalteparin Therapy as Intervention in Recurrent Pregnancy Loss NCT00400387	Phase 3	Completed	University of Jena	449	2006-11 → 2013-04
Study of Pralatrexate vs. Erlotinib for Non-Small Cell Lung Cancer After at Least 1 Prior Platinum-based Treatment NCT00606502	Phase 2	Completed	Spectrum Pharmaceuticals, Inc	201	2008-01 → 2010-06-24
Study of Pralatrexate & Gemcitabine With B12 & Folic Acid to Treat Relapsed/Refractory Lymphoproliferative Malignancies NCT00481871	Phase 1/2	Completed	Acrotech Biopharma Inc.	119	2007-05 → 2011-08

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

API Supply Chain3 active DMFs6 inactive

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

EUROAPI FRANCECYANOCOBALAMIN

DMF 40951981

HEBEI YUXING BIO-ENGINEERING CO LTDCYANOCOBALAMIN

DMF 213912008

HEBEI HUARONG PHARMACEUTICAL CO LTDCYANOCOBALAMIN

DMF 361912021

FARMITALIA SPAInactiveCYANOCOBALAMIN (VITAMIN B 12)

DMF 32221978

SANOFI CHIMIEInactiveCYANOCOBALAMIN PH. EUR. USP, JP

DMF 51381983

ANTIBIOTICE SAInactiveCYANOCOBALAMIN (VITAMIN B12)

DMF 165562003

NORTH CHINA PHARMACEUTICAL VICTOR CO LTDInactiveCYANOCOBALAMIN, USP (VITAMIN B-12)

DMF 169062003

WOCKHARDT LTDInactiveCYANOCOBALAMIN USP

DMF 197022006

HEBEI HUARONG PHARMACEUTICAL CO LTDInactiveCYANOCOBALAMIN

DMF 209732007

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

Products (1)

#001 — 1MG/ML

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.