Cyclophosphamide - Generic Drug Details
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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 Alembic, Ani Pharms, Cipla, Hikma, Kanchan Hlthcare, Tri-source Pharma, Zydus Lifesciences, Amneal, Baxter Hlthcare, Epic Pharma Llc, Hainan Poly, Hengrui Pharma, Sagent Pharms Inc, Sunny, Xgen Pharms, Bedford, Teva Parenteral, Avyxa Holdings, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma Speclts, Nexus, Sandoz, and Roxane, and is included in thirty-one NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Cyclophosphamide has twelve patent family members in nine countries.
There are nineteen drug master file entries for cyclophosphamide. Twenty-four suppliers are listed for this compound.
Summary for cyclophosphamide
International Patents: | 12 |
US Patents: | 4 |
Tradenames: | 5 |
Applicants: | 24 |
NDAs: | 31 |
Drug Master File Entries: | 19 |
Finished Product Suppliers / Packagers: | 24 |
Raw Ingredient (Bulk) Api Vendors: | 95 |
Clinical Trials: | 3,948 |
Patent Applications: | 7,455 |
Drug Prices: | Drug price trends for cyclophosphamide |
What excipients (inactive ingredients) are in cyclophosphamide? | cyclophosphamide excipients list |
DailyMed Link: | cyclophosphamide at DailyMed |
Recent Clinical Trials for cyclophosphamide
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Adelaide | Phase 3 |
The University of Queensland | Phase 3 |
Fred Hutchinson Cancer Center | Phase 2 |
Pharmacology for cyclophosphamide
Drug Class | Alkylating Drug |
Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for cyclophosphamide
Anatomical Therapeutic Chemical (ATC) Classes for cyclophosphamide
Paragraph IV (Patent) Challenges for CYCLOPHOSPHAMIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
CYCLOPHOSPHAMIDE | Injection | cyclophosphamide | 2 g/10 mL | 212501 | 1 | 2023-01-17 |
CYCLOPHOSPHAMIDE | Injection | cyclophosphamide | 500 mg/2.5 mL and 1 g/5 mL | 212501 | 1 | 2022-03-07 |
US Patents and Regulatory Information for cyclophosphamide
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 | 4,537,883 | ⤷ Try for Free |
Baxter Hlthcare | CYTOXAN (LYOPHILIZED) | cyclophosphamide | INJECTABLE;INJECTION | 012142-008 | Jan 4, 1984 | 4,537,883 | ⤷ Try for Free |
Baxter Hlthcare | CYTOXAN (LYOPHILIZED) | cyclophosphamide | INJECTABLE;INJECTION | 012142-009 | Dec 10, 1985 | 4,537,883 | ⤷ Try for Free |
Baxter Hlthcare | LYOPHILIZED CYTOXAN | cyclophosphamide | INJECTABLE;INJECTION | 012142-007 | Dec 10, 1985 | 4,537,883 | ⤷ Try for Free |
Baxter Hlthcare | LYOPHILIZED CYTOXAN | cyclophosphamide | INJECTABLE;INJECTION | 012142-006 | Dec 5, 1985 | 4,537,883 | ⤷ Try for Free |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for cyclophosphamide
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 106456654 | 环磷酰胺液体浓缩制剂 (Formulations of cyclophosphamide liquid concentrate) | ⤷ Try for Free |
World Intellectual Property Organization (WIPO) | 2016132270 | ⤷ Try for Free | |
Japan | 2017514924 | シクロホスファミド液状濃縮物の製剤 | ⤷ Try for Free |
World Intellectual Property Organization (WIPO) | 2016005962 | ⤷ Try for Free | |
World Intellectual Property Organization (WIPO) | 2015171460 | ⤷ Try for Free | |
European Patent Office | 3139929 | FORMULATIONS D'UN CONCENTRÉ LIQUIDE DE CYCLOPHOSPHAMIDE (FORMULATIONS OF CYCLOPHOSPHAMIDE LIQUID CONCENTRATE) | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Market Dynamics and Financial Trajectory for Cyclophosphamide
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