Viewing data from:

SEREVENT

NDA

SALMETEROL XINAFOATE | N020236 | GLAXOSMITHKLINE

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 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma NCT06676319	Phase 2	Active	Sanofi	556	2024-11-07 → 2027-07-19

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

Medicare Part D Spending

CMS annual spending data for Serevent Diskus (2023)

Total Spending

$43.3M

Total Claims

68,127

Beneficiaries

17,314

Avg Cost/Unit

$7.34

Spending Trend

$59.9M(2019)→$60.4M(2020)→$52.8M(2021)→$47.6M(2022)→$43.3M(2023)

YoY Change:+0.8%

5yr CAGR:+3.0%

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

API Supply Chain12 active DMFs9 inactive

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

NATCO PHARMA LTDSALMETEROL XINAFOATE

DMF 183942005

AARTI PHARMALABS LTDSALMETEROL XINAFOATE

DMF 220542008

NEULAND LABORATORIES LTDSALMETEROL XINAFOATE USP

DMF 229732009

INKE SASALMETEROL XINAFOATE

DMF 239142010

GLAXOSMITHKLINE LLCSALMETEROL XINAFOATE

DMF 245822011

GANGWAL HEALTHCARE PRIVATE LTDSALMETEROL XINAFOATE IP/BP

DMF 268632013

MELODY HEALTHCARE PVT LTDSALMETEROL XINAFOATE USP

DMF 303872016

MSN LABORATORIES PRIVATE LTDSALMETEROL XINAFOATE USP

DMF 312422016

HOVIONE FARMACIENCIA SASALMETEROL XINAFOATE INHALATION GRADE

DMF 317952017

HOVIONE PHARMASCIENCE LTDSALMETEROL XINAFOATE MICRONIZED

DMF 327852018

CIPLA LTDSALMETEROL XINAFOATE USP

DMF 343352019

PORTON PHARMA SOLUTIONS LTDSALMETEROL XINAFOATE API

DMF 370702022

CIPLA LTDInactiveSALMETEROL XINAFOATE

DMF 157062001

CIPLA LTDInactiveSALMETEROL XINAFOATE

DMF 183782005

MYLAN LABORATORIES LTDInactiveSALMETEROL XINAFOATE USP

DMF 218592008

DR REDDYS LABORATORIES LTDInactiveSALMETEROL XINAFOATE

DMF 225862009

MELODY HEALTHCARE PVT LTDInactiveSALMETEROL XINAFOATE

DMF 240402010

MSN LABORATORIES PRIVATE LTDInactiveSALMETEROL XINAFOATE USP [ROUTE CODE - SX]

DMF 248282011

CADILA HEALTHCARE LTDInactiveSALMETEROL XINAFOATE USP

DMF 256462012

ASYMCHEM LIFE SCIENCE TIANJIN CO LTDInactiveSALMETEROL XINAFOATE

DMF 286992014

VAMSI LABS LTDInactiveSALMETEROL XINAFOATE EP

DMF 402842024

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Oct 4, 2004	SUPPL -30	View Letter (PDF)
Aug 14, 2003	SUPPL -28	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.021MG BASE/INH

0 patents0 exclusivities▴

AEROSOL, METERED;INHALATION | Approved: Feb 4, 1994

No patent or exclusivity listings for this strength.