Calquence is a drug owned by Astrazeneca Uk Ltd. It is protected by 9 US drug patents filed from 2018 to 2026 out of which none have expired yet. Calquence's patents have been open to challenges since 31 October, 2021. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 01, 2036. Details of Calquence'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. | |||
| US9796721 | Crystal forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide |
Jul, 2036
(9 years from now) | Active |
| US9290504 | 4-imidazopyridazin-1-yl-benzamides and 4-imidazotriazin-1-yl-benzamides as Btk inhibitors |
Jul, 2032
(5 years from now) | Active |
| US7459554 | Imidazopyrazine tyrosine kinase inhibitors |
Nov, 2026
(a month from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10167291 | Pharmaceutical composition comprising a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl) pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide |
Jul, 2036
(9 years from now) | Active |
| US11166951 | Therapeutic Combinations Of A Btk Inhibitor, A Pi3K Inhibitor, A Jak-2 Inhibitor, And/Or A Bcl-2 Inhibitor |
Aug, 2035
(8 years from now) | Active |
| US10272083 | Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor |
Jan, 2035
(8 years from now) | Active |
| US11771696 | Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor |
Jan, 2035
(8 years from now) | Active |
| US10239883 | 4-imidazopyridazin-1-yl-benzamides as BTK inhibitors |
Jul, 2032
(5 years from now) | Active |
| US9758524 | 4-imidazopyridazin-1-yl-benzamides as Btk inhibitors |
Jul, 2032
(5 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 Calquence's patents.
Latest Legal Activities on Calquence's Patents
Given below is the list of recent legal activities going on the following patents of Calquence.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Post Issue Communication - Certificate of Correction | 03 Apr, 2025 | US10272083 |
| Surcharge for Late Payment, Large Entity | 02 Apr, 2025 | US11059829 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 02 Apr, 2025 | US11059829 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 12 Mar, 2025 | US9758524 |
| Maintenance Fee Reminder Mailed | 03 Mar, 2025 | US11059829 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 12 Feb, 2025 | US9796721 |
| Recordation of Patent eCertificate of Correction | 26 Mar, 2024 | US11771696 |
| Patent eCofC Notification | 26 Mar, 2024 | US11771696 |
| Email Notification
Critical | 26 Mar, 2024 | US11771696 |
| Mail Patent eCofC Notification | 26 Mar, 2024 | US11771696 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets
invalidated somehow, the
generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal
pitfalls. Given
below are details of the litigation history of Calquence and ongoing
litigations to
help you estimate the early arrival of Calquence generic.
Calquence's Litigations
Calquence been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Feb 03, 2023, against patent number US10272083. The petitioner Sandoz Inc., challenged the validity of this patent, with Acerta Pharma B.V. et al. as the respondent. Click below to track the latest information on how companies are challenging Calquence's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US10272083 | February, 2023 |
Institution Denied
(07 Aug, 2023) | Acerta Pharma B.V. et al. | Sandoz Inc. |
FDA has granted some exclusivities to Calquence. Till the time these
exclusivities are
active, no other company can market a generic or bioequivalent version of Calquence,
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
Calquence.
Exclusivity Information
Calquence holds 6 exclusivities out of which 3 have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Calquence's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 31, 2022 |
| New Indication(I-817) | Nov 21, 2022 |
| Orphan Drug Exclusivity(ODE-175) | Oct 31, 2024 |
| Orphan Drug Exclusivity(ODE-274) | Nov 21, 2026 |
| New Indication(I-960) | Jan 16, 2028 |
| New Dosing Schedule(D-200) | Feb 19, 2029 |
Several oppositions have been filed on Calquence's European patents.
EP oppositions
can significantly impact the timeline for the generic launch of drugs. If an opposition results in the
revocation or
amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an
earlier entry
of generic versions into the market. To help you estimate the potential early arrival of Calquence's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Calquence patents.
Calquence's Oppositions Filed in EPO
Calquence has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jan 21, 2021, by Lederer & Keller Patentanwälte Partnerschaft Mbb. This opposition was filed on patent number EP16735945A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP16735945A | Jan, 2021 | Lederer & Keller Patentanwälte Partnerschaft mbB | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but
Calquence 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 Calquence's family patents as well as insights into
ongoing legal events
on those patents.
Calquence's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Calquence:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Calquence's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 01, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Calquence Generics:
There are no approved generic versions for Calquence as of now.
How can I launch a generic of Calquence before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Calquence's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Calquence's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Calquence -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 01 Nov, 2021 | 01 Jul, 2036 | Moderate |
Alternative Brands for Calquence
Calquence which is used for treating adult patients with various types of leukemia and lymphoma., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Beone Medicines Usa |
| |||
About Calquence
Calquence is a drug owned by Astrazeneca Uk Ltd. It is used for treating adult patients with various types of leukemia and lymphoma. Calquence uses Acalabrutinib as an active ingredient. Calquence was launched by Astrazeneca in 2017.
Approval Date:
Calquence was approved by FDA for market use on 31 October, 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 Calquence is 31 October, 2017, its NCE-1 date is estimated to be 31 October, 2021.
Active Ingredient:
Calquence uses Acalabrutinib as the active ingredient. Check out other Drugs and Companies using Acalabrutinib ingredient
Treatment:
Calquence is used for treating adult patients with various types of leukemia and lymphoma.
Dosage:
Calquence is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG | CAPSULE | Prescription | ORAL |
Calquence is a drug owned by Astrazeneca Uk Ltd. It is protected by 8 US drug patents filed from 2022 to 2026 out of which none have expired yet. Calquence's patents have been open to challenges since 31 October, 2021. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 01, 2036. Details of Calquence'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. | |||
| US11059829 | Crystal forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide maleate |
Jul, 2036
(9 years from now) | Active |
| US9290504 | 4-imidazopyridazin-1-yl-benzamides and 4-imidazotriazin-1-yl-benzamides as Btk inhibitors |
Jul, 2032
(5 years from now) | Active |
| US7459554 | Imidazopyrazine tyrosine kinase inhibitors |
Nov, 2026
(a month from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11166951 | Therapeutic Combinations Of A Btk Inhibitor, A Pi3K Inhibitor, A Jak-2 Inhibitor, And/Or A Bcl-2 Inhibitor |
Aug, 2035
(8 years from now) | Active |
| US11771696 | Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor |
Jan, 2035
(8 years from now) | Active |
| US10272083 | Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor |
Jan, 2035
(8 years from now) | Active |
| US10239883 | 4-imidazopyridazin-1-yl-benzamides as BTK inhibitors |
Jul, 2032
(5 years from now) | Active |
| US9758524 | 4-imidazopyridazin-1-yl-benzamides as Btk inhibitors |
Jul, 2032
(5 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 Calquence's patents.
Latest Legal Activities on Calquence's Patents
Given below is the list of recent legal activities going on the following patents of Calquence.
| Activity | Date | Patent Number |
|---|---|---|
| | ||
| Post Issue Communication - Certificate of Correction | 03 Apr, 2025 | US10272083 |
| Surcharge for Late Payment, Large Entity | 02 Apr, 2025 | US11059829 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 02 Apr, 2025 | US11059829 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 12 Mar, 2025 | US9758524 |
| Maintenance Fee Reminder Mailed | 03 Mar, 2025 | US11059829 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 12 Feb, 2025 | US9796721 |
| Recordation of Patent eCertificate of Correction | 26 Mar, 2024 | US11771696 |
| Patent eCofC Notification | 26 Mar, 2024 | US11771696 |
| Email Notification
Critical | 26 Mar, 2024 | US11771696 |
| Mail Patent eCofC Notification | 26 Mar, 2024 | US11771696 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets
invalidated somehow, the
generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal
pitfalls. Given
below are details of the litigation history of Calquence and ongoing
litigations to
help you estimate the early arrival of Calquence generic.
Calquence's Litigations
Calquence been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Feb 03, 2023, against patent number US10272083. The petitioner Sandoz Inc., challenged the validity of this patent, with Acerta Pharma B.V. et al. as the respondent. Click below to track the latest information on how companies are challenging Calquence's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
| | ||||
| US10272083 | February, 2023 |
Institution Denied
(07 Aug, 2023) | Acerta Pharma B.V. et al. | Sandoz Inc. |
FDA has granted some exclusivities to Calquence. Till the time these
exclusivities are
active, no other company can market a generic or bioequivalent version of Calquence,
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
Calquence.
Exclusivity Information
Calquence holds 6 exclusivities out of which 3 have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Calquence's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 31, 2022 |
| New Indication(I-817) | Nov 21, 2022 |
| Orphan Drug Exclusivity(ODE-175) | Oct 31, 2024 |
| Orphan Drug Exclusivity(ODE-274) | Nov 21, 2026 |
| New Indication(I-960) | Jan 16, 2028 |
| New Dosing Schedule(D-200) | Feb 19, 2029 |
Several oppositions have been filed on Calquence's European patents.
EP oppositions
can significantly impact the timeline for the generic launch of drugs. If an opposition results in the
revocation or
amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an
earlier entry
of generic versions into the market. To help you estimate the potential early arrival of Calquence's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Calquence patents.
Calquence's Oppositions Filed in EPO
Calquence has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jan 21, 2021, by Lederer & Keller Patentanwälte Partnerschaft Mbb. This opposition was filed on patent number EP16735945A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP16735945A | Jan, 2021 | Lederer & Keller Patentanwälte Partnerschaft mbB | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but
Calquence 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 Calquence's family patents as well as insights into
ongoing legal events
on those patents.
Calquence's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Calquence:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Calquence's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 01, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Calquence Generics:
There are no approved generic versions for Calquence as of now.
How can I launch a generic of Calquence before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Calquence's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Calquence's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Calquence -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 13 Feb, 2024 | 01 Jul, 2036 | Less |
Alternative Brands for Calquence
Calquence which is used for treating adult patients with various types of leukemia and lymphoma., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Beone Medicines Usa |
| |||
About Calquence
Calquence is a drug owned by Astrazeneca Uk Ltd. It is used for treating adult patients with various types of leukemia and lymphoma. Calquence uses Acalabrutinib Maleate as an active ingredient. Calquence was launched by Astrazeneca in 2022.
Approval Date:
Calquence was approved by FDA for market use on 03 August, 2022.
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 Calquence is 03 August, 2022, its NCE-1 date is estimated to be 31 October, 2021.
Active Ingredient:
Calquence uses Acalabrutinib Maleate as the active ingredient. Check out other Drugs and Companies using Acalabrutinib Maleate ingredient
Treatment:
Calquence is used for treating adult patients with various types of leukemia and lymphoma.
Dosage:
Calquence is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 100MG BASE | TABLET | Prescription | ORAL |