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Serving leading biopharmaceutical companies globally:

Argus Health
Colorcon
QuintilesIMS
Johnson and Johnson
Baxter
Chinese Patent Office
Farmers Insurance
Queensland Health
Federal Trade Commission
Cantor Fitzgerald

Generated: December 15, 2017

DrugPatentWatch Database Preview

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.

This drug has seventy-nine patent family members in thirty-two countries and seven supplementary protection certificates in seven countries.

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

Summary for MYCAMINE

Drug patent expirations by year for MYCAMINE

Pharmacology for MYCAMINE

Ingredient-typeLipopeptides
Drug ClassEchinocandin Antifungal

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
AstellasMYCAMINEmicafungin sodiumINJECTABLE;IV (INFUSION)021506-002Mar 16, 2005RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
AstellasMYCAMINEmicafungin sodiumINJECTABLE;IV (INFUSION)021506-003Jun 27, 2006RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
AstellasMYCAMINEmicafungin sodiumINJECTABLE;IV (INFUSION)021506-002Mar 16, 2005RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
AstellasMYCAMINEmicafungin sodiumINJECTABLE;IV (INFUSION)021506-003Jun 27, 2006RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: MYCAMINE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
AstellasMYCAMINEmicafungin sodiumINJECTABLE;IV (INFUSION)021506-002Mar 16, 2005► Subscribe► Subscribe
AstellasMYCAMINEmicafungin sodiumINJECTABLE;IV (INFUSION)021506-003Jun 27, 2006► Subscribe► Subscribe
AstellasMYCAMINEmicafungin sodiumINJECTABLE;IV (INFUSION)021506-003Jun 27, 2006► Subscribe► Subscribe
AstellasMYCAMINEmicafungin sodiumINJECTABLE;IV (INFUSION)021506-002Mar 16, 2005► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for MYCAMINE

Drugname Dosage Strength RLD Submissiondate
micafungin sodiumFor Injection50 mg/vial and 100 mg/vialMycamine6/16/2014

Non-Orange Book Patents for Tradename: MYCAMINE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,265,536 Cyclic hexapeptides having antibiotic activity► Subscribe
7,112,565Stabilized pharmaceutical composition in lyophilized form► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: MYCAMINE

Country Document Number Estimated Expiration
Spain2225161► Subscribe
Denmark1107777► Subscribe
Germany122008000025► Subscribe
Germany60015279► Subscribe
Germany69529172► Subscribe
Australia696949► Subscribe
Poland200141► Subscribe
Austria229541► Subscribe
Portugal788511► Subscribe
Hungary229089► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: MYCAMINE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2008 00030Denmark► Subscribe
0788511/01Switzerland► SubscribePRODUCT NAME: MICAFUNGIN; REGISTRATION NO/DATE: SWISSMEDIC 60724 11.07.2012
0352Netherlands► Subscribe300352, 20150929, EXPIRES: 20200928
C0028France► SubscribePRODUCT NAME: MICAFUNGINE; REGISTRATION NO/DATE: EU/1/08/448/001-002 20080425
C/GB08/036United Kingdom► SubscribePRODUCT 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
452Luxembourg► Subscribe91452, EXPIRES: 20200929
C022/2008Ireland► SubscribeSPC022/2008: 20090219, EXPIRES: 20200928
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Serving leading biopharmaceutical companies globally:

Harvard Business School
Chinese Patent Office
Healthtrust
McKinsey
Queensland Health
Fuji
Fish and Richardson
Merck
Colorcon
Citi

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. thinkBiotech performs no independent verifification 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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