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Lansoprazole - Generic Drug Details

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

This ingredient has fifty-three patent family members in nineteen countries.

There are fifty-three drug master file entries for lansoprazole. Eighty-one suppliers are listed for this compound.

Summary for Generic Name: lansoprazole

Tradenames:7
Patents:5
Applicants:17
NDAs:24
Drug Master File Entries: see list53
Suppliers / Packaging: see list81
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: lansoprazole

Clinical Trials for: lansoprazole

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Ltd
LANSOPRAZOLE
lansoprazole
CAPSULE, DELAYED REL PELLETS;ORAL202194-001May 18, 2012OTCNo<disabled><disabled>
Takeda Pharms Na
PREVACID NAPRAPAC 500 (COPACKAGED)
lansoprazole; naproxen
CAPSULE, DELAYED REL PELLETS, TABLET;ORAL021507-004Nov 14, 2003DISCNNo<disabled><disabled>
Anchen Pharms
LANSOPRAZOLE
lansoprazole
CAPSULE, DELAYED REL PELLETS;ORAL203203-002Jul 25, 2016RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: lansoprazole

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Na
PREVACID
lansoprazole
FOR SUSPENSION, DELAYED RELEASE;ORAL021281-002May 3, 20014,689,333<disabled>
Takeda Pharms Usa
PREVACID
lansoprazole
TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL021428-002Aug 30, 20024,689,333<disabled>
Takeda Pharms Usa
PREVACID
lansoprazole
CAPSULE, DELAYED REL PELLETS;ORAL020406-002May 10, 19955,013,743*PED<disabled>
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Non-Orange Book Patents for Generic Ingredient: 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
7,070,805Rapidly disintegrable solid preparation<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: lansoprazole

Country Document Number Estimated Expiration
Canada2525555<disabled in preview>
Malaysia151098<disabled in preview>
European Patent Office1561458<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: LANSOPRAZOLE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0021Belgium<disabled>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
C0021Belgium<disabled>PRODUCT NAME: LANSOPRAZOLE; NAT. REG.: 150 S 539 F 4 19921119; FIRST REG.: FR 333 412.1 19901211
14/008Ireland<disabled>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
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