Chloramphenicol sodium succinate - Generic Drug Details

What are the generic sources for chloramphenicol sodium succinate and what is the scope of patent protection?

Chloramphenicol sodium succinate is the generic ingredient in four branded drugs marketed by Elkins Sinn, Fresenius Kabi Usa, Gruppo Lepetit, Parkedale, and Angus, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for chloramphenicol sodium succinate

US Patents:	0
Tradenames:	4
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	29
Patent Applications:	401
What excipients (inactive ingredients) are in chloramphenicol sodium succinate?	chloramphenicol sodium succinate excipients list
DailyMed Link:	chloramphenicol sodium succinate at DailyMed

Pharmacology for chloramphenicol sodium succinate

Drug Class

Amphenicol-class Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for chloramphenicol sodium succinate

D06AX	Other antibiotics for topical use
D06A	ANTIBIOTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

D10AF	Antiinfectives for treatment of acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

G01AA	Antibiotics
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

J01BA	Amphenicols
J01B	AMPHENICOLS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AA	Antibiotics
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

S03AA	Antiinfectives
S03A	ANTIINFECTIVES
S03	OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S	Sensory organs

US Patents and Regulatory Information for chloramphenicol sodium succinate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Parkedale	CHLOROMYCETIN	chloramphenicol sodium succinate	INJECTABLE;INJECTION	050155-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Angus	MYCHEL-S	chloramphenicol sodium succinate	INJECTABLE;INJECTION	060132-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Elkins Sinn	CHLORAMPHENICOL	chloramphenicol sodium succinate	INJECTABLE;INJECTION	062406-001	Nov 9, 1982		DISCN	No	No

Chloramphenicol sodium succinate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Chloramphenicol Sodium Succinate

Introduction

Chloramphenicol sodium succinate is a bacteriostatic antibiotic used to treat serious bacterial infections. Despite its clinical utility, the market dynamics and financial trajectory of this drug are influenced by several factors, including its side effects, regulatory environment, and the broader context of antimicrobial resistance.

Clinical Utility and Indications

Chloramphenicol sodium succinate is reserved for serious infections where other therapeutic agents are ineffective or contraindicated. It is particularly useful against gram-positive and gram-negative bacteria, making it a broad-spectrum antibiotic[1][2][5].

Side Effects and Safety Concerns

One of the significant challenges in the market for chloramphenicol sodium succinate is its potential for serious side effects. The most notable of these is the risk of bone marrow depression, which can lead to potentially fatal blood dyscrasias. This has significantly reduced its use over the years[1][2].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of chloramphenicol sodium succinate. The drug was granted FDA approval in 1959, but its use has been strictly regulated due to its adverse effects. It is contraindicated in trivial infections and must not be used as a prophylactic agent[1][2].

Market Size and Growth

The global market for chloramphenicol sodium succinate has seen a decline in recent years due to the availability of safer alternatives and the increasing concern over antimicrobial resistance. However, the broader antibacterial market is expected to grow, driven by demand from emerging markets. The antibacterial market is projected to reach USD 55.8 billion by 2023, up from USD 38.3 billion in 2018[3].

Demand and Consumption Patterns

The demand for chloramphenicol sodium succinate is largely driven by its use in treating serious bacterial infections. However, human consumption of antibacterials, including chloramphenicol, is growing primarily in low- and middle-income countries (LMICs) where these drugs are often accessed over-the-counter rather than by prescription. This unregulated use can drive the emergence of resistant strains[3].

Financial Trajectory

The financial trajectory of chloramphenicol sodium succinate is influenced by several factors, including its declining use, regulatory constraints, and the low profit margins associated with antibacterial drugs. The development and marketing of new antibacterials are risky and expensive, and the growth in demand comes mainly from the poorest regions, which further reduces the financial attractiveness of this market[3].

Incentives for R&D

To incentivize the development of new antimicrobial medicines, including those like chloramphenicol sodium succinate, various push and pull mechanisms have been established. These include research grants, tax incentives, public-private partnerships, and data-sharing initiatives. For example, the Generating Antibiotic Incentives Now (GAIN) Act in the United States grants an additional five years of market exclusivity to companies developing new antibacterials[3].

Competitive Landscape

The competitive landscape for chloramphenicol sodium succinate is characterized by a limited number of players due to the high risks and low returns associated with antibacterial drug development. Several large pharmaceutical companies have exited this market, leading to a drying up of the global antibacterial pipeline. However, some companies remain committed to antimicrobial R&D, and smaller biopharmaceutical companies are also entering this space[3].

Challenges in the Antibacterial Market

The antibacterial market faces significant challenges, including the emergence of antimicrobial resistance, poor surveillance and stewardship, and low profit margins. Only 15 new antibacterials have been approved since 2000, compared to 63 between 1980 and 2000. This scarcity of new products exacerbates the financial and market challenges for drugs like chloramphenicol sodium succinate[3].

Future Outlook

The future outlook for chloramphenicol sodium succinate is cautious. While it remains a clinically useful drug for serious infections, its use is likely to be further restricted due to safety concerns and the availability of safer alternatives. The broader antibacterial market will continue to grow, but the development of new products will be crucial to addressing the growing threat of antimicrobial resistance.

Key Takeaways

• Chloramphenicol sodium succinate is a broad-spectrum antibiotic with significant clinical utility but serious side effects.
• The market for this drug is declining due to safety concerns and regulatory constraints.
• The broader antibacterial market is growing, driven by demand from emerging markets.
• Low profit margins and high development risks characterize the financial trajectory of antibacterial drugs.
• Incentives such as push and pull mechanisms are necessary to encourage R&D in this sector.

FAQs

What are the primary indications for chloramphenicol sodium succinate?

Chloramphenicol sodium succinate is indicated for serious bacterial infections where other therapeutic agents are ineffective or contraindicated.

What are the major side effects of chloramphenicol sodium succinate?

The most serious side effect is the risk of bone marrow depression, leading to potentially fatal blood dyscrasias.

How has the market for chloramphenicol sodium succinate evolved?

The market has declined due to safety concerns and the availability of safer alternatives, despite the broader antibacterial market growth.

What are the key drivers of the antibacterial market?

The drivers include growing demand from emerging markets, particularly in LMICs, and the need for new products to combat antimicrobial resistance.

What incentives are available to encourage R&D in antibacterial drugs?

Incentives include research grants, tax incentives, public-private partnerships, and data-sharing initiatives, as well as extended market exclusivity under laws like the GAIN Act.

Sources

1. RxList: Chloramphenicol Sodium Succinate Injection.
2. DrugBank Online: Chloramphenicol sodium succinate.
3. Access to Medicine Foundation: Antimicrobial Resistance Benchmark 2020.
4. Ricerca Alfa: Chloramphenicol Sodium Succinate Industry Report for Global and China.
5. Sigma-Aldrich: Chloramphenicol succinate sodium salt.