Rifamycin sodium - Generic Drug Details

What are the generic sources for rifamycin sodium and what is the scope of freedom to operate?

Rifamycin sodium is the generic ingredient in one branded drug marketed by Cosmo Technologies and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Rifamycin sodium has twenty-eight patent family members in twenty-one countries.

There are two drug master file entries for rifamycin sodium.

Summary for rifamycin sodium

International Patents:	28
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	1
Patent Applications:	6,470
DailyMed Link:	rifamycin sodium at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for rifamycin sodium

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

Dosage:

TABLET, DELAYED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for rifamycin sodium

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

Sponsor	Phase
University of Sao Paulo	Phase 3

See all rifamycin sodium clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for rifamycin sodium

A07AA	Antibiotics
A07A	INTESTINAL ANTIINFECTIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

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

J04AB	Antibiotics
J04A	DRUGS FOR TREATMENT OF TUBERCULOSIS
J04	ANTIMYCOBACTERIALS
J	Antiinfectives for systemic use

S01AA	Antibiotics
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for rifamycin sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cosmo Technologies	AEMCOLO	rifamycin sodium	TABLET, DELAYED RELEASE;ORAL	210910-001	Nov 16, 2018		DISCN	Yes	No	8,263,120		Y
Cosmo Technologies	AEMCOLO	rifamycin sodium	TABLET, DELAYED RELEASE;ORAL	210910-001	Nov 16, 2018		DISCN	Yes	No	8,741,948		Y
Cosmo Technologies	AEMCOLO	rifamycin sodium	TABLET, DELAYED RELEASE;ORAL	210910-001	Nov 16, 2018		DISCN	Yes	No	8,486,446		Y
Cosmo Technologies	AEMCOLO	rifamycin sodium	TABLET, DELAYED RELEASE;ORAL	210910-001	Nov 16, 2018		DISCN	Yes	No
Cosmo Technologies	AEMCOLO	rifamycin sodium	TABLET, DELAYED RELEASE;ORAL	210910-001	Nov 16, 2018		DISCN	Yes	No	8,529,945		Y
Cosmo Technologies	AEMCOLO	rifamycin sodium	TABLET, DELAYED RELEASE;ORAL	210910-001	Nov 16, 2018		DISCN	Yes	No

Expired US Patents for rifamycin sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosmo Technologies	AEMCOLO	rifamycin sodium	TABLET, DELAYED RELEASE;ORAL	210910-001	Nov 16, 2018	8,529,945
Cosmo Technologies	AEMCOLO	rifamycin sodium	TABLET, DELAYED RELEASE;ORAL	210910-001	Nov 16, 2018	8,263,120
Cosmo Technologies	AEMCOLO	rifamycin sodium	TABLET, DELAYED RELEASE;ORAL	210910-001	Nov 16, 2018	8,741,948
Cosmo Technologies	AEMCOLO	rifamycin sodium	TABLET, DELAYED RELEASE;ORAL	210910-001	Nov 16, 2018	8,486,446

International Patents for rifamycin sodium

Country	Patent Number	Title	Estimated Expiration
Slovenia	1763339
Poland	1763339
European Patent Office	1894560	Compositions pharmaceutiques antimicrobiennes orales comprenant du métronidazole (Oral antimicrobial pharmaceutical compositions comprising metronidazole)
Japan	2008163038	ORAL ANTIMICROBIAL PHARMACEUTICAL COMPOSITION
Austria	E392889
Canada	2628005	COMPOSITIONS PHARMACEUTIQUES ANTIMICROBIENNES ORALES (ORAL ANTIMICROBIAL PHARMACEUTICAL COMPOSITIONS)

Supplementary Protection Certificates for rifamycin sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1763339	SPC/GB19/037	United Kingdom		PRODUCT NAME: RIFAMYCIN SV; REGISTERED: UK PL08637/0028 20181218
1763339	122019000048	Germany		PRODUCT NAME: RIFAMYCIN SV; NAT. REGISTRATION NO/DATE: 2200986.00.00 20190509; FIRST REGISTRATION: GB PL 08637/0028 20181218
1763339	C201930053	Spain		PRODUCT NAME: RIFAMICINA SV; NATIONAL AUTHORISATION NUMBER: 84120-DE/H/5379/001/DC; DATE OF AUTHORISATION: 20190628; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): PL 08637/0028; DATE OF FIRST AUTHORISATION IN EEA: 20181218

Rifamycin Sodium: Market Dynamics and Financial Trajectory

Introduction

Rifamycin sodium, a member of the rifamycin family, is a potent antibiotic derived from the gram-positive bacterium Amycolatopsis mediterranei. This drug has been instrumental in the treatment of various bacterial infections, particularly tuberculosis. Here, we delve into the market dynamics and financial trajectory of rifamycin sodium, exploring its current state, growth drivers, challenges, and future outlook.

Market Size and Growth Rate

The global rifamycin derivatives market, which includes rifamycin sodium, is expected to experience robust growth. According to market assessments, the rifamycin derivatives market is projected to register a revenue Compound Annual Growth Rate (CAGR) of 6.62% from 2023 to 2031[3].

Key Drivers of Market Growth

Several factors contribute to the growth of the rifamycin sodium market:

High Burden of Tuberculosis

The persistent high burden of tuberculosis globally drives the demand for rifamycin derivatives. Tuberculosis remains a major public health concern, especially in regions like the Asia Pacific, where it significantly contributes to the growth of the rifamycin derivatives market[3].

Research and Development

Pharmaceutical companies are investing heavily in research and development to discover and develop new rifamycin derivatives. These efforts aim to improve efficacy, reduce side effects, and expand activity against drug-resistant bacteria, thereby driving market growth[3].

Government Initiatives

Governments and international organizations are implementing initiatives to combat infectious diseases, including tuberculosis. These programs often involve the procurement and distribution of rifamycin derivatives, supporting market growth[3].

Technological Advancements

Advancements in drug delivery systems, such as nanoparticle-based formulations and targeted drug delivery, can enhance the efficacy and bioavailability of rifamycin derivatives. These technological advancements improve treatment outcomes and patient compliance, contributing to market growth[3].

Increasing Healthcare Expenditure

Rising healthcare expenditure, particularly in emerging economies, allows for better access to healthcare facilities, diagnostic tests, and medications, including rifamycin derivatives. This increased access positively influences market growth[3].

Regional Market Dynamics

The global rifamycin derivatives market is segmented into several regions, with the Asia Pacific region being a significant contributor:

Asia Pacific Dominance

The Asia Pacific region dominates the market due to the high incidence of tuberculosis and a large population base. Countries like India and China, with their strong pharmaceutical manufacturing capabilities, are major producers of generic rifamycin derivatives, further contributing to the region's dominance[3].

Challenges and Constraints

Despite the positive growth trajectory, the rifamycin sodium market faces several challenges:

Bacterial Resistance

Bacterial resistance to antibiotics, including rifamycin derivatives, poses a significant challenge. Overuse and misuse of antibiotics contribute to the development of drug-resistant strains, limiting the effectiveness of rifamycin derivatives in treating certain infections[3].

Access and Affordability

Ensuring affordable and widespread access to rifamycin derivatives, particularly in developing countries with high burdens of infectious diseases, can be challenging due to limited healthcare infrastructure, inadequate funding, and regulatory barriers[3].

Patent Expiration and Generic Competition

The expiration of patents for specific rifamycin derivatives allows generic versions to enter the market, leading to increased competition and potential price erosion. This can impact the revenues of originator pharmaceutical companies and pose market growth challenges[3].

Regulatory Requirements

Stringent regulatory requirements, including safety and efficacy evaluations, can delay market entry and increase development costs. High development costs and uncertainties associated with clinical trials can deter pharmaceutical companies, limiting the pace of innovation in the market[3].

Financial Performance and Forecast

The financial performance of the rifamycin sodium market is influenced by several factors:

Revenue Growth

The global rifamycin derivatives market is expected to grow significantly, driven by the factors mentioned above. The market size was valued at a substantial amount in recent years and is projected to expand further[4].

Segment Analysis

The market is segmented by drug, indication, distribution channel, and region. Rifabutin, rifampin, rifapentine, rifaximin, and rifalazil are key drugs within the rifamycin derivatives market. The segmentation helps in understanding the specific growth drivers and challenges within each segment[3].

Innovations and Future Outlook

The future of rifamycin sodium is promising due to ongoing innovations:

Novel Derivatives

Research is ongoing to develop novel rifamycin derivatives that can overcome antimicrobial resistance. For example, novel C-3-(N-alkyl-aryl)-aminomethyl rifamycin SV derivatives have shown activity against rifampicin-resistant Mycobacterium tuberculosis strains, offering a potential solution to the resistance challenge[5].

Technological Advancements

Advancements in drug delivery systems and targeted therapies are expected to enhance the efficacy and bioavailability of rifamycin derivatives, improving treatment outcomes and patient compliance.

Key Takeaways

• The rifamycin derivatives market, including rifamycin sodium, is expected to grow at a CAGR of 6.62% from 2023 to 2031.
• The high burden of tuberculosis, research and development efforts, government initiatives, and technological advancements are key drivers of market growth.
• The Asia Pacific region dominates the market due to its high incidence of tuberculosis and strong pharmaceutical manufacturing capabilities.
• Challenges include bacterial resistance, access and affordability issues, patent expiration, and stringent regulatory requirements.
• Innovations in novel derivatives and drug delivery systems are expected to drive future growth.

FAQs

What is rifamycin sodium used for?

Rifamycin sodium is used primarily for the treatment of bacterial infections, including tuberculosis. It is part of the rifamycin family of antibiotics derived from the gram-positive bacterium Amycolatopsis mediterranei[2].

What are the key drivers of the rifamycin derivatives market?

Key drivers include the high burden of tuberculosis, research and development efforts, government initiatives, technological advancements, and increasing healthcare expenditure[3].

Which region dominates the rifamycin derivatives market?

The Asia Pacific region dominates the market due to the high incidence of tuberculosis and a large population base, along with strong pharmaceutical manufacturing capabilities in countries like India and China[3].

What challenges does the rifamycin sodium market face?

Challenges include bacterial resistance, access and affordability issues, patent expiration leading to generic competition, and stringent regulatory requirements[3].

Are there any ongoing innovations in rifamycin derivatives?

Yes, ongoing research is focused on developing novel rifamycin derivatives to overcome antimicrobial resistance and improve treatment outcomes. Examples include novel C-3-(N-alkyl-aryl)-aminomethyl rifamycin SV derivatives[5].

Sources

1. Market Research Intellect: Global Rifamycin Sodium Injection Market Size, Trends and ...
2. DrugBank Online: Rifamycin sodium
3. Growth Plus Reports: Rifamycin Derivatives Market Forecast 2031
4. Prof Research: Rifamycin sodium salt Market Size, Share, Trend and Forecast to ...
5. UCL Discovery: aminomethyl rifamycin SV derivatives exhibit activity against rifampicin-resistant Mycobacterium tuberculosis

Last updated: 2024-12-17