CASPOFUNGIN ACETATE - Generic Drug Details
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What are the generic drug sources for caspofungin acetate and what is the scope of freedom to operate?
Caspofungin acetate
is the generic ingredient in two branded drugs marketed by Merck, Areva Pharms, Cipla, Fresenius Kabi Usa, Gland, Hengrui Pharma, Mylan Labs Ltd, and Xellia Pharms Aps, and is included in eight NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Caspofungin acetate has fourteen patent family members in fourteen countries.
There are six drug master file entries for caspofungin acetate. Nine suppliers are listed for this compound.
Summary for CASPOFUNGIN ACETATE
International Patents: | 14 |
US Patents: | 1 |
Tradenames: | 2 |
Applicants: | 8 |
NDAs: | 8 |
Drug Master File Entries: | 6 |
Finished Product Suppliers / Packagers: | 9 |
Raw Ingredient (Bulk) Api Vendors: | 74 |
Clinical Trials: | 20 |
Patent Applications: | 1,198 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for CASPOFUNGIN ACETATE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CASPOFUNGIN ACETATE |
What excipients (inactive ingredients) are in CASPOFUNGIN ACETATE? | CASPOFUNGIN ACETATE excipients list |
DailyMed Link: | CASPOFUNGIN ACETATE at DailyMed |
Recent Clinical Trials for CASPOFUNGIN ACETATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Phase 4 |
European Organisation for Research and Treatment of Cancer - EORTC | Phase 3 |
Children's Oncology Group | Phase 3 |
Pharmacology for CASPOFUNGIN ACETATE
Drug Class | Echinocandin Antifungal |
Anatomical Therapeutic Chemical (ATC) Classes for CASPOFUNGIN ACETATE
Paragraph IV (Patent) Challenges for CASPOFUNGIN ACETATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
CANCIDAS | for Injection | caspofungin acetate | 50 mg/vial and 70 mg/vial | 021227 | 1 | 2009-06-26 |
US Patents and Regulatory Information for CASPOFUNGIN ACETATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Xellia Pharms Aps | CASPOFUNGIN ACETATE | caspofungin acetate | POWDER;INTRAVENOUS | 205923-001 | Jul 2, 2018 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Cipla | CASPOFUNGIN ACETATE | caspofungin acetate | POWDER;INTRAVENOUS | 209489-001 | Jul 12, 2018 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Merck | CANCIDAS | caspofungin acetate | POWDER;INTRAVENOUS | 021227-002 | Jan 26, 2001 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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 CASPOFUNGIN ACETATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Merck | CANCIDAS | caspofungin acetate | POWDER;INTRAVENOUS | 021227-002 | Jan 26, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Merck | CANCIDAS | caspofungin acetate | POWDER;INTRAVENOUS | 021227-001 | Jan 26, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Merck | CANCIDAS | caspofungin acetate | POWDER;INTRAVENOUS | 021227-002 | Jan 26, 2001 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CASPOFUNGIN ACETATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2014081443 | ⤷ Sign Up | |
Cyprus | 1120016 | ⤷ Sign Up | |
Lithuania | 2922530 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CASPOFUNGIN ACETATE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0620232 | 01C0054 | France | ⤷ Sign Up | PRODUCT NAME: CASPOFUNGIN ACETATE; REGISTRATION NO/DATE: EU/1/01/196/001 20011024 |
0620232 | C300076 | Netherlands | ⤷ Sign Up | PRODUCT NAME: CASPOFUNGINE, DESGEWENST IN DE VORM VAN EEN ZUURADDITIEZOUT, IN HET BIJZONDER CASPOFUNGINE ACETAAT; REGISTRATION NO/DATE: EU/1/01/196/001-003 20011024 |
0620232 | 44/2001 | Austria | ⤷ Sign Up | PRODUCT NAME: CASPOFUNGIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE CASPOFUNGINACETAT; REGISTRATION NO/DATE: EU/01/196/001-003 20011024 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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