You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: January 6, 2025

Chloramphenicol; hydrocortisone acetate; polymyxin b sulfate - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic drug sources for chloramphenicol; hydrocortisone acetate; polymyxin b sulfate and what is the scope of patent protection?

Chloramphenicol; hydrocortisone acetate; polymyxin b sulfate is the generic ingredient in one branded drug marketed by Parkedale and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for chloramphenicol; hydrocortisone acetate; polymyxin b sulfate
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
DailyMed Link:chloramphenicol; hydrocortisone acetate; polymyxin b sulfate at DailyMed
Anatomical Therapeutic Chemical (ATC) Classes for chloramphenicol; hydrocortisone acetate; polymyxin b sulfate
A01AC Corticosteroids for local oral treatment
A01A STOMATOLOGICAL PREPARATIONS
A01 STOMATOLOGICAL PREPARATIONS
A Alimentary tract and metabolism
A07AA Antibiotics
A07A INTESTINAL ANTIINFECTIVES
A07 ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A Alimentary tract and metabolism
A07EA Corticosteroids acting locally
A07E INTESTINAL ANTIINFLAMMATORY AGENTS
A07 ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A Alimentary tract and metabolism
C05AA Corticosteroids
C05A AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05 VASOPROTECTIVES
C Cardiovascular system
D06AX Other antibiotics for topical use
D06A ANTIBIOTICS FOR TOPICAL USE
D06 ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D Dermatologicals
D07AA Corticosteroids, weak (group I)
D07A CORTICOSTEROIDS, PLAIN
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D07XA Corticosteroids, weak, other combinations
D07X CORTICOSTEROIDS, OTHER COMBINATIONS
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
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
H02AB Glucocorticoids
H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02 CORTICOSTEROIDS FOR SYSTEMIC USE
H Systemic hormonal preparations, excluding sex hormones and insulins
H02AB Glucocorticoids
H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02 CORTICOSTEROIDS FOR SYSTEMIC USE
H Systemic hormonal preparations, excluding sex hormones and insulins
J01BA Amphenicols
J01B AMPHENICOLS
J01 ANTIBACTERIALS FOR SYSTEMIC USE
J Antiinfectives for systemic use
J01XB Polymyxins
J01X OTHER ANTIBACTERIALS
J01 ANTIBACTERIALS FOR SYSTEMIC USE
J Antiinfectives for systemic use
S01AA Antibiotics
S01A ANTIINFECTIVES
S01 OPHTHALMOLOGICALS
S Sensory organs
S01AA Antibiotics
S01A ANTIINFECTIVES
S01 OPHTHALMOLOGICALS
S Sensory organs
S01BA Corticosteroids, plain
S01B ANTIINFLAMMATORY AGENTS
S01 OPHTHALMOLOGICALS
S Sensory organs
S01BA Corticosteroids, plain
S01B ANTIINFLAMMATORY AGENTS
S01 OPHTHALMOLOGICALS
S Sensory organs
S01CB Corticosteroids/antiinfectives/mydriatics in combination
S01C ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
S01 OPHTHALMOLOGICALS
S Sensory organs
S02AA Antiinfectives
S02A ANTIINFECTIVES
S02 OTOLOGICALS
S Sensory organs
S02AA Antiinfectives
S02A ANTIINFECTIVES
S02 OTOLOGICALS
S Sensory organs
S02BA Corticosteroids
S02B CORTICOSTEROIDS
S02 OTOLOGICALS
S Sensory organs
S03AA Antiinfectives
S03A ANTIINFECTIVES
S03 OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S Sensory organs
S03AA Antiinfectives
S03A ANTIINFECTIVES
S03 OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S Sensory organs

US Patents and Regulatory Information for chloramphenicol; hydrocortisone acetate; polymyxin b sulfate

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Parkedale OPHTHOCORT chloramphenicol; hydrocortisone acetate; polymyxin b sulfate OINTMENT;OPHTHALMIC 050201-002 Approved Prior to Jan 1, 1982 DISCN No 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
Showing 1 to 1 of 1 entries

Chloramphenicol; hydrocortisone acetate; polymyxin b sulfate Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Chloramphenicol, Hydrocortisone Acetate, and Polymyxin B Sulfate

Introduction

The market for antibiotics and combination therapies like chloramphenicol, hydrocortisone acetate, and polymyxin B sulfate is complex and influenced by various factors, including regulatory environments, market demand, and economic viability. Here, we delve into the market dynamics and financial trajectory of these drugs.

Market Challenges for Antibiotics

The antibiotic market, including drugs like chloramphenicol, faces significant challenges. The development and deployment of new antibiotics are commercially unattractive due to low profit margins and stringent regulatory controls aimed at limiting antibiotic resistance[1].

Low Profit Margins

Antibiotics, particularly those like chloramphenicol, are often cheaper and prescribed for shorter durations compared to other medications. This reduces their revenue potential. Additionally, the risk-adjusted net present value (rNPV) for antibiotic R&D projects is significantly lower than for other therapeutic categories, making them less appealing to pharmaceutical companies[1].

Regulatory Hurdles

The regulatory environment for antibiotics is stringent, with a focus on limiting the risk of resistance. This tight control over the use of antibiotics once they reach the market further reduces their commercial appeal[1].

Specific Market Dynamics for Chloramphenicol

Usage and Side Effects

Chloramphenicol is a broad-spectrum antibiotic effective against various bacterial infections but is rarely used due to its high risk of serious side effects, such as bone marrow toxicity and aplastic anemia. Its use is generally reserved for life-threatening infections[3].

Market Availability

Despite its effectiveness, chloramphenicol's oral forms have been withdrawn by the FDA due to the risk of fatal aplastic anemia. It is still used in topical forms, such as eye drops or ointments, for conditions like bacterial conjunctivitis[3].

Market Dynamics for Hydrocortisone Acetate

Combination Therapies

Hydrocortisone acetate is often combined with antibiotics like chloramphenicol and polymyxin B sulfate in ointments and creams to treat infections and provide anti-inflammatory relief. These combination therapies are more common in the market due to their synergistic effects[3].

Market Demand

The demand for hydrocortisone acetate in combination therapies is relatively stable, driven by the need for effective treatments for skin and eye infections. However, the market is subject to fluctuations based on the availability and pricing of these combination products[5].

Market Dynamics for Polymyxin B Sulfate

Antibiotic Resistance

Polymyxin B sulfate is used in combination with other antibiotics to treat infections caused by resistant bacteria. Its market is influenced by the growing concern over antibiotic resistance, which increases the demand for effective combination therapies[1].

Combination Products

Polymyxin B sulfate is commonly combined with chloramphenicol and hydrocortisone acetate in ophthalmic and topical preparations. These products are effective against a range of bacterial infections and are well-tolerated, contributing to their market stability[2].

Financial Trajectory

Revenue and Growth

The antibiotic market, including combination therapies with chloramphenicol, hydrocortisone acetate, and polymyxin B sulfate, is expected to grow but at a modest rate. The global antibiotic market was valued at $27.1 billion in 2015 and is projected to reach $35.6 billion by 2022, driven by increasing demand from emerging markets[1].

Consolidation and Pricing

The generic drug market, which includes many antibiotic products, has seen significant consolidation through mergers and acquisitions. This consolidation can lead to reduced competition and increased prices, as seen in cases where companies acquire sole-source drugs and impose substantial price hikes[5].

Example: Price Hikes

The acquisition of older drugs by companies and subsequent price increases illustrate the financial dynamics. For instance, the price of pyrimethamine, a 62-year-old drug, was increased by 5,000% after Turing acquired its rights, highlighting the potential for significant price manipulation in the generic market[5].

Impact of Regulatory and Economic Factors

Regulatory Environment

The regulatory environment plays a crucial role in the financial trajectory of these drugs. Strict regulations and the need for continuous monitoring to prevent antibiotic resistance can increase development and maintenance costs, affecting profitability[1].

Economic Incentives

The economic incentives for developing new antibiotics are weak due to the low rNPV compared to other therapeutic areas. This discourages investment in antibiotic R&D, leading to a shortage of new antibiotics in the pipeline[1].

Key Takeaways

  • The market for antibiotics like chloramphenicol, hydrocortisone acetate, and polymyxin B sulfate is challenging due to low profit margins and stringent regulations.
  • Combination therapies are more common and stable in the market due to their synergistic effects.
  • The generic drug market has seen significant consolidation, leading to reduced competition and potential price hikes.
  • Regulatory and economic factors significantly influence the financial trajectory of these drugs.

FAQs

Q: Why is the development of new antibiotics commercially unattractive?

A: The development of new antibiotics is commercially unattractive due to low profit margins, stringent regulatory controls, and the need to limit the use of these drugs to prevent resistance[1].

Q: What are the common side effects of chloramphenicol?

A: Chloramphenicol has serious side effects, including bone marrow toxicity and aplastic anemia, which limit its use to life-threatening infections[3].

Q: How does market consolidation affect the pricing of generic antibiotics?

A: Market consolidation can lead to reduced competition, allowing companies to impose significant price hikes on generic antibiotics, as seen in cases like the acquisition of pyrimethamine[5].

Q: What is the projected growth of the global antibiotic market?

A: The global antibiotic market is projected to grow from $27.1 billion in 2015 to $35.6 billion by 2022, driven by increasing demand from emerging markets[1].

Q: Why are combination therapies with hydrocortisone acetate and polymyxin B sulfate more stable in the market?

A: Combination therapies are more stable due to their synergistic effects and the consistent demand for effective treatments for skin and eye infections[3].

Sources

  1. Antimicrobial Resistance Benchmark 2018 - Access to Medicine Foundation.
  2. Trimethoprim-polymyxin B sulphate ophthalmic ointment versus chloramphenicol ophthalmic ointments - PubMed.
  3. Chloramphenicol: Uses, Interactions, Mechanism of Action - DrugBank.
  4. Neomycin, polymyxin B, and hydrocortisone (otic route) - Mayo Clinic.
  5. Costly Cures: The Broken Generic Drug Market and the Urgent Need for the Affordable Drug Manufacturing Act - Congresswoman Jan Schakowsky.

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.