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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, Glaxosmithkline Cons, 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
Drug Prices:see low prices

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
Takeda Pharms Na
PREVACID NAPRAPAC 375 (COPACKAGED)
lansoprazole; naproxen
CAPSULE, DELAYED REL PELLETS, TABLET;ORAL021507-003Nov 14, 2003DISCNNo
Dr Reddys Labs Ltd
LANSOPRAZOLE
lansoprazole
CAPSULE, DELAYED REL PELLETS;ORAL091269-001Oct 15, 2010RXNo
Takeda Pharms Usa
PREVACID
lansoprazole
TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL021428-001Aug 30, 2002RXNo6,328,994*PEDNov 17, 2019Y
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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 Usa
PREVACID
lansoprazole
TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL021428-001Aug 30, 20025,464,632*PED<disabled>
Takeda Pharms Usa
PREVACID
lansoprazole
TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL021428-002Aug 30, 20026,749,864<disabled>
Takeda Pharms Usa
PREVACID
lansoprazole
TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL021428-001Aug 30, 20025,013,743*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
China1149077<disabled in preview>
Argentina019935<disabled in preview>
Japan2000103731<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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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 verifification 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.

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