Drug facts
MoleculeTiotropium (Spiriva Respimat)
Generics already compete: 1 maker on the market. 1 A-rated product from 1 maker substitute at the counter.
Spiriva was first approved by the FDA on 01/30/2004 under NDA 021395; the application holder is Boehringer Ingelheim Pharmaceuticals Inc.
The latest NADAC for TIOTROPIUM 18 MCG CAP-INHALER is $11.90 per unit (as of 10/28/2026).
Holder Boehringer Ingelheim Pharmaceuticals IncApplication NDA 021395Approved 01/30/2004
01Patents and exclusivity
When competition can legally begin. A generic can launch once both exclusivity and the last listed patent expire, unless a court or settlement says otherwise.
Latest listed protection expired 07/19/2026
ExclusivityPatent onlyOpen to generics
Today
Approved01/30/2004
Last patent07/19/2026
200520092013201720212025
- Latest patent
- 07/19/2026Spiriva Orange Book
- Later patents, other products
- Spiriva Respimat 04/16/2031 Orange Book
02Competition
- Generics
- 1 generic maker Orange Book
- First generic approved
- 06/20/2023 Orange Book
Every listingEach listing and maker behind the generics count.
Price erosionHow NADAC moves as generics enter.
PrescribersWho prescribes it, from Medicare data.
Available in the full Tiotropium profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $11.90 per unitTIOTROPIUM 18 MCG CAP-INHALER, as of 10/28/2026 CMS NADAC
- Latest recall
- 01/26/2022Class II, Tiotropium Bromide, Cardinal Healthcare FDA enforcement
04Product
- Application holder
- Boehringer Ingelheim Pharmaceuticals Inc Orange Book
- Application
- NDA 021395 Orange Book
- First approved
- 01/30/2004 Orange Book
- Dosage forms
- powder; spray, metered
- Routes
- inhalation
- Other brand names
- Spiriva
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.