.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021395

« Back to Dashboard
NDA 021395 describes SPIRIVA, which is a drug marketed by Boehringer Ingelheim and is included in two NDAs. It is available from three suppliers. There are twenty-seven patents protecting this drug. Additional details are available on the SPIRIVA profile page.

The generic ingredient in SPIRIVA 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: 021395

Tradename:
SPIRIVA
Applicant:
Boehringer Ingelheim
Ingredient:
tiotropium bromide
Patents:9

Pharmacology for NDA: 021395

Mechanism of ActionCholinergic Antagonists

Suppliers and Packaging for NDA: 021395

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SPIRIVA
tiotropium bromide
POWDER;INHALATION 021395 NDA Boehringer Ingelheim Pharmaceuticals Inc. 0597-0075 0597-0075-27 1 BLISTER PACK in 1 CARTON (0597-0075-27) > 10 CAPSULE in 1 BLISTER PACK
SPIRIVA
tiotropium bromide
POWDER;INHALATION 021395 NDA Boehringer Ingelheim Pharmaceuticals Inc. 0597-0075 0597-0075-41 3 BLISTER PACK in 1 CARTON (0597-0075-41) > 10 CAPSULE in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrengthEQ 0.018MG BASE/INH
Approval Date:Jan 30, 2004TE:RLD:Yes
Patent:6,777,423Patent Expiration:Sep 24, 2021Product Flag?YSubstance Flag?YDelist Request?
Patent:7,309,707Patent Expiration:Sep 24, 2021Product Flag?YSubstance Flag?YDelist Request?
Patent:7,642,268Patent Expiration:Sep 24, 2021Product Flag?YSubstance Flag?YDelist Request?

Expired Orange Book Patents for NDA: 021395

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
SPIRIVA
tiotropium bromide
POWDER;INHALATION021395-001Jan 30, 20045,478,578► subscribe
Boehringer Ingelheim
SPIRIVA
tiotropium bromide
POWDER;INHALATION021395-001Jan 30, 20045,610,163► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.



Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

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.

`abc