BENICAR Drug Patent Profile

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

Benicar is a drug marketed by Cosette and is included in two NDAs.

The generic ingredient in BENICAR is hydrochlorothiazide; olmesartan medoxomil. There are thirty-two drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; olmesartan medoxomil profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Benicar

A generic version of BENICAR was approved as hydrochlorothiazide; olmesartan medoxomil by ALKEM LABS LTD on July 11^th, 2024.

Summary for BENICAR

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	17
Patent Applications:	4,893
Drug Prices:	Drug price information for BENICAR
Drug Sales Revenues:	Drug sales revenues for BENICAR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BENICAR
What excipients (inactive ingredients) are in BENICAR?	BENICAR excipients list
DailyMed Link:	BENICAR at DailyMed

See drug prices for BENICAR

See drug sales revenues for BENICAR

Recent Clinical Trials for BENICAR

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

Sponsor	Phase
EMS	Phase 3
Daiichi Sankyo Co., Ltd.	N/A
Chinese PLA General Hospital	Phase 4

See all BENICAR clinical trials

Pharmacology for BENICAR

Drug Class	Angiotensin 2 Receptor Blocker
Mechanism of Action	Angiotensin 2 Receptor Antagonists

Paragraph IV (Patent) Challenges for BENICAR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BENICAR	Tablets	olmesartan medoxomil	5 mg, 20 mg and 40 mg	021286	1	2006-04-25

US Patents and Regulatory Information for BENICAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-001	Apr 25, 2002	AB	RX	Yes	No
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-002	Jun 5, 2003	AB	RX	Yes	No
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-003	Apr 25, 2002	AB	RX	Yes	No
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-004	Apr 25, 2002	AB	RX	Yes	Yes
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-005	Jun 5, 2003	AB	RX	Yes	Yes
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-003	Jun 5, 2003	AB	RX	Yes	No

Expired US Patents for BENICAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-004	Apr 25, 2002
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-001	Apr 25, 2002
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-004	Apr 25, 2002
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-003	Apr 25, 2002
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-003	Apr 25, 2002
Cosette	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-001	Apr 25, 2002

International Patents for BENICAR

See the table below for patents covering BENICAR around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	324890
China	1045770
Norway	2011013
Luxembourg	91056
Hungary	9200578
Hong Kong	1011361

Supplementary Protection Certificates for BENICAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0503785	CA 2011 00026	Denmark		PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
0503785	C00503785/04	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
0503785	91056	Luxembourg		91056, EXPIRES: 20170221
0503785	91847	Luxembourg		91847, EXPIRES: 20170221
0503785	20/2009	Austria		PRODUCT NAME: KOMBINATION VON OLMESARTAN MEDOXOMIL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH AKZEPTABLEN SALZES, MIT AMLODIPINBESILAT; NAT. REGISTRATION NO/DATE: 1-27894, 1-27895, 1-27896 20081217; FIRST REGISTRATION: NL 100989, 100990, 100991 20080819
0503785	CA 2006 00012	Denmark

BENICAR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Benicar (Olmesartan)

Introduction to Benicar (Olmesartan)

Benicar, also known by its generic name olmesartan, is an antihypertensive medication developed and marketed by Daiichi Sankyo. It is used to treat high blood pressure and has been a significant player in the pharmaceutical market.

Market Drivers

The market for Benicar is driven by several key factors:

Rising Prevalence of Hypertension

The increasing prevalence of hypertension and related cardiovascular conditions is a major driver. As lifestyles become more sedentary and stress levels rise, the demand for effective antihypertensive medications like Benicar continues to grow[1].

Emphasis on Preventive Care

There is a growing emphasis on cardiovascular risk reduction and preventive care. Both physicians and patients recognize the importance of maintaining healthy blood pressure levels to prevent heart attacks, strokes, and other cardiovascular events, leading to increased prescriptions for Benicar[1].

Personalized Medicine

The trend towards personalized medicine is also impacting the market. Tailored treatment plans that include medications like Benicar are becoming more common, contributing to its market presence[1].

Generic Versions and Cost-Efficiency

The introduction of generic versions of olmesartan has made the medication more cost-efficient and accessible to patients. This shift has driven market growth by making the treatment more affordable[1][4].

Financial Performance of Benicar

Peak Revenue Years

Benicar was one of Daiichi Sankyo's mainstay products, generating significant revenue. In the 2013 fiscal year, it earned $3.1 billion for the company, and in 2014, it generated $2.4 billion. However, revenue began to decline as the patent expired and generic versions entered the market[4].

Decline Post-Patent Expiry

In 2016, Daiichi Sankyo lost exclusive rights to Benicar in the U.S., and generic versions started to dominate the market. This led to a substantial decline in revenue from Benicar. By 2016, the annual revenue from the drug had dropped to $661 million, a significant reduction from its peak years[4].

Impact of Generic Competition

The entry of generic versions of olmesartan into the market had a profound impact on Daiichi Sankyo's revenue. It was estimated that generic versions would account for $950 million in sales in the 2016-2017 fiscal year, further eroding the company's market share and revenue from the drug[4].

Financial Trajectory Post-2016

Quarterly and Annual Revenue

In the financial reports for 2016, it was noted that the revenue from Benicar/Benicar HCT in the U.S. was $79.5 billion for the year, with a slight increase in some quarters but an overall decline compared to previous years[2].

Revenue Comparison

The revenue from Benicar in different regions showed varying trends. For instance, in Japan, the revenue from Olmetec (the Japanese brand name for olmesartan) declined, while in the U.S., the revenue from Benicar/Benicar HCT showed some stability but was ultimately on a downward trend due to generic competition[2].

Legal and Regulatory Challenges

Litigation and Settlements

Benicar has been involved in several lawsuits related to its side effects, which have further impacted Daiichi Sankyo's financials. In 2017, the company spent $300 million to settle lawsuits related to Benicar, adding to the financial strain[5].

Strategic Response by Daiichi Sankyo

Focus on New Products and Markets

To address the decline in revenue from Benicar, Daiichi Sankyo has been focusing on developing new drugs and expanding into other markets, particularly in the specialty area of oncology. The company aims to center its business around oncology treatments by 2025, recognizing the large and growing market in this area[4].

U.S. Market Growth

Despite challenges, the U.S. market remains a key target for growth for Daiichi Sankyo. The company sees ongoing stable growth in the U.S. pharmaceutical market, despite pressures on pricing and insurance coverage[4].

Key Takeaways

• The market for Benicar is driven by the rising prevalence of hypertension, emphasis on preventive care, personalized medicine, and the availability of generic versions.
• The financial performance of Benicar peaked in the early 2010s but declined significantly after the patent expiry and the introduction of generic versions.
• Daiichi Sankyo has faced legal challenges related to Benicar and has been investing in new product development and market expansion, particularly in oncology.
• The U.S. market remains crucial for Daiichi Sankyo’s growth strategy despite the challenges posed by generic competition and regulatory pressures.

FAQs

What is Benicar used for?

Benicar, or olmesartan, is used to treat high blood pressure and reduce the risk of cardiovascular events such as heart attacks and strokes.

Why did the revenue from Benicar decline?

The revenue from Benicar declined significantly after the patent expired and generic versions of the drug entered the market, reducing Daiichi Sankyo's exclusive rights and market share.

How has Daiichi Sankyo responded to the decline in Benicar revenue?

Daiichi Sankyo has focused on developing new drugs, particularly in the oncology sector, and is targeting growth in the U.S. pharmaceutical market despite the challenges.

What were the financial impacts of the lawsuits related to Benicar?

In 2017, Daiichi Sankyo spent $300 million to settle lawsuits related to Benicar, adding to the financial strain on the company.

What is Daiichi Sankyo's long-term strategy?

Daiichi Sankyo aims to center its business around oncology treatments by 2025 and continues to target growth in the U.S. pharmaceutical market.

Sources

1. IMARC Group - Olmesartan (Benicar) Manufacturing Plant Project Report 2024
2. Daiichi Sankyo - Reference Data
3. CVS Health - Driving More Affordable, Accessible and Effective Care
4. DrugWatch - Daiichi Sankyo - Benicar Manufacturer, History, Products
5. BioPharma Dive - Daiichi spends $300M to settle Benicar suits