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NDA

TERBUTALINE SULFATE | N017466 | SANOFI AVENTIS US 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from ANDA Consultants FDA-2016-P-3162 ANDA Consultants filed this citizen petition on October 5, 2016, requesting that the FDA Commissioner designate Terbutaline Sulfate Tablets, 5 mg (ANDA 77-152, held by Lannett Holdings Inc.) as a reference listed drug to serve as the reference standard for bioequivalence testing in subsequent abbrev	Other	2016-10-11	Open	ANDA Consultants

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Terbutaline Sulfate* (2023)

Total Spending

$1.5M

Total Claims

3,979

Beneficiaries

1,087

Avg Cost/Unit

$3.29

Spending Trend

$2.8M(2019)→$2.3M(2020)→$2.0M(2021)→$1.7M(2022)→$1.5M(2023)

YoY Change:-5.5%

5yr CAGR:-4.8%

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

API Supply Chain2 active DMFs2 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

CAMBREX PROFARMACO MILANO SRLTERBUTALINE SULFATE

DMF 119271996

MELODY HEALTHCARE PVT LTDTERBUTALINE SULFATE USP

DMF 265632012

CIPLA LTDInactiveTERBUTALINE SULFATE USP

DMF 80621989

INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPAInactiveTERBUTALINE SULFATE

DMF 90651991

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

Products (1)

#001 — 1MG/ML

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.