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FOLVITE

NDA

FOLIC ACID | N005897 | WYETH PHARMACEUTICALS 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

6 trials from ClinicalTrials.gov — 4 recruiting, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Multi-epitope Folate Receptor Alpha Peptide Vaccine, GM-CSF, and Cyclophosphamide in Treating Patients With Triple Negative Breast Cancer NCT03012100	Phase 2	Active	Academic and Community Cancer Research United	280	2017-03-31 → 2026-07-31
How Precision Diets, Through Gut Bacteria, Affect Anemia in Nepalese Adolescent NCT07661602	Phase 3	Not Yet Recruiting	Southern Medical University, China	60	2026-07 → 2026-11
MMS, IFA, and MMS+IFA Supplementation in Pregnant Women NCT07665957	N/A	Not Yet Recruiting	Sindh Institute of Child Health and Neonatology	402	2026-06-25 → 2027-01-25
Evaluation of Mirvetuximab Soravtansine (IMGN853) in Women With Folate Receptor-α Positive Endometrial Cancer NCT03832361	Phase 2	Recruiting	Alessandro Santin	50	2020-07-15 → 2028-10
Prospective Management of Plaque Instability With Statins and Extra Folic Acid NCT07680595	Phase 1/2	Recruiting	Ruijin Hospital	180	2026-03-01 → 2027-12-31
A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers NCT06376253	Phase 1	Terminated	Novartis Pharmaceuticals	4	2024-09-08 → 2025-07-10

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

Medicare Part D Spending

CMS annual spending data for Folic Acid* (2023)

Total Spending

$4.0M

Total Claims

971,473

Beneficiaries

271,059

Avg Cost/Unit

$0.06

Spending Trend

$690K(2019)→$744K(2020)→$2.9M(2021)→$4.0M(2022)→$4.0M(2023)

YoY Change:-16.0%

5yr CAGR:+2.2%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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 (2)

Sort:

#004 — 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.

#008 — 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

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