Amlodipine besylate; celecoxib - Generic Drug Details

What are the generic drug sources for amlodipine besylate; celecoxib and what is the scope of freedom to operate?

Amlodipine besylate; celecoxib is the generic ingredient in one branded drug marketed by Purple Biotech and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Amlodipine besylate; celecoxib has two patent family members in two countries.

Summary for amlodipine besylate; celecoxib

International Patents:	2
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Clinical Trials:	3
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for amlodipine besylate; celecoxib
DailyMed Link:	amlodipine besylate; celecoxib at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for amlodipine besylate; celecoxib

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.

Recent Clinical Trials for amlodipine besylate; celecoxib

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

Sponsor	Phase
Haining Health-Coming Biotech Co., Ltd.	Phase 2
Alphacait, LLC	Phase 2
Kitov Pharma Ltd	Phase 3

See all amlodipine besylate; celecoxib clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for amlodipine besylate; celecoxib

C08CA	Dihydropyridine derivatives
C08C	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

L01XX	Other antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

M01AH	Coxibs
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

Paragraph IV (Patent) Challenges for AMLODIPINE BESYLATE; CELECOXIB

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CONSENSI	Tablets	amlodipine besylate; celecoxib	2.5 mg/200 mg, 5 mg/200 mg, 10 mg/200 mg	210045	1	2020-06-29

US Patents and Regulatory Information for amlodipine besylate; celecoxib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Purple Biotech	CONSENSI	amlodipine besylate; celecoxib	TABLET;ORAL	210045-003	May 31, 2018		DISCN	Yes	No			Y
Purple Biotech	CONSENSI	amlodipine besylate; celecoxib	TABLET;ORAL	210045-001	May 31, 2018		DISCN	Yes	No			Y
Purple Biotech	CONSENSI	amlodipine besylate; celecoxib	TABLET;ORAL	210045-002	May 31, 2018		DISCN	Yes	No			Y

International Patents for amlodipine besylate; celecoxib

Country	Patent Number	Title	Estimated Expiration
China	111065382
World Intellectual Property Organization (WIPO)	2019008583

Supplementary Protection Certificates for amlodipine besylate; celecoxib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0443983	2007C/043	Belgium		PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
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	C300445	Netherlands		PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
0502314	C300478	Netherlands		PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007
0678503	C300499	Netherlands		PRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114

Last updated: February 15, 2026

What are the current market dynamics for amlodipine besylate and celecoxib?

Amlodipine Besylate

Market Overview:
Amlodipine besylate, a calcium channel blocker primarily used for hypertension and angina, remains a key component in cardiovascular treatment regimens. The drug’s global sales in 2022 reached approximately $4.2 billion, driven by its established efficacy, low cost, and widespread use. The U.S. accounts for roughly 40% of this market, with Europe contributing about 25%, and the rest spread across Asia-Pacific and other regions.

Pricing and Market Shares:
In the U.S., generic versions account for over 80% of prescriptions, maintaining prices between $0.10 to $0.25 per tablet. Branded versions by Pfizer and other incumbents retain a premium, with prices ranging from $2 to $4 per tablet. These factors contribute to high volume sales rather than high margins.

Market Drivers:

• Growing prevalence of hypertension and cardiovascular disease, especially in aging populations.
• Increased screening programs.
• Launch of combination drugs leveraging amlodipine as a component to increase therapeutic adherence.

Competitive Landscape:
The market is characterized by high generic penetration; few new formulations or delivery methods have emerged. Patent expirations have occurred for most major versions, fostering a highly competitive environment.

Celecoxib

Market Overview:
Celecoxib, a selective non-steroidal anti-inflammatory drug (NSAID) mainly used for osteoarthritis, rheumatoid arthritis, and acute pain, generated global revenues of approximately $1.2 billion in 2022. The drug’s patent expired in several key markets, including the U.S., in 2015, allowing generics to proliferate.

Pricing and Market Shares:
Brand-name Celebrex by Pfizer retailed at roughly $10 to $15 per capsule before generic entry. Generics now dominate with price points falling below $2 per capsule, resulting in rapid volume increases. Despite this, regional disparities exist: in the U.S., generic market share exceeds 70%, while in some developing markets, brand-name prescribing persists due to cost or regulatory slowdowns.

Market Drivers:

• Expansion of indications, especially in postoperative pain management and cancer risk reduction (colorectal polyps).
• Increasing usage in chronic inflammatory conditions.
• Heightened awareness of cardiovascular risks associated with traditional NSAIDs, positioning celecoxib as a safer alternative.

Competitive Landscape:
Multiple generic manufacturers, including Teva, Mylan, and Sandoz, produce celecoxib. Patent challenges and litigation have influenced the timing and scope of generic launches. Strategic alliances and patent litigations shape the competitive dynamics.

How do these drugs' financial trajectories compare?

Revenue Trends

Drug	2022 Global Revenue	Dominant Markets	Price Range (per unit)	Patent Status	Major Generics/Manufacturers
Amlodipine Besylate	$4.2 billion	U.S., Europe, Asia-Pacific	$0.10–$4	Patents expired in 2007 (U.S.)	Mylan, Sandoz, Pfizer
Celecoxib	$1.2 billion	U.S., Europe, Asia	$2–$15 (brand), <$2 (generic)	Patent expired in 2015 (U.S.)	Teva, Mylan, Sandoz

Growth Projections (Next 5 Years)

• Amlodipine Besylate: Projected CAGR of approximately 2-3% driven by demographic aging, increased hypertension diagnosis rates, and combination formulations. Despite patent losses, stable demand persists.

• Celecoxib: Anticipated CAGR of 4-6%, supported by expanding indications, new formulations, and off-label uses. Patent expirations have resulted in sharp price reductions, but increased volume partially offsets margin erosion.

Revenue Forecasts (2023–2027)

Drug	2023 Estimated Revenue	2027 Projected Revenue	Compound Annual Growth Rate	Key Drivers
Amlodipine Besylate	~$4.1 billion	~$4.3 billion	~1.5%	Demographics, combination drug strategies
Celecoxib	~$1.0 billion	~$1.3 billion	~6%	New indications, increased off-label use

Market Risks and Opportunities

• Amlodipine Besylate: Pressure from novel antihypertensive agents, including angiotensin receptor blockers and combination drugs. Opportunities exist in biosimilars and extended-release formulations.

• Celecoxib: Competition from other NSAIDs, including non-selective options, affects market share. Opportunities lie in expanding indications like cancer prevention and personalized medicine approaches.

What are the regulatory and patent landscapes influencing these drugs?

Patent Expirations and Patent Strategies

Amlodipine Besylate:
Patents expired in the U.S. in 2007. Manufacturers use secondary patents on formulations or combination drugs to extend exclusivity in certain markets. Patent litigations have been minimal since expiry; market entry by generics is widespread.

Celecoxib:
Patent expired in 2015 in the U.S. and applicable in other jurisdictions. Strategic patenting around formulation and delivery methods persists in some regions, delaying generic entry.

Regulatory Pathways

• FDA and EMA approvals for generics follow the ANDA pathway in the U.S., with bioequivalence demonstrated.
• Biosimilar development is limited due to the small molecule nature of these drugs, but innovator companies explore combination therapies and extended-release versions for market differentiation.

How do pricing and reimbursement policies impact revenues?

Pricing policies:

• U.S. pricing is influenced by payer negotiations and formulary placements.
• In Europe, national health systems significantly regulate drug prices.

Reimbursement trends:

• Increased focus on cost-effectiveness favors generics, pressuring prices downward.
• Managed care organizations favor combination therapies and once-daily formulations to improve adherence, influencing market preferences.

Closing Summary

Amlodipine besylate and celecoxib exhibit contrasting market trajectories shaped by patent status, competition, and clinical indications. Amlodipine remains a stable, high-volume product with slow growth. Celecoxib faces significant generic competition but benefits from expanding indications, supporting moderate growth. Both drugs are influenced by shifting reimbursement policies and patent strategies, impacting future revenue streams.

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Key Takeaways

• Amlodipine besylate: Dominates hypertension treatment, with high generic penetration. Revenue growth remains modest; innovation is limited.

• Celecoxib: Faces price erosion from generics but maintains niche through expanding indications and potential new formulations.

• Market risks: Patent expirations, regulatory changes, and evolving clinical guidelines can redefine competitive landscapes.

• Opportunities: Biosimilars, combination products, and new indications.

• Pricing pressure: Continues to lower margins, especially for off-patent drugs.

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FAQs

1. What factors could extend the market life of amlodipine besylate?
Innovation in combination therapies and extended-release formulations. Strategic patenting, although limited, may provide short-term exclusivity extensions.

2. How do patent expirations impact sales?
Patent expirations lead to increased generic competition, significantly reducing per-unit prices and overall revenues, though high volume sales mitigate revenue loss.

3. Are there new formulations or delivery methods for celecoxib in development?
Yes, some companies are exploring extended-release and combination formulations, aiming to improve adherence and expand indications.

4. How does regional variation affect the market?
In countries with strict price controls, generic penetration is faster, reducing revenues. In regions with less regulation, brand-name drugs maintain higher prices longer.

5. What regulatory barriers exist for introducing biosimilars of these drugs?
Since both drugs are small molecules, biosimilars are not applicable. However, generics face bioequivalence requirements through abbreviated pathways, simplifying approval processes.

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Sources:
[1] IQVIA, "Global Use of Medicines," 2022.
[2] EvaluatePharma, "World Market for Cardiovascular Drugs," 2022.
[3] U.S. FDA, "ANDA Approvals and Patent Monographs," 2023.
[4] Pharma Intelligence, "Generic Drug Launches," 2022.