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Details for New Drug Application (NDA): 021936

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NDA 021936 describes SPIRIVA RESPIMAT, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are twenty-four patents protecting this drug. Additional details are available on the SPIRIVA RESPIMAT profile page.

The generic ingredient in SPIRIVA RESPIMAT is tiotropium bromide. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the tiotropium bromide profile page.

Summary for NDA: 021936

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1

Pharmacology for NDA: 021936

Mechanism of ActionCholinergic Antagonists

Suppliers and Packaging for NDA: 021936

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SPIRIVA RESPIMAT
tiotropium bromide
SPRAY, METERED;INHALATION 021936 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0100 0597-0100-28 1 CARTRIDGE in 1 CARTON (0597-0100-28) > 28 SPRAY, METERED in 1 CARTRIDGE
SPIRIVA RESPIMAT
tiotropium bromide
SPRAY, METERED;INHALATION 021936 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0100 0597-0100-61 1 CARTRIDGE in 1 CARTON (0597-0100-61) > 60 SPRAY, METERED in 1 CARTRIDGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;INHALATIONStrengthEQ 0.0025MG BASE/INH
Approval Date:Sep 24, 2014TE:RLD:Yes
Patent:5,964,416*PEDPatent Expiration:Apr 4, 2017Product Flag?Substance Flag?Delist Request?Y
Patent:6,149,054*PEDPatent Expiration:Jun 16, 2017Product Flag?Substance Flag?Delist Request?Y
Patent:6,176,442*PEDPatent Expiration:Dec 1, 2016Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021936

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
SPIRIVA RESPIMAT
tiotropium bromide
SPRAY, METERED;INHALATION021936-001Sep 24, 20146,176,442*PED► Subscribe
Boehringer Ingelheim
SPIRIVA RESPIMAT
tiotropium bromide
SPRAY, METERED;INHALATION021936-001Sep 24, 20146,176,242► Subscribe
Boehringer Ingelheim
SPIRIVA RESPIMAT
tiotropium bromide
SPRAY, METERED;INHALATION021936-002Sep 15, 20156,149,054► Subscribe
Boehringer Ingelheim
SPIRIVA RESPIMAT
tiotropium bromide
SPRAY, METERED;INHALATION021936-002Sep 15, 20157,104,470► Subscribe
Boehringer Ingelheim
SPIRIVA RESPIMAT
tiotropium bromide
SPRAY, METERED;INHALATION021936-002Sep 15, 20157,246,615► Subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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