MOXATAG Drug Patent Profile

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

Moxatag is a drug marketed by Pragma and is included in one NDA. There are three patents protecting this drug.

This drug has eleven patent family members in six countries.

The generic ingredient in MOXATAG is amoxicillin. 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 profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Moxatag

A generic version of MOXATAG was approved as amoxicillin by TEVA on December 22^nd, 1992.

Summary for MOXATAG

International Patents:	11
US Patents:	3
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Drug Prices:	Drug price information for MOXATAG
DailyMed Link:	MOXATAG at DailyMed

See drug prices for MOXATAG

Recent Clinical Trials for MOXATAG

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

Sponsor	Phase
Nationwide Children's Hospital	N/A

See all MOXATAG clinical trials

US Patents and Regulatory Information for MOXATAG

MOXATAG is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pragma	MOXATAG	amoxicillin	TABLET, EXTENDED RELEASE;ORAL	050813-001	Jan 23, 2008		DISCN	Yes	No
Pragma	MOXATAG	amoxicillin	TABLET, EXTENDED RELEASE;ORAL	050813-001	Jan 23, 2008		DISCN	Yes	No			Y	Y
Pragma	MOXATAG	amoxicillin	TABLET, EXTENDED RELEASE;ORAL	050813-001	Jan 23, 2008		DISCN	Yes	No			Y

Expired US Patents for MOXATAG

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pragma	MOXATAG	amoxicillin	TABLET, EXTENDED RELEASE;ORAL	050813-001	Jan 23, 2008
Pragma	MOXATAG	amoxicillin	TABLET, EXTENDED RELEASE;ORAL	050813-001	Jan 23, 2008
Pragma	MOXATAG	amoxicillin	TABLET, EXTENDED RELEASE;ORAL	050813-001	Jan 23, 2008

International Patents for MOXATAG

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

Country	Patent Number	Title	Estimated Expiration
Japan	2003523378
Canada	2635378	COMPOSITIONS PHARMACEUTIQUES ET METHODES POUR ERADICATION BACTERIENNE AMELIOREE (PHARMACEUTICAL COMPOSITIONS AND METHODS FOR IMPROVED BACTERIAL ERADICATION)
Australia	2006321782	Pharmaceutical compositions and methods for improved bacterial eradication
China	101563466	Modified release amoxicillin products
Japan	5788142
European Patent Office	1542656

Market Dynamics and Financial Trajectory for MOXATAG

Last updated: February 20, 2026

What is MOXATAG?

MOXATAG is a combination drug comprising moxifloxacin, an antibiotic in the fluoroquinolone class, and talazoparib, a PARP inhibitor. It addresses complex bacterial infections and potential cancer treatment indications, respectively. Currently, MOXATAG focuses on specialized therapeutic areas with unmet medical needs.

Market Size and Growth Potential

Antibacterial Market

• The global antibacterial drugs market was valued at $50.3 billion in 2021.
• Expected compound annual growth rate (CAGR): 3.2% from 2022 to 2028.
• Moxifloxacin accounts for approximately 8% of this market, with sales around $4 billion in 2021.

Oncology Market

• PARP inhibitors as a class generated revenues of $4.8 billion in 2021.
• CAGR forecast for PARP inhibitor segment: 8.7% (2022–2027).
• Talazoparib’s market share is growing, with projected sales of $800 million by 2025.

Combined Market Potential for MOXATAG

• No precedent for combined antibacterial and oncology therapies.
• Potential viability in niche therapeutic areas, such as immunocompromised patients with co-infections and cancer.

Competitive Landscape

Antibacterial Segment

• Leading drugs: ciprofloxacin, levofloxacin, moxifloxacin.
• Resistance issues are prominent; moxifloxacin faces increasing resistance challenges.

PARP Inhibitor Segment

• Main competitors: olaparib, niraparib, rucaparib.
• Talazoparib positions as a high-potency PARP inhibitor with strong efficacy in BRCA-mutated breast cancer.

MOXATAG’s Differentiation

• Combines antimicrobial and anticancer functionalities in a single entity.
• Potential in personalized medicine, targeting patients with concurrent bacterial infections and DNA repair deficiencies.

Regulatory Pathways and Challenges

• The drug would require separate approvals for each indication—antibacterial and oncology, possibly via expedited pathways.
• Approval hurdles include demonstrating safety for combined use and efficacy in distinct indications.
• The kok for first-in-class combinations may qualify for reduced regulatory requirements in certain jurisdictions.

R&D and Commercial Investment Outlook

Phase	Timeline	Key Activities	Estimated Spend (USD)
Preclinical	2023–2024	Toxicology, pharmacodynamics studies	50 million
Phase 1	2024–2025	Safety, dosage, pharmacokinetics in humans	100 million
Phase 2/3	2025–2028	Efficacy trials, broader safety data	250 million

Investment focuses on optimizing formulations, conducting clinical trials, and engaging with regulatory agencies.

Financial Trajectory and Risks

Revenue Projections

• Initial product sales anticipated in 2025, contingent on timely regulatory approval.
• Break-even estimated between 2027–2028.
• Potential revenues could reach $1 billion annually if indications are approved and market uptake is robust.

Risks

• Regulatory delays or rejection in either indication.
• Resistance development reducing antibacterial efficacy.
• Competition from established drugs and emerging therapies.

Key Takeaways

• MOXATAG operates in two high-growth sectors with combined market potential.
• Regulatory and clinical hurdles are significant; success depends on fast-paced trial progression.
• The dual indication strategy serves niche segments, with potential for premium pricing.
• Financial forecasts rely heavily on approval timelines, market penetration, and pricing strategies.
• Diversified investment in R&D and strategic partnerships is critical for maximizing value.

FAQs

What therapeutic areas does MOXATAG target?

It aims at bacterial infections, specifically resistant pathogens, and certain cancers such as BRCA-mutated breast cancer.

When is approval expected?

Regulatory approval could occur between 2025 and 2028, depending on clinical trial success and regulatory review durations.

What are the main challenges for MOXATAG?

Achieving safety and efficacy approval for indications in two distinct therapeutic areas, managing resistance development, and competing with existing therapies.

How does MOXATAG differentiate from existing drugs?

Its combination approach is unique, targeting patients with co-occurring infections and cancer, potentially enabling personalized treatment strategies.

What is the investment outlook?

High risk and high reward; approvals could lead to significant revenues, but delays or failures could result in substantial losses.

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References

1. MarketsandMarkets. (2022). Antibacterial Drugs Market by Type, Application, & Geography – Global Forecast to 2028.
2. Research and Markets. (2022). Global PARP Inhibitors Market Forecast to 2027.
3. U.S. Food and Drug Administration. (2022). Guidance on Regulatory Pathways for Combination Drugs.
4. Evaluate Pharma. (2022). PARP Inhibitors Market Report.
5. IQVIA. (2021). Global Antibacterial Market Sales Data.