Details for New Drug Application (NDA): 210595
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NDA 210595 describes DUAKLIR 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 DUAKLIR PRESSAIR profile page.
The generic ingredient in DUAKLIR PRESSAIR is aclidinium bromide; formoterol fumarate. 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; formoterol fumarate profile page.
The generic ingredient in DUAKLIR PRESSAIR is aclidinium bromide; formoterol fumarate. 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; formoterol fumarate profile page.
Summary for 210595
| Tradename: | DUAKLIR PRESSAIR |
| Applicant: | Covis |
| Ingredient: | aclidinium bromide; formoterol fumarate |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210595
Generic Entry Date for 210595*:
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: 210595
| Mechanism of Action | Adrenergic beta2-Agonists Cholinergic Antagonists |
Suppliers and Packaging for NDA: 210595
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DUAKLIR PRESSAIR | aclidinium bromide; formoterol fumarate | POWDER, METERED;INHALATION | 210595 | NDA | Covis Pharma US, Inc | 70515-001 | 70515-001-01 | 1 POUCH in 1 CARTON (70515-001-01) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER |
| DUAKLIR PRESSAIR | aclidinium bromide; formoterol fumarate | POWDER, METERED;INHALATION | 210595 | NDA | Covis Pharma US, Inc | 70515-001 | 70515-001-03 | 1 POUCH in 1 CARTON (70515-001-03) / 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;0.012MG/INH | ||||
| Approval Date: | Mar 29, 2019 | 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 210595
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