AUGMENTIN XR Drug Patent Profile

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

Augmentin Xr is a drug marketed by Us Antibiotics and is included in one NDA.

The generic ingredient in AUGMENTIN XR is amoxicillin; clavulanate potassium. There are forty-six drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Augmentin Xr

A generic version of AUGMENTIN XR was approved as amoxicillin; clavulanate potassium by SANDOZ on March 14^th, 2002.

Summary for AUGMENTIN XR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	15
Clinical Trials:	75
Patent Applications:	720
Drug Prices:	Drug price information for AUGMENTIN XR
DailyMed Link:	AUGMENTIN XR at DailyMed

See drug prices for AUGMENTIN XR

Recent Clinical Trials for AUGMENTIN XR

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

Sponsor	Phase
University of Wisconsin, Madison	Phase 4
Patient-Centered Outcomes Research Institute	Phase 4
Daniel Merenstein	Phase 4

See all AUGMENTIN XR clinical trials

Paragraph IV (Patent) Challenges for AUGMENTIN XR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AUGMENTIN XR	Extended-release Tablets	amoxicillin; clavulanate potassium	1000 mg/62.5 mg	050785	1	2009-01-21

US Patents and Regulatory Information for AUGMENTIN XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Us Antibiotics	AUGMENTIN XR	amoxicillin; clavulanate potassium	TABLET, EXTENDED RELEASE;ORAL	050785-001	Sep 25, 2002		DISCN	Yes	No

Expired US Patents for AUGMENTIN XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Us Antibiotics	AUGMENTIN XR	amoxicillin; clavulanate potassium	TABLET, EXTENDED RELEASE;ORAL	050785-001	Sep 25, 2002
Us Antibiotics	AUGMENTIN XR	amoxicillin; clavulanate potassium	TABLET, EXTENDED RELEASE;ORAL	050785-001	Sep 25, 2002
Us Antibiotics	AUGMENTIN XR	amoxicillin; clavulanate potassium	TABLET, EXTENDED RELEASE;ORAL	050785-001	Sep 25, 2002
Us Antibiotics	AUGMENTIN XR	amoxicillin; clavulanate potassium	TABLET, EXTENDED RELEASE;ORAL	050785-001	Sep 25, 2002
Us Antibiotics	AUGMENTIN XR	amoxicillin; clavulanate potassium	TABLET, EXTENDED RELEASE;ORAL	050785-001	Sep 25, 2002

International Patents for AUGMENTIN XR

See the table below for patents covering AUGMENTIN XR around the world.

Country	Patent Number	Title	Estimated Expiration
Slovenia	20304	Formulacija za modificirano sproščanje, ki obsega amoksicilin in kalijev klavulanat (A FORMULATION FOR MODIFIED RELEASE COMPRISING AMOXYCILLIN AND POTASSIUM CLAVULANATE)
Peru	00532001
Japan	2002541187
Israel	145580
Brazil	0009719	PROCESSO DE TRATAMENTO

AUGMENTIN XR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for AUGMENTIN XR

Introduction

AUGMENTIN XR, a combination of amoxicillin and clavulanic acid, is a widely used antibiotic for treating various bacterial infections. Understanding its market dynamics and financial trajectory is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Overview

The antibiotic market, particularly for amoxicillin-based drugs like AUGMENTIN XR, is characterized by several key factors:

Growing Demand for Antibiotics

The demand for antibiotics, including amoxicillin, is driven by the rising prevalence of bacterial infections, especially in developing countries where access to healthcare is limited. This trend is expected to continue, with the global amoxicillin market valued at $4.8 billion in 2022 and projected to reach $5.3 billion by 2030 at a CAGR of 1.2%[4].

Generic Competition

The market for AUGMENTIN XR is heavily influenced by generic competition. Generic amoxicillin is more affordable than branded versions, leading to increased demand and a more competitive market. This has resulted in a rise in the number of generic manufacturers, further pressuring the pricing and market share of branded antibiotics like AUGMENTIN XR[4].

Financial Performance of AUGMENTIN XR

Revenue and Market Position

AUGMENTIN XR, produced by GlaxoSmithKline, is a significant player in the antibiotic market. While specific annual revenue figures for AUGMENTIN XR are not provided in the sources, it is part of the broader amoxicillin market, which is dominated by generic versions. For instance, generic amoxicillin was the second-highest selling antibiotic in the U.S. in 2022, with annual revenues of $213.2 million[3].

Impact of Generic Entry

The financial performance of AUGMENTIN XR is significantly impacted by the entry of generic competitors. When a brand-name drug loses its exclusivity (LOE), generic versions enter the market, leading to substantial price reductions and changes in market utilization. For example, after the LOE, the average price per day of therapy for AUGMENTIN XR fell sharply, despite being in a duopoly market structure without an authorized generic entrant during the 180-day exclusivity window[1].

