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Serving leading biopharmaceutical companies globally:

Argus Health
US Department of Justice
Merck
US Army
Julphar
Deloitte
Accenture
AstraZeneca
Baxter
Novartis

Generated: January 18, 2018

DrugPatentWatch Database Preview

Lansoprazole - Generic Drug Details

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What are the generic drug sources for lansoprazole and what is the scope of lansoprazole freedom to operate?

Lansoprazole
is the generic ingredient in seven branded drugs marketed by Ajanta Pharma Ltd, Dr Reddys Labs Ltd, Inventia Hlthcare, Kremers Urban Pharms, Labs Liconsa, Mylan Pharms Inc, Natco Pharma Ltd, Perrigo R And D, Sandoz, Sun Pharm Inds Ltd, Teva Pharms, Wockhardt Ltd, Wockhardt Usa, Zydus Hlthcare, Krka Tovarna Zdravil, Takeda Pharms Usa, Glaxosmithkline Cons, Takeda Pharms Na, Ani Pharms Inc, Dexcel Pharma, and Teva Pharms Usa, and is included in twenty-nine NDAs. There are five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lansoprazole has sixty-three patent family members in nineteen countries.

There are fifty-four drug master file entries for lansoprazole. Eighty-six suppliers are listed for this compound.
Pharmacology for lansoprazole
Medical Subject Heading (MeSH) Categories for lansoprazole

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
Takeda Pharms Usa PREVACID lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 020406-002 May 10, 1995 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Wockhardt Usa LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 202176-001 Sep 14, 2012 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa PREVACID lansoprazole TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL 021428-001 Aug 30, 2002 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Takeda Pharms Usa PREVACID lansoprazole TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL 021428-001 Aug 30, 2002 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Teva Pharms Usa LANSOPRAZOLE lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 208784-002 Sep 21, 2017 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa PREVACID lansoprazole TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL 021428-002 Aug 30, 2002 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Teva Pharms LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 077255-001 Nov 10, 2009 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva Pharms LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 077255-002 Nov 10, 2009 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan Pharms Inc LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 090763-001 Nov 10, 2009 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Perrigo R And D LANSOPRAZOLE lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 202319-001 May 18, 2012 OTC No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for lansoprazole

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa PREVACID lansoprazole TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL 021428-002 Aug 30, 2002 ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa PREVACID lansoprazole TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL 021428-001 Aug 30, 2002 ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa PREVACID lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 020406-001 May 10, 1995 ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa PREVACID lansoprazole TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL 021428-002 Aug 30, 2002 ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa PREVACID lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 020406-002 May 10, 1995 ➤ Subscribe ➤ Subscribe
Takeda Pharms Na PREVACID lansoprazole FOR SUSPENSION, DELAYED RELEASE;ORAL 021281-001 May 3, 2001 ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa PREVACID lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 020406-001 May 10, 1995 ➤ Subscribe ➤ Subscribe
Takeda Pharms Na PREVACID lansoprazole FOR SUSPENSION, DELAYED RELEASE;ORAL 021281-001 May 3, 2001 ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa PREVACID lansoprazole TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL 021428-002 Aug 30, 2002 ➤ Subscribe ➤ Subscribe
Takeda Pharms Na PREVACID lansoprazole FOR SUSPENSION, DELAYED RELEASE;ORAL 021281-001 May 3, 2001 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for lansoprazole

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,070,805 Rapidly disintegrable solid preparation ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for lansoprazole

Supplementary Protection Certificates for lansoprazole

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
14/008 Ireland ➤ Subscribe 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
C0021 Belgium ➤ Subscribe PRODUCT NAME: LANSOPRAZOLE; NAT. REG.: 150 S 539 F 4 19921119; FIRST REG.: FR 333 412.1 19901211
C0021 Belgium ➤ Subscribe 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

US Army
UBS
Farmers Insurance
Cantor Fitzgerald
Teva
Baxter
US Department of Justice
Citi
Fish and Richardson

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