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CASPOFUNGIN ACETATE Drug Profile
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See Plans and PricingWhich patents cover Caspofungin Acetate, and when can generic versions of Caspofungin Acetate launch?
Caspofungin Acetate is a drug marketed by Cipla, Fresenius Kabi Usa, Gland Pharma Ltd, Jiangsu Hengrui Med, Mylan Labs Ltd, and Xellia Pharms Aps. and is included in six NDAs. There is one patent protecting this drug.
This drug has fourteen patent family members in fourteen countries.
The generic ingredient in CASPOFUNGIN ACETATE is caspofungin acetate. There are eight drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the caspofungin acetate profile page.
US ANDA Litigation and Generic Entry Outlook for Caspofungin Acetate
A generic version of CASPOFUNGIN ACETATE was approved as caspofungin acetate by FRESENIUS KABI USA on December 30th, 2016.
Summary for CASPOFUNGIN ACETATE
| International Patents: | 14 |
| US Patents: | 1 |
| Applicants: | 6 |
| NDAs: | 6 |
| Suppliers / Packagers: | 8 |
| Bulk Api Vendors: | 35 |
| Clinical Trials: | 14 |
| Patent Applications: | 386 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for CASPOFUNGIN ACETATE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CASPOFUNGIN ACETATE |
| DailyMed Link: | CASPOFUNGIN ACETATE at DailyMed |
Recent Clinical Trials for CASPOFUNGIN ACETATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| European Organisation for Research and Treatment of Cancer - EORTC | Phase 3 |
| Children's Oncology Group | Phase 3 |
| Merck Sharp & Dohme Corp. | Phase 3 |
Recent Litigation for CASPOFUNGIN ACETATE
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Merck Sharp & Dohme Corp. v. Xellia Pharmaceuticals ApS | 2014-02-14 |
| MERCK & CO, INC. v. SANDOZ INC. | 2010-05-06 |
| MERCK & CO., INC. v. SANDOZ INC. | 2010-03-30 |
Pharmacology for CASPOFUNGIN ACETATE
| Drug Class | Echinocandin Antifungal |
Synonyms for CASPOFUNGIN ACETATE
| 1-((4R,5S)-5-((2-Aminoethyl)amino)-N(sup 2)-(10,12-dimethyl-1-oxotetradecyl)-4-hydroxy-L-ornithine)-5-((3R)-3-hydroxy-L-ornithine)pneumocandin B0, diacetate (salt) |
| 1-[(4R,5S)-5-[(2-aminoethyl)amino]-N(2)-(10,12-dimethyl-1-oxotetradecyl)-4-hydroxy-L-ornithine]-5-[(3R)-3-hydroxy-L-ornithine]-pneumocandin B0 diacetate |
| 1-[(4R,5S)-5-[(2-Aminoethyl)amino]-N2-(10,12-dimethyl-1-oxotetradecyl)-4-hydroxy-L-ornithine]-5-[(3R)-3-hydroxy-L-ornithine]-pneumocandin B0 |
| 1)-peptide diacetate salt |
| 179463-17-3 |
| 463C173 |
| AC-27763 |
| AKOS025401982 |
| AKOS026750216 |
| AOB3093 |
| C52H88N10O15.2C2H4O2 |
| C56H96N10O19 |
| Cancidas |
| Cancidas (TN) |
| Caspofungin (Acetate) |
| Caspofungin acetate (JAN/USAN) |
| Caspofungin acetate [USAN:BAN:JAN] |
| Caspofungin Acetate [USAN] |
| caspofungin diacetate |
| CHEBI:59900 |
| CS-0578 |
| D02501 |
| HY-17006 |
| J-011452 |
| L 743,872 |
| L 743872 |
| L-743,872 |
| L-743872 |
| LS-173700 |
| MK 0991 |
| MK-0991 |
| MK0991 |
| MolPort-029-887-122 |
| MolPort-035-395-717 |
| MolPort-044-561-291 |
| OGUJBRYAAJYXQP-LLXMLGLCSA-N |
| Pneumocandin B0, 1-((4R,5S)-5-((2-aminoethyl)amino)-N2-(10,12-dimethyl-1-oxotetradecyl)-4-hydroxy-L-ornithine)-5-((3R)-3-hydroxy-L-ornithine)-, diacetate (salt) |
| s3073 |
| SCHEMBL149293 |
| SW219088-1 |
| UNII-VUW370O5QE |
| VUW370O5QE |
| W-5367 |
| Y1176 |
Paragraph IV (Patent) Challenges for CASPOFUNGIN ACETATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| CANCIDAS | POWDER;INTRAVENOUS | caspofungin acetate | 021227 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cipla | CASPOFUNGIN ACETATE | caspofungin acetate | POWDER;INTRAVENOUS | 209489-001 | Jul 12, 2018 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Jiangsu Hengrui Med | CASPOFUNGIN ACETATE | caspofungin acetate | POWDER;INTRAVENOUS | 200833-001 | Jun 28, 2018 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Fresenius Kabi Usa | CASPOFUNGIN ACETATE | caspofungin acetate | POWDER;INTRAVENOUS | 206110-002 | Dec 30, 2016 | AP | RX | No | No | Start Trial | Start Trial | Y | Start Trial | ||
| Xellia Pharms Aps | CASPOFUNGIN ACETATE | caspofungin acetate | POWDER;INTRAVENOUS | 205923-002 | Jul 2, 2018 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Jiangsu Hengrui Med | CASPOFUNGIN ACETATE | caspofungin acetate | POWDER;INTRAVENOUS | 200833-002 | Jun 28, 2018 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Cipla | CASPOFUNGIN ACETATE | caspofungin acetate | POWDER;INTRAVENOUS | 209489-002 | Jul 12, 2018 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Fresenius Kabi Usa | CASPOFUNGIN ACETATE | caspofungin acetate | POWDER;INTRAVENOUS | 206110-001 | Dec 30, 2016 | AP | RX | No | No | Start Trial | 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 CASPOFUNGIN ACETATE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hong Kong | 1215668 | Start Trial |
| Spain | 2607646 | Start Trial |
| Portugal | 2922530 | Start Trial |
| Cyprus | 1120016 | Start Trial |
| Hungary | E032392 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2014081443 | Start Trial |
| European Patent Office | 2922530 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for CASPOFUNGIN ACETATE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0620232 | 01C0054 | France | Start Trial | PRODUCT NAME: CASPOFUNGIN ACETATE; REGISTRATION NO/DATE: EU/1/01/196/001 20011024 |
| 0620232 | C300076 | Netherlands | Start Trial | 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 | SPC/GB02/002 | United Kingdom | Start Trial | A SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB02/002 GRANTED TO MERCK SHARP + DOHME, CORP IN RESPECT OF THE PRODUCT CASPOFUNGIN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY CASPOFUNGIN ACETATE, WHICH WAS ADVERTISED AS COMING INTO FORCE IN JOURNAL NO 5919 DATED 30 OCTOBER 2002 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, IT WILL EXPIRE ON 24 OCTOBER 2016. |
| 0620232 | 2001/029 | Ireland | Start Trial | PRODUCT NAME: CASPOFUNGIN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY CASPOFUNGIN ACETATE; REGISTRATION NO/DATE: EU/1/01/196/001-003 20011024; PAEDIATRIC INV. PLAN: P/30/2008 |
| 0620232 | 44/2001 | Austria | Start Trial | 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 |
