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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 203108


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NDA 203108 describes STRIVERDI RESPIMAT, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the STRIVERDI RESPIMAT profile page.

The generic ingredient in STRIVERDI RESPIMAT is olodaterol hydrochloride. One supplier is listed for this compound. Additional details are available on the olodaterol hydrochloride profile page.
Summary for 203108
Tradename:STRIVERDI RESPIMAT
Applicant:Boehringer Ingelheim
Ingredient:olodaterol hydrochloride
Patents:9
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 203108
Generic Entry Date for 203108*:
Constraining patent/regulatory exclusivity:
Dosage:
SPRAY, METERED;INHALATION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 203108
Mechanism of ActionAdrenergic beta2-Agonists
Suppliers and Packaging for NDA: 203108
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
STRIVERDI RESPIMAT olodaterol hydrochloride SPRAY, METERED;INHALATION 203108 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0192 0597-0192-61 1 CARTRIDGE in 1 CARTON (0597-0192-61) / 60 SPRAY, METERED in 1 CARTRIDGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;INHALATIONStrengthEQ 0.0025MG BASE/INH
Approval Date:Jul 31, 2014TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:May 12, 2025Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), CHRONIC BRONCHITIS OR EMPHYSEMA
Patent:⤷  Sign UpPatent Expiration:Aug 26, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Oct 10, 2026Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), CHRONIC BRONCHITIS OR EMPHYSEMA

Expired US Patents for NDA 203108

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim STRIVERDI RESPIMAT olodaterol hydrochloride SPRAY, METERED;INHALATION 203108-001 Jul 31, 2014 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim STRIVERDI RESPIMAT olodaterol hydrochloride SPRAY, METERED;INHALATION 203108-001 Jul 31, 2014 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim STRIVERDI RESPIMAT olodaterol hydrochloride SPRAY, METERED;INHALATION 203108-001 Jul 31, 2014 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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