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 six branded drugs marketed by Alembic, Ani Pharms, Cipla, Eirgen, Hikma, Senores Pharms, Zydus Lifesciences, Amneal, Baxter Hlthcare, Epic Pharma Llc, Hainan Poly, Hengrui Pharma, Sagent Pharms Inc, Sunny, Xgen Pharms, Bedford, Teva Parenteral, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma Speclts, Nexus, Sandoz, Avyxa Holdings, and Roxane, and is included in thirty-one NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Twenty-five suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for cyclophosphamide
| International Patents: | 12 |
| US Patents: | 5 |
| Tradenames: | 6 |
| Applicants: | 24 |
| NDAs: | 31 |
| Finished Product Suppliers / Packagers: | 25 |
| Raw Ingredient (Bulk) Api Vendors: | 70 |
| Clinical Trials: | 4,365 |
| Patent Applications: | 7,558 |
| Drug Prices: | Drug price trends for cyclophosphamide |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases 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 |
|---|---|
| Zhujiang Hospital | PHASE1 |
| Indapta Therapeutics, INC. | PHASE1 |
| Andrew Hantel, MD | PHASE1 |
Generic filers with tentative approvals for CYCLOPHOSPHAMIDE
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Start Trial | ⤷ Start Trial | 2000MG/10ML | INJECTION;SOLUTION |
| ⤷ Start Trial | ⤷ Start Trial | 500MG/2.5ML | INJECTION;SOLUTION |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dr Reddys | CYCLOPHOSPHAMIDE | cyclophosphamide | SOLUTION;INTRAVENOUS | 212501-001 | Jul 30, 2020 | AP | RX | Yes | Yes | 10,993,952 | ⤷ Start Trial | Y | ⤷ Start Trial | ||
| Hikma | CYCLOPHOSPHAMIDE | cyclophosphamide | INJECTABLE;INJECTION | 216958-001 | Dec 18, 2023 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Hikma | CYCLOPHOSPHAMIDE | cyclophosphamide | CAPSULE;ORAL | 203856-002 | Sep 16, 2013 | AB | RX | Yes | Yes | ⤷ 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 | ||||
| Baxter Hlthcare | LYOPHILIZED CYTOXAN | cyclophosphamide | INJECTABLE;INJECTION | 012142-006 | Dec 5, 1985 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Hengrui Pharma | CYCLOPHOSPHAMIDE | cyclophosphamide | INJECTABLE;INJECTION | 204555-002 | Oct 31, 2014 | AP | RX | 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 | 4,537,883 | ⤷ Start Trial |
| Baxter Hlthcare | LYOPHILIZED CYTOXAN | cyclophosphamide | INJECTABLE;INJECTION | 012142-006 | Dec 5, 1985 | 4,537,883 | ⤷ Start Trial |
| Baxter Hlthcare | CYTOXAN (LYOPHILIZED) | cyclophosphamide | INJECTABLE;INJECTION | 012142-008 | Jan 4, 1984 | 4,537,883 | ⤷ Start Trial |
| Baxter Hlthcare | LYOPHILIZED CYTOXAN | cyclophosphamide | INJECTABLE;INJECTION | 012142-007 | Dec 10, 1985 | 4,537,883 | ⤷ Start Trial |
| Baxter Hlthcare | CYTOXAN (LYOPHILIZED) | cyclophosphamide | INJECTABLE;INJECTION | 012142-009 | Dec 10, 1985 | 4,537,883 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for cyclophosphamide
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2016005962 | ⤷ Start Trial | |
| World Intellectual Property Organization (WIPO) | 2016132270 | ⤷ Start Trial | |
| Australia | 2015256331 | Formulations of Cyclophosphamide liquid concentrate | ⤷ Start Trial |
| Brazil | 112016026140 | formulações de concentrado líquido de ciclofosfamida. | ⤷ Start Trial |
| Canada | 2948148 | FORMULATIONS D'UN CONCENTRE LIQUIDE DE CYCLOPHOSPHAMIDE (FORMULATIONS OF CYCLOPHOSPHAMIDE LIQUID CONCENTRATE) | ⤷ Start Trial |
| China | 106456654 | 环磷酰胺液体浓缩制剂 (Formulations of cyclophosphamide liquid concentrate) | ⤷ Start Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
