AZOR Drug Patent Profile

Which patents cover Azor, and when can generic versions of Azor launch?

Azor is a drug marketed by Cosette and is included in one NDA.

The generic ingredient in AZOR is amlodipine besylate; olmesartan medoxomil. There are fifty drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the amlodipine besylate; olmesartan medoxomil profile page.

Summary for AZOR

US Patents:	0
Applicants:	1
NDAs:	1

Paragraph IV (Patent) Challenges for AZOR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AZOR	Tablets	amlodipine besylate; olmesartan medoxomil	10 mg/20 mg and 5 mg/40 mg	022100	1	2008-03-31
AZOR	Tablets	amlodipine besylate; olmesartan medoxomil	5 mg/20 mg and 10 mg/40 mg	022100	1	2008-02-11

US Patents and Regulatory Information for AZOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cosette	AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100-001	Sep 26, 2007	AB	RX	Yes	No
Cosette	AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100-004	Sep 26, 2007	AB	RX	Yes	Yes
Cosette	AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100-002	Sep 26, 2007	AB	RX	Yes	No
Cosette	AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100-003	Sep 26, 2007	AB	RX	Yes	No

International Patents for AZOR

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

Country	Patent Number	Title	Estimated Expiration
Austria	199548
Austria	200777
Austria	200778
Australia	1112592
Australia	3988093

Supplementary Protection Certificates for AZOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0503785	C00503785/01	Switzerland		FORMER OWNER: SANKYO COMPANY LIMITED, JP
0503785	CA 2009 00015	Denmark		PRODUCT NAME: EN KOMBINATION AF OLMESARTANMEDOXOMIL, EVT. I FORM AF ET FARMACEUTISK ACCEPTABELT SALT OG AMLODIPIN-BESILAT; NAT. REG. NO/DATE: MT 42061, 42062, 42063 20081120; FIRST REG. NO/DATE: NL RVG 100984 20080819
0503785	300133	Netherlands		300133, 20120221, EXPIRES: 20170220
0503785	C300133	Netherlands		PRODUCT NAME: OLMESARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN DE CARBOXYGROEP GEKOZEN UIT DE VOLGENDE : EEN ALKYLGROEP 1-4 KOOLSTOFATOMEN, EEN BENZYLGROEP, EEN ALKANOYLOXYALKYLGROEP WAARIN HET ALKANOYLDEEL 1-5; NATL. REGISTRATION NO/DATE: RVG 28785-RVG 28787 20030527; FIRST REGISTRATION: DE 502.02.00.00,502.02.01.00, 502.02.02.00 20020813

Last updated: February 3, 2026

What is the current market and regulatory status of AZOR?

AZOR, a combination therapy of amlodipine and olmesartan, is approved by the FDA for hypertension treatment. It competes in the global antihypertensive market estimated at $16.4 billion in 2022, projected to grow at around 3.8% annually through 2030[1]. AZOR’s patent expiry occurred in 2015, exposing it to generic competition. Despite this, its brand sales remained notable in the US through 2021, with approximately $245 million in sales[2].

How does AZOR compare to competitors in efficacy and market share?

AZOR’s fixed-dose combination (FDC) delivers antihypertensive effects comparable to monotherapies but advantages include improved compliance. Competitors include drugs like Norvasc (amlodipine), Cozaar (losartan), and newer agents like Entresto (sacubitril/valsartan). Market share for AZOR has declined post-patent expiry; however, it persists due to prescriber familiarity and patient adherence benefits. Brand sales post-2015 have plateaued at a lower level, with ongoing use in certain segments.

What are the patent and exclusivity prospects influencing investment?

The original AZOR patent expired in 2015. Although the FDC faced generic competition, some formulations or secondary patents related to specific formulations or uses could extend exclusivity. As of 2022, no active patents prevent generic sales, implying limited barriers for market entry. Companies may leverage product labeling, branding, and distribution networks instead of patent protection for differentiation.

What are the R&D and lifecycle management opportunities?

Potential R&D avenues include developing extended-release formulations, combination therapies with novel mechanisms, or biomarkers for personalized therapy. Lifecycle management could involve label extensions, such as indications for heart failure or diabetic nephropathy, under FDA pathways. Regulatory agencies in other jurisdictions (e.g., EMA) may have different patent or exclusivity timelines, affecting global strategy.

How do pricing and reimbursement trends affect AZOR’s investment outlook?

Price competition is intense following patent expiration. The drug’s generic version commonly sells at 60-80% discount compared to the branded product. Reimbursement by major insurers in the US makes AZOR-based therapies widely accessible, but insurers favor generics to contain costs. Market penetration of generics limits the branded product’s revenue potential, requiring new formulations or indications for higher margins.

What is the future revenue outlook and investment risk?

Current revenue derives mainly from legacy prescriptions in markets where generics are not fully adopted. The risk includes ongoing generic erosion, potential loss of market share, and regulatory changes. However, established prescriber familiarity may sustain some demand. Investment in AZOR’s pipeline or lifecycle extensions offers marginal upside, but fundamental revenue prospects decline without differentiation or new indications.

Key Takeaways

• AZOR’s patent exclusivity ended in 2015; it faces substantial generic competition.
• Market share has declined post-patent but persists in certain segments due to brand loyalty.
• R&D prospects center on formulation improvements and new therapeutic indications.
• Pricing pressure from generics reduces revenue, impacting investment returns.
• Long-term prospects rely on lifecycle management strategies and pipeline expansion.

FAQs

1. Can AZOR hold market share without patent protection?
Yes, through brand recognition, prescriber loyalty, and formulation advantages. However, sustained revenues are limited unless new uses or formulations are developed.

2. Are there ongoing patent protections or exclusivities?
No active patents prevent generic competition as of 2022, but secondary patents or formulation patents could provide limited extensions.

3. What are the main competitors for AZOR?
Generic versions of amlodipine-olmesartan combinations, brand-name drugs like Benicar (olmesartan), and other antihypertensives such as ACE inhibitors or ARBs.

4. What regulatory strategies could prolong AZOR's commercial viability?
Seeking label extensions, introducing new formulations, or pursuing indications beyond hypertension.

5. How significant are lifecycle management approaches for AZOR?
Crucial. They could offset revenue declines from generics by creating new markets or improving patient adherence.

References
[1] Market Data Forecast: Global Hypertension Drugs Market, 2022-2030.
[2] IQVIA. U.S. Prescription Sales Data, 2021.