Price Dynamics

Post-LOE, the price per day of therapy for AUGMENTIN XR declined more sharply and was more sustained compared to other molecules. This is counterintuitive, as one might expect a three-competitor market to generate higher and more stable prices than a duopoly. This phenomenon suggests that the brand and its authorized generic agent play a crucial role in creating price discipline during the 180-day exclusivity window[1].

Utilization Trends

Post-LOE Utilization

The utilization of AUGMENTIN XR increased substantially post-LOE, driven primarily by third-party payer (TPP) prescriptions. This increase was more pronounced for AUGMENTIN XR compared to other molecules, despite the absence of an authorized generic entrant during the 180-day exclusivity period. In contrast, Medicaid payers showed the smallest utilization increase or largest decrease post-LOE[1].

Age and Payer Type Variations

There is considerable variation in utilization trends by age group and payer type. For AUGMENTIN XR, the increase in utilization post-LOE was not significantly different across age groups. However, payer types showed distinct patterns, with TPP payers driving the increase and Medicaid payers experiencing the largest reductions[1].

Clinical and Economic Considerations

Clinical Efficacy

AUGMENTIN XR has demonstrated clinical and bacteriological efficacy in treating various bacterial infections, including sinusitis, pneumonia, and ear infections. Clinical trials have shown high success rates, particularly in infections due to Streptococcus pneumoniae[5].

Adverse Reactions and Compliance

The drug has a profile of common adverse reactions such as diarrhea, vaginal mycosis, and nausea. Despite these, the overall discontinuation rate due to drug-related adverse reactions is relatively low at 2%[2].

Economic Rationales

The economic performance of antibiotics like AUGMENTIN XR is influenced by the dominance of generic, off-patent products in the market. The majority of antibiotic volume is comprised of old, low-priced generic products, which work reasonably well most of the time. This makes it challenging for new, branded antibiotics to achieve high revenues[3].

Future Outlook

Market Growth and Competition

The amoxicillin market, including AUGMENTIN XR, is expected to grow steadily, driven by increasing demand for antibiotics. However, the market will remain competitive due to the presence of generic manufacturers. The CAGR of 1.2% from 2023 to 2030 indicates a stable but not explosive growth trajectory[4].

Addressing Antibiotic Resistance

The growing concern of antibiotic resistance will continue to influence the market dynamics. Efforts to develop new antibiotics and alternative treatment options are underway, but the economic incentives for developing new antibiotics remain a challenge. High rewards, such as those proposed in pull incentive models, may be necessary to encourage innovation in this area[3].

Key Takeaways

• Market Demand: The demand for antibiotics, including AUGMENTIN XR, is driven by the rising prevalence of bacterial infections.
• Generic Competition: Generic amoxicillin significantly impacts the market share and pricing of branded antibiotics like AUGMENTIN XR.
• Price Dynamics: Post-LOE, AUGMENTIN XR experienced a sharp decline in price per day of therapy, despite being in a duopoly market.
• Utilization Trends: Utilization increased post-LOE, driven by TPP payers, with variations across age groups and payer types.
• Clinical Efficacy: AUGMENTIN XR has demonstrated high clinical and bacteriological efficacy in treating bacterial infections.
• Economic Considerations: The economic performance is influenced by the dominance of generic products and the need for incentives to develop new antibiotics.

FAQs

What is AUGMENTIN XR used for?

AUGMENTIN XR is a prescription medicine used to treat symptoms of bacterial infections such as sinusitis, pneumonia, ear infections, and bronchitis[2].

How does the entry of generic competitors affect AUGMENTIN XR?

The entry of generic competitors leads to significant price reductions and changes in market utilization for AUGMENTIN XR, with a sharp decline in price per day of therapy post-LOE[1].

What are the common adverse reactions associated with AUGMENTIN XR?

Common adverse reactions include diarrhea, vaginal mycosis, nausea, and loose stools, with a discontinuation rate due to drug-related adverse reactions of about 2%[2].

How does the market for AUGMENTIN XR grow in the future?

The market for AUGMENTIN XR is expected to grow steadily, driven by increasing demand for antibiotics, but will remain competitive due to generic manufacturers, with a projected CAGR of 1.2% from 2023 to 2030[4].

What are the economic challenges in developing new antibiotics like AUGMENTIN XR?

The economic challenges include the dominance of generic, off-patent products and the need for high rewards or incentives to encourage innovation in developing new antibiotics[3].

Sources

1. The Regulation of Prescription Drug Competition and Market Exclusivity - MIT Sloan School of Management[1]
2. Augmentin XR (Amoxicillin Clavulanic Potassium) - RxList[2]
3. Sizing A Market Entry Reward for the Development of New Antibiotics - Harvard Kennedy School[3]
4. Amoxicillin Market Size Report, 2023 - 2030 - IndustryARC[4]
5. AUGMENTIN® XR 1000/62.5 TABLETS PRODUCT INFORMATION - TGA Australia[5]