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. There are three patents protecting this drug. Additional details are available on the ALIQOPA profile page.
The generic ingredient in ALIQOPA is copanlisib dihydrochloride. There is one drug master file entry for this compound. Additional details are available on the copanlisib dihydrochloride profile page.
The generic ingredient in ALIQOPA is copanlisib dihydrochloride. There is one drug master file entry 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: | 3 |
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 | |||||
| Patent: | 10,383,876 | Patent Expiration: | Mar 29, 2032 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | 9,636,344 | Patent Expiration: | Mar 29, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ADULT PATIENTS WITH RELAPSED FOLLICULAR LYMPHOMA WHO HAVE RECEIVED AT LEAST TWO PRIOR SYSTEMIC THERAPIES | ||||||||
| Patent: | RE46856 | Patent Expiration: | Oct 22, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF ADULT PATIENTS WITH RELAPSED FOLLICULAR LYMPHOMA WHO HAVE RECEIVED AT LEAST TWO PRIOR SYSTEMIC THERAPIES | ||||||||
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 | 7,511,041 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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