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PRESTALIA Drug Patent Profile

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

Prestalia is a drug marketed by Adhera and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty patent family members in twenty-seven countries.

The generic ingredient in PRESTALIA is amlodipine besylate; perindopril arginine. There are fifty drug master file entries for this compound. Additional details are available on the amlodipine besylate; perindopril arginine profile page.

DrugPatentWatch^® Generic Entry Outlook for Prestalia

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 5, 2029. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for PRESTALIA

International Patents:	30
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	2
Patent Applications:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PRESTALIA
What excipients (inactive ingredients) are in PRESTALIA?	PRESTALIA excipients list
DailyMed Link:	PRESTALIA at DailyMed

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

NDA:

205003

Dosage:

TABLET;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.

Paragraph IV (Patent) Challenges for PRESTALIA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PRESTALIA	Tablets	amlodipine besylate; perindopril arginine	3.5 mg/2.5 mg, 7 mg/5 mg and 14 mg/10 mg	205003	1	2016-11-04

US Patents and Regulatory Information for PRESTALIA

PRESTALIA is protected by one 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
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-001	Jan 21, 2015		DISCN	Yes	No			Y	Y
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-002	Jan 21, 2015		DISCN	Yes	No			Y	Y
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-003	Jan 21, 2015		DISCN	Yes	No			Y	Y

Expired US Patents for PRESTALIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-001	Jan 21, 2015
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-002	Jan 21, 2015
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-003	Jan 21, 2015

International Patents for PRESTALIA

When does loss-of-exclusivity occur for PRESTALIA?

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

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

France

Georgia, Republic of

Hong Kong

Hungary

Japan

Malaysia

Montenegro

Morocco

New Zealand

Norway

Poland

Serbia

Slovenia

South Africa

South Korea

Spain

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 PRESTALIA around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2003321493	NEW PERINDOPRIL SALT AND PHARMACEUTICAL COMPOSITION CONTAINING THE SAME
South Africa	200301395	Salt of perindopril and pharmaceutical compositions containing it.
Norway	324323
Eurasian Patent Organization	014716	α-КРИСТАЛЛИЧЕСКАЯ ФОРМА АРГИНИНОВОЙ СОЛИ ПЕРИНДОПРИЛА, СПОСОБ ЕЁ ПОЛУЧЕНИЯ И ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, КОТОРЫЕ ЕЁ СОДЕРЖАТ (α CRYSTALLINE FORM OF THE ARGININE SALT OF PERINDOPRIL, PROCESS FOR PREPARING IT, AND PHARMACEUTICAL COMPOSITIONS COMPRISING IT)
Montenegro	02456	KRISTALNI OBLIK ARGININSKE SOLI PERINDOPRILA, POSTUPAK NJENE PROIZVODNJE I FARMACEUTSKE SMEŠE KOJE JE SADRŽE (CRYSTALLINE FORM OF THE ARGININE SALT OF PERINDOPRIL, PROCESS FOR PREPARING IT, AND PHARMACEUTICAL COMPOSITIONS COMPRISING IT)
Germany	60300011
Canada	2644467	FORME CRISTALLINE A DU SEL D'ARGININE DU PERINDOPRIL, SON PROCEDE DE PREPARATION, ET LES COMPOSITIONS PHARMACEUTIQUES QUI LA CONTIENNENT (A CRYSTALLINE FORM OF THE ARGININE SALT OF PERINDOPRIL, PROCESS FOR PREPARING IT, AND PHARMACEUTICAL COMPOSITIONS COMPRISING IT)

Supplementary Protection Certificates for PRESTALIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0503785	C300486	Netherlands		PRODUCT NAME: COMBINATIE VAN OLMESARTANMEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, AMLODIPINEBESYLAAT AND HYDROCHLOORTHIAZIDE; NATL REGISTRATION NO/DATE: RVG 106667, RVG 106671-74, RVG 106682-86 20101221; FIRST REGISTRATION: DE 79810.00.00-79814.00.00 20101216
1507558	12C0033	France		PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: CH - 6167801 20110705
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
1507558	2012/018	Ireland		PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705
0443983	2007C/043	Belgium		PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
1003503	05C0048	France		PRODUCT NAME: AMLODIPINE OU UN DE SES SELS D?ADDITION D?ACIDES PHARMACAUTIQUEMENT ACCEPTABLES/ ATORVASTATINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: NL 29929 DU 20050707; REGISTRATION NO/DATE AT EEC: NL 29929 DU 20050707
0443983	C300445	Netherlands		PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016

PRESTALIA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Prestalia

Introduction to Prestalia

Prestalia, a fixed-dose combination of perindopril arginine and amlodipine besylate, is a significant player in the hypertension treatment market. Approved by the U.S. FDA in 2015, it is indicated for the treatment of hypertension to lower blood pressure, particularly in patients whose blood pressure is not adequately controlled on monotherapy or those likely to need multiple drugs to achieve their blood pressure goals[4].

Market Need and Demand

Hypertension remains a major health issue, affecting approximately 34% of adults in the U.S. as of 2013-2014. This widespread prevalence underscores the continuous demand for effective antihypertensive medications. Prestalia, by combining two established antihypertensive agents, addresses this need by offering a simpler regimen for patients who require multiple medications to manage their blood pressure[2].

Competitive Landscape

The antihypertensive market is highly competitive, with various pharmacologic classes available. However, Prestalia stands out due to its unique combination of an ACE inhibitor (perindopril arginine) and a calcium channel blocker (amlodipine besylate) in a single pill. This combination has been shown to be more effective in reducing blood pressure than either component drug alone, making it a valuable option for patients and healthcare providers[3].

Clinical Efficacy and Safety

The efficacy of Prestalia was demonstrated in the Phase III PATH trial, which involved 837 patients. The study showed that the fixed-dose combination was significantly better than monotherapy with either perindopril or amlodipine in reducing both systolic and diastolic blood pressure. Additionally, Prestalia has been found to be generally well-tolerated, with adverse events consistent with the profiles of the individual component drugs[5].

Regulatory and Patent Protection

Prestalia is protected by two U.S. patents (6696481 and 7846961) listed in the FDA's Orange Book, providing product exclusivity until 2029. This patent protection is crucial for maintaining market exclusivity and protecting the financial interests of the drug's manufacturers[2].

Commercialization and Distribution

Initially launched by Symplmed Pharmaceuticals, Prestalia was later acquired by Marina Biotech in 2017. Marina Biotech has leveraged Symplmed’s patented telehealth technology platform, DyrctAxess™, to enhance patient compliance and reduce costs by enabling direct delivery of medications to patients' homes. This approach addresses the issue of unfilled prescriptions and improves patient adherence to treatment[2].

Financial Trajectory

The acquisition of Prestalia by Marina Biotech marked a significant financial milestone for the company. The addition of Prestalia to Marina Biotech's portfolio provided immediate commercial revenue and expanded the company's presence in the specialty pharma market for hypertension. Here are some key financial implications:

• Revenue Generation: Prestalia has become a commercial product for Marina Biotech, contributing to the company's revenue stream. The drug's market position and the efficiency of the DyrctAxess™ platform have helped in generating consistent revenue.
• Cost Savings: By using the DyrctAxess™ platform, Marina Biotech can reduce costs associated with traditional distribution channels and improve patient compliance, which can lead to better treatment outcomes and reduced healthcare costs in the long run.
• Market Expansion: The success of Prestalia has also paved the way for Marina Biotech to expand its pipeline in multiple therapeutic areas, including the development of other hypertension therapies like IT102 and IT103. This strategic expansion is expected to further enhance the company's financial trajectory[2][5].

Impact of New Guidelines and Market Trends

New guidelines from the American College of Cardiology (ACC) and the American Heart Association (AHA) recommending earlier treatment of hypertension have the potential to increase the demand for effective antihypertensive medications like Prestalia. These guidelines emphasize the importance of lifestyle changes and pharmacological treatment to achieve lower blood pressure targets, which could drive up the adoption of Prestalia and other similar drugs[5].

Challenges and Opportunities

While Prestalia has a strong market position, there are challenges to consider:

• Competition: The antihypertensive market is highly competitive, with numerous drugs available. Prestalia must continue to demonstrate its efficacy and safety to maintain market share.
• Patient Compliance: Ensuring patient adherence to treatment remains a challenge. However, the DyrctAxess™ platform has been instrumental in addressing this issue.
• Future Developments: Marina Biotech's plans to expand its pipeline and develop new therapies could provide additional revenue streams and further solidify the company's position in the market[2][5].

Key Takeaways

• Unique Combination: Prestalia combines perindopril arginine and amlodipine besylate, offering a more effective treatment option for hypertension.
• Clinical Efficacy: Demonstrated superiority over monotherapy in reducing blood pressure.
• Regulatory Protection: Protected by two U.S. patents until 2029.
• Commercial Strategy: Leveraging the DyrctAxess™ platform for direct delivery and improved patient compliance.
• Financial Impact: Significant revenue contributor for Marina Biotech with potential for further growth through pipeline expansion.

FAQs

1. What is Prestalia used for? Prestalia is used for the treatment of hypertension to lower blood pressure, particularly in patients whose blood pressure is not adequately controlled on monotherapy or those likely to need multiple drugs to achieve their blood pressure goals[4].

2. What are the active ingredients in Prestalia? Prestalia contains perindopril arginine, an ACE inhibitor, and amlodipine besylate, a dihydropyridine calcium channel blocker[4].

3. Who acquired Prestalia in 2017? Marina Biotech acquired Prestalia from Symplmed Pharmaceuticals in 2017[2].

4. What is the DyrctAxess™ platform? The DyrctAxess™ platform is a telehealth technology that enables direct delivery of medications to patients' homes, improving compliance and reducing costs associated with unfilled prescriptions[2].

5. What are the benefits of using Prestalia over monotherapy? Prestalia has been shown to be more effective in reducing blood pressure than either perindopril or amlodipine alone, and it may provide a better benefit/risk ratio than monotherapy[3][5].

Cited Sources

1. Symplmed Launches Prestalia For Treatment Of Hypertension - Biospace
2. Marina Biotech Acquires Prestalia, A U.S. FDA Approved Drug For Patients Whose Blood Pressure Is Not Adequately Controlled By Monotherapy - Biospace
3. Perindopril/amlodipine (Prestalia(®)): a review in hypertension - PubMed
4. Prestalia: Package Insert / Prescribing Information - Drugs.com
5. Marina Biotech Announces a New Publication on Prestalia® - GlobeNewswire