CYCLOPHOSPHAMIDE Drug Patent Profile
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When do Cyclophosphamide patents expire, and when can generic versions of Cyclophosphamide launch?
Cyclophosphamide is a drug marketed by Alembic, Ani Pharms, Anima, Cipla, Hikma, Zydus Lifesciences, Amneal, Baxter Hlthcare, Hengrui Pharma, Sagent Pharms Inc, Sunny, Xgen Pharms, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma Speclts, Ingenus Pharms Llc, Sandoz, and Roxane. and is included in twenty-three NDAs. There are four patents protecting this drug and two Paragraph IV challenges.
This drug has twelve patent family members in nine countries.
The generic ingredient in CYCLOPHOSPHAMIDE is cyclophosphamide. There are nineteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the cyclophosphamide profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Cyclophosphamide
A generic version of CYCLOPHOSPHAMIDE was approved as cyclophosphamide by BAXTER HLTHCARE on May 21st, 2008.
Summary for CYCLOPHOSPHAMIDE
International Patents: | 12 |
US Patents: | 4 |
Applicants: | 18 |
NDAs: | 23 |
Finished Product Suppliers / Packagers: | 24 |
Raw Ingredient (Bulk) Api Vendors: | 95 |
Clinical Trials: | 3,860 |
Patent Applications: | 4,551 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information 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 |
---|---|
James Michael Martin | Phase 1 |
Affimed GmbH | Phase 2 |
Artiva Biotherapeutics, Inc. | 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
CYCLOPHOSPHAMIDE is protected by four US patents.
Patents protecting CYCLOPHOSPHAMIDE
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Stable ready to use cyclophosphamide liquid formulations
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Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Formulations of cyclophosphamide liquid concentrate
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
International Patents for CYCLOPHOSPHAMIDE
See the table below for patents covering CYCLOPHOSPHAMIDE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Brazil | 112016026140 | formulações de concentrado líquido de ciclofosfamida. | ⤷ Try a Trial |
Japan | 6516831 | ⤷ Try a Trial | |
China | 106456654 | 环磷酰胺液体浓缩制剂 (Formulations of cyclophosphamide liquid concentrate) | ⤷ Try a Trial |
South Korea | 20170008252 | 사이클로포스파미드 액상 농축 제제 (FORMULATIONS OF CYCLOPHOSPHAMIDE LIQUID CONCENTRATE) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2016132270 | ⤷ Try a Trial | |
Australia | 2015256331 | Formulations of Cyclophosphamide liquid concentrate | ⤷ Try a Trial |
Russian Federation | 2016147362 | ПРЕПАРАТЫ ЖИДКОГО КОНЦЕТРАТА ЦИКЛОФОСФАМИДА | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |