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Generated: October 18, 2018

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MYCAMINE Drug Profile

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Which patents cover Mycamine, and when can generic versions of Mycamine launch?

Mycamine is a drug marketed by Astellas and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in MYCAMINE is micafungin sodium. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the micafungin sodium profile page.

Drug patent expirations by year for MYCAMINE
Generic Entry Opportunity Date for MYCAMINE
Generic Entry Date for MYCAMINE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
INJECTABLE;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for MYCAMINE
Ingredient-typeLipopeptides
Drug ClassEchinocandin Antifungal
Synonyms for MYCAMINE
208538-73-2
AKOS027461043
C15819
C56H70N9NaO23S
CHEBI:80105
CHEMBL1237070
D02465
FK 463
FK-463
FK463
FK463 Sodium
FT-0687494
Funguard
Funguard (TN)
IS1UP79R56
J-013676
KOOAFHGJVIVFMZ-WZPXRXMFSA-M
MCFG
Micafungin
Micafungin sodium
Micafungin sodium (JAN/USAN)
Micafungin sodium [USAN]
MolPort-028-720-447
MolPort-035-789-689
Mycamine (TN)
oxo-9-(4-(5-(4-(pentyloxy)phenyl)isoxazol-3-yl)benzamido)tetracosahydro-1H-dipyrrolo[2,1-c:2',1'-l][1,4,7,10,13,16]hexaazacyclohenicosin-23-yl)-1,2-dihydroxyethyl)-2-hydroxyphenyl sulfate
Pneumocandin A0, 1-((4R,5R)-4,5-dihydroxy-N2-(4-(5-(5-(pentyloxy)phenyl)-3-isoxazolyl)benzoyl)-L-ornithine)-4-((4S)-4-hydroxy-4-(4-hydroxy-3-(sulfooxy)phenyl)-L-threonine)-, monosodium salt
PWAXVQURCGJSNE-WZPXRXMFSA-N
s4287
sodium 5-((1S,2S)-2-((2R,6S,9S,11R,12R,14aS,15S,16S,20S,23S,25aS)-20-((R)-3-amino-1-hydroxy-3-oxopropyl)-2,11,12,15-tetrahydroxy-6-((R)-1-hydroxyethyl)-16-methyl-5,8,14,19,22,25-hexa
sodium Micafungin
UNII-IS1UP79R56
Z1867

US Patents and Regulatory Information for MYCAMINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-002 Mar 16, 2005 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-003 Jun 27, 2006 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-002 Mar 16, 2005 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-003 Jun 27, 2006 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y 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 MYCAMINE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-002 Mar 16, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-003 Jun 27, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-002 Mar 16, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-003 Jun 27, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for MYCAMINE
Drugname Dosage Strength RLD Date
➤ Subscribe For Injection 50 mg/vial and 100 mg/vial ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for MYCAMINE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
452 Luxembourg ➤ Try a Free Trial 91452, EXPIRES: 20200929
C/GB08/036 United Kingdom ➤ Try a Free Trial PRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425
0788511/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: MICAFUNGIN; REGISTRATION NO/DATE: SWISSMEDIC 60724 11.07.2012
0352 Netherlands ➤ Try a Free Trial 300352, 20150929, EXPIRES: 20200928
C022/2008 Ireland ➤ Try a Free Trial SPC022/2008: 20090219, EXPIRES: 20200928
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Harvard Business School
Teva
Johnson and Johnson
Chubb
Queensland Health
AstraZeneca
Farmers Insurance
Merck

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