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Generated: June 26, 2019

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Caspofungin acetate - Generic Drug Details

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What are the generic sources for caspofungin acetate and what is the scope of caspofungin acetate freedom to operate?

Caspofungin acetate is the generic ingredient in two branded drugs marketed by Merck, Cipla, Fresenius Kabi Usa, Gland Pharma Ltd, Mylan Labs Ltd, Sandoz Inc, and Xellia Pharms Aps, and is included in seven 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 eight drug master file entries for caspofungin acetate. Nine suppliers are listed for this compound. There is one tentative approval for this compound.

Pharmacology for caspofungin acetate
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
Generic filers with tentative approvals for CASPOFUNGIN ACETATE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial70MG/VIALINJECTABLE; INJECTION
➤ Try a Free Trial➤ Try a Free Trial50MG/VIALINJECTABLE; INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Sandoz Inc CASPOFUNGIN ACETATE caspofungin acetate POWDER;INTRAVENOUS 200833-001 Jun 28, 2018 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Cipla CASPOFUNGIN ACETATE caspofungin acetate POWDER;INTRAVENOUS 209489-001 Jul 12, 2018 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Merck CANCIDAS caspofungin acetate POWDER;INTRAVENOUS 021227-001 Jan 26, 2001 AP RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Labs Ltd CASPOFUNGIN ACETATE caspofungin acetate POWDER;INTRAVENOUS 207650-002 Sep 29, 2017 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Fresenius Kabi Usa CASPOFUNGIN ACETATE caspofungin acetate POWDER;INTRAVENOUS 206110-002 Dec 30, 2016 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for caspofungin acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck CANCIDAS caspofungin acetate POWDER;INTRAVENOUS 021227-001 Jan 26, 2001 ➤ Try a Free Trial ➤ Try a Free Trial
Merck CANCIDAS caspofungin acetate POWDER;INTRAVENOUS 021227-002 Jan 26, 2001 ➤ Try a Free Trial ➤ Try a Free Trial
Merck CANCIDAS caspofungin acetate POWDER;INTRAVENOUS 021227-001 Jan 26, 2001 ➤ Try a Free Trial ➤ Try a Free Trial
Merck CANCIDAS caspofungin acetate POWDER;INTRAVENOUS 021227-001 Jan 26, 2001 ➤ Try a Free Trial ➤ Try a Free Trial
Merck CANCIDAS caspofungin acetate POWDER;INTRAVENOUS 021227-002 Jan 26, 2001 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for caspofungin acetate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0620232 44/2001 Austria ➤ Try a Free Trial PRODUCT NAME: CASPOFUNGIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE CASPOFUNGINACETAT; REGISTRATION NO/DATE: EU/01/196/001-003 20011024
0620232 2001/029 Ireland ➤ Try a Free 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 SPC/GB02/002 United Kingdom ➤ Try a Free 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 C300076 Netherlands ➤ Try a Free 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 01C0054 France ➤ Try a Free Trial PRODUCT NAME: CASPOFUNGIN ACETATE; REGISTRATION NO/DATE: EU/1/01/196/001 20011024
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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