Details for New Drug Application (NDA): 202450
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NDA 202450 describes TUDORZA PRESSAIR, which is a drug marketed by Covis and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the TUDORZA PRESSAIR profile page.
The generic ingredient in TUDORZA PRESSAIR is aclidinium bromide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the aclidinium bromide profile page.
The generic ingredient in TUDORZA PRESSAIR is aclidinium bromide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the aclidinium bromide profile page.
Summary for 202450
| Tradename: | TUDORZA PRESSAIR |
| Applicant: | Covis |
| Ingredient: | aclidinium bromide |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 202450
Generic Entry Date for 202450*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER, METERED;INHALATION |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 202450
| Mechanism of Action | Cholinergic Antagonists |
Suppliers and Packaging for NDA: 202450
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TUDORZA PRESSAIR | aclidinium bromide | POWDER, METERED;INHALATION | 202450 | NDA | Covis Pharma US, Inc | 70515-002 | 70515-002-01 | 1 POUCH in 1 CARTON (70515-002-01) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER |
| TUDORZA PRESSAIR | aclidinium bromide | POWDER, METERED;INHALATION | 202450 | NDA | Covis Pharma US, Inc | 70515-002 | 70515-002-02 | 1 POUCH in 1 CARTON (70515-002-02) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER, METERED;INHALATION | Strength | 0.4MG/INH | ||||
| Approval Date: | Jul 23, 2012 | TE: | RLD: | Yes | |||||
| Patent: | 10,085,974 | Patent Expiration: | Mar 13, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) | ||||||||
| Patent: | 11,000,517 | Patent Expiration: | Mar 13, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) | ||||||||
Expired US Patents for NDA 202450
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Covis | TUDORZA PRESSAIR | aclidinium bromide | POWDER, METERED;INHALATION | 202450-001 | Jul 23, 2012 | RE46417 | ⤷ Get Started Free |
| Covis | TUDORZA PRESSAIR | aclidinium bromide | POWDER, METERED;INHALATION | 202450-001 | Jul 23, 2012 | 6,681,768 | ⤷ Get Started Free |
| Covis | TUDORZA PRESSAIR | aclidinium bromide | POWDER, METERED;INHALATION | 202450-001 | Jul 23, 2012 | 9,333,195 | ⤷ Get Started Free |
| Covis | TUDORZA PRESSAIR | aclidinium bromide | POWDER, METERED;INHALATION | 202450-001 | Jul 23, 2012 | 10,034,867 | ⤷ Get Started Free |
| Covis | TUDORZA PRESSAIR | aclidinium bromide | POWDER, METERED;INHALATION | 202450-001 | Jul 23, 2012 | 7,078,412 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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