AEMCOLO Drug Patent Profile

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

Aemcolo is a drug marketed by Cosmo Technologies and is included in one NDA. There are four patents protecting this drug.

This drug has twenty-eight patent family members in twenty-one countries.

The generic ingredient in AEMCOLO is rifamycin sodium. There are eleven drug master file entries for this compound. Additional details are available on the rifamycin sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Aemcolo

Aemcolo was eligible for patent challenges on November 16, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 16, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for AEMCOLO

International Patents:	28
US Patents:	4
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	54
Clinical Trials:	2
Patent Applications:	2,406
Drug Prices:	Drug price information for AEMCOLO
What excipients (inactive ingredients) are in AEMCOLO?	AEMCOLO excipients list
DailyMed Link:	AEMCOLO at DailyMed

See drug prices for AEMCOLO

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

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

NDA:

210910

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 AEMCOLO

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

Sponsor	Phase
Bradley Connor	Phase 2
Bradley A. Connor, M.D.	Phase 2
Hunter Holmes Mcguire Veteran Affairs Medical Center	Phase 2

See all AEMCOLO clinical trials

US Patents and Regulatory Information for AEMCOLO

AEMCOLO is protected by four US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on GENERATING ANTIBIOTIC INCENTIVES NOW.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	8,741,948		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	8,529,945		Y
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
Cosmo Technologies	AEMCOLO	rifamycin sodium	TABLET, DELAYED RELEASE;ORAL	210910-001	Nov 16, 2018		DISCN	Yes	No

Expired US Patents for AEMCOLO

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 AEMCOLO

See the table below for patents covering AEMCOLO around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1894560	Compositions pharmaceutiques antimicrobiennes orales comprenant du métronidazole (Oral antimicrobial pharmaceutical compositions comprising metronidazole)
Japan	2008503540
China	1976685	Oral antimicrobial pharmceutical compositions
Italy	MI20041295	COMPOSIZIONI FARMACEUTICHE ANTIMICROBICHE ORALI
Japan	5026262
South Korea	101157486

Supplementary Protection Certificates for AEMCOLO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

Market Dynamics and Financial Trajectory for AEMCOLO

Introduction

AEMCOLO, a rifamycin antibiotic developed by Cosmo Pharmaceuticals, has recently entered the market with significant implications for the treatment of travelers’ diarrhea and potential future applications in other gastrointestinal disorders. Here, we delve into the market dynamics and financial trajectory of AEMCOLO, exploring its impact on the pharmaceutical industry, particularly in relation to Bausch Health's Xifaxan.

FDA Approval and Market Exclusivity

AEMCOLO received FDA approval in November 2018 for the treatment of travelers’ diarrhea caused by non-invasive strains of Escherichia coli in adults. This approval was bolstered by the drug's Qualified Infectious Disease Product (QIDP) and Fast Track designations, which grant AEMCOLO an additional five years of market exclusivity through 2028[2][4][5].

Clinical Trials and Efficacy

The approval of AEMCOLO was based on data from two randomized, multi-center, controlled Phase 3 clinical trials. These trials demonstrated AEMCOLO's superiority to placebo and non-inferiority to ciprofloxacin, a commonly used antibiotic for travelers’ diarrhea. The drug was dosed at 388mg twice daily for three days, showing a significant reduction in the time to last unformed stool[4].

Market Impact on Bausch Health's Xifaxan

AEMCOLO's entry into the market poses a significant challenge to Bausch Health's Xifaxan, a leading treatment for travelers’ diarrhea and irritable bowel syndrome with diarrhea (IBS-D). Xifaxan is a crucial product for Bausch Health, accounting for 15% of the company's third-quarter sales in 2018. Analysts, such as Wells Fargo's David Maris, predict that AEMCOLO could lead to a slowdown and potential decline in Xifaxan revenues due to its competitive pricing and dosing convenience. AEMCOLO is likely to be priced at a discount to Xifaxan and may also be used off-label for IBS-D, further eroding Xifaxan's market share[1].

Competitive Advantage

AEMCOLO's dosing regimen, which involves twice-daily administration for three days, offers a convenience advantage over Xifaxan, which requires a more frequent three-times-per-day schedule. This difference in dosing could make AEMCOLO more appealing to patients, potentially shifting market share away from Xifaxan[1].

Future Indications and Pipeline

Beyond its current indication for travelers’ diarrhea, AEMCOLO is being studied for other gastrointestinal conditions, including IBS-D and uncomplicated diverticulitis. The phase 2 studies for IBS-D are ongoing, and if successful, AEMCOLO could further encroach on Xifaxan's market territory. This expansion into additional indications could significantly enhance AEMCOLO's financial trajectory and solidify its position in the gastrointestinal treatment market[4].

Financial Projections

The financial impact of AEMCOLO on Cosmo Pharmaceuticals and the broader market is substantial. With its QIDP designation and market exclusivity, AEMCOLO is poised to capture a significant share of the travelers’ diarrhea treatment market. Analysts project that AEMCOLO could launch in IBS-D by 2021 or 2022, which would further boost its revenue potential. The drug's success could also alleviate some of the financial pressures on Cosmo Pharmaceuticals, allowing the company to invest in further research and development of its pipeline products[1].

Market Exclusivity and Regulatory Benefits

The QIDP designation not only provides AEMCOLO with market exclusivity but also facilitates its development and review process through the FDA's Fast Track program. This designation is intended to expedite the development and review of new drugs that treat serious conditions and fill unmet medical needs, thereby getting important new drugs to patients earlier[2][4].

Risks and Uncertainties

Despite the promising outlook, there are risks and uncertainties associated with AEMCOLO's commercialization. These include the risk that the company may not successfully commercialize the product, as well as uncertainties related to the initiation, timing, and results of ongoing and future clinical trials. Additionally, market acceptance and competition from other treatments could impact AEMCOLO's financial performance[5].

Industry Context: Antibacterial Drug Development

The development and approval of antibacterial drugs like AEMCOLO are critical due to the growing issue of antibiotic resistance. The Generating Antibiotic Incentives Now (GAIN) Act, which provides the QIDP designation, aims to encourage the development of new antibiotic drugs for serious or life-threatening infections. AEMCOLO's approval highlights the importance of innovative treatments in addressing unmet medical needs in the gastrointestinal and infectious disease spaces[2][3].

Conclusion

AEMCOLO's entry into the market marks a significant shift in the treatment landscape for travelers’ diarrhea and potentially other gastrointestinal disorders. With its competitive pricing, convenient dosing regimen, and market exclusivity, AEMCOLO is well-positioned to challenge Xifaxan's dominance. As Cosmo Pharmaceuticals continues to develop AEMCOLO for additional indications, the drug's financial trajectory is expected to be robust, driven by its clinical efficacy, regulatory benefits, and market demand.

Key Takeaways

• FDA Approval and Market Exclusivity: AEMCOLO received FDA approval in 2018 with QIDP and Fast Track designations, granting it market exclusivity through 2028.
• Clinical Efficacy: AEMCOLO demonstrated superiority to placebo and non-inferiority to ciprofloxacin in Phase 3 trials.
• Market Impact: AEMCOLO poses a significant challenge to Bausch Health's Xifaxan due to its competitive pricing and dosing convenience.
• Future Indications: Ongoing studies for IBS-D and uncomplicated diverticulitis could expand AEMCOLO's market share.
• Financial Projections: AEMCOLO is projected to capture a significant share of the travelers’ diarrhea treatment market and potentially launch in IBS-D by 2021 or 2022.
• Regulatory Benefits: QIDP designation and Fast Track program facilitate AEMCOLO's development and review.

FAQs

Q: What is AEMCOLO, and what is it used for? A: AEMCOLO is a rifamycin antibiotic approved for the treatment of travelers’ diarrhea caused by non-invasive strains of Escherichia coli in adults.

Q: How does AEMCOLO compare to Xifaxan? A: AEMCOLO has a more convenient dosing regimen (twice daily) compared to Xifaxan (three times daily) and is likely to be priced at a discount, making it a competitive alternative.

Q: What are the future indications being studied for AEMCOLO? A: AEMCOLO is being studied for irritable bowel syndrome with diarrhea (IBS-D) and uncomplicated diverticulitis.

Q: What regulatory benefits does AEMCOLO have? A: AEMCOLO has Qualified Infectious Disease Product (QIDP) and Fast Track designations, providing market exclusivity through 2028 and expedited development and review.

Q: How does the QIDP designation impact AEMCOLO's market position? A: The QIDP designation grants AEMCOLO an additional five years of market exclusivity, protecting it from generic competition and allowing it to capture a significant market share.

Sources

1. FiercePharma: "Cosmo to give Bausch Health a run for its money with FDA nod for Xifaxan rival"
2. BusinessWire: "FDA Grants Cosmo Pharmaceuticals Both QIDP and Fast Track Designations for Aemcolo"
3. ASPE: "Antimicrobial Drugs Market Returns Analysis"
4. BioSpace: "FDA Approves AEMCOLO™ (rifamycin), the First Antibiotic Approved for the Treatment of Travelers’ Diarrhea in Over a Decade"
5. PR Newswire: "RedHill's Aemcolo Granted FDA QIDP 5-Year Exclusivity Extension"

Last updated: 2024-12-18