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PREVACID Drug Profile

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Prevacid is a drug marketed by Takeda Pharms Usa, Takeda Pharms Na, and Novartis. and is included in six NDAs. It is available from eight suppliers. There are five patents protecting this drug and two Paragraph IV challenges.

This drug has fifty-three patent family members in nineteen countries.

The generic ingredient in PREVACID is lansoprazole; naproxen. There are fifty-three drug master file entries for this compound. Additional details are available on the lansoprazole; naproxen profile page.

Summary for Tradename: PREVACID

Patents:5
Applicants:3
NDAs:6
Suppliers / Packagers: see list8

Pharmacology for Tradename: PREVACID

Clinical Trials for: PREVACID

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa
PREVACID
lansoprazole
CAPSULE, DELAYED REL PELLETS;ORAL020406-001May 10, 1995RXNo<disabled><disabled>
Takeda Pharms Usa
PREVACID
lansoprazole
TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL021428-002Aug 30, 2002RXYes7,875,292*PED<disabled>Y<disabled>
Takeda Pharms Usa
PREVACID
lansoprazole
TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL021428-001Aug 30, 2002RXNo7,431,942*PED<disabled>Y<disabled>
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Expired Patents for Tradename: PREVACID

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Na
PREVACID
lansoprazole
FOR SUSPENSION, DELAYED RELEASE;ORAL021281-002May 3, 20015,013,743*PED<disabled>
Takeda Pharms Usa
PREVACID
lansoprazole
TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL021428-002Aug 30, 20025,093,132*PED<disabled>
Takeda Pharms Na
PREVACID
lansoprazole
FOR SUSPENSION, DELAYED RELEASE;ORAL021281-002May 3, 20015,026,560*PED<disabled>
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Paragraph IV activity for: PREVACID

Drugname Dosage Strength RLD Submissiondate
lansoprazoleDelayed-release Orally Disinte15 mg and 30 mgPrevacid12/27/2006
lansoprazoleDelayed-release Pellets/Capsul15 mg and 30 mgPrevacid12/5/2005

Non-Orange Book Patents for Tradename: PREVACID

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
7,070,805Rapidly disintegrable solid preparation<disabled in preview>
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International Patent Family for Tradename: PREVACID

Country Document Number Estimated Expiration
Japan3404648<disabled in preview>
Denmark1100469<disabled in preview>
China1195500<disabled in preview>
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Supplementary Protection Certificates for Tradename: PREVACID

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0021Belgium<disabled>PRODUCT NAME: LANSOPRAZOLE + CLARITHROMYCINE + METRONIDAZOLE; REGISTRATION NO/DATE IN FRANCE: K 27 17033R DU 19960209; REGISTRATION NO/DATE AT EEC: K 27 17033R DU 19960209
14/008Ireland<disabled>PRODUCT NAME: DEXLANSOPRAZOLE OR A SALT THEREOF; NAT REGISTRATION NO/DATE: PA1864/001/001-002;PA1864/002/001-002 20131125; FIRST REGISTRATION NO/DATE: 47911 47912 47913 47914 20130919
C0021Belgium<disabled>PRODUCT NAME: LANSOPRAZOLE; NAT. REG.: 150 S 539 F 4 19921119; FIRST REG.: FR 333 412.1 19901211
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