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Serving leading biopharmaceutical companies globally:

Moodys
QuintilesIMS
US Army
Farmers Insurance
Baxter
Express Scripts
McKesson
Colorcon
US Department of Justice
AstraZeneca

Generated: December 12, 2017

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Ferric carboxymaltose - Generic Drug Details

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What are the generic sources for ferric carboxymaltose and what is the scope of ferric carboxymaltose patent protection?

Ferric carboxymaltose
is the generic ingredient in one branded drug marketed by Luitpold Pharms Inc and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ferric carboxymaltose has sixty-five patent family members in thirty countries.

There are fourteen drug master file entries for ferric carboxymaltose. One supplier is listed for this compound.

Summary for ferric carboxymaltose

Pharmacology for ferric carboxymaltose

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Luitpold Pharms IncINJECTAFERferric carboxymaltoseINJECTABLE;INTRAVENOUS203565-001Jul 25, 2013RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Luitpold Pharms IncINJECTAFERferric carboxymaltoseINJECTABLE;INTRAVENOUS203565-001Jul 25, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Luitpold Pharms IncINJECTAFERferric carboxymaltoseINJECTABLE;INTRAVENOUS203565-001Jul 25, 2013RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Luitpold Pharms IncINJECTAFERferric carboxymaltoseINJECTABLE;INTRAVENOUS203565-001Jul 25, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Luitpold Pharms IncINJECTAFERferric carboxymaltoseINJECTABLE;INTRAVENOUS203565-001Jul 25, 2013RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: ferric carboxymaltose

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
8,431,549Methods and compositions for administration of iron► 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 Ingredient: ferric carboxymaltose

Country Document Number Estimated Expiration
Austria507246► Subscribe
Russian Federation2303039► Subscribe
Japan4777653► Subscribe
Brazil0315452► Subscribe
South Africa200504174► Subscribe
Taiwan200420289► Subscribe
Spain2385788► Subscribe
Portugal1554315► Subscribe
Hong Kong1149574► Subscribe
Slovenia2287204► 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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Serving leading biopharmaceutical companies globally:

Citi
Moodys
Farmers Insurance
Accenture
Fish and Richardson
Medtronic
Federal Trade Commission
Harvard Business School
UBS
Chubb

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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