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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition FDA-2009-P-0597 · 35 docket documents GlaxoSmithKline filed this citizen petition on December 16, 2009, requesting that the FDA ensure that abbreviated new drug applications (ANDAs) for generic versions of inhalation products containing fluticasone propionate and/or salmeterol xinafoate not be approved unless the generic copies maintain	505(q)	2009-12-29	Partially Denied	—

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

Clinical Trials

263 trials from ClinicalTrials.gov — 1 recruiting, 227 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Mechanism(s) of Airflow Limitation During Exacerbation of Asthma NCT01225913	Phase 4	Recruiting	Gelb, Arthur F., M.D.	50	2007-10 → 2027-06
Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets NCT00328718	Phase 3	Completed	GlaxoSmithKline	526	2005-10 → 2007-04
Clinical Endpoint Bioequivalence Study for Fluticasone Propionate and Salmeterol Xinafoate NCT02649478	N/A	Completed	Roxane Laboratories	1,430	2014-08 → 2015-11
A Bioequivalence Study Between Fluticasone Propionate 100 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 100/50 Inhalation Powder/GSK in Healthy Volunteers NCT03975166	Phase 1	Completed	Respirent Pharmaceuticals Co Ltd.	34	2019-05-21 → 2019-08-10
A Study to Assess the Efficacy of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)NCT01706328	Phase 3	Completed	GlaxoSmithKline	828	2012-10-15 → 2013-06-17
Evaluating the Control of COPD Symptoms in Patients Treated With Tiotropium Bromide 18mcg Once Daily Alone, ADOAIR 50/250mcg Twice Daily Alone or ADOAIR 50/250mcg Plus Tiotropium Bromide 18mcg NCT01762800	Phase 4	Completed	GlaxoSmithKline	407	2013-02 → 2015-09
Bioequivalence Study of Synflutide HFA Inhaler and Seretide Evohaler in Healthy Volunteers With Charcoal Block NCT02466503	Phase 1	Completed	Intech Biopharm Ltd.	45	2014-08 → 2014-09
Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler NCT02980133	Phase 3	Completed	Teva Branded Pharmaceutical Products R&D, Inc.	841	2016-12-28 → 2019-04-13
Study Of Asthma In Patients Of African Descent NCT00102765	Phase 4	Completed	GlaxoSmithKline	479	2004-11 → 2007-04
Advair® DISKUS® Versus Serevent® DISKUS® For Chronic Obstructive Pulmonary Disease Exacerbations NCT00115492	Phase 4	Completed	GlaxoSmithKline	797	2004-12 → 2007-06

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

API Supply Chain13 active DMFs9 inactive

13 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

AMPHASTAR NANJING PHARMACEUTICALS INCSALMETEROL XINAFOATE, USP

DMF 294912015

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.