LANSOPRAZOLE Drug Patent Profile

When do Lansoprazole patents expire, and what generic alternatives are available?

Lansoprazole is a drug 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, Ani Pharms, Aurobindo Pharma Ltd, Dexcel, Dr Reddys, Teva Pharms Usa, Zydus Pharms, and Rising. and is included in thirty-three NDAs. There are two patents protecting this drug.

This drug has three patent family members in three countries.

The generic ingredient in LANSOPRAZOLE is amoxicillin; clarithromycin; lansoprazole. There are forty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amoxicillin; clarithromycin; lansoprazole profile page.

DrugPatentWatch^® Generic Entry Outlook for Lansoprazole

Annual sales in 2021 were $138mm indicating the motivation for generic entry (peak sales were $689mm in 2010).

There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for LANSOPRAZOLE

International Patents:	3
US Patents:	2
Applicants:	28
NDAs:	33
Finished Product Suppliers / Packagers:	70
Raw Ingredient (Bulk) Api Vendors:	162
Clinical Trials:	181
Patent Applications:	3,988
Drug Prices:	Drug price information 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
Fu Jen Catholic University Hospital	Phase 4
Beaujon Hospital	Phase 4
Karolinska Institutet	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

LANSOPRAZOLE is protected by two US patents.

Patents protecting LANSOPRAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Ltd	LANSOPRAZOLE	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	207167-001	Mar 28, 2023	AB	RX	No	No
Teva Pharms	LANSOPRAZOLE	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	077255-002	Nov 10, 2009	AB	RX	No	No
Teva Pharms Usa	LANSOPRAZOLE	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208784-001	Sep 21, 2017	AB	RX	No	No
Dr Reddys	LANSOPRAZOLE	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	210465-001	Feb 1, 2021	AB	RX	No	No
Teva Pharms Usa	LANSOPRAZOLE	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208784-002	Sep 21, 2017	AB	RX	No	No
Sandoz	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	amoxicillin; clarithromycin; lansoprazole	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL	202588-001	Mar 4, 2014	AB	RX	No	No
Sandoz	LANSOPRAZOLE	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	090331-002	Apr 23, 2010		DISCN	No	No

International Patents for LANSOPRAZOLE

See the table below for patents covering LANSOPRAZOLE around the world.

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

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