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Last Updated: December 22, 2024

ROCEPHIN Drug Patent Profile


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

Rocephin is a drug marketed by Hoffmann La Roche and Roche and is included in five NDAs.

The generic ingredient in ROCEPHIN is ceftriaxone sodium; lidocaine. There are twenty-six drug master file entries for this compound. Additional details are available on the ceftriaxone sodium; lidocaine profile page.

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Summary for ROCEPHIN
Drug patent expirations by year for ROCEPHIN
Recent Clinical Trials for ROCEPHIN

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

SponsorPhase
Imperial College Healthcare NHS TrustPhase 3
Singapore Clinical Research InstitutePhase 3
Royal Brisbane and Women's HospitalPhase 3

See all ROCEPHIN clinical trials

US Patents and Regulatory Information for ROCEPHIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hoffmann La Roche ROCEPHIN ceftriaxone sodium INJECTABLE;INJECTION 062654-002 Apr 30, 1987 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hoffmann La Roche ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER ceftriaxone sodium INJECTABLE;INJECTION 050624-002 Feb 11, 1987 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hoffmann La Roche ROCEPHIN ceftriaxone sodium INJECTABLE;INJECTION 063239-002 Aug 13, 1993 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hoffmann La Roche ROCEPHIN ceftriaxone sodium INJECTABLE;INJECTION 050585-005 Dec 21, 1984 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hoffmann La Roche ROCEPHIN ceftriaxone sodium INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 050585-004 Dec 21, 1984 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

ROCEPHIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ceftriaxone (Rocephin)

Market Overview

The global ceftriaxone market, which includes the popular brand Rocephin, is poised for significant growth over the next few years. Ceftriaxone, a broad-spectrum cephalosporin antibiotic, is widely used in the treatment of various bacterial infections, including urinary tract infections, intra-abdominal infections, endocarditis, and others[1][4].

Market Size and Growth

The ceftriaxone market is projected to grow at a Compound Annual Growth Rate (CAGR) of 2.9% to 3.2% from 2022 to 2031, depending on the forecast. By 2031, the market is expected to reach more than $2.2 billion, up from $1.7 billion in 2021[1][4].

Key Drivers

Several factors are driving the growth of the ceftriaxone market:

Increasing Incidence of Bacterial Infections

The rising prevalence of bacterial infections globally is a primary driver. This includes an increase in urinary tract infections, intra-abdominal infections, and other bacterial infections[1][4].

Generic and Branded Versions

The availability of both generic and branded versions of ceftriaxone, such as Rocephin, is a significant factor. Generic versions offer cost-effective treatments, which are particularly beneficial in developing countries[1][4].

Off-Label Use

Many ceftriaxone products are used off-label for several indications, expanding their market reach[1][4].

Healthcare Expenditure and Technological Advancements

High healthcare expenditure, early adoption of advanced technologies, and favorable funding by governments and charitable trusts in regions like North America are also driving the market[1][4].

Market Segmentation

By Indication

The global ceftriaxone market is segmented into various indications, including intra-abdominal infections, endocarditis, meningitis, urinary tract infections, acute bacterial otitis media, pneumonia, and others. Urinary tract infections are expected to have significant market growth due to their high prevalence among the adult population[4].

By Distribution Channel

The market is also segmented by distribution channels, with hospital pharmacies expected to account for a significant share. Hospitals are preferred for the treatment of bacterial infections due to favorable reimbursement policies[1][4].

Geographic Overview

North America

North America, particularly the U.S., dominates the global ceftriaxone market due to the high incidence rate of bacterial infections, significant healthcare expenditure, and early adoption of advanced technologies. This region is expected to remain highly lucrative during the forecast period[1][4].

Asia Pacific

The Asia Pacific region is anticipated to record the fastest market growth during the forecast period. Countries like India and China have a large patient base, contributing to the rapid expansion of the market in this region[1][4].

Competitive Landscape

The global ceftriaxone market is competitive, with several key players such as Hikma Pharmaceuticals plc, Qilu Pharmaceutical Co. Ltd., Novartis AG, Baxter International, Inc., Aurobindo Pharma, and others. These companies are investing heavily in research and development to introduce generic forms of ceftriaxone and expand their product portfolios[1][4].

Financial Trajectory

Revenue Forecast

By 2031, the global ceftriaxone market is expected to reach more than $2.2 billion, with a CAGR of 2.9% from 2022 to 2031. In another forecast, the market is projected to reach $2.8 billion by 2030, growing at a CAGR of 3.2% from 2025 to 2030[1][4].

Cost-Effectiveness

Generic versions of ceftriaxone provide affordable therapy, which is expected to present significant opportunities for market growth, especially in developing countries. This cost-effectiveness is a key factor in the financial trajectory of the market[1][4].

Clinical and Pharmacological Aspects

Pharmacokinetics

Ceftriaxone has a broad spectrum of activity and is administered intravenously or intramuscularly. It has a long elimination half-life, ranging from 5.8 to 8.7 hours, and is highly bound to plasma proteins. This pharmacokinetic profile makes it effective for treating a variety of bacterial infections[2].

Clinical Use

Ceftriaxone is used to treat infections such as skin and skin structure infections, urinary tract infections, and others. It is also used to prevent infections before certain types of surgery[2][4].

Challenges and Opportunities

Antimicrobial Resistance

The use of ceftriaxone and other antibiotics must be managed carefully to reduce the development of drug-resistant bacteria. Antimicrobial stewardship programs are crucial in this regard[2][5].

Market Expansion

The expiration of patents for blockbuster drugs will allow generic manufacturers to produce their versions, driving market expansion. Collaborations between big pharma companies and generic manufacturers are expected to propel the market forward[4].

Key Takeaways

  • The global ceftriaxone market is projected to grow significantly, driven by the increasing incidence of bacterial infections and the availability of generic and branded versions.
  • North America and the Asia Pacific region are key markets, with North America dominating due to high healthcare expenditure and technological advancements.
  • Hospital pharmacies are a significant distribution channel due to favorable reimbursement policies.
  • The market is competitive, with key players investing in research and development to introduce generic forms of ceftriaxone.
  • Antimicrobial stewardship programs are essential to manage the use of ceftriaxone and prevent drug resistance.

FAQs

1. What is the primary use of ceftriaxone?

Ceftriaxone is primarily used in the treatment of various bacterial infections, including urinary tract infections, intra-abdominal infections, endocarditis, and others.

2. Which region dominates the global ceftriaxone market?

North America, particularly the U.S., dominates the global ceftriaxone market due to the high incidence rate of bacterial infections and significant healthcare expenditure.

3. What is the expected CAGR of the global ceftriaxone market from 2022 to 2031?

The global ceftriaxone market is expected to grow at a CAGR of 2.9% from 2022 to 2031.

4. Why are generic versions of ceftriaxone significant?

Generic versions of ceftriaxone provide cost-effective treatments, which are particularly beneficial in developing countries and drive market growth.

5. What are the key challenges in the use of ceftriaxone?

One of the key challenges is the potential development of drug-resistant bacteria, which necessitates careful management through antimicrobial stewardship programs.

Cited Sources:

  1. Transparency Market Research: Ceftriaxone Market Size, Share, and Forecast 2022–2031.
  2. FDA: ROCEPHIN (ceftriaxone sodium) FOR INJECTION Rx only.
  3. Introspective Market Research: Ceftriaxone Sodium Market - Comprehensive Study Report.
  4. VynZ Research: Ceftriaxone Market Size, Share | Report | Forecast 2030.
  5. Oxford Academic: Is the “Low-Hanging Fruit” Worth Picking for Antimicrobial Stewardship?

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