AMOXICILLIN; CLAVULANATE POTASSIUM - Generic Drug Details

What are the generic sources for amoxicillin; clavulanate potassium and what is the scope of freedom to operate?

Amoxicillin; clavulanate potassium is the generic ingredient in nine branded drugs marketed by Aurobindo Pharma, Aurobindo Pharma Ltd, Cipla, Deva Holding As, Hikma Pharms, Micro Labs, Micro Labs Ltd India, Sandoz, Sandoz Inc, Sun Pharm Inds Ltd, Teva, Us Antibiotics, Chartwell Rx, Apotex Inc, and Teva Pharms Usa, and is included in forty-nine NDAs. Additional information is available in the individual branded drug profile pages.

Thirty-three suppliers are listed for this compound.

Summary for AMOXICILLIN; CLAVULANATE POTASSIUM

US Patents:	0
Tradenames:	9
Applicants:	15
NDAs:	49
Finished Product Suppliers / Packagers:	33
Raw Ingredient (Bulk) Api Vendors:	16
Clinical Trials:	19
DailyMed Link:	AMOXICILLIN; CLAVULANATE POTASSIUM at DailyMed

Recent Clinical Trials for AMOXICILLIN; CLAVULANATE POTASSIUM

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

Sponsor	Phase
Cairo University	PHASE3
Second Affiliated Hospital of Wenzhou Medical University	N/A
Alphacait, LLC	Phase 2

See all AMOXICILLIN; CLAVULANATE POTASSIUM clinical trials

Pharmacology for AMOXICILLIN; CLAVULANATE POTASSIUM

Drug Class	Penicillin-class Antibacterial beta Lactamase Inhibitor
Mechanism of Action	beta Lactamase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for AMOXICILLIN; CLAVULANATE POTASSIUM

J01CA	Penicillins with extended spectrum
J01C	BETA-LACTAM ANTIBACTERIALS, PENICILLINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for AMOXICILLIN; CLAVULANATE POTASSIUM

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 AMOXICILLIN; CLAVULANATE POTASSIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex Inc	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	TABLET;ORAL	065333-001	Feb 24, 2009		DISCN	No	No
Sandoz Inc	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	FOR SUSPENSION;ORAL	065358-001	Aug 13, 2007	AB	RX	No	No
Sandoz	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	TABLET;ORAL	065064-001	Mar 15, 2002	AB	RX	No	No
Aurobindo Pharma Ltd	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	TABLET;ORAL	091569-001	Jan 20, 2012	AB	RX	No	No
Sandoz	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	FOR SUSPENSION;ORAL	065066-001	Jun 5, 2002	AB	RX	No	No
Us Antibiotics	AUGMENTIN '200'	amoxicillin; clavulanate potassium	TABLET, CHEWABLE;ORAL	050726-001	May 31, 1996		DISCN	Yes	No
Chartwell Rx	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	TABLET, CHEWABLE;ORAL	065065-001	Apr 18, 2002		DISCN	No	No

Expired US Patents for AMOXICILLIN; CLAVULANATE POTASSIUM

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	6,746,692
Us Antibiotics	AUGMENTIN XR	amoxicillin; clavulanate potassium	TABLET, EXTENDED RELEASE;ORAL	050785-001	Sep 25, 2002	6,783,773
Us Antibiotics	AUGMENTIN XR	amoxicillin; clavulanate potassium	TABLET, EXTENDED RELEASE;ORAL	050785-001	Sep 25, 2002	7,250,176
Us Antibiotics	AUGMENTIN XR	amoxicillin; clavulanate potassium	TABLET, EXTENDED RELEASE;ORAL	050785-001	Sep 25, 2002	7,217,430
Us Antibiotics	AUGMENTIN XR	amoxicillin; clavulanate potassium	TABLET, EXTENDED RELEASE;ORAL	050785-001	Sep 25, 2002	6,878,386

Market Dynamics and Financial Trajectory for Amoxicillin Clavulanate Potassium

Last updated: February 20, 2026

What are the current market drivers for amoxicillin-clavulanate potassium?

Amoxicillin-clavulanate potassium is a combination antibiotic marketed under various brand names, including Augmentin. It treats bacterial infections such as respiratory tract infections, urinary tract infections, and skin infections. The primary market drivers include rising antibiotic resistance, increasing prevalence of bacterial infections, and expanding healthcare access in emerging markets.

Key points:

• The global antibiotic market is projected to reach USD 50 billion by 2027, growing at a compound annual growth rate (CAGR) of 4.8% (Fortune Business Insights, 2022).
• Rise in antimicrobial resistance (AMR) elevates demand for broad-spectrum antibiotics like amoxicillin-clavulanate.
• Growing healthcare infrastructure investment in Asia-Pacific increases prescription rates.

How has the pharmaceutical industry responded to resistance challenges?

Manufacturers have focused on developing novel formulations and extended-release versions to improve efficacy. Some companies are investing in combination therapies with enhanced pharmacokinetics. Patent expirations for key formulations have prompted generic entrants, intensifying price competition.

Notable trends:

• Patent expiry of branded formulations since 2019 has prompted a surge in generic versions.
• R&D efforts aim to improve stability, spectrum of activity, and dosing convenience.
• Regulatory pathways for biosimilars and fixed-dose combinations are evolving, affecting market offerings.

What is the geographic distribution of market opportunity?

Developed markets in North America and Europe represent established demand, with high antibiotic usage rates. However, emerging markets in Asia, Latin America, and Africa demonstrate high growth due to increasing infection rates and expanding healthcare coverage.

Region	Market Share (2022)	Growth Rate (2022-2027)	Key Factors
North America	30%	3.5%	High antibiotic consumption, regulation
Europe	20%	3%	Early patent expiries, resistance issues
Asia-Pacific	35%	6%	Growing healthcare infrastructure, prevalence of infections
Latin America	10%	4.5%	Increased prescription rates
Africa	5%	8%	Low base, rapid expansion

What are the key financial indicators for market players?

• Pricing dynamics: Generic versions sell at 20-40% lower prices than branded counterparts, impacting margins.
• Market share: Leading players include GlaxoSmithKline, Sandoz, and Mylan. Market share for generics has risen to approximately 65% globally.
• Investment in R&D: Approximate R&D expenditure constitutes 15-20% of revenue for innovative companies, focusing on extended-release formulations and novel combinations.
• Revenue forecasts: The global amoxicillin-clavulanate market is expected to reach USD 3.8 billion by 2028, growing at an 8% CAGR from 2022 to 2028 (MarketWatch, 2023).

How do patent and regulatory environments influence the trajectory?

Patents on original formulations expired in major markets between 2019 and 2022, prompting a wave of generic entries. Regulatory agencies, including FDA and EMA, have streamlined approval processes for generics and biosimilars, reducing time to market.

Policy Impact	Result
Patent expiries	Surge in generics, price reduction
Regulatory acceleration	Faster approval, market entry
Antimicrobial stewardship policies	Reduced unnecessary prescriptions (pressure on margins)

What are the risks and challenges affecting financial performance?

• Stringent regulatory oversight increases compliance costs.
• Growing resistance may reduce efficacy, necessitating dosage adjustments or combination therapies, raising R&D costs.
• Pricing pressures from generics and healthcare policies could compress profit margins.
• Market saturation in mature regions may slow revenue growth.

What is the future outlook for the pharmaceutical market for amoxicillin-clavulanate?

The market is poised for sustained growth driven by expansion in emerging markets and ongoing R&D initiatives. The global focus on antimicrobial stewardship may temper volume growth but will promote innovation in formulations and combination therapies. Price competition will remain intense among generic manufacturers, while branded efforts may focus on improving formulations.

Projected timeline:

• 2023-2025: Market consolidation among generics, stabilization of prices.
• 2025-2028: Introduction of extended-release formulations and biosimilars.
• Post-2028: Potential development of resistance management strategies influencing drug utilization.

Key Takeaways

• The amoxicillin-clavulanate market is expanding, chiefly in emerging regions.
• Patent expiries have increased generic market share, driving price competition.
• R&D investment focuses on reformulations and resistance mitigation.
• Regulatory environments have become more accommodating, facilitating faster market entry.
• Price pressures and antimicrobial resistance pose significant risks.

FAQs

1. How does antimicrobial resistance affect market growth?
It increases demand for broad-spectrum antibiotics like amoxicillin-clavulanate but may also lead to regulatory restrictions, influencing overall sales volume and formulations.

2. Are new formulations expected to replace existing products?
Extended-release and combination formulations are anticipated to complement current offerings, not necessarily replace them.

3. What role do generics play in market dynamics?
Generics account for about 65% of the global market, exerting downward pressure on prices and profit margins for branded drugs.

4. How might regulatory trends influence future market opportunities?
Regulatory streamlining accelerates approvals, supporting faster product launches, but stricter antimicrobial stewardship policies could restrict prescribing and growth.

5. Which regions are expected to drive the most revenue in the coming years?
Asia-Pacific and Latin America are expected to see the highest growth rates due to expanding healthcare access and rising infection rates.

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References

[1] Fortune Business Insights. (2022). Antibiotic Market Size, Share & Industry Analysis, 2027. Retrieved from [URL]
[2] MarketWatch. (2023). Amoxicillin Clavulanate Market Analysis. Retrieved from [URL]