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FACTIVE Drug Profile

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Factive is a drug marketed by Lg Life Sciences and is included in one NDA. It is available from two suppliers. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-six patent family members in thirty-nine countries.

The generic ingredient in FACTIVE is gemifloxacin mesylate. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the gemifloxacin mesylate profile page.

Summary for Tradename: FACTIVE

Patents:7
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Drug Prices: :see details

Pharmacology for Tradename: FACTIVE

Ingredient-typeQuinolones
Drug ClassQuinolone Antimicrobial
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lg Life Sciences
FACTIVE
gemifloxacin mesylate
TABLET;ORAL021158-001Apr 4, 2003RXYes6,262,071► subscribe ► subscribe
Lg Life Sciences
FACTIVE
gemifloxacin mesylate
TABLET;ORAL021158-001Apr 4, 2003RXYes5,776,944► subscribeYY ► subscribe
Lg Life Sciences
FACTIVE
gemifloxacin mesylate
TABLET;ORAL021158-001Apr 4, 2003RXYes6,455,540► subscribe ► subscribe
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Expired Patents for Tradename: FACTIVE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lg Life Sciences
FACTIVE
gemifloxacin mesylate
TABLET;ORAL021158-001Apr 4, 20035,633,262► subscribe
Lg Life Sciences
FACTIVE
gemifloxacin mesylate
TABLET;ORAL021158-001Apr 4, 20035,962,468► subscribe
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Paragraph IV activity for: FACTIVE

Drugname Dosage Strength RLD Submissiondate
gemifloxacin mesylateTablets320 mgFactive3/4/2008

Non-Orange Book Patents for Tradename: FACTIVE

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
7,595,328Methods of use of quinolone compounds against pneumococcal and Haemophilus bacteria► subscribe
5,633,262 Quinoline carboxylic acid derivatives having 7-(4-amino-methyl-3-oxime) pyrrolidine substituent and processes for preparing thereof► subscribe
7,700,617Salt of naphthyridine carboxylic acid derivative► 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: FACTIVE

Country Document Number Estimated Expiration
Canada2281817► subscribe
Morocco24500► subscribe
European Patent Office1179533► 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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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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