Viewing data from:

MACROBID

NDA

NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE | N020064 | ALMATICA PHARMA LLC

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Kidney Stone Surgery (Percutaneous Nephrolithotomy [PCNL])NCT02384200	Phase 4	Completed	University of California, San Diego	86	2015-03 → 2019-06-01

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$0.3079

per ea

Lowest NADAC/Unit

$0.3079

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
47781030301NITROFURANTOIN MONO-MCR 100 MG	$0.3079	EA	Generic	—	2026-06-17

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 (2 FSS, 2 Big4)

Lowest Price

$0.69

Highest Price

$567.93

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
47781-0303-01NITROFURANTOIN MACROCRYSTALLINE 100MG CAP	$18.84	FSS	Alvogen Inc	08/31/2026
47781-0303-01NITROFURANTOIN MACROCRYSTALLINE 100MG CAP	$0.69	Big4	Alvogen Inc	08/31/2026
52427-0285-01MACROBID 100MG CAPSULES	$567.93	FSS	Almatica LLC.	07/14/2030
52427-0285-01MACROBID 100MG CAPSULES	$440.88	Big4	Almatica LLC.	07/14/2030

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

Medicare Part D Spending

CMS annual spending data for Macrobid (2024)

Total Spending

$75K

Total Claims

590

Beneficiaries

399

Avg Cost/Unit

$5.65

Spending Trend

$104K(2019)→$79K(2020)→$54K(2021)→$57K(2022)→$64K(2023)→$75K(2024)

YoY Change:-1.7%

5yr CAGR:-0.1%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Mar 7, 2023	SUPPL -33	View Letter (PDF)
Jan 22, 2021	SUPPL -29	View Letter (PDF)
Sep 11, 2013	SUPPL -21	View Letter (PDF)
Jun 9, 2011	SUPPL -20	View Letter (PDF)
Mar 6, 2009	SUPPL -19	View Letter (PDF)
Jul 5, 2007	SUPPL -17	View Letter (PDF)
Nov 5, 2003	SUPPL -14	View Letter (PDF)
Feb 4, 2003	SUPPL -13	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 75MG;25MG

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Dec 24, 1991

No patent or exclusivity listings for this strength.