Cephradine - Generic Drug Details

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

Cephradine is the generic ingredient in six branded drugs marketed by Glaxosmithkline, Barr, Ivax Sub Teva Pharms, Teva, Vitarine, Apothecon, Ersana, and Bristol Myers Squibb, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for cephradine.

Summary for cephradine

US Patents:	0
Tradenames:	6
Applicants:	8
NDAs:	15
Drug Master File Entries:	10
Raw Ingredient (Bulk) Api Vendors:	74
Patent Applications:	5,485
DailyMed Link:	cephradine at DailyMed

Medical Subject Heading (MeSH) Categories for cephradine

Anti-Bacterial Agents

US Patents and Regulatory Information for cephradine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	ANSPOR	cephradine	FOR SUSPENSION;ORAL	061866-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Ersana	VELOSEF '500'	cephradine	CAPSULE;ORAL	050548-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Barr	CEPHRADINE	cephradine	CAPSULE;ORAL	062851-001	Apr 22, 1988		DISCN	No	No
Apothecon	VELOSEF '125'	cephradine	FOR SUSPENSION;ORAL	061763-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Ersana	VELOSEF '250'	cephradine	CAPSULE;ORAL	050548-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Apothecon	VELOSEF	cephradine	INJECTABLE;INJECTION	061976-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Cephradine Market Analysis and Financial Projection Experimental

Cephradine Market Dynamics and Financial Trajectory

Market Overview

The cephradine market is a segment of the broader cephalosporin antibiotics market, which is experiencing significant growth driven by various factors. Here, we delve into the market dynamics, financial trajectory, and key trends shaping the future of cephradine.

Market Drivers

• Increasing Prevalence of Bacterial Infections: The global rise in bacterial infections, particularly in regions with improving healthcare infrastructure, is a major driver for the cephradine market. This increase is prompting health authorities and pharmaceutical companies to invest in R&D to develop more effective antibiotics[3][4].
• Rising Trend Toward Personalized Medicine: The shift toward personalized medicine, especially in the treatment of bacterial infections, is another significant driver. This approach involves using genomic data to tailor antibiotic therapy, enhancing patient outcomes and reducing unnecessary antibiotic use[1][4].

Market Restraints

• Concerns Over Adverse Effects: One of the primary restraints is the concern over potential adverse effects or side effects associated with cephradine. This necessitates rigorous clinical trials and safety assessments to ensure the drug's safety profile[1][4].
• Market Saturation in Developed Regions: Market saturation in developed regions, where the demand for cephradine may be plateauing, poses a challenge. This saturation can lead to intense competition from generic manufacturers, affecting the market share of branded cephradine products[1].

Market Opportunities

• Innovations in Drug Delivery Mechanisms: Innovations in drug delivery systems, such as sustained-release formulations, offer significant opportunities. These formulations can enhance therapeutic efficacy, improve patient compliance, and reduce the frequency of dosing[1][3].
• Research and Development: Continued investments in R&D are crucial for discovering new formulations and expanding the spectrum of cephradine to include broader or more resistant bacterial strains. This can address global health needs more effectively and open up new market opportunities[1][3].

Market Challenges

• Strict Regulatory Standards: Compliance with strict regulatory standards across different regions is a significant challenge. Pharmaceutical companies must ensure that their products meet international regulatory requirements, which can be time-consuming and costly[1][4].
• Competition from Generic Manufacturers: The presence of generic manufacturers in the market poses a challenge, especially in regions where generic drugs are preferred due to their lower cost. This competition can erode the market share of branded cephradine products[1][3].

Regional Framework

• North America: This region dominates the cephradine market due to the presence of a large number of generic antibiotic manufacturers offering products at competitive prices. Companies like AbbVie Inc., F. Hoffman-La Roche Ltd., Merck & Co., Inc., and Lupin have a strong presence here[3][4].
• Asia-Pacific: This region is expected to witness the fastest growth due to the increasing prevalence of respiratory infections and high demand for cephalosporin drugs. Countries like China and India are key markets due to their large populations and improving healthcare infrastructure[3][4].
• Europe, Middle East & Africa: These regions also present opportunities, particularly in countries with growing healthcare needs. The market here is segmented by country, with each country having its own set of challenges and opportunities[1][4].

Market Segmentation

• By Type: The cephradine market is segmented into USP (United States Pharmacopeia) and EP (European Pharmacopeia) types. This segmentation is crucial for ensuring the quality and efficacy of the drug across different regions[4].
• By Application: The market is categorized into tablets and capsules, with oral formulations being the most preferred due to their ease of use and high patient compliance[3][4].

Financial Trajectory

• Market Size: The global cephalosporin drugs market, which includes cephradine, was valued at USD 19.38 billion in 2023 and is expected to grow at a CAGR of 2.94% from 2023 to 2030[3].
• Growth Projections: The cephradine market is projected to grow significantly, driven by the increasing prevalence of bacterial infections and the need for more effective and personalized antibiotic treatments. By 2031, the market is expected to reach a substantial size, although exact figures vary by report[1][3][4].

Key Players

• Alkem Labs: Known for its extensive range of pharmaceutical products, including cephalosporins.
• CSPC Pharmaceutical Group Limited: A major player in the Chinese pharmaceutical market with a strong presence in the cephalosporin segment.
• Lupin Pharmaceuticals, Inc.: A global pharmaceutical company with a significant portfolio of antibiotics, including cephradine.
• Qilu Pharmaceutical Co., Ltd.: Another key player in the Chinese market, known for its innovative drug formulations[4].

PEST Analysis

• Political Factors: Regulatory policies and government initiatives to combat antibiotic resistance play a crucial role in shaping the market. Supportive regulatory policies can expedite the approval process for new antibiotics[4].
• Economic Factors: The cost of R&D, manufacturing, and distribution affects the market. Economic stability and funding for healthcare can influence the demand for cephradine[4].
• Social Factors: Increasing awareness about the importance of proper antibiotic use and the rise in patient-centric medicine are social factors driving the market[3][4].
• Technological Factors: Advances in drug delivery systems and personalized medicine are technological factors that are significantly impacting the cephradine market[1][3].

Key Takeaways

• The cephradine market is driven by the increasing prevalence of bacterial infections and the trend toward personalized medicine.
• Innovations in drug delivery mechanisms and continued R&D are crucial for market growth.
• Strict regulatory standards and competition from generic manufacturers are significant challenges.
• The Asia-Pacific region is expected to witness the fastest growth due to high demand and improving healthcare infrastructure.
• Key players are investing heavily in R&D and expanding their product portfolios to capture market share.

FAQs

Q: What are the primary drivers of the cephradine market? A: The primary drivers include the increasing prevalence of bacterial infections and the rising trend toward personalized medicine.

Q: What are the main challenges facing the cephradine market? A: The main challenges include concerns over adverse effects, market saturation in developed regions, and strict regulatory standards.

Q: Which region is expected to witness the fastest growth in the cephradine market? A: The Asia-Pacific region is expected to witness the fastest growth due to the high demand for cephalosporin drugs and improving healthcare infrastructure.

Q: What role do innovations in drug delivery mechanisms play in the cephradine market? A: Innovations in drug delivery mechanisms, such as sustained-release formulations, can enhance therapeutic efficacy, improve patient compliance, and reduce dosing frequency.

Q: Who are some of the key players in the cephradine market? A: Key players include Alkem Labs, CSPC Pharmaceutical Group Limited, Lupin Pharmaceuticals, Inc., and Qilu Pharmaceutical Co., Ltd.

Cited Sources

1. Research and Markets: Cephradine Market Size, Competitors & Forecast to 2030.
2. FDA: Clinical Review for NDA 213535.
3. Grand View Research: Cephalosporin Drugs Market Size And Share Report, 2030.
4. The Insight Partners: Cephradine Market Dynamics 2021-2031.