Details for New Drug Application (NDA): 209936
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The generic ingredient in ALIQOPA is copanlisib dihydrochloride. 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.
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: | ⤷ Subscribe | Patent Expiration: | Mar 29, 2032 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patent: | ⤷ Subscribe | Patent Expiration: | May 13, 2024 | Product Flag? | Y | Substance Flag? | Y | Delist Request? |
Expired US Patents for NDA 209936
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bayer Healthcare | ALIQOPA | copanlisib dihydrochloride | POWDER;INTRAVENOUS | 209936-001 | Sep 14, 2017 | ⤷ Subscribe | ⤷ Subscribe |
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