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Last Updated: October 26, 2021

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Lansoprazole - Generic Drug Details

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What are the generic 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, Dexcel Pharma, Teva Pharms Usa, and Zydus Pharms, and is included in thirty-five NDAs. There are two patents 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-three 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
Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.Phase 3
ParexelPhase 2
Cinclus Pharma AGPhase 2

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
Teva Pharms LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 077255-002 Nov 10, 2009 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Mylan Pharms Inc LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 090763-001 Nov 10, 2009 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Zydus Hlthcare LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 202366-001 Aug 19, 2013 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 Na PREVACID lansoprazole FOR SUSPENSION, DELAYED RELEASE;ORAL 021281-001 May 3, 2001 ⤷  Free Forever Trial ⤷  Free Forever Trial
Takeda Pharms Usa PREVACID lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 021428-001 Aug 30, 2002 ⤷  Free Forever Trial ⤷  Free Forever Trial
Takeda Pharms Na PREVACID lansoprazole FOR SUSPENSION, DELAYED RELEASE;ORAL 021281-002 May 3, 2001 ⤷  Free Forever Trial ⤷  Free Forever 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
0328535 96C0021 Belgium ⤷  Free Forever 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
1129088 2014/008 Ireland ⤷  Free Forever 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
0174726 93C0021 Belgium ⤷  Free Forever 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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Serving leading biopharmaceutical companies globally:

Moodys
Medtronic
Merck
Baxter
Boehringer Ingelheim
Mallinckrodt

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