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VAZALORE Drug Patent Profile

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

Vazalore is a drug marketed by Plx Pharma and is included in one NDA. There are four patents protecting this drug.

This drug has twenty patent family members in nine countries.

The generic ingredient in VAZALORE is aspirin. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the aspirin profile page.

DrugPatentWatch^® Generic Entry Outlook for Vazalore

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 29, 2032. This may change due to patent challenges or generic licensing.

There is one tentative approval for the generic drug (aspirin), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Summary for VAZALORE

International Patents:	20
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	135
Patent Applications:	3,971
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in VAZALORE?	VAZALORE excipients list
DailyMed Link:	VAZALORE at DailyMed

Drug patent expirations by year for VAZALORE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VAZALORE

Generic Entry Date for VAZALORE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 203697 Dosage: CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for VAZALORE

Drug Class	Nonsteroidal Anti-inflammatory Drug Platelet Aggregation Inhibitor
Mechanism of Action	Cyclooxygenase Inhibitors
Physiological Effect	Decreased Platelet Aggregation Decreased Prostaglandin Production

US Patents and Regulatory Information for VAZALORE

VAZALORE is protected by six US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VAZALORE is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting VAZALORE

PH dependent carriers for targeted release of pharmaceuticals along the gastrointestinal tract, compositions therefrom, and making and using same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF TARGETING RELEASE OF A NON-STEROIDAL ANTI-INFLAMMATORY DRUG (NSAID) TO THE SMALL INTESTINE OF THE SUBJECT WHEN ADMINISTERED ORALLY

pH dependent carriers for targeted release of pharmaceuticals along the gastrointestinal tract, compositions therefrom, and making and using same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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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
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-002	Feb 26, 2021		OTC	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-001	Jan 14, 2013		OTC	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-001	Jan 14, 2013		OTC	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-002	Feb 26, 2021		OTC	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-001	Jan 14, 2013		OTC	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-001	Jan 14, 2013		OTC	Yes	Yes	⤷ 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 VAZALORE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-001	Jan 14, 2013	⤷ Sign Up	⤷ Sign Up
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-001	Jan 14, 2013	⤷ Sign Up	⤷ Sign Up
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-001	Jan 14, 2013	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for VAZALORE

When does loss-of-exclusivity occur for VAZALORE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 12315545
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 50187
Estimated Expiration: ⤷ Sign Up

China

Patent: 3957888
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 60433
Estimated Expiration: ⤷ Sign Up

Hong Kong

Patent: 00098
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 68645
Estimated Expiration: ⤷ Sign Up

Patent: 99504
Estimated Expiration: ⤷ Sign Up

Patent: 14531460
Estimated Expiration: ⤷ Sign Up

Patent: 17222650
Estimated Expiration: ⤷ Sign Up

Patent: 20090499
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 0951
Estimated Expiration: ⤷ Sign Up

Patent: 6017
Estimated Expiration: ⤷ Sign Up

Patent: 14003890
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 2162901
Estimated Expiration: ⤷ Sign Up

Patent: 2180667
Estimated Expiration: ⤷ Sign Up

Patent: 2188840
Estimated Expiration: ⤷ Sign Up

Patent: 140105436
Estimated Expiration: ⤷ Sign Up

Patent: 200008032
Estimated Expiration: ⤷ Sign Up

Patent: 200118219
Estimated Expiration: ⤷ Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering VAZALORE around the world.

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Country	Patent Number	Title	Estimated Expiration
Cyprus	1110474		⤷ Sign Up
Japan	2017222650	胃腸管に沿った医薬の標的化放出のためのｐＨ依存性担体、それによる組成物、ならびにこれらの製造および使用 (PH DEPENDENT CARRIERS FOR TARGETED RELEASE OF PHARMACEUTICALS ALONG THE GASTROINTESTINAL TRACT, COMPOSITIONS THEREFROM, AND MAKING AND USING SAME)	⤷ Sign Up
China	103957888	Ph dependent carriers for targeted release of pharmaceuticals along the gastrointestinal tract, compositions therefrom, and making and using same	⤷ Sign Up
Japan	6368645		⤷ Sign Up
South Korea	102188840		⤷ Sign Up
Japan	6799504		⤷ Sign Up
Mexico	340951	PORTADORES DEPENDIENTES DEL PH PARA LA LIBERACION DIRIGIDA DE PRODUCTOS FARMACEUTICOS A LO LARGO DEL TRACTO GASTROINTESTINAL, COMPOSICIONES DE LOS MISMOS, Y FABRICACIÓN Y USO DE LAS MISMAS. (pH DEPENDENT CARRIERS FOR TARGETED RELEASE OF PHARMACEUTICALS ALONG THE GASTROINTESTINAL TRACT, COMPOSITIONS THEREFROM, AND MAKING AND USING SAME.)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for VAZALORE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0984957	2012/048	Ireland	⤷ Sign Up	PRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812
0984957	122012000017	Germany	⤷ Sign Up	PRODUCT NAME: ASPIRIN UND ESOMEPRAZOL - MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 81047.00.00 20110930 FIRST REGISTRATION: PORTUGAL 5402359 5402367 5402375 20110812
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description