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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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Macrobid (2023)

Total Spending

$64K

Total Claims

483

Beneficiaries

365

Avg Cost/Unit

$5.74

Spending Trend

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

YoY Change:-4.3%

5yr CAGR:+0.4%

Source: CMS Medicare Part D Spending by Drug (2023). 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.