ALIQOPA Drug Patent Profile
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When 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-three 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.
DrugPatentWatch® Generic Entry Outlook for Aliqopa
Aliqopa was eligible for patent challenges on September 14, 2021.
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: | 153 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 73 |
| Clinical Trials: | 16 |
| Patent Applications: | 717 |
| Drug Prices: | Drug price information for ALIQOPA |
| What excipients (inactive ingredients) are in ALIQOPA? | ALIQOPA excipients list |
| DailyMed Link: | ALIQOPA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 |
|---|---|
| NRG Oncology | Phase 2 |
| City of Hope Medical Center | Phase 1/Phase 2 |
| Dana-Farber Cancer Institute | Phase 1/Phase 2 |
Pharmacology for ALIQOPA
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for ALIQOPA
US Patents and Regulatory Information for ALIQOPA
ALIQOPA is protected by four US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ALIQOPA is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting ALIQOPA
Substituted 2,3-dihydroimidazo[1,2-c]quinazoline salts
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Fused azole-pyrimidine derivatives
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Substituted 2,3-dihydroimidazo[1,2-C]quinazoline salts
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH RELAPSED FOLLICULAR LYMPHOMA WHO HAVE RECEIVED AT LEAST TWO PRIOR SYSTEMIC THERAPIES
Substituted 2,3-dihydroimidazo[1,2-c]quinazoline derivatives useful for treating hyper-proliferative disorders and diseases associated with angiogenesis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH RELAPSED FOLLICULAR LYMPHOMA WHO HAVE RECEIVED AT LEAST TWO PRIOR SYSTEMIC THERAPIES
FDA Regulatory Exclusivity protecting ALIQOPA
TREATMENT OF ADULT PATIENTS WITH RELAPSED FOLLICULAR LYMPHOMA WHO HAVE RECEIVED AT LEAST TWO PRIOR SYSTEMIC THERAPIES
Exclusivity Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Bayer Healthcare | ALIQOPA | copanlisib dihydrochloride | POWDER;INTRAVENOUS | 209936-001 | Sep 14, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Bayer Healthcare | ALIQOPA | copanlisib dihydrochloride | POWDER;INTRAVENOUS | 209936-001 | Sep 14, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Bayer Healthcare | ALIQOPA | copanlisib dihydrochloride | POWDER;INTRAVENOUS | 209936-001 | Sep 14, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a 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
When does loss-of-exclusivity occur for ALIQOPA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
African Regional IP Organization (ARIPO)
Patent: 09
Estimated Expiration: ⤷ Try a Trial
Argentina
Patent: 5718
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 12238891
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2013025549
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 32123
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 13002870
Estimated Expiration: ⤷ Try a Trial
China
Patent: 3649091
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 81534
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 130511
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0150138
Estimated Expiration: ⤷ Try a Trial
Cuba
Patent: 208
Estimated Expiration: ⤷ Try a Trial
Patent: 130133
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 16231
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 94508
Estimated Expiration: ⤷ Try a Trial
Dominican Republic
Patent: 013000223
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 13013006
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 3646
Estimated Expiration: ⤷ Try a Trial
Patent: 1391470
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 08525
Estimated Expiration: ⤷ Try a Trial
Patent: 94508
Estimated Expiration: ⤷ Try a Trial
Guatemala
Patent: 1300234
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 95907
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 8561
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 63834
Estimated Expiration: ⤷ Try a Trial
Patent: 26961
Estimated Expiration: ⤷ Try a Trial
Patent: 14510119
Estimated Expiration: ⤷ Try a Trial
Patent: 15164936
Estimated Expiration: ⤷ Try a Trial
Jordan
Patent: 58
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 9452
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 6057
Estimated Expiration: ⤷ Try a Trial
Patent: 13011583
Estimated Expiration: ⤷ Try a Trial
Montenegro
Patent: 021
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 014
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 6198
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 141038
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 94508
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 94508
Estimated Expiration: ⤷ Try a Trial
San Marino
Patent: 01500037
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 811
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 3595
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 94508
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1307105
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1937501
Estimated Expiration: ⤷ Try a Trial
Patent: 140021637
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 29653
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 49954
Estimated Expiration: ⤷ Try a Trial
Patent: 92158
Estimated Expiration: ⤷ Try a Trial
Patent: 1249847
Estimated Expiration: ⤷ Try a Trial
Patent: 1637656
Estimated Expiration: ⤷ Try a Trial
Tunisia
Patent: 13000401
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 1604
Estimated Expiration: ⤷ Try a Trial
Uruguay
Patent: 985
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering ALIQOPA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Denmark | 2096919 | ⤷ Try a Trial | |
| Cyprus | 1112174 | ⤷ Try a Trial | |
| Poland | 226562 | ⤷ Try a Trial | |
| Malaysia | 169452 | SUBSTITUTED 2,3-DIHYDROIMIDAZO[1,2-C]QUINAZOLINE SALTS | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2023, www.DrugPatentWatch.com.
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