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Cyclophosphamide - Generic Drug Details
What are the generic drug sources for cyclophosphamide and what is the scope of freedom to operate?
Cyclophosphamide
is the generic ingredient in five branded drugs marketed by Ani Pharms Inc, Cipla, Hikma, Sti Pharma Llc, Amneal, Baxter Hlthcare, Jiangsu Hengrui Med, Bedford, Teva Parenteral, and Roxane, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.There are nineteen drug master file entries for cyclophosphamide. Nine suppliers are listed for this compound.
Summary for cyclophosphamide
| US Patents: | 0 |
| Tradenames: | 5 |
| Applicants: | 10 |
| NDAs: | 16 |
| Drug Master File Entries: | 19 |
| Suppliers / Packagers: | 9 |
| Bulk Api Vendors: | 73 |
| Clinical Trials: | 3,055 |
| Patent Applications: | 7,433 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for cyclophosphamide |
| DailyMed Link: | cyclophosphamide at DailyMed |
Recent Clinical Trials for cyclophosphamide
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Radboud University | Phase 1/Phase 2 |
| Brooklyn ImmunoTherapeutics, LLC | Phase 2 |
| City of Hope Medical Center | Early Phase 1 |
Pharmacology for cyclophosphamide
| Drug Class | Alkylating Drug |
| Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for cyclophosphamide
Paragraph IV (Patent) Challenges for CYCLOPHOSPHAMIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| CYTOXAN (LYOPHILIZED) | INJECTABLE;INJECTION | cyclophosphamide | 012142 | |
| LYOPHILIZED CYTOXAN | INJECTABLE;INJECTION | cyclophosphamide | 012142 | |
| CYTOXAN | INJECTABLE;INJECTION | cyclophosphamide | 012142 |
US Patents and Regulatory Information for cyclophosphamide
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva Parenteral | NEOSAR | cyclophosphamide | INJECTABLE;INJECTION | 040015-003 | Apr 29, 1993 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Bedford | NEOSAR | cyclophosphamide | INJECTABLE;INJECTION | 087442-003 | Feb 16, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Cipla | CYCLOPHOSPHAMIDE | cyclophosphamide | CAPSULE;ORAL | 211608-002 | Jan 18, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Baxter Hlthcare | CYCLOPHOSPHAMIDE | cyclophosphamide | INJECTABLE;INJECTION | 040745-003 | May 21, 2008 | AP | RX | No | Yes | Start Trial | Start Trial | Start Trial | |||
| Baxter Hlthcare | CYTOXAN | cyclophosphamide | TABLET;ORAL | 012141-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Bedford | NEOSAR | cyclophosphamide | INJECTABLE;INJECTION | 087442-001 | Feb 16, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for cyclophosphamide
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Baxter Hlthcare | CYTOXAN (LYOPHILIZED) | cyclophosphamide | INJECTABLE;INJECTION | 012142-010 | Sep 24, 1985 | Start Trial | Start Trial |
| Baxter Hlthcare | LYOPHILIZED CYTOXAN | cyclophosphamide | INJECTABLE;INJECTION | 012142-006 | Dec 5, 1985 | Start Trial | Start Trial |
| Baxter Hlthcare | CYTOXAN (LYOPHILIZED) | cyclophosphamide | INJECTABLE;INJECTION | 012142-008 | Jan 4, 1984 | Start Trial | Start Trial |
| Baxter Hlthcare | LYOPHILIZED CYTOXAN | cyclophosphamide | INJECTABLE;INJECTION | 012142-007 | Dec 10, 1985 | Start Trial | Start Trial |
| Baxter Hlthcare | CYTOXAN (LYOPHILIZED) | cyclophosphamide | INJECTABLE;INJECTION | 012142-009 | Dec 10, 1985 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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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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