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ALIQOPA Drug Profile
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» See Plans and PricingWhen do Aliqopa patents expire, and when can generic versions of Aliqopa launch?
Aliqopa is a drug marketed by Bayer Healthcare and is included in one NDA. There are four patents protecting this drug.
This drug has one hundred and fifty-two patent family members in fifty countries.
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.
US ANDA Litigation and Generic Entry Outlook for Aliqopa
Aliqopa will be eligible for patent challenges on September 14, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be March 29, 2032. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for ALIQOPA
| International Patents: | 152 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 55 |
| Clinical Trials: | 6 |
| Patent Applications: | 34 |
| Drug Prices: | Drug price information for ALIQOPA |
| DailyMed Link: | ALIQOPA at DailyMed |
Generic Entry Opportunity Date for ALIQOPA
Generic Entry Date for ALIQOPA*:
Constraining patent/regulatory exclusivity:
NDA:
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.
Recent Clinical Trials for ALIQOPA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Bayer | Phase 1/Phase 2 |
| The Miriam Hospital | Phase 1/Phase 2 |
| Clovis Oncology, Inc. | Phase 1/Phase 2 |
Pharmacology for ALIQOPA
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Kinase Inhibitors |
US Patents and Regulatory Information for ALIQOPA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bayer Healthcare | ALIQOPA | copanlisib dihydrochloride | POWDER;INTRAVENOUS | 209936-001 | Sep 14, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Bayer Healthcare | ALIQOPA | copanlisib dihydrochloride | POWDER;INTRAVENOUS | 209936-001 | Sep 14, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Bayer Healthcare | ALIQOPA | copanlisib dihydrochloride | POWDER;INTRAVENOUS | 209936-001 | Sep 14, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for ALIQOPA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Guatemala | 201300234 | Start Trial |
| Taiwan | I406662 | Start Trial |
| Mexico | PA05001808 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
