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FOLIC ACID

NDA

FOLIC ACID | N006135 | ELI LILLY AND 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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition Amendment from Method Pharmaceuticals, LLC FDA-2024-P-0422 · 11 docket documents Method Pharmaceuticals LLC filed this ANDA suitability petition under section 505(j)(2)(C) requesting permission to file an Abbreviated New Drug Application for Folic Acid Oral Solution in two strengths (0.1 mg/mL and 1 mg/mL), and sought a waiver of pediatric assessment requirements under the Pedia	Suitability	2024-02-26	Granted	—
Buchanan Ingersoll & Rooney PC - Citizen Petition FDA-2009-P-0587 · 13 docket documents Buchanan Ingersoll & Rooney PC filed this citizen petition on December 8, 2009, requesting that the FDA Commissioner issue an order confirming that certain prescription prenatal vitamins containing 1 mg to 4 mg of folic acid, indicated for reducing neural tube defect risks, are generally recognized	Other	2009-12-14	Denied	—

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

Clinical Trials

197 trials from ClinicalTrials.gov — 3 recruiting, 146 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Impact of High-dose Folic Acid Supplementation on Pathways Linked to DNA Formation NCT01687127	N/A	Not Yet Recruiting	University of British Columbia	25	2024-01-01 → 2026-12-31
Folic Acid Supplement Versus Placebo for Treating Mucositis Adverse Events in Metastatic Renal Cell Carcinoma Patients Receiving Targeted Therapy NCT03581773	Phase 2	Recruiting	Niels Fristrup	100	2017-12-20 → 2029-09-01
Neurovascular Transduction During Exercise in Chronic Kidney Disease NCT02947750	Phase 2	Recruiting	Emory University	150	2016-10 → 2027-04-30
Folic Acid Supplementation in Gambian Primigravidae NCT00120822	Phase 3	Completed	London School of Hygiene and Tropical Medicine	1,000	2002-07 → 2004-01
Evaluation of the Clinical Efficacy and Safety of Dapoxetine, Combined Dapoxetine With Folic Acid and Combined Dapoxetine With Vitamin B12 in Treatment of Patients With Premature Ejaculation NCT04085354	Phase 3	Completed	Sohag University	120	2019-02-10 → 2019-08-29
Effect of Folic Acid on Primary Folate Forms in Relation to MTHFR NCT01105351	N/A	Completed	Universität des Saarlandes	75	2010-06 → 2013-12
Long-term Iron Supplements and Malaria Risk in Early Pregnancy: a Randomized Controlled Trial NCT01210040	N/A	Completed	Liverpool School of Tropical Medicine	1,959	2011-04 → 2014-01
Phase II Study of Folotyn With Leucovorin to Prevent/Reduce Mucositis in Patients With Hematological Malignancies NCT02106650	Phase 2	Completed	Acrotech Biopharma Inc.	36	2014-07 → 2019-06
Effect of a Fortified Balanced Energy-Protein Supplement on Birth Outcome and Child Growth in Houndé District, Burkina Faso.NCT03533712	Phase 4	Completed	University Ghent	1,788	2019-10-30 → 2022-03-15
Effect of Iron and Folic Acid on Skin Fungal Pattern in Patients With Arsenicosis NCT02908581	Phase 2	Completed	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh	42	2016-06 → 2017-07

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

API Supply Chain5 active DMFs3 inactive

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

HENGSHUI JIHENG PHARMACEUTICAL CO LTDFOLIC ACID

DMF 170042003

SRI KRISHNA PHARMACEUTICALS LTDFOLIC ACID USP

DMF 176002004

DSM-FIRMENICH SWITZERLAND AGFOLIC ACID

DMF 306512016

HEBEI JIHENG PHARMACEUTICAL CO LTDFOLIC ACID

DMF 329762018

ZHEJIANG KINGLAND PHARMACEUTICAL CO LTDFOLIC ACID

DMF 396532024

TAKEDA PHARMACEUTICAL CO LTDInactiveFOLIC ACID

DMF 23181974

KONGO CHEMICAL CO LTDInactiveFOLIC ACID

DMF 38701980

SUMIKA FINE CHEMICALS CO LTDInactiveFOLIC ACID

DMF 48981983

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

Products (1)

#003 — 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.