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Last Updated: September 29, 2020

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Lansoprazole - Generic Drug Details

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What are the generic drug sources for lansoprazole and what is the scope of patent protection?

Lansoprazole is the generic ingredient in seven branded drugs marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Breckenridge, Dr Reddys Labs Ltd, Hetero Labs Ltd Iii, Inventia, Krka Tovarna Zdravil, Lannett Co Inc, Mylan, Mylan Pharms Inc, Natco Pharma Ltd, Perrigo R And D, Sandoz, Sun Pharm, Teva Pharms, Wockhardt Ltd, Wockhardt Usa, Xiromed, Zydus Hlthcare, Takeda Pharms Usa, Perrigo Pharma Intl, Takeda Pharms Na, Ani Pharms Inc, Dexcel Pharma, Teva Pharms Usa, and Zydus Pharms, and is included in thirty-four NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lansoprazole has six patent family members in five countries.

There are fifty-six drug master file entries for lansoprazole. Seventy-eight suppliers are listed for this compound.

Drug Prices for lansoprazole

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Drug Sales Revenue Trends for lansoprazole

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Recent Clinical Trials for lansoprazole

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

SponsorPhase
University of Roma La SapienzaEarly Phase 1
Daewoong Pharmaceutical Co. LTD.Phase 3
PETHEMA FoundationPhase 3

See all lansoprazole clinical trials

Pharmacology for lansoprazole
Medical Subject Heading (MeSH) Categories for lansoprazole
Paragraph IV (Patent) Challenges for LANSOPRAZOLE
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 lansoprazole

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 090331-001 Apr 23, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Hetero Labs Ltd Iii LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 203083-002 May 18, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Krka Tovarna Zdravil LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 091212-002 Sep 16, 2013 DISCN No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Ltd LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 202194-001 May 18, 2012 OTC 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 lansoprazole

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa PREVACID lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 020406-002 May 10, 1995   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 021428-002 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for lansoprazole

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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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