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NDA

CROMOLYN SODIUM | N016990 | 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Inhaled Cromolyn Sodium in Patients With Locally Advanced Lung Cancer NCT07675876	Phase 1	Not Yet Recruiting	Carcinex Inc	10	2026-08 → 2027-08

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

Medicare Part D Spending

CMS annual spending data for Cromolyn Sodium* (2023)

Total Spending

$9.1M

Total Claims

88,121

Beneficiaries

37,634

Avg Cost/Unit

$1.29

Spending Trend

$7.6M(2019)→$9.0M(2020)→$9.9M(2021)→$10.5M(2022)→$9.1M(2023)

YoY Change:+0.1%

5yr CAGR:+2.5%

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

API Supply Chain4 active DMFs6 inactive

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

CAMBREX PROFARMACO MILANO SRLCROMOLYN SODIUM / SODIUM CROMOGLICATE

DMF 81641989

OLON SPACROMOLYN SODIUM

DMF 82341989

FERMION OYCROMOLYN SODIUM

DMF 100061992

MICRO LABS LTDCROMOLYN SODIUM USP

DMF 375982022

AVENTIS PHARMA SAInactiveCROMOLYN SODIUM AND CROMOLYN SODIUM/LACTOSE BLEND

DMF 15811970

FRANCIS SPAInactiveCROMOLYN SODIUM

DMF 77191988

RALLIS INDIA LTDInactiveCROMOLYN SODIUM

DMF 82081989

SOCIETA ITALIANA MEDICINALI SCANDICCIInactiveCROMOLYN SODIUM

DMF 107361994

FARMHISPANIA SAInactiveCROMOLYN SODIUM

DMF 110501994

LIPHA SASInactiveCROMOLYN SODIUM

DMF 117241995

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

Products (1)

#001 — 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.