OMADACYCLINE TOSYLATE - Generic Drug Details

What are the generic drug sources for omadacycline tosylate and what is the scope of patent protection?

Omadacycline tosylate is the generic ingredient in one branded drug marketed by Paratek Pharms Inc and is included in two NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Omadacycline tosylate has two hundred and fifty-one patent family members in forty countries.

One supplier is listed for this compound.

Summary for OMADACYCLINE TOSYLATE

International Patents:	251
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	12
DailyMed Link:	OMADACYCLINE TOSYLATE at DailyMed

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

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

Dosage:

POWDER;INTRAVENOUS

Constraining patent/regulatory exclusivity:

9,314,475

Dosage:

TABLET;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.

Pharmacology for OMADACYCLINE TOSYLATE

Drug Class

Tetracycline-class Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for OMADACYCLINE TOSYLATE

J01AA	Tetracyclines
J01A	TETRACYCLINES
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for OMADACYCLINE TOSYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Paratek Pharms Inc	NUZYRA	omadacycline tosylate	POWDER;INTRAVENOUS	209817-001	Oct 2, 2018		RX	Yes	Yes	9,265,740		Y
Paratek Pharms Inc	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816-001	Oct 2, 2018		RX	Yes	Yes	10,835,542
Paratek Pharms Inc	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816-001	Oct 2, 2018		RX	Yes	Yes
Paratek Pharms Inc	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816-001	Oct 2, 2018		RX	Yes	Yes	9,265,740
Paratek Pharms Inc	NUZYRA	omadacycline tosylate	POWDER;INTRAVENOUS	209817-001	Oct 2, 2018		RX	Yes	Yes	10,383,884
Paratek Pharms Inc	NUZYRA	omadacycline tosylate	POWDER;INTRAVENOUS	209817-001	Oct 2, 2018		RX	Yes	Yes	10,835,542
Paratek Pharms Inc	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816-001	Oct 2, 2018		RX	Yes	Yes	10,124,014

Expired US Patents for OMADACYCLINE TOSYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Paratek Pharms Inc	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816-001	Oct 2, 2018	9,365,500
Paratek Pharms Inc	NUZYRA	omadacycline tosylate	POWDER;INTRAVENOUS	209817-001	Oct 2, 2018	7,326,696
Paratek Pharms Inc	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816-001	Oct 2, 2018	7,326,696
Paratek Pharms Inc	NUZYRA	omadacycline tosylate	POWDER;INTRAVENOUS	209817-001	Oct 2, 2018	9,365,500

International Patents for OMADACYCLINE TOSYLATE

Country	Patent Number	Title	Estimated Expiration
Brazil	0112269	Composto de minociclina ou um seu sal farmaceuticamente aceitável, método para tratar um estado responsivo à tetraciclina em um mamìfero, composição farmacêutica, composto de minociclina 9-substituìda, e, método para tratar um estado responsivo à tetraciclina em um indivìduo
South Korea	101893740
Brazil	112019001948	método de tratamento de um indivíduo humano.
Mexico	PA03000055	COMPUESTOS DE MONOCICLINA SUSTITUIDOS EN POSICION 9.. (9-SUBSTITUTED MINOCYCLINE COMPOUNDS.)
Spain	2271070
China	1649582	Amino-methyl substituted tetracycline compounds
Cyprus	1120240

OMADACYCLINE TOSYLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Omadacycline Tosylate

Market Overview

Omadacycline tosylate, a semisynthetic derivative of the tetracycline class, has been gaining significant traction in the pharmaceutical market due to its broad-spectrum efficacy against various bacterial infections.

Market Size and Growth Projections

The omadacycline market was valued at USD 50 million in 2023 and is projected to reach USD 1.3 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 25% from 2024 to 2031. This robust growth is driven by the increasing demand for effective antibiotics, particularly those that can combat antibiotic-resistant bacteria[1].

Key Drivers of Market Growth

Rising Antibiotic Resistance

The growing prevalence of antibiotic-resistant bacterial infections is a major driver of the omadacycline market. Omadacycline's effectiveness against gram-positive, gram-negative, atypical, and anaerobic bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), makes it a valuable treatment option in this context[2].

Broad-Spectrum Efficacy

Omadacycline's broad-spectrum efficacy in treating acute bacterial skin and skin structure infections (ABSSSI), community-acquired bacterial pneumonia (CABP), and other infections contributes to its market growth. Its ability to treat severe infections effectively is a significant factor in its increasing adoption[1].

Healthcare Spending and Infrastructure

Increased healthcare spending and improvements in healthcare infrastructure are facilitating greater access to advanced medications like omadacycline. This trend is expected to continue, supporting the market's expansion[1].

Pharmaceutical Company Strategies

Pharmaceutical companies' ongoing research and development, regulatory approvals, and strategic alliances are crucial in expanding the use and availability of omadacycline. These efforts include partnerships and the development of both intravenous and oral formulations, which enhance the drug's accessibility and convenience[1].

Economic Impact and Cost Considerations

Budget Impact Model

Studies have analyzed the economic impact of introducing omadacycline as a treatment option for ABSSSI. The budget impact model suggests that while omadacycline may increase drug acquisition costs, it can also reduce hospital length of stay (LOS) and potentially shift inpatient care to the outpatient setting. This could lead to overall cost savings in the long term. For instance, reducing hospital LOS by 2 days could result in significant cost reductions[3].

Cost Analysis

The total incremental cost for treating ABSSSI with omadacycline was found to be modest, ranging from $11,168 to $88,777 over three years. However, the main cost increase was attributed to higher drug acquisition costs in emergency department and inpatient settings. Sensitivity analyses indicated that hospital LOS, success rate of treatment, and the cost of omadacycline were key factors influencing the cumulative budget impact[3].

Clinical Success and Market Potential

Clinical Trials and Efficacy

Recent clinical trials, including a Phase IIb study, have highlighted omadacycline's potential in treating nontuberculous mycobacteria pulmonary disease (NTM-PD). The study showed that oral omadacycline was safe, well-tolerated, and demonstrated higher response rates compared to a placebo. Specifically, 34.1% of