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Last Updated: March 28, 2024

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, Chartwell Molecular, Dr Reddys Labs Ltd, Glenmark Pharms Inc, Hetero Labs Ltd Iii, Inventia, Krka Tovarna Zdravil, Lannett Co Inc, Mylan, Mylan Pharms Inc, Natco, Natco Pharma Ltd, Perrigo R And D, Sandoz, Sun Pharm, Teva Pharms, Wockhardt, Xiromed, Zydus Hlthcare, Takeda Pharms Usa, Perrigo Pharma Intl, Takeda Pharms Na, Ani Pharms, Aurobindo Pharma Ltd, Dexcel, Dr Reddys, Teva Pharms Usa, and Zydus Pharms, and is included in thirty-six 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 three patent family members in three countries.

There are fifty-six drug master file entries for lansoprazole. Seventy 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
Jeil Pharmaceutical Co., Ltd.Phase 4
Daejeon St. Mary's hospitalPhase 4
Nanfang Hospital of Southern Medical UniversityPhase 4

See all lansoprazole clinical trials

Pharmacology for lansoprazole
Drug ClassProton Pump Inhibitor
Mechanism of ActionProton Pump Inhibitors
Physiological EffectInhibition Gastric Acid Secretion
Medical Subject Heading (MeSH) Categories for lansoprazole
Paragraph IV (Patent) Challenges for LANSOPRAZOLE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PREVACID Delayed-release Orally Disintegrating Tablets lansoprazole 15 mg and 30 mg 021428 1 2006-12-27
PREVACID Delayed-release Pellets/Capsules lansoprazole 15 mg and 30 mg 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
Sun Pharm LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 091509-001 Sep 13, 2013 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Perrigo R And D LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 202319-001 May 18, 2012 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan LANSOPRAZOLE lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 202396-001 Nov 28, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 090331-002 Apr 23, 2010 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 203187-001 Jun 1, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa PREVACID lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 021428-002 Aug 30, 2002 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 021428-002 Aug 30, 2002 ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa PREVACID lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 020406-002 May 10, 1995 ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Na PREVACID lansoprazole FOR SUSPENSION, DELAYED RELEASE;ORAL 021281-001 May 3, 2001 ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa PREVACID lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 021428-002 Aug 30, 2002 ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa PREVACID lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 021428-002 Aug 30, 2002 ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa PREVACID lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 021428-001 Aug 30, 2002 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for lansoprazole

Country Patent Number Title Estimated Expiration
Israel 255048 הרכבים המתפוררים בפה (Orally disintegrating compositions) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2016174664 ⤷  Try a Trial
European Patent Office 3288556 COMPOSITIONS À DÉSINTÉGRATION PAR VOIE ORALE (ORALLY DISINTEGRATING COMPOSITIONS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for lansoprazole

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1129088 2014/008 Ireland ⤷  Try a 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 ⤷  Try a 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 93C0021 Belgium ⤷  Try a Trial PRODUCT NAME: LANSOPRAZOLE; NAT. REG.: 150 S 539 F 4 19921119; FIRST REG.: FR 333 412.1 19901211
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.