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Last Updated: September 23, 2020

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PREVACID Drug Profile

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US ANDA Litigation and Generic Entry Outlook for Prevacid

Prevacid was eligible for patent challenges on May 10, 1999.

Annual sales in 2018 were $408mm indicating the motivation for generic entry (peak sales were $3.4bn in 2005).

There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for PREVACID
Drug Prices for PREVACID

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Drug Sales Revenue Trends for PREVACID

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Recent Clinical Trials for PREVACID

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
TakedaPhase 3
Janssen Research & Development, LLCPhase 1
McGill University Health CenterPhase 4

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Pharmacology for PREVACID
Paragraph IV (Patent) Challenges for PREVACID
Tradename Dosage Ingredient NDA Submissiondate
PREVACID TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL lansoprazole 021428 2006-12-27
PREVACID CAPSULE, DELAYED REL PELLETS;ORAL lansoprazole 020406 2005-12-05

US Patents and Regulatory Information for PREVACID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa PREVACID lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 020406-001 May 10, 1995 AB RX Yes No   Start Trial   Start Trial   Start Trial
Perrigo Pharma Intl PREVACID 24 HR lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 022327-001 May 18, 2009 OTC Yes Yes   Start Trial   Start Trial   Start Trial
Takeda Pharms Na PREVACID lansoprazole FOR SUSPENSION, DELAYED RELEASE;ORAL 021281-002 May 3, 2001 DISCN No No   Start Trial   Start Trial   Start Trial
Takeda Pharms Na PREVACID IV lansoprazole INJECTABLE;INTRAVENOUS 021566-001 May 27, 2004 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Takeda Pharms Usa PREVACID lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 020406-002 May 10, 1995 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Takeda Pharms Na PREVACID lansoprazole FOR SUSPENSION, DELAYED RELEASE;ORAL 021281-001 May 3, 2001 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for PREVACID

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa PREVACID lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 021428-002 Aug 30, 2002   Start Trial   Start Trial
Takeda Pharms Usa PREVACID lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 021428-002 Aug 30, 2002   Start Trial   Start Trial
Takeda Pharms Usa PREVACID lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 021428-001 Aug 30, 2002   Start Trial   Start Trial
Takeda Pharms Usa PREVACID lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 021428-001 Aug 30, 2002   Start Trial   Start Trial
Takeda Pharms Na PREVACID lansoprazole FOR SUSPENSION, DELAYED RELEASE;ORAL 021281-002 May 3, 2001   Start Trial   Start Trial
Takeda Pharms Na PREVACID lansoprazole FOR SUSPENSION, DELAYED RELEASE;ORAL 021281-001 May 3, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for PREVACID

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0174726 93C0021 Belgium   Start Trial PRODUCT NAME: LANSOPRAZOLE; NAT. REG.: 150 S 539 F 4 19921119; FIRST REG.: FR 333 412.1 19901211
1129088 2014/008 Ireland   Start Trial 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
0328535 96C0021 Belgium   Start Trial 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
0174726 SPC/GB94/011 United Kingdom   Start Trial SPC/GB94/011, EXPIRES: 20051210
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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