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TESSALON

NDA

BENZONATATE | N011210 | PFIZER 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Lachman Consultant Services, Inc. FDA-2009-P-0190 · 6 docket documents Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Benzonatate Capsules at 125 mg and 175 mg dosage strengths suitable for consideration in an abbreviated new	Other	2009-04-21	Denied	Lachman Consultant Services, Inc.

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

Clinical Trials

4 trials from ClinicalTrials.gov, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Benzonatate Dose Tolerance Study NCT01690975	Phase 1	Completed	Pfizer	9	2012-07 → 2012-08
Evaluation of the Effect of Benzonatate on QT Intervals Following Single Dose Administration of Benzonatate to Healthy Volunteers NCT02207699	Phase 1	Completed	Pfizer	68	2014-05 → 2014-07
A Study on the Efficacy and Safety of Benzonatate Soft Capsules for Improving Adult Cough Symptoms NCT03722914	Phase 3	UNKNOWN	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	220	2018-03-01 → 2019-07-31
A Study of Benzonatate Soft Capsule in Chinese Healthy Subjects NCT03922373	Phase 1	UNKNOWN	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	40	2018-09-10 → 2019-04-30

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

Medicare Part D Spending

CMS annual spending data for Benzonatate (2024)

Total Spending

$1.9M

Total Claims

169,630

Beneficiaries

120,880

Avg Cost/Unit

$0.37

Spending Trend

$382K(2019)→$562K(2020)→$626K(2021)→$1.2M(2022)→$1.5M(2023)→$1.9M(2024)

YoY Change:+1.7%

5yr CAGR:-0.6%

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

API Supply Chain4 active DMFs1 inactive

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

W R GRACE AND CO -CONNBENZONATATE USP

DMF 51961983

SIEGFRIED EVIONNAZ SABENZONATATE

DMF 78431988

FORMOSA LABORATORIES INCBENZONATATE USP

DMF 217032008

AMI LIFESCIENCES PRIVATE LTDBENZONATATE

DMF 390022023

KINGLAND CHEMICALS CO LTDInactiveBENZONATATE

DMF 241942010

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 25, 2011	SUPPL -53	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 100MG

RLDAA

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#003 — 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jun 25, 1999