CYCLOPHOSPHAMIDE Drug Patent Profile
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Which patents cover Cyclophosphamide, and when can generic versions of Cyclophosphamide launch?
Cyclophosphamide is a drug marketed by Alembic Pharms, Ani Pharms, Anima, Cipla, Hikma, Amneal, Baxter Hlthcare, Hengrui Pharma, Xellia Pharms Aps, Eugia Pharma Speclts, Ingenus Pharms Llc, and Roxane. and is included in sixteen NDAs. There are two patents protecting this drug and two Paragraph IV challenges.
This drug has eleven patent family members in nine countries.
The generic ingredient in CYCLOPHOSPHAMIDE is cyclophosphamide. There are nineteen drug master file entries for this compound. Seventeen 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: | 11 |
| US Patents: | 2 |
| Applicants: | 12 |
| NDAs: | 16 |
| Finished Product Suppliers / Packagers: | 17 |
| Raw Ingredient (Bulk) Api Vendors: | 91 |
| Clinical Trials: | 3,814 |
| Patent Applications: | 4,510 |
| 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 |
| Invectys | Phase 1/Phase 2 |
| Anhui Provincial Hospital | Phase 1 |
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 two US patents.
Patents protecting CYCLOPHOSPHAMIDE
Stable ready to use cyclophosphamide liquid formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Formulations of cyclophosphamide liquid concentrate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Roxane | CYCLOPHOSPHAMIDE | cyclophosphamide | TABLET;ORAL | 040032-001 | Aug 17, 1999 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Eugia Pharma Speclts | CYCLOPHOSPHAMIDE | cyclophosphamide | SOLUTION;INTRAVENOUS | 210735-001 | Aug 25, 2021 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Roxane | CYCLOPHOSPHAMIDE | cyclophosphamide | TABLET;ORAL | 040032-002 | Aug 17, 1999 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Ingenus Pharms Llc | CYCLOPHOSPHAMIDE | cyclophosphamide | SOLUTION;INTRAVENOUS | 212501-002 | Jul 30, 2020 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for CYCLOPHOSPHAMIDE
See the table below for patents covering CYCLOPHOSPHAMIDE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2017514924 | シクロホスファミド液状濃縮物の製剤 | See Plans and Pricing |
| Australia | 2015256331 | Formulations of Cyclophosphamide liquid concentrate | See Plans and Pricing |
| World Intellectual Property Organization (WIPO) | 2015171460 | See Plans and Pricing | |
| Japan | 6516831 | See Plans and Pricing | |
| >Country | >Patent Number | >Title | >Estimated 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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