yosprala Drug Patent Profile

When do Yosprala patents expire, and when can generic versions of Yosprala launch?

Yosprala is a drug marketed by Genus Lifesciences and is included in one NDA. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has nine patent family members in eight countries.

The generic ingredient in YOSPRALA is aspirin; omeprazole. There are twenty-two drug master file entries for this compound. Additional details are available on the aspirin; omeprazole profile page.

DrugPatentWatch^® Generic Entry Outlook for Yosprala

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 2, 2033. This may change due to patent challenges or generic licensing.

There have been eleven 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 yosprala

International Patents:	9
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	3
Drug Prices:	Drug price information for yosprala
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for yosprala
What excipients (inactive ingredients) are in yosprala?	yosprala excipients list
DailyMed Link:	yosprala at DailyMed

See drug prices for yosprala

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

NDA:

205103

Dosage:

TABLET, DELAYED RELEASE;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.

Recent Clinical Trials for yosprala

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

Sponsor	Phase
POZEN	Phase 3

See all yosprala clinical trials

Paragraph IV (Patent) Challenges for YOSPRALA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
YOSPRALA	Delayed-release Tablets	aspirin; omeprazole	81 mg/40 mg and 325 mg/40 mg	205103	1	2016-10-17
YOSPRALA	Delayed-release Tablets	aspirin; omeprazole	81 mg/40 mg and 325 mg/40 mg	205103	1	2016-10-14

US Patents and Regulatory Information for yosprala

yosprala is protected by two US patents.

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 yosprala

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-001	Sep 14, 2016		DISCN	Yes	No
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-002	Sep 14, 2016		DISCN	Yes	No
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-001	Sep 14, 2016		DISCN	Yes	No
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-002	Sep 14, 2016		DISCN	Yes	No

Expired US Patents for yosprala

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-002	Sep 14, 2016
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-002	Sep 14, 2016
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-001	Sep 14, 2016
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-002	Sep 14, 2016

International Patents for yosprala

When does loss-of-exclusivity occur for yosprala?

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

Brazil

Canada

China

Eurasian Patent Organization

European Patent Office

Mexico

Ukraine

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 yosprala around the world.

Country	Patent Number	Title	Estimated Expiration
China	104519888	Improved compositions and methods for delivery of omeprazole plus acetylsalicylic acid
Tunisia	2011000096	METHOD FOR DELIVERING A PHARMACEUTICAL COMPOSITION TO PATIENT IN NEED THEREOF
Germany	60237087
Eurasian Patent Organization	006398	ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ КООРДИНИРОВАННОЙ ДОСТАВКИ НЕСТЕРОИДНЫХ ПРОТИВОВОСПАЛИТЕЛЬНЫХ ЛЕКАРСТВЕННЫХ СРЕДСТВ (PHARMACEUTICAL COMPOSITIONS FOR COORDINATED DELIVERY OF NSAIDS)

Supplementary Protection Certificates for yosprala

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	C300481	Netherlands		PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
1411900	132012902015795	Italy		PRODUCT NAME: NAPROSSENE E ESOMEPRAZOLO SALE DI MAGNESIO TRIIDRATO(VIMOVO); AUTHORISATION NUMBER(S) AND DATE(S): PL 17901/0263-0001, 20101105;DA 40611016/M A 40611129/M, 20110808
1411900	122012000052	Germany		PRODUCT NAME: NAPROXEN MIT ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
1411900	18/2011	Austria		PRODUCT NAME: NAPROXEN UND ESOMEPRAZOL SOWIE DEREN PHARMAZEUTISCH ANNEHMBARE SALZE; NAT. REGISTRATION NO/DATE: 1-29937 20110105; FIRST REGISTRATION: GB PL 17901/0263-0001 20101105