Cyclophosphamide Patent Expiration
Cyclophosphamide was first introduced by Baxter Healthcare Corp
Cyclophosphamide Patents
Given below is the list of patents protecting Cyclophosphamide, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Cyclophosphamide | US10849916 | Stable liquid formulations of cyclophosphamide and its impurities | Jul 13, 2035 | Avyxa Holdings |
| Cyclophosphamide | US10993952 | Stable ready to use cyclophosphamide liquid formulations | Feb 15, 2036 | Dr Reddys |
| Cyclophosphamide | US11382923 | Stable liquid formulations of cyclophosphamide and processes to prepare the same | Dec 01, 2035 | Avyxa Holdings |
| Cyclophosphamide | US9662342 | Formulations of cyclophosphamide liquid concentrate | Jun 26, 2035 | Eugia Pharma Speclts |
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 recent legal activities going on the following patents of Cyclophosphamide.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| 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 | 12 Jul, 2022 | US11382923 |
| Recordation of Patent Grant Mailed | 12 Jul, 2022 | US11382923 |
| Email Notification | 23 Jun, 2022 | US11382923 |
| Issue Notification Mailed | 22 Jun, 2022 | US11382923 |
| Application Is Considered Ready for Issue | 08 Jun, 2022 | US11382923 |
| Dispatch to FDC | 08 Jun, 2022 | US11382923 |
| Issue Fee Payment Received | 06 Jun, 2022 | US11382923 |
| Issue Fee Payment Verified | 06 Jun, 2022 | US11382923 |
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Cyclophosphamide Generics
Several generic applications have been filed for Cyclophosphamide. The first generic version for Cyclophosphamide was by Bedford Laboratories Div Ben Venue Laboratories Inc and was approved on Feb 16, 1982. And the latest generic version is by Hikma Pharmaceuticals Usa Inc and was approved on Dec 18, 2023.
Given below is the list of companies who have filed for Cyclophosphamide generic.
1. CIPLA
Cipla Ltd has filed for 2 different strengths of generic version for Cyclophosphamide. Given below are the details of the strengths of this generic introduced by Cipla.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 25MG | capsule | Prescription | ORAL | AB | Jan 18, 2019 |
| 50MG | capsule | Prescription | ORAL | AB | Jan 18, 2019 |
2. AMNEAL
Amneal Eu Ltd has filed for 3 different strengths of generic version for Cyclophosphamide. Given below are the details of the strengths of this generic introduced by Amneal.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 2GM/VIAL | injectable | Prescription | INJECTION | AP | May 25, 2018 |
| 1GM/VIAL | injectable | Prescription | INJECTION | AP | May 25, 2018 |
| 500MG/VIAL | injectable | Prescription | INJECTION | AP | May 25, 2018 |
3. ANI PHARMS
Ani Pharmaceuticals Inc has filed for 2 different strengths of generic version for Cyclophosphamide. Given below are the details of the strengths of this generic introduced by Ani Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 50MG | capsule | Discontinued | ORAL | N/A | Mar 19, 2018 |
| 25MG | capsule | Discontinued | ORAL | N/A | Mar 19, 2018 |
4. HIKMA
Hikma Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Cyclophosphamide. Given below are the details of the strengths of this generic introduced by Hikma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 2GM/VIAL | injectable | Prescription | INJECTION | AP | Dec 18, 2023 |
| 1GM/VIAL | injectable | Prescription | INJECTION | AP | Dec 18, 2023 |
| 500MG/VIAL | injectable | Prescription | INJECTION | AP | Dec 18, 2023 |
5. ROXANE
Roxane Laboratories Inc has filed for 2 different strengths of generic version for Cyclophosphamide. Given below are the details of the strengths of this generic introduced by Roxane.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 50MG | tablet | Discontinued | ORAL | N/A | Aug 17, 1999 |
| 25MG | tablet | Discontinued | ORAL | N/A | Aug 17, 1999 |
6. SUNNY
Sunny Pharmtech Inc has filed for 3 different strengths of generic version for Cyclophosphamide. Given below are the details of the strengths of this generic introduced by Sunny.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG/VIAL | injectable | Prescription | INJECTION | AP | Oct 26, 2023 |
| 2GM/VIAL | injectable | Prescription | INJECTION | AP | Oct 26, 2023 |
| 1GM/VIAL | injectable | Prescription | INJECTION | AP | Oct 26, 2023 |
7. HENGRUI PHARMA
Jiangsu Hengrui Pharmaceuticals Co Ltd has filed for 3 different strengths of generic version for Cyclophosphamide. Given below are the details of the strengths of this generic introduced by Hengrui Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG/VIAL | injectable | Prescription | INJECTION | AP | Oct 31, 2014 |
| 1GM/VIAL | injectable | Prescription | INJECTION | AP | Oct 31, 2014 |
| 2GM/VIAL | injectable | Prescription | INJECTION | AP | Oct 31, 2014 |
8. BEDFORD
Bedford Laboratories Div Ben Venue Laboratories Inc has filed for 5 different strengths of generic version for Cyclophosphamide. All of these versions come by the name NEOSAR. Given below are the details of the strengths of this generic introduced by Bedford.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 100MG/VIAL | injectable | Discontinued | INJECTION | N/A | Feb 16, 1982 |
| 500MG/VIAL | injectable | Discontinued | INJECTION | N/A | Feb 16, 1982 |
| 200MG/VIAL | injectable | Discontinued | INJECTION | N/A | Feb 16, 1982 |
| 1GM/VIAL | injectable | Discontinued | INJECTION | N/A | Jul 8, 1983 |
| 2GM/VIAL | injectable | Discontinued | INJECTION | N/A | Mar 30, 1989 |
9. ANIMA
Anima Pharmaceuticals Pvt Ltd has filed for 2 different strengths of generic version for Cyclophosphamide. Given below are the details of the strengths of this generic introduced by Anima.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 25MG | capsule | Prescription | ORAL | AB | May 7, 2018 |
| 50MG | capsule | Prescription | ORAL | AB | May 7, 2018 |
10. BAXTER HLTHCARE
Baxter Healthcare Corp has filed for 5 different strengths of generic version for Cyclophosphamide. Given below are the details of the strengths of this generic introduced by Baxter Hlthcare.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG/VIAL
(reference standard) | injectable | Prescription | INJECTION | AP | May 21, 2008 |
| 100MG/VIAL | injectable | Discontinued | INJECTION | N/A | Jul 3, 1986 |
| 200MG/VIAL | injectable | Discontinued | INJECTION | N/A | Jul 3, 1986 |
| 1GM/VIAL
(reference standard) | injectable | Prescription | INJECTION | AP | May 21, 2008 |
| 2GM/VIAL
(reference standard) | injectable | Prescription | INJECTION | AP | May 21, 2008 |
11. ZYDUS LIFESCIENCES
Zydus Lifesciences Ltd has filed for 2 different strengths of generic version for Cyclophosphamide. Given below are the details of the strengths of this generic introduced by Zydus Lifesciences.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 25MG | capsule | Prescription | ORAL | AB | Dec 13, 2023 |
| 50MG | capsule | Prescription | ORAL | AB | Dec 13, 2023 |
12. SAGENT PHARMS INC
Sagent Pharmaceuticals Inc has filed for 3 different strengths of generic version for Cyclophosphamide. Given below are the details of the strengths of this generic introduced by Sagent Pharms Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG/VIAL | injectable | Prescription | INJECTION | AP | Jul 17, 2023 |
| 1GM/VIAL | injectable | Prescription | INJECTION | AP | Jul 17, 2023 |
| 2GM/VIAL | injectable | Prescription | INJECTION | AP | Jul 17, 2023 |
13. TEVA PARENTERAL
Teva Parenteral Medicines Inc has filed for 5 different strengths of generic version for Cyclophosphamide. All of these versions come by the name NEOSAR. Given below are the details of the strengths of this generic introduced by Teva Parenteral.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 2GM/VIAL | injectable | Discontinued | INJECTION | N/A | Apr 29, 1993 |
| 1GM/VIAL | injectable | Discontinued | INJECTION | N/A | Apr 29, 1993 |
| 500MG/VIAL | injectable | Discontinued | INJECTION | N/A | Apr 29, 1993 |
| 200MG/VIAL | injectable | Discontinued | INJECTION | N/A | Apr 29, 1993 |
| 100MG/VIAL | injectable | Discontinued | INJECTION | N/A | Apr 29, 1993 |
14. XGEN PHARMS
Xgen Pharmaceuticals Djb Inc has filed for 3 different strengths of generic version for Cyclophosphamide. Given below are the details of the strengths of this generic introduced by Xgen Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1GM/VIAL | injectable | Prescription | INJECTION | AP | Oct 18, 2022 |
| 500MG/VIAL | injectable | Prescription | INJECTION | AP | Oct 18, 2022 |
| 2GM/VIAL | injectable | Prescription | INJECTION | AP | Oct 18, 2022 |
15. ALEMBIC
Alembic Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Cyclophosphamide. Given below are the details of the strengths of this generic introduced by Alembic.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 25MG | capsule | Prescription | ORAL | AB | Nov 10, 2022 |
| 50MG | capsule | Prescription | ORAL | AB | Nov 10, 2022 |