Cyclophosphamide is a drug owned by Dr Reddys Laboratories Inc. It is protected by 1 US drug patent filed in 2022 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 15, 2036. Details of Cyclophosphamide's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10993952 | Stable ready to use cyclophosphamide liquid formulations |
Feb, 2036
(10 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 Cyclophosphamide's patents.
Latest Legal Activities on Cyclophosphamide's Patents
Given below is the list of recent legal activities going on the following patents of Cyclophosphamide.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 30 May, 2024 | US10849916 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 08 May, 2024 | US10993952 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 12 Jul, 2022 | US11382923 |
| Recordation of Patent Grant Mailed Critical | 12 Jul, 2022 | US11382923 |
| Email Notification Critical | 23 Jun, 2022 | US11382923 |
| Issue Notification Mailed Critical | 22 Jun, 2022 | US11382923 |
| Application Is Considered Ready for Issue Critical | 08 Jun, 2022 | US11382923 |
| Dispatch to FDC | 08 Jun, 2022 | US11382923 |
| Issue Fee Payment Received Critical | 06 Jun, 2022 | US11382923 |
| Issue Fee Payment Verified Critical | 06 Jun, 2022 | US11382923 |
US patents provide insights into the exclusivity only within the United States, but Cyclophosphamide 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 Cyclophosphamide's family patents as well as insights into ongoing legal events on those patents.
Cyclophosphamide's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Cyclophosphamide's generic launch date based on the expiry of its last outstanding patent is estimated to be Feb 15, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Cyclophosphamide Generic API suppliers:
Cyclophosphamide is the generic name for the brand Cyclophosphamide. 19 different companies have already filed for the generic of Cyclophosphamide, with Baxter Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Cyclophosphamide's generic
How can I launch a generic of Cyclophosphamide before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Cyclophosphamide's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Cyclophosphamide'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 Cyclophosphamide -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 500 mg/2.5 mL and 1 g/5 mL | 07 Mar, 2022 | 1 | 15 Feb, 2036 | ||
| 2 g/10 mL | 17 Jan, 2023 | 1 | 15 Feb, 2036 |
About Cyclophosphamide
Cyclophosphamide is a drug owned by Dr Reddys Laboratories Inc. Cyclophosphamide uses Cyclophosphamide as an active ingredient. Cyclophosphamide was launched by Dr Reddys in 2020.
Approval Date:
Cyclophosphamide was approved by FDA for market use on 30 July, 2020.
Active Ingredient:
Cyclophosphamide uses Cyclophosphamide as the active ingredient. Check out other Drugs and Companies using Cyclophosphamide ingredient
Dosage:
Cyclophosphamide is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1GM/5ML (200MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 500MG/2.5ML (200MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 2GM/10ML (200MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
Cyclophosphamide is a drug owned by Avyxa Holdings Llc. It is protected by 2 US drug patents filed in 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 01, 2035. Details of Cyclophosphamide's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11382923 | Stable liquid formulations of cyclophosphamide and processes to prepare the same |
Dec, 2035
(10 years from now) | Active |
| US10849916 | Stable liquid formulations of cyclophosphamide and its impurities |
Jul, 2035
(10 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 Cyclophosphamide's patents.
Latest Legal Activities on Cyclophosphamide's Patents
Given below is the list of recent legal activities going on the following patents of Cyclophosphamide.
| Activity | Date | Patent Number |
|---|---|---|
| | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 30 May, 2024 | US10849916 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 08 May, 2024 | US10993952 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 12 Jul, 2022 | US11382923 |
| Recordation of Patent Grant Mailed Critical | 12 Jul, 2022 | US11382923 |
| Email Notification Critical | 23 Jun, 2022 | US11382923 |
| Issue Notification Mailed Critical | 22 Jun, 2022 | US11382923 |
| Application Is Considered Ready for Issue Critical | 08 Jun, 2022 | US11382923 |
| Dispatch to FDC | 08 Jun, 2022 | US11382923 |
| Issue Fee Payment Received Critical | 06 Jun, 2022 | US11382923 |
| Issue Fee Payment Verified Critical | 06 Jun, 2022 | US11382923 |
US patents provide insights into the exclusivity only within the United States, but Cyclophosphamide 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 Cyclophosphamide's family patents as well as insights into ongoing legal events on those patents.
Cyclophosphamide's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Cyclophosphamide's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 01, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Cyclophosphamide Generic API suppliers:
Cyclophosphamide is the generic name for the brand Cyclophosphamide. 19 different companies have already filed for the generic of Cyclophosphamide, with Baxter Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Cyclophosphamide's generic
How can I launch a generic of Cyclophosphamide before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Cyclophosphamide's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Cyclophosphamide'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 Cyclophosphamide -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 500 mg/2.5 mL and 1 g/5 mL | 07 Mar, 2022 | 1 | 15 Feb, 2036 | ||
| 2 g/10 mL | 17 Jan, 2023 | 1 | 15 Feb, 2036 |
About Cyclophosphamide
Cyclophosphamide is a drug owned by Avyxa Holdings Llc. Cyclophosphamide uses Cyclophosphamide as an active ingredient. Cyclophosphamide was launched by Avyxa Holdings in 2023.
Approval Date:
Cyclophosphamide was approved by FDA for market use on 07 June, 2023.
Active Ingredient:
Cyclophosphamide uses Cyclophosphamide as the active ingredient. Check out other Drugs and Companies using Cyclophosphamide ingredient
Dosage:
Cyclophosphamide is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1GM/2ML (500MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 2GM/4ML (500MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 500MG/ML (500MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
Cyclophosphamide is a drug owned by Eugia Pharma Specialities Ltd. It is protected by 1 US drug patent filed in 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 26, 2035. Details of Cyclophosphamide's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9662342 | Formulations of cyclophosphamide liquid concentrate |
Jun, 2035
(10 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 Cyclophosphamide's patents.
Latest Legal Activities on Cyclophosphamide's Patents
Given below is the list of recent legal activities going on the following patents of Cyclophosphamide.
| Activity | Date | Patent Number |
|---|---|---|
| | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 30 May, 2024 | US10849916 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 08 May, 2024 | US10993952 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 12 Jul, 2022 | US11382923 |
| Recordation of Patent Grant Mailed Critical | 12 Jul, 2022 | US11382923 |
| Email Notification Critical | 23 Jun, 2022 | US11382923 |
| Issue Notification Mailed Critical | 22 Jun, 2022 | US11382923 |
| Application Is Considered Ready for Issue Critical | 08 Jun, 2022 | US11382923 |
| Dispatch to FDC | 08 Jun, 2022 | US11382923 |
| Issue Fee Payment Received Critical | 06 Jun, 2022 | US11382923 |
| Issue Fee Payment Verified Critical | 06 Jun, 2022 | US11382923 |
US patents provide insights into the exclusivity only within the United States, but Cyclophosphamide 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 Cyclophosphamide's family patents as well as insights into ongoing legal events on those patents.
Cyclophosphamide's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Cyclophosphamide's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 26, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Cyclophosphamide Generic API suppliers:
Cyclophosphamide is the generic name for the brand Cyclophosphamide. 19 different companies have already filed for the generic of Cyclophosphamide, with Baxter Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Cyclophosphamide's generic
How can I launch a generic of Cyclophosphamide before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Cyclophosphamide's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Cyclophosphamide'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 Cyclophosphamide -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 500 mg/2.5 mL and 1 g/5 mL | 07 Mar, 2022 | 1 | 15 Feb, 2036 | ||
| 2 g/10 mL | 17 Jan, 2023 | 1 | 15 Feb, 2036 |
About Cyclophosphamide
Cyclophosphamide is a drug owned by Eugia Pharma Specialities Ltd. Cyclophosphamide uses Cyclophosphamide as an active ingredient. Cyclophosphamide was launched by Eugia Pharma Speclts in 2021.
Approval Date:
Cyclophosphamide was approved by FDA for market use on 25 August, 2021.
Active Ingredient:
Cyclophosphamide uses Cyclophosphamide as the active ingredient. Check out other Drugs and Companies using Cyclophosphamide ingredient
Dosage:
Cyclophosphamide is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1GM/5ML (200MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 500MG/2.5ML (200MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 2GM/10ML (200MG/ML) | SOLUTION | Prescription | INTRAVENOUS |