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Last Updated: April 10, 2025

CAFCIT Drug Patent Profile


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

Cafcit is a drug marketed by Hikma and is included in one NDA.

The generic ingredient in CAFCIT is caffeine citrate. There are eleven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the caffeine citrate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Cafcit

A generic version of CAFCIT was approved as caffeine citrate by EXELA PHARMA SCIENCE on September 21st, 2006.

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Summary for CAFCIT
Drug patent expirations by year for CAFCIT
Drug Prices for CAFCIT

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Recent Clinical Trials for CAFCIT

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

SponsorPhase
University of ArkansasPhase 1
Thrasher Research FundPhase 1
University of North Carolina, Chapel HillPhase 1

See all CAFCIT clinical trials

Pharmacology for CAFCIT

US Patents and Regulatory Information for CAFCIT

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Hikma CAFCIT caffeine citrate SOLUTION;INTRAVENOUS 020793-001 Sep 21, 1999 AP RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Hikma CAFCIT caffeine citrate SOLUTION;ORAL 020793-002 Apr 12, 2000 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 2 of 2 entries

EU/EMA Drug Approvals for CAFCIT

CompanyDrugnameInnProduct Number / IndicationStatusGenericBiosimilarOrphanMarketing AuthorisationMarketing Refusal
Gennisium Pharma Gencebok caffeine citrate EMEA/H/C/005435
Treatment of primary apnoea of premature newborns.
Authorised no no no 2020-08-19
>Company>Drugname>Inn>Product Number / Indication>Status>Generic>Biosimilar>Orphan>Marketing Authorisation>Marketing Refusal
Showing 1 to 1 of 1 entries

Caffeine Citrate Market Dynamics and Financial Trajectory: A Comprehensive Analysis

Introduction to Caffeine Citrate

Caffeine citrate, a compound combining the stimulant caffeine with citric acid, is primarily used in the treatment of apnea of prematurity (AOP) in premature infants. This drug plays a crucial role in neonatal care, particularly in neonatal intensive care units (NICUs).

Market Growth and CAGR

The global caffeine citrate market is projected to grow at a compound annual growth rate (CAGR) of 3.2% from 2023 to 2030, according to Stratistics MRC[1]. However, other sources suggest a higher CAGR, such as 6.5% from 2024 to 2031, highlighting the dynamic and growing nature of the market[3].

Market Segmentation

Types of Caffeine Citrate

The market is segmented into several types, including:

  • Injection: Preferred for rapid action and higher bioavailability, especially in neonatal care for treating AOP. The injection segment is expected to have the highest CAGR during the forecast period due to its critical role in treating premature infants[1][3].
  • Oral Solution: Offers flexibility in dosing and is suitable for patients with swallowing difficulties. Advances in taste masking and formulation technologies drive its growth[3].
  • Tablet: Dominates due to convenience, stability, and cost-effectiveness, although it faces pressure from liquid formulations and personalized medicine[3].

Market Applications

Pharmaceuticals and Healthcare

The healthcare segment is anticipated to secure the largest share in the caffeine citrate market. This is due to the compound's fundamental role in neonatal and pediatric care, particularly for treating AOP in premature infants. As neonatal care standards and NICU admissions rise, caffeine citrate remains a vital pharmaceutical solution[1].

Other Applications

Beyond pharmaceuticals, caffeine citrate finds applications in biotechnology, consumer goods, and healthcare technology. These sectors are driven by innovations such as telemedicine, digital health records, AI in drug discovery, and wearable health tech[3].

Regional Analysis

North America

North America is expected to dominate the market due to advanced healthcare infrastructure, rising NICU admissions, and a strong focus on research and development in the pharmaceutical sector. The region's emphasis on improving neonatal care contributes significantly to the market's growth[1].

Asia Pacific

The Asia Pacific region is poised for significant growth due to its large population, growing emphasis on improving neonatal care, and expanding healthcare infrastructure. Increased NICU admissions in this region drive the demand for caffeine citrate[1][3].

Other Regions

Europe, Latin America, and the Middle East & Africa also contribute to the global market, with each region having unique characteristics and growth drivers. Urbanization and increasing awareness of neonatal health are key factors in these regions[3].

Key Players and Competitive Landscape

The caffeine citrate market is influenced by several key players, including:

  • Akorn
  • Amphastar Pharmaceuticals
  • Angel Labs
  • Fresenius Kabi
  • Mylan N.V.
  • Novartis AG
  • Pasteur Laboratories Pvt Ltd
  • Perrigo Company plc
  • Pfizer Inc.
  • Sagent Pharmaceuticals
  • Teva Pharmaceutical Industries Ltd.[1]

These companies are driving innovation through technological advancements, mergers and acquisitions, and strategic partnerships. For instance, the market is witnessing a wave of consolidations as companies seek to expand their product portfolios and leverage synergies to drive growth and competitiveness[4].

Market Drivers

Increasing NICU Admissions

The growing number of admissions to NICUs, driven by advancements in healthcare, higher birth complications, and improved neonatal survival rates, significantly increases the demand for caffeine citrate[1].

Technological Advancements

Advances in extraction and formulation processes enhance product efficacy and bioavailability, appealing to both manufacturers and consumers. Innovations in healthcare technology, such as telemedicine and digital health records, also support market growth[3].

Consumer Demand

The rising popularity of healthy lifestyle choices and growing awareness of caffeine’s cognitive benefits contribute to market growth. Additionally, the demand for performance-enhancing supplements and energy-boosting products in the sports and fitness sectors drives the market forward[3].

Challenges and Threats

Regulatory Restrictions

The COVID-19 pandemic exerted a mixed impact on the caffeine citrate market, with disruptions in global supply chains and shifts in healthcare priorities leading to sporadic shortages. Regulatory scrutiny and the potential for overconsumption are ongoing challenges[1].

Adverse Effects

Caffeine citrate is associated with potential adverse effects, such as necrotizing enterocolitis, although a causal relationship has not been established. It should be used with caution in infants with cardiovascular disease or impaired renal or hepatic function[2].

Financial Trajectory

The financial trajectory of the caffeine citrate market is positive, driven by the increasing demand for neonatal care solutions. The market's growth is supported by the expanding patient pool generated by rising NICU admissions and the critical role of caffeine citrate in treating AOP.

Revenue and Sales

Key players in the market are expected to see significant revenue growth as the market expands. For instance, the caffeine citrate injection market is anticipated to witness a CAGR of 9.35% from 2024 to 2031, indicating substantial financial growth opportunities[4].

Key Takeaways

  • The global caffeine citrate market is growing at a CAGR of 3.2% to 6.5% from 2023 to 2031.
  • The injection segment is expected to have the highest CAGR due to its critical role in neonatal care.
  • The healthcare segment dominates the market due to the compound's role in treating AOP.
  • North America and the Asia Pacific region are key drivers of market growth.
  • Technological advancements and increasing consumer demand for health and performance-enhancing supplements drive market expansion.
  • Regulatory scrutiny and potential adverse effects are significant challenges.

Frequently Asked Questions (FAQs)

What is the primary use of caffeine citrate?

Caffeine citrate is primarily used to treat apnea of prematurity (AOP) in premature infants.

Which segment is expected to have the highest CAGR in the caffeine citrate market?

The injection segment is expected to have the highest CAGR due to its rapid action and higher bioavailability in treating AOP.

What are the key regions driving the growth of the caffeine citrate market?

North America and the Asia Pacific region are key drivers of market growth due to advanced healthcare infrastructure and increasing NICU admissions.

What are the main challenges facing the caffeine citrate market?

The market faces challenges such as regulatory scrutiny, potential adverse effects like necrotizing enterocolitis, and disruptions in global supply chains.

Who are the key players in the caffeine citrate market?

Key players include Akorn, Amphastar Pharmaceuticals, Angel Labs, Fresenius Kabi, Mylan N.V., Novartis AG, Pasteur Laboratories Pvt Ltd, Perrigo Company plc, Pfizer Inc., Sagent Pharmaceuticals, and Teva Pharmaceutical Industries Ltd.

Cited Sources:

  1. Stratistics MRC: Caffeine Citrate Market CAGR, size, share, trends, growth, value ...
  2. FDA: CAFCIT® Injection (caffeine citrate injection, USP)
  3. Hashnode: Global Caffeine Citrate Market Analysis 2024-2031: Industry Size ...
  4. OpenPR: Caffeine Citrate Injection Market Size, Share and Forecast

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