TIOTROPIUM BROMIDE Drug Patent Profile
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Which patents cover Tiotropium Bromide, and what generic alternatives are available?
Tiotropium Bromide is a drug marketed by Lupin and is included in one NDA.
The generic ingredient in TIOTROPIUM BROMIDE is tiotropium bromide. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the tiotropium bromide profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Tiotropium Bromide
A generic version of TIOTROPIUM BROMIDE was approved as tiotropium bromide by LUPIN on June 20th, 2023.
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Summary for TIOTROPIUM BROMIDE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 103 |
| Clinical Trials: | 115 |
| Patent Applications: | 3,419 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TIOTROPIUM BROMIDE |
| DailyMed Link: | TIOTROPIUM BROMIDE at DailyMed |
Recent Clinical Trials for TIOTROPIUM BROMIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Boehringer Ingelheim | N/A |
| Guangzhou Institute of Respiratory Disease | N/A |
| University of Saskatchewan | Phase 4 |
Pharmacology for TIOTROPIUM BROMIDE
| Drug Class | Anticholinergic |
| Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for TIOTROPIUM BROMIDE
Anatomical Therapeutic Chemical (ATC) Classes for TIOTROPIUM BROMIDE
Paragraph IV (Patent) Challenges for TIOTROPIUM BROMIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| SPIRIVA RESPIMAT | Inhalation Aerosol | tiotropium bromide | 2.5 mcg per actuation | 021936 | 1 | 2023-03-07 |
| SPIRIVA | Inhalation Powder Capsules | tiotropium bromide | 18 mcg | 021395 | 1 | 2018-05-11 |
US Patents and Regulatory Information for TIOTROPIUM BROMIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lupin | TIOTROPIUM BROMIDE | tiotropium bromide | POWDER;INHALATION | 211287-001 | Jun 20, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
