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-six 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:	69
Clinical Trials:	1
Patent Applications:	4,435
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	8,299,052
Pragma	MOXATAG	amoxicillin	TABLET, EXTENDED RELEASE;ORAL	050813-001	Jan 23, 2008		DISCN	Yes	No	8,778,924		Y	Y
Pragma	MOXATAG	amoxicillin	TABLET, EXTENDED RELEASE;ORAL	050813-001	Jan 23, 2008		DISCN	Yes	No	8,357,394		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	6,544,555
Pragma	MOXATAG	amoxicillin	TABLET, EXTENDED RELEASE;ORAL	050813-001	Jan 23, 2008	6,669,948
Pragma	MOXATAG	amoxicillin	TABLET, EXTENDED RELEASE;ORAL	050813-001	Jan 23, 2008	6,723,341

International Patents for MOXATAG

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

Country	Patent Number	Title	Estimated Expiration
Canada	2470016
European Patent Office	1968586	COMPOSITIONS PHARMACEUTIQUES ET MÉTHODES POUR ÉRADICATION BACTÉRIENNE AMÉLIORÉE (PHARMACEUTICAL COMPOSITIONS AND METHODS FOR IMPROVED BACTERIAL ERADICATION)
Japan	5377465
Japan	2003523378

MOXATAG Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MOXATAG®

Introduction to MOXATAG®

MOXATAG® is the first and only approved once-daily formulation of the widely-used antibiotic amoxicillin. It is indicated for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatric patients 12 years of age or older. Approved by the FDA in 2008, MOXATAG® is protected by six Orange Book listed patents, with the last patent expiring in 2027[1][5].

Acquisition and Relaunch

In 2015, Vernalis Therapeutics acquired the U.S. rights to MOXATAG® from Pragma Pharmaceuticals. This acquisition was part of Vernalis's strategy to expand its commercial presence in the U.S. market. Vernalis planned to relaunch MOXATAG® in early 2016, leveraging its newly established U.S. commercial infrastructure and targeting the same physician audience as its recently launched product, Tuzistra™ XR[1][5].

Market Fit and Target Audience

MOXATAG® has a strong fit with Vernalis's existing product portfolio, particularly with Tuzistra™ XR, an extended-release cough cold oral suspension. Both products offer extended-release alternatives to existing treatments, which aligns well with the needs of primary care physicians and their patients. This strategic alignment is expected to enhance the commercial performance of MOXATAG®[1][5].

Financial Considerations

The acquisition of MOXATAG® involved an undisclosed up-front cash payment from Vernalis to Pragma, along with a further payment upon the successful manufacture of the re-launched finished dose product. Vernalis also agreed to pay royalties on net sales and potential sales-related milestones to Pragma. This financial structure reflects the potential for significant revenue generation from MOXATAG®[1].

Sales and Marketing Strategy

Vernalis took over the sales, marketing, and distribution of MOXATAG® in the United States. The company planned to resume full promotion of MOXATAG® in September 2017, as part of its broader strategy to grow its commercial business. This included integrating its sales force and optimizing its marketing efforts to target the appropriate physician audience[2].

Market Performance and Growth

Although MOXATAG® had not been actively promoted since 2010, its relaunch was expected to capitalize on the growing demand for antibiotics, particularly those with convenient dosing regimens. The global amoxicillin market, which includes MOXATAG®, is projected to grow at a CAGR of 2.0% from 2022 to 2029, reaching a market size of USD 5.51 billion by 2029. This growth is driven by the increasing use of amoxicillin for various infections and the convenience of once-daily dosing[4].

Competitive Landscape

The antibiotic market, including amoxicillin formulations like MOXATAG®, is highly competitive. However, MOXATAG®'s unique once-daily formulation provides a competitive edge. Vernalis's strategy to leverage its existing commercial infrastructure and target the same audience as Tuzistra™ XR helps in differentiating MOXATAG® in the market[1][5].

Regulatory and Patent Protection

MOXATAG® is protected by six Orange Book listed patents, with the last patent expiring in 2027. This patent protection provides a significant barrier to entry for generic competitors, allowing Vernalis to maintain market exclusivity and potentially higher pricing for the product during this period[1].

Financial Trajectory for Vernalis

The acquisition and relaunch of MOXATAG® are part of Vernalis's broader financial strategy. In the financial year ended June 30, 2017, Vernalis reported total revenues ahead of market expectations, driven by larger-than-expected research collaboration milestones. The company's cash position was £61 million, reflecting careful cost control and favorable foreign exchange impacts. The relaunch of MOXATAG® was expected to contribute to Vernalis's commercial business, aligning with the company's goal of expanding its product portfolio and enhancing its financial performance[2].

Key Takeaways

• Market Position: MOXATAG® is the first and only approved once-daily formulation of amoxicillin, targeting tonsillitis and pharyngitis.
• Acquisition and Relaunch: Acquired by Vernalis in 2015, with plans to relaunch in early 2016.
• Financial Structure: Involved an up-front cash payment and royalties on net sales.
• Market Growth: Part of a growing global amoxicillin market expected to reach USD 5.51 billion by 2029.
• Competitive Edge: Unique once-daily formulation and strategic marketing alignment with Tuzistra™ XR.
• Regulatory Protection: Protected by six Orange Book listed patents until 2027.

FAQs

Q: What is MOXATAG® and its indication? A: MOXATAG® is the first and only approved once-daily formulation of the antibiotic amoxicillin, indicated for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatric patients 12 years of age or older.

Q: Who acquired the U.S. rights to MOXATAG®? A: Vernalis Therapeutics acquired the U.S. rights to MOXATAG® from Pragma Pharmaceuticals in 2015.

Q: What is the expected market growth for amoxicillin formulations like MOXATAG®? A: The global amoxicillin market is expected to grow at a CAGR of 2.0% from 2022 to 2029, reaching a market size of USD 5.51 billion by 2029.

Q: What is the competitive advantage of MOXATAG®? A: MOXATAG®'s unique once-daily formulation provides a competitive edge in the antibiotic market.

Q: How long is MOXATAG® protected by patents? A: MOXATAG® is protected by six Orange Book listed patents, with the last patent expiring in 2027.

References

1. PR Newswire: Vernalis Acquires U.S. Rights To MOXATAG® (Amoxicillin Extended Release Tablets) From Pragma Pharmaceuticals.
2. Biospace: Vernalis PLC: Year-End Trading Update And Notice Of Full Year Results.
3. Data Bridge Market Research: Global Amoxicillin Market – Industry Trends and Forecast to 2029.
4. Vernalis: Vernalis plc acquires US rights to MOXATAG®.