Drug
Who makes tiotropium bromide?
3 companies list tiotropium bromide as a human prescription drug, including under the names Spiriva HandiHaler. Forms: capsule. Routes: oral, respiratory (inhalation).
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing tiotropium bromide
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| International Medication Systems, Ltd.United States | capsule | NDANDA021395 | 2 | 3 |
| Lupin LimitedIndia | capsule | ANDAANDA211287 | 1 | 14 |
| Boehringer Ingelheim Biopharmaceuticals China LtdGermany | capsule | NDANDA021395 | 1 | 3 |
Bulk ingredient listings
- Boehringer Ingelheim Biopharmaceuticals China LtdGermany · 1 NDC
- Cerbios-Pharma SASwitzerland · 1 NDC
- WAVELENGTH ENTERPRISES LTDIsrael · 1 NDC
Orange Book patents
4 unexpired patents list tiotropium bromide as the active ingredient, expiring between Apr 2027 and Apr 2031. Application holder: BOEHRINGER INGELHEIM PHARMACEUTICALS INC.
Enquiry
Common questions
- Who makes tiotropium bromide?
- 3 companies list tiotropium bromide as a human prescription drug in the openFDA NDC Directory, led by International Medication Systems, Ltd., Lupin Limited, Boehringer Ingelheim Biopharmaceuticals China Ltd. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Spiriva HandiHaler?
- 1 company lists tiotropium bromide under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies tiotropium bromide active ingredient?
- 3 companies list tiotropium bromide as a bulk ingredient, including Boehringer Ingelheim Biopharmaceuticals China Ltd, Cerbios-Pharma SA, WAVELENGTH ENTERPRISES LTD.