CAFFEINE CITRATE - Generic Drug Details

What are the generic drug sources for caffeine citrate and what is the scope of patent protection?

Caffeine citrate is the generic ingredient in two branded drugs marketed by Hikma, Am Regent, Eugia Pharma, Exela Pharma Science, Fresenius Kabi Usa, Micro Labs, Sagent Pharms, Sun Pharm, and Exela Pharma, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

Eight suppliers are listed for this compound.

Summary for CAFFEINE CITRATE

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	14
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	31
Patent Applications:	534
Drug Prices:	Drug price trends for CAFFEINE CITRATE
What excipients (inactive ingredients) are in CAFFEINE CITRATE?	CAFFEINE CITRATE excipients list
DailyMed Link:	CAFFEINE CITRATE at DailyMed

See drug prices for CAFFEINE CITRATE

Recent Clinical Trials for CAFFEINE CITRATE

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

Sponsor	Phase
Al-Azhar University	Early Phase 1
Amgen	Early Phase 1
University of Michigan	Phase 2

See all CAFFEINE CITRATE clinical trials

Pharmacology for CAFFEINE CITRATE

Drug Class	Central Nervous System Stimulant Methylxanthine
Physiological Effect	Central Nervous System Stimulation

Medical Subject Heading (MeSH) Categories for CAFFEINE CITRATE

Central Nervous System Stimulants

Phosphodiesterase Inhibitors

Purinergic P1 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for CAFFEINE CITRATE

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

N06BC	Xanthine derivatives
N06B	PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for CAFFEINE CITRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	CAFFEINE CITRATE	caffeine citrate	SOLUTION;ORAL	090357-001	Sep 30, 2009	AA	RX	No	No
Sagent Pharms	CAFFEINE CITRATE	caffeine citrate	SOLUTION;ORAL	091102-001	Aug 29, 2012	AA	RX	No	No
Exela Pharma Science	CAFFEINE CITRATE	caffeine citrate	SOLUTION;INTRAVENOUS	077233-001	Sep 21, 2006	AP	RX	No	No
Micro Labs	CAFFEINE CITRATE	caffeine citrate	SOLUTION;ORAL	213202-001	Dec 16, 2019	AA	RX	No	No
Fresenius Kabi Usa	CAFFEINE CITRATE	caffeine citrate	SOLUTION;INTRAVENOUS	077997-001	Jul 20, 2007	AP	RX	No	No
Hikma	CAFCIT	caffeine citrate	SOLUTION;INTRAVENOUS	020793-001	Sep 21, 1999	AP	RX	Yes	Yes

EU/EMA Drug Approvals for CAFFEINE CITRATE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gennisium Pharma	Gencebok	caffeine citrate	EMEA/H/C/005435 Treatment of primary apnoea of premature newborns.	Authorised	no	no	no	2020-08-19

CAFFEINE CITRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Caffeine Citrate

Introduction

Caffeine citrate, a medication widely used in neonatology and other medical fields, is experiencing significant growth and transformation in its market dynamics. This article delves into the current state, future projections, and financial trajectory of the caffeine citrate market.

Market Size and Growth Projections

The caffeine citrate market is poised for substantial growth over the forecast period from 2024 to 2031. As of 2023, the market size was valued at USD 0.25 billion and is expected to reach USD 0.42 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.8%[4].

Segmentation of the Market

The market is segmented based on several key factors:

By Type

Caffeine citrate injections are available in different concentrations, such as 1ml:20mg and 3ml:60mg. These variations cater to different medical needs and patient profiles[1].

By Application

The primary applications include hospitals and clinics, where caffeine citrate is used to treat apnea of prematurity, central nervous system stimulation, and respiratory stimulation. Its use is also expanding into clinical research and other therapeutic areas[1][4].

By Geography

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its own growth trajectory and market dynamics influenced by local healthcare systems, regulatory frameworks, and consumer behavior[1][4].

Drivers of Market Growth

Several factors are driving the growth of the caffeine citrate market:

Increasing Prevalence of Preterm Births

The rising number of preterm births globally has increased the demand for treatments like caffeine citrate, which is crucial for managing apnea of prematurity[4].

Advancements in Neonatal Medicine

Improvements in neonatal care and the development of more effective treatments have boosted the use of caffeine citrate. This trend is expected to continue as neonatal medicine advances[4].

Expanding Applications

Beyond its traditional use in treating apnea, caffeine citrate is being explored for its cognitive benefits and performance enhancement. This broader application is expanding its market reach[4].

Regulatory Support

Encouraging regulatory frameworks and ongoing research into novel medicinal applications are further promoting market growth[4].

Economic Evaluation and Cost-Effectiveness

Caffeine citrate has been shown to be highly cost-effective in several studies:

Cost-Effectiveness in Apnea of Prematurity

A cost-effectiveness analysis revealed that caffeine therapy for apnea of prematurity is economically appealing, with lower mean costs and better outcomes compared to placebo. This analysis demonstrated that caffeine-treated infants had better outcomes and lower costs in over 99% of the bootstrap replications[2].

Impact on Healthcare Costs

Despite the current higher prices of caffeine citrate compared to its introduction, rigorous clinical trials and economic evaluations have confirmed its value in reducing healthcare costs while improving clinical outcomes[5].

Competitive Landscape

The market for caffeine citrate is characterized by a mix of established and emerging players:

Key Companies

Companies such as Chiesi Farmaceutici S.p.A., Alpha Pharma, Easton Biopharmaceutical, and others are prominent in the market. These companies are profiled based on their product offerings, market entry year, and other market-related factors[1][4].

Market Share and Strategies

The competitive landscape is shaped by new product launches, collaborations, company expansions, and acquisitions. Understanding these strategies is crucial for market entrance plans and investment decisions[4].

Regional Market Dynamics

North America and Europe

These regions are expected to maintain significant market shares due to advanced healthcare systems and high adoption rates of new treatments. Regulatory support and strong research infrastructure also contribute to their growth[1][4].

Asia-Pacific

This region is anticipated to be one of the fastest-growing markets due to increasing healthcare expenditure, rising awareness of neonatal care, and expanding consumer base[1][4].

Challenges and Opportunities

Pricing and Accessibility

The current high prices of caffeine citrate, driven by factors such as small market size and government-imposed barriers to competition, pose a challenge. However, ongoing research and economic evaluations can help ensure that the drug remains a good use of societal resources[5].

Regulatory Frameworks

Encouraging regulatory frameworks can facilitate market growth by supporting innovation and ensuring the safety and efficacy of caffeine citrate formulations[4].

Future Outlook

The caffeine citrate market is at the threshold of significant development, driven by its expanding applications, advancements in neonatal medicine, and favorable regulatory environments. As the market continues to grow, it is expected to see innovative formulations and delivery technologies, further enhancing its market reach and financial trajectory.

Key Takeaways

• The caffeine citrate market is projected to grow from USD 0.25 billion in 2023 to USD 0.42 billion by 2031 at a CAGR of 5.8%.
• The market is driven by the increasing prevalence of preterm births, advancements in neonatal medicine, and expanding applications.
• Caffeine citrate has been shown to be highly cost-effective in treating apnea of prematurity.
• The competitive landscape includes both established and emerging players, with key companies like Chiesi Farmaceutici S.p.A. and Alpha Pharma.
• Regional dynamics vary, with North America and Europe maintaining significant market shares and the Asia-Pacific region expected to be one of the fastest-growing markets.

FAQs

1. What are the primary applications of caffeine citrate?

   • Caffeine citrate is primarily used to treat apnea of prematurity, central nervous system stimulation, and respiratory stimulation. It is also used in clinical research and other therapeutic areas[1][4].

2. How cost-effective is caffeine citrate in treating apnea of prematurity?

   • Caffeine citrate has been shown to be highly cost-effective, with lower mean costs and better outcomes compared to placebo. It is considered a "win-win" therapy in over 99% of bootstrap replications[2].

3. Which regions are expected to drive the growth of the caffeine citrate market?

   • North America and Europe are expected to maintain significant market shares, while the Asia-Pacific region is anticipated to be one of the fastest-growing markets due to increasing healthcare expenditure and rising awareness of neonatal care[1][4].

4. What are the key drivers of the caffeine citrate market growth?

   • The market growth is driven by the increasing prevalence of preterm births, advancements in neonatal medicine, expanding applications, and favorable regulatory frameworks[4].

5. Who are the major players in the caffeine citrate market?

   • Major players include Chiesi Farmaceutici S.p.A., Alpha Pharma, Easton Biopharmaceutical, Anhui Healstar Pharmaceutical, and others. These companies are profiled based on their product offerings and market-related factors[1][4].

Sources

[1] https://www.marketresearchintellect.com/product/caffeine-citrate-injection-market/ [2] https://pubmed.ncbi.nlm.nih.gov/21173002/ [3] https://bmjopen.bmj.com/content/13/5/e073945 [4] https://www.marketresearchintellect.com/product/global-caffeine-citrate-market-size-and-forecast/ [5] https://pubmed.ncbi.nlm.nih.gov/33277220/