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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, Dr Reddys Labs Ltd, Hetero Labs Ltd Iii, Inventia, Krka Tovarna Zdravil, Lannett Co Inc, Mylan, Mylan Pharms Inc, Natco Pharma Ltd, Perrigo R And D, Sandoz, Sun Pharm, Teva Pharms, Wockhardt Ltd, Wockhardt Usa, Xiromed, Zydus Hlthcare, Takeda Pharms Usa, Perrigo Pharma Intl, Takeda Pharms Na, Ani Pharms, Dexcel Pharma, 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 six patent family members in five countries.

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

Summary for lansoprazole

International Patents:	6
US Patents:	2
Tradenames:	7
Applicants:	26
NDAs:	35
Drug Master File Entries:	56
Finished Product Suppliers / Packagers:	73
Raw Ingredient (Bulk) Api Vendors:	135
Clinical Trials:	155
Patent Applications:	6,933
Formulation / Manufacturing:	see details
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

See drug sales revenues for lansoprazole

Recent Clinical Trials for lansoprazole

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

Sponsor	Phase
Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.	Phase 3
Parexel	Phase 2
Cinclus Pharma AG	Phase 2

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

Paragraph IV (Patent) Challenges for LANSOPRAZOLE

Tradename	Dosage	Ingredient	NDA	Submissiondate
PREVACID	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	lansoprazole	021428	2006-12-27
PREVACID	CAPSULE, DELAYED REL PELLETS;ORAL	lansoprazole	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
Teva Pharms	LANSOPRAZOLE	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	077255-002	Nov 10, 2009	AB	RX	No	No
Mylan Pharms Inc	LANSOPRAZOLE	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	090763-001	Nov 10, 2009	AB	RX	No	No
Zydus Hlthcare	LANSOPRAZOLE	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	202366-001	Aug 19, 2013	AB	RX	No	No

Expired US Patents for lansoprazole

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

International Patents for lansoprazole

Country	Patent Number	Estimated Expiration
Canada	2419067
Japan	2002128675
World Intellectual Property Organization (WIPO)	0215908

Supplementary Protection Certificates for lansoprazole

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0328535	96C0021	Belgium		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		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		PRODUCT NAME: LANSOPRAZOLE; NAT. REG.: 150 S 539 F 4 19921119; FIRST REG.: FR 333 412.1 19901211