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PREVACID Drug Profile

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Which patents cover Prevacid, and what generic alternatives are available?

Prevacid is a drug marketed by Takeda Pharms Usa, Takeda Pharms Na, and Perrigo Pharma Intl. and is included in six NDAs. There is one patent protecting this drug and two Paragraph IV challenges.

The generic ingredient in PREVACID is lansoprazole; naproxen. There are fifty-six drug master file entries for this compound. Additional details are available on the lansoprazole; naproxen profile page.

DrugPatentWatch^® Generic Entry Outlook for Prevacid

Prevacid was eligible for patent challenges on May 10, 1999.

Annual sales in 2018 were $408mm indicating the motivation for generic entry (peak sales were $3.4bn in 2005).

There have been six 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 PREVACID

US Patents:	0
Applicants:	3
NDAs:	6
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	23
Patent Applications:	3,845
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for PREVACID
Drug Sales Revenues:	Drug sales revenues for PREVACID
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PREVACID
What excipients (inactive ingredients) are in PREVACID?	PREVACID excipients list
DailyMed Link:	PREVACID at DailyMed

See drug prices for PREVACID

See drug sales revenues for PREVACID

Recent Clinical Trials for PREVACID

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

Sponsor	Phase
Takeda	Phase 3
Janssen Research & Development, LLC	Phase 1
McGill University Health Center	Phase 4

See all PREVACID clinical trials

Pharmacology for PREVACID

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

ATC Classes for PREVACID

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 PREVACID

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 PREVACID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	PREVACID	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	020406-001	May 10, 1995	AB	RX	Yes	No
Perrigo Pharma Intl	PREVACID 24 HR	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	022327-001	May 18, 2009		OTC	Yes	Yes
Takeda Pharms Na	PREVACID	lansoprazole	FOR SUSPENSION, DELAYED RELEASE;ORAL	021281-002	May 3, 2001		DISCN	No	No
Takeda Pharms Na	PREVACID IV	lansoprazole	INJECTABLE;INTRAVENOUS	021566-001	May 27, 2004		DISCN	Yes	No					Y
Takeda Pharms Usa	PREVACID	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	020406-002	May 10, 1995	AB	RX	Yes	Yes
Takeda Pharms Na	PREVACID	lansoprazole	FOR SUSPENSION, DELAYED RELEASE;ORAL	021281-001	May 3, 2001		DISCN	No	No

Expired US Patents for PREVACID

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
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 Usa	PREVACID	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	021428-001	Aug 30, 2002
Takeda Pharms Usa	PREVACID	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	020406-001	May 10, 1995
Takeda Pharms Usa	PREVACID	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	021428-001	Aug 30, 2002

International Patents for PREVACID

Country	Patent Number	Estimated Expiration
South Korea	100197465
Canada	1312548
Austria	481090
Slovenia	1100469
Ireland	851976
Hong Kong	1096021

Supplementary Protection Certificates for PREVACID

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
0174726	SPC/GB94/011	United Kingdom		SPC/GB94/011, EXPIRES: 20051210
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