Lansoprazole - Generic Drug Details

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What are the generic drug 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, Aurobindo Pharma Ltd, Dexcel, Dr Reddys, Teva Pharms Usa, and Zydus Pharms, and is included in thirty-six 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 three patent family members in three countries.

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

Summary for lansoprazole

International Patents:	3
US Patents:	2
Tradenames:	7
Applicants:	30
NDAs:	36
Drug Master File Entries:	56
Finished Product Suppliers / Packagers:	71
Raw Ingredient (Bulk) Api Vendors:	162
Clinical Trials:	181
Patent Applications:	6,943
Drug Prices:	Drug price trends for lansoprazole
Drug Sales Revenues:	Drug sales revenues for lansoprazole
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lansoprazole
What excipients (inactive ingredients) are in lansoprazole?	lansoprazole excipients list
DailyMed Link:	lansoprazole at DailyMed

See drug prices for lansoprazole

Drug Sales Revenue Trends for lansoprazole

See drug sales revenues for lansoprazole

Recent Clinical Trials for lansoprazole

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Fu Jen Catholic University Hospital	Phase 4
Hospital Clinico Universitario de Santiago	Phase 4
Complejo Hospitalario de Navarra	Phase 4

See all lansoprazole clinical trials

Pharmacology for lansoprazole

Drug Class	Proton Pump Inhibitor
Mechanism of Action	Proton Pump Inhibitors
Physiological Effect	Inhibition Gastric Acid Secretion

Medical Subject Heading (MeSH) Categories for lansoprazole

Anti-Ulcer Agents
Proton Pump Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for lansoprazole

A02BC	Proton pump inhibitors
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys Labs Ltd	LANSOPRAZOLE	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	202194-001	May 18, 2012		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Takeda Pharms Na	PREVACID	lansoprazole	FOR SUSPENSION, DELAYED RELEASE;ORAL	021281-002	May 3, 2001		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Takeda Pharms Na	PREVACID	lansoprazole	FOR SUSPENSION, DELAYED RELEASE;ORAL	021281-001	May 3, 2001		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	LANSOPRAZOLE	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	202396-002	Nov 28, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	PREVACID	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	021428-002	Aug 30, 2002	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	PREVACID	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	021428-001	Aug 30, 2002	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	PREVACID	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	021428-002	Aug 30, 2002	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	PREVACID	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	020406-002	May 10, 1995	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for lansoprazole

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Country	Patent Number	Title	Estimated Expiration
Israel	255048	הרכבים המתפוררים בפה (Orally disintegrating compositions)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2016174664		⤷ Sign Up
European Patent Office	3288556	COMPOSITIONS À DÉSINTÉGRATION PAR VOIE ORALE (ORALLY DISINTEGRATING COMPOSITIONS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for lansoprazole

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0328535	96C0021	Belgium	⤷ Sign Up	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	⤷ Sign Up	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	⤷ Sign Up	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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