Lansoprazole - Generic Drug Details

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, 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, Dexcel, Dr Reddys, 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 nine patent family members in six countries.

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

Summary for lansoprazole

International Patents:	9
US Patents:	2
Tradenames:	7
Applicants:	29
NDAs:	35
Drug Master File Entries:	56
Finished Product Suppliers / Packagers:	75
Raw Ingredient (Bulk) Api Vendors:	160
Clinical Trials:	176
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
Nanfang Hospital of Southern Medical University	Phase 4
Future pharmaceutical industries	Phase 4
National Liver Institute, Egypt	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

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	LANSOPRAZOLE	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	090331-001	Apr 23, 2010	AB	RX	No	No
Takeda Pharms Na	PREVACID NAPRAPAC 250 (COPACKAGED)	lansoprazole; naproxen	CAPSULE, DELAYED REL PELLETS, TABLET;ORAL	021507-002	Nov 14, 2003		DISCN	Yes	No
Dr Reddys	LANSOPRAZOLE	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	210465-002	Feb 1, 2021	AB	RX	No	No
Wockhardt	LANSOPRAZOLE	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	202176-001	Sep 14, 2012	AB	RX	No	No
Takeda Pharms Usa	PREVACID	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	021428-001	Aug 30, 2002	AB	RX	Yes	No
Glenmark Pharms Inc	LANSOPRAZOLE	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	202727-001	May 18, 2012		OTC	No	No
Takeda Pharms Na	PREVACID	lansoprazole	FOR SUSPENSION, DELAYED RELEASE;ORAL	021281-001	May 3, 2001		DISCN	No	No

Expired US Patents for lansoprazole

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

International Patents for lansoprazole

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	0215908
Canada	2419067	COMPOSITION INJECTABLE COMRENANT UN COMPOSE DE BENZIMIDAZOLEET UN ALKALI FORT (INJECTABLE COMPOSITION COMPRISING BENZIMIDAZOLE COMPOUND ANDSTRONG ALKALI)
World Intellectual Property Organization (WIPO)	2016174664
Japan	4136340
European Patent Office	3288556	COMPOSITIONS À DÉSINTÉGRATION PAR VOIE ORALE (ORALLY DISINTEGRATING COMPOSITIONS)
Israel	255048	הרכבים המתפוררים בפה (Orally disintegrating compositions)
Australia	7875501

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
0174726	93C0021	Belgium		PRODUCT NAME: LANSOPRAZOLE; NAT. REG.: 150 S 539 F 4 19921119; FIRST REG.: FR 333 412.1 19901211
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