YOSPRALA Drug Patent Profile

Which patents cover Yosprala, 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.

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	205103-001	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	205103-001	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
Cyprus	1110842
World Intellectual Property Organization (WIPO)	2013101897
China	102209529	Method for delivering a pharmaceutical composition to patient in need thereof
Australia	2006235929	Pharmaceutical compositions for the coordinated delivery of NSAIDs
Mexico	2014007935	COMPOSICIONES Y METODOS MEJORADOS PARA EL SUMINISTRO DE OMEPRAZOL Y DE ACIDO ACETILSALICILICO. (IMPROVED COMPOSITIONS AND METHODS FOR DELIVERY OF OMEPRAZOLE PLUS ACETYLSALICYLIC ACID.)

Supplementary Protection Certificates for YOSPRALA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	CA 2012 00036	Denmark
1411900	2011/016	Ireland		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
1411900	C300481	Netherlands		PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
1411900	C01411900/01	Switzerland		FORMER OWNER: POZEN, INC., US
1411900	122012000052	Germany		PRODUCT NAME: NAPROXEN MIT ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105

YOSPRALA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for YOSPRALA

Introduction to YOSPRALA

YOSPRALA is a prescription fixed-dose combination of aspirin, an anti-platelet agent, and omeprazole, a proton pump inhibitor (PPI). It is specifically designed for patients who require aspirin for the secondary prevention of cardiovascular (CV) and cerebrovascular events and are at risk of developing aspirin-associated gastric ulcers[1][4].

Market Need and Target Population

YOSPRALA addresses a significant public health issue by providing a solution for patients who need the cardio-protective benefits of daily aspirin but are at risk of gastric ulcers. Up to an estimated 26.2 million adults in the U.S. are at risk for secondary CV events, making this a substantial market[1].

Approval and Launch

The U.S. Food and Drug Administration (FDA) approved YOSPRALA in September 2016. Aralez Pharmaceuticals Inc. launched the product in the U.S. in October 2016, supported by a fully trained sales force of 110 representatives targeting cardiologists and high-prescribing primary care physicians[1][4].

Product Features and Benefits

YOSPRALA is formulated using the proprietary Intelli-COAT™ system, which sequentially delivers immediate-release omeprazole (40 mg) followed by a delayed-release, enteric-coated aspirin core in either 81 mg or 325 mg dose strengths. This design helps in reducing aspirin intolerance and improving patient compliance with therapy[1][4].

Commercial Strategy and Sales Performance

Aralez expanded its U.S. sales force significantly to promote YOSPRALA. Despite the initial enthusiasm, the product's prescription uptake was slower than expected. By the end of 2016 and into 2017, the company reduced its revenue estimates for YOSPRALA from $20 million to $3.1 million due to the slower-than-anticipated prescription growth[2].

Financial Performance and Projections

In 2016, Aralez reported total revenues of $54.3 million, but the financial performance of YOSPRALA was below expectations. The company projected 2017 net revenues of $80 to $100 million, with adjusted EBITDA ranging from $(25) to $(10) million. However, the actual performance was impacted by the slower uptake of YOSPRALA, leading to a significant reduction in revenue projections for the drug[2].

Debt and Financial Challenges

Aralez faced substantial financial challenges, including long-term debt of $275 million, comprising $75 million in senior secured convertible notes and $200 million under a credit facility with Deerfield Management. The company was expected to pay $26.9 million in interest in 2017, which added to its financial strain[2].

Acquisition by Nuvo Pharmaceuticals

In September 2018, Nuvo Pharmaceuticals announced the acquisition of a portfolio of products from Aralez, including YOSPRALA. This transaction included the worldwide rights and royalties for YOSPRALA and other products, providing Nuvo with a significant expansion of revenue and adjusted EBITDA. The acquisition was funded through a combination of cash and debt financing provided by Deerfield Management[3].

Post-Acquisition Performance

After the acquisition, YOSPRALA continued to be part of the product portfolio of Nuvo Pharmaceuticals. While specific financial details post-acquisition are limited, the overall performance of Nuvo's commercial business segment has shown mixed results. For instance, in the nine months ended September 30, 2022, Nuvo (now known as Miravo Healthcare) reported milestone revenue related to YOSPRALA, but the overall financial performance was influenced by various segments of their business[5].

Key Takeaways

• Market Need: YOSPRALA addresses a critical need for patients requiring aspirin therapy while at risk of gastric ulcers.
• Launch and Sales: Despite a strong launch strategy, the product faced slower-than-expected prescription uptake.
• Financial Performance: Initial revenue projections were significantly reduced due to slower sales, impacting Aralez's financial health.
• Acquisition: The acquisition by Nuvo Pharmaceuticals provided a new platform for YOSPRALA, but its financial performance remained part of a broader business segment.
• Ongoing Impact: YOSPRALA continues to be an important therapeutic option, though its financial trajectory has been influenced by various market and corporate factors.

FAQs

Q: What is YOSPRALA, and what is it used for? A: YOSPRALA is a prescription fixed-dose combination of aspirin and omeprazole, used for the secondary prevention of cardiovascular and cerebrovascular events in patients at risk of aspirin-associated gastric ulcers.

Q: When was YOSPRALA approved by the FDA? A: YOSPRALA was approved by the FDA in September 2016.

Q: How was YOSPRALA launched in the U.S.? A: YOSPRALA was launched in the U.S. in October 2016, supported by a sales force of 110 representatives targeting cardiologists and primary care physicians.

Q: Why did YOSPRALA's sales performance fall short of expectations? A: The slower-than-expected prescription uptake was a key factor, leading to reduced revenue estimates.

Q: Who acquired YOSPRALA from Aralez Pharmaceuticals? A: Nuvo Pharmaceuticals acquired YOSPRALA as part of a larger portfolio of products from Aralez in September 2018.

Citations

1. Aralez Announces FDA Approval Of YOSPRALA For Secondary Prevention Of Cardiovascular And Cerebrovascular Events In Patients At Risk For Aspirin Associated Gastric Ulcers. Biospace.
2. Small-Cap Research. Q4cdn.
3. Nuvo Pharmaceuticals™ Announces Signing of Definitive Agreements to Acquire Commercial Products and Infrastructure from Aralez Pharmaceuticals. PR Newswire.
4. Aralez Announces U.S. Commercial Launch Of YOSPRALA For Secondary Prevention Of Cardiovascular And Cerebrovascular Events In Patients At Risk For Aspirin Associated Gastric Ulcers. PR Newswire.
5. Miravo Healthcare™ Announces Third Quarter 2022 Results. Business Wire.