Details for New Drug Application (NDA): 209936
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NDA 209936 describes ALIQOPA, which is a drug marketed by Bayer Healthcare and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the ALIQOPA profile page.
The generic ingredient in ALIQOPA is copanlisib dihydrochloride. One supplier is listed for this compound. Additional details are available on the copanlisib dihydrochloride profile page.
The generic ingredient in ALIQOPA is copanlisib dihydrochloride. One supplier is listed for this compound. Additional details are available on the copanlisib dihydrochloride profile page.
Summary for 209936
| Tradename: | ALIQOPA |
| Applicant: | Bayer Healthcare |
| Ingredient: | copanlisib dihydrochloride |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209936
Generic Entry Date for 209936*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;INTRAVENOUS |
*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: 209936
| Mechanism of Action | Kinase Inhibitors |
Suppliers and Packaging for NDA: 209936
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALIQOPA | copanlisib dihydrochloride | POWDER;INTRAVENOUS | 209936 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-385 | 50419-385-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (50419-385-01) / 4 mL in 1 VIAL, SINGLE-DOSE |
| ALIQOPA | copanlisib dihydrochloride | POWDER;INTRAVENOUS | 209936 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-385 | 50419-385-72 | 1 VIAL, SINGLE-DOSE in 1 CARTON (50419-385-72) / 4 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;INTRAVENOUS | Strength | 60MG/VIAL | ||||
| Approval Date: | Sep 14, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 14, 2024 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH RELAPSED FOLLICULAR LYMPHOMA WHO HAVE RECEIVED AT LEAST TWO PRIOR SYSTEMIC THERAPIES | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 29, 2032 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Try a Trial | Patent Expiration: | May 13, 2024 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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