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Last Updated: January 27, 2023

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, 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, Dexcel, Dr Reddys, 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 nine patent family members in six countries.

There are fifty-six drug master file entries for lansoprazole. Seventy-five 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
Nanfang Hospital of Southern Medical UniversityPhase 4
Future pharmaceutical industriesPhase 4
National Liver Institute, EgyptPhase 4

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Pharmacology for lansoprazole
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
Sandoz LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 090331-001 Apr 23, 2010 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Takeda Pharms Na PREVACID NAPRAPAC 250 (COPACKAGED) lansoprazole; naproxen CAPSULE, DELAYED REL PELLETS, TABLET;ORAL 021507-002 Nov 14, 2003 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Dr Reddys LANSOPRAZOLE lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 210465-002 Feb 1, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Wockhardt LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 202176-001 Sep 14, 2012 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa PREVACID lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 021428-001 Aug 30, 2002 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Glenmark Pharms Inc LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 202727-001 May 18, 2012 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Takeda Pharms Na PREVACID lansoprazole FOR SUSPENSION, DELAYED RELEASE;ORAL 021281-001 May 3, 2001 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 021428-001 Aug 30, 2002 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa PREVACID lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 021428-001 Aug 30, 2002 See Plans and Pricing See Plans and Pricing
Takeda Pharms Na PREVACID lansoprazole FOR SUSPENSION, DELAYED RELEASE;ORAL 021281-001 May 3, 2001 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa PREVACID lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 020406-002 May 10, 1995 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa PREVACID lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 020406-002 May 10, 1995 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa PREVACID lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 021428-002 Aug 30, 2002 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa PREVACID lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 021428-002 Aug 30, 2002 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for lansoprazole

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 0215908 See Plans and Pricing
Canada 2419067 COMPOSITION INJECTABLE COMRENANT UN COMPOSE DE BENZIMIDAZOLEET UN ALKALI FORT (INJECTABLE COMPOSITION COMPRISING BENZIMIDAZOLE COMPOUND ANDSTRONG ALKALI) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2016174664 See Plans and Pricing
Japan 4136340 See Plans and Pricing
European Patent Office 3288556 COMPOSITIONS À DÉSINTÉGRATION PAR VOIE ORALE (ORALLY DISINTEGRATING COMPOSITIONS) See Plans and Pricing
Israel 255048 הרכבים המתפוררים בפה (Orally disintegrating compositions) See Plans and Pricing
Australia 7875501 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for lansoprazole

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0328535 96C0021 Belgium See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: LANSOPRAZOLE; NAT. REG.: 150 S 539 F 4 19921119; FIRST REG.: FR 333 412.1 19901211
1129088 2014/008 Ireland See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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