Viewing data from:

METHYLDOPA

NDA

METHYLDOPA | N018934 | CHARTWELL RX SCIENCES LLC

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

12 trials from ClinicalTrials.gov, 7 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy NCT01912677	Phase 4	Completed	Gynuity Health Projects	894	2015-04 → 2017-12
Clinical Bioequivalence Study on Two Methyldopa Tablet 250mg Formulations NCT03210025	Phase 1	Completed	Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited	17	2017-09-20 → 2017-10-15
The Pathophysiology of Orthostatic Hypotension NCT00748059	Phase 1	Completed	Vanderbilt University Medical Center	10	1996-12 → 2020-12
Autonomic Nervous System and Chronic Fatigue Syndrome NCT00580619	Phase 1	Completed	Vanderbilt University	170	2007-04 → 2017-01
Community Level Interventions for Pre-eclampsia NCT01911494	N/A	Completed	University of British Columbia	87,500	2013-09 → 2018-06
Effect of Methyldopa on Uterine Artery Diameter in Pregnant Women With Mild Preeclampsia NCT01674127	Phase 2	Completed	Isfahan University of Medical Sciences	50	2011-08 → 2012-05
Effect of Methyldopa on MHC Class II Antigen Presentation in Type 1 Diabetes NCT01883804	N/A	Completed	University of Colorado, Denver	30	2013-06 → 2016-02
Cardiovascular and Autonomic Reactivity in Women With a History of Pre-eclampsia NCT00117546	Phase 4	UNKNOWN	Radboud University Medical Center	35	2005-09 → 2008-12
Early Vascular Adjustments During Hypertensive Pregnancy NCT02531490	Phase 4	UNKNOWN	Maastricht University Medical Center	368	2015-01-01 → 2023-04
Methyldopa for Reduction of DQ8 Antigen Presentation in At-Risk Subjects for Type 1 Diabetes NCT03396484	Phase 2	Withdrawn	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	—	2020-09 → 2022-03

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$7.50

per ea

Lowest NADAC/Unit

$7.50

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
62135032118METHYLDOPA 250 MG TABLET	$7.50	EA	Generic	—	2025-07-23
62135032190METHYLDOPA 250 MG TABLET	$7.50	EA	Generic	—	2025-07-23

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (4 FSS)

Lowest Price

$641.24

Highest Price

$1709.99

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
62135-0321-18METHYLDOPA 250MG TAB	$1282.49	FSS	Chartwell RX LLC	02/28/2027
62135-0321-90METHYLDOPA 250MG TAB	$641.24	FSS	Chartwell RX LLC	02/28/2027
62135-0322-18METHYLDOPA 500MG TAB	$1709.99	FSS	Chartwell RX LLC	02/28/2027
62135-0322-90METHYLDOPA 500MG TAB	$854.99	FSS	Chartwell RX LLC	02/28/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain4 active DMFs5 inactive

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

ZHEJIANG CHIRAL MEDICINE CHEMICALS CO LTDMETHYLDOPA

DMF 205652007

ZHEJIANG WILD WIND PHARMACEUTICAL CO LTDMETHYLDOPA (NON-STERILE, BULK FORM)

DMF 224252008

TAPI NL BVMETHYLDOPA

DMF 267262013

ZHEJIANG YONGTAI CHIRAL MEDICINE TECHNOLOGY CO LTDMETHYLDOPA

DMF 428292025

ANTIBIOTICOS SPAInactiveMETHYLDOPA USP

DMF 26961976

PLANTEX LTD CHEMICAL AND PHARMACEUTICAL WORKSInactiveMETHYLDOPA USP

DMF 32431978

ACIC LTDInactiveMETHYLDOPA USP

DMF 34721979

FARCHEMIA SRLInactiveMETHYLDOPA

DMF 61401985

DIVIS LABORATORIES LTDInactiveMETHYLDOPA USP

DMF 176992004

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

Products (2)

Sort:

#001 — 250MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 29, 1984

No patent or exclusivity listings for this strength.

#002 — 500MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 29, 1984