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, 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, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma Speclts, Nexus, Sandoz, and Roxane. and is included in twenty-six NDAs. There are three 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. Twenty-six 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.
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Questions you can ask:
- What is the 5 year forecast for CYCLOPHOSPHAMIDE?
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- What is Average Wholesale Price for CYCLOPHOSPHAMIDE?
Summary for CYCLOPHOSPHAMIDE
| International Patents: | 11 |
| US Patents: | 3 |
| Applicants: | 21 |
| NDAs: | 26 |
| Finished Product Suppliers / Packagers: | 24 |
| Raw Ingredient (Bulk) Api Vendors: | 70 |
| Clinical Trials: | 4,365 |
| Patent Applications: | 4,927 |
| Drug Prices: | Drug price information 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 |
| NovelMed Therapeutics | PHASE2 |
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 three US patents.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sunny | CYCLOPHOSPHAMIDE | cyclophosphamide | INJECTABLE;INJECTION | 215089-003 | Oct 26, 2023 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Hengrui Pharma | CYCLOPHOSPHAMIDE | cyclophosphamide | INJECTABLE;INJECTION | 204555-003 | Oct 31, 2014 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Dr Reddys | CYCLOPHOSPHAMIDE | cyclophosphamide | SOLUTION;INTRAVENOUS | 212501-002 | Jul 30, 2020 | AP | RX | Yes | Yes | 12,329,767 | ⤷ Start Trial | Y | ⤷ Start Trial | ||
| Sandoz | CYCLOPHOSPHAMIDE | cyclophosphamide | SOLUTION;INTRAVENOUS | 217150-003 | Sep 12, 2023 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Xgen Pharms | CYCLOPHOSPHAMIDE | cyclophosphamide | INJECTABLE;INJECTION | 211757-001 | Oct 18, 2022 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Dr Reddys | CYCLOPHOSPHAMIDE | cyclophosphamide | SOLUTION;INTRAVENOUS | 212501-003 | Nov 19, 2021 | RX | Yes | Yes | 12,329,767 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Eugia Pharma Speclts | CYCLOPHOSPHAMIDE | cyclophosphamide | SOLUTION;INTRAVENOUS | 210735-003 | Nov 20, 2023 | RX | Yes | Yes | 9,662,342 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| >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 |
|---|---|---|---|
| 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 |
| European Patent Office | 3139929 | FORMULATIONS D'UN CONCENTRÉ LIQUIDE DE CYCLOPHOSPHAMIDE (FORMULATIONS OF CYCLOPHOSPHAMIDE LIQUID CONCENTRATE) | ⤷ Start Trial |
| Japan | 2017514924 | シクロホスファミド液状濃縮物の製剤 | ⤷ Start Trial |
| Japan | 6516831 | ⤷ Start Trial | |
| >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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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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