Details for New Drug Application (NDA): 021395
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NDA 021395 describes SPIRIVA, which is a drug marketed by Boehringer Ingelheim and is included in two NDAs. It is available from two suppliers. There are sixteen patents protecting this drug and one Paragraph IV challenge. 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. Two suppliers are listed for this compound. Additional details are available on the tiotropium bromide profile page.
The generic ingredient in SPIRIVA is tiotropium bromide. There are eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the tiotropium bromide profile page.
Summary for 021395
| Tradename: | SPIRIVA |
| Applicant: | Boehringer Ingelheim |
| Ingredient: | tiotropium bromide |
| Patents: | 9 |
Pharmacology for NDA: 021395
| Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 021395
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 | 0597-0075-41 | 3 BLISTER PACK in 1 CARTON (0597-0075-41) / 10 CAPSULE in 1 BLISTER PACK |
| SPIRIVA | tiotropium bromide | POWDER;INHALATION | 021395 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0075 | 0597-0075-47 | 9 BLISTER PACK in 1 CARTON (0597-0075-47) / 10 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INHALATION | Strength | EQ 0.018MG BASE/INH | ||||
| Approval Date: | Jan 30, 2004 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Mar 24, 2022 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patent: | ⤷ Sign Up | Patent Expiration: | Mar 24, 2022 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jul 22, 2022 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 021395
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | SPIRIVA | tiotropium bromide | POWDER;INHALATION | 021395-001 | Jan 30, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Boehringer Ingelheim | SPIRIVA | tiotropium bromide | POWDER;INHALATION | 021395-001 | Jan 30, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Boehringer Ingelheim | SPIRIVA | tiotropium bromide | POWDER;INHALATION | 021395-001 | Jan 30, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Boehringer Ingelheim | SPIRIVA | tiotropium bromide | POWDER;INHALATION | 021395-001 | Jan 30, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Boehringer Ingelheim | SPIRIVA | tiotropium bromide | POWDER;INHALATION | 021395-001 | Jan 30, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Boehringer Ingelheim | SPIRIVA | tiotropium bromide | POWDER;INHALATION | 021395-001 | Jan 30, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Boehringer Ingelheim | SPIRIVA | tiotropium bromide | POWDER;INHALATION | 021395-001 | Jan 30, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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