Aliqopa is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is protected by 5 US drug patents filed from 2017 to 2019. Out of these, 4 drug patents are active and 1 has expired. Aliqopa's patents have been open to challenges since 14 September, 2021. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 29, 2032. Details of Aliqopa's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US10383876 | Substituted 2,3-dihydroimidazo[1,2-c]quinazoline salts |
Mar, 2032
(7 years from now) | Active |
| US8466283 | Substituted 2,3-dihydroimidazo[1,2-c]quinazoline derivatives useful for treating hyper-proliferative disorders and diseases associated with angiogenesis |
Oct, 2029
(4 years from now) | Active |
| USRE46856 | Substituted 2,3-dihydroimidazo[1,2-c]quinazoline derivatives useful for treating hyper-proliferative disorders and diseases associated with angiogenesis |
Oct, 2029
(4 years from now) | Active |
| US7511041 | Fused azole-pyrimidine derivatives |
May, 2024
(6 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9636344 | Substituted 2,3-dihydroimidazo[1,2-C]quinazoline salts |
Mar, 2032
(7 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Aliqopa's patents.
Latest Legal Activities on Aliqopa's Patents
Given below is the list of recent legal activities going on the following patents of Aliqopa.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Letter from FDA or Dept of Agriculture re PTE application | 18 Mar, 2024 | US7511041 |
| Notice of Final Determination -Eligible | 07 Dec, 2023 | US7511041 |
| FDA Final Eligibility Letter Critical | 14 Nov, 2023 | US7511041 |
| transaction for FDA Determination of Regulatory Review Period | 14 Feb, 2023 | US7511041 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 08 Feb, 2023 | US10383876 |
| transaction for FDA Determination of Regulatory Review Period | 18 Jan, 2023 | US7511041 |
| Second letter to regulating agency to determine regulatory review period | 23 Mar, 2021 | US7511041 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 28 Sep, 2020 | US9636344 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 17 Sep, 2020 | US7511041 |
| Recordation of Patent Grant Mailed Critical | 20 Aug, 2019 | US10383876 |
FDA has granted several exclusivities to Aliqopa. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Aliqopa, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Aliqopa.
Exclusivity Information
Aliqopa holds 3 exclusivities. All of its exclusivities have expired in 2024. Details of Aliqopa's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 14, 2022 |
| Orphan Drug Exclusivity(ODE) | Sep 14, 2024 |
| Orphan Drug Exclusivity(ODE-155) | Sep 14, 2024 |
US patents provide insights into the exclusivity only within the United States, but Aliqopa is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Aliqopa's family patents as well as insights into ongoing legal events on those patents.
Aliqopa's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Aliqopa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 29, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Aliqopa Generics:
There are no approved generic versions for Aliqopa as of now.
About Aliqopa
Aliqopa is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is used for treating relapsed follicular lymphoma in adult patients who have not responded to at least two prior systemic therapies. Aliqopa uses Copanlisib Dihydrochloride as an active ingredient. Aliqopa was launched by Bayer Healthcare in 2017.
Approval Date:
Aliqopa was approved by FDA for market use on 14 September, 2017.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Aliqopa is 14 September, 2017, its NCE-1 date is estimated to be 14 September, 2021.
Active Ingredient:
Aliqopa uses Copanlisib Dihydrochloride as the active ingredient. Check out other Drugs and Companies using Copanlisib Dihydrochloride ingredient
Treatment:
Aliqopa is used for treating relapsed follicular lymphoma in adult patients who have not responded to at least two prior systemic therapies.
Dosage:
Aliqopa is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 60MG/VIAL | POWDER | Discontinued | INTRAVENOUS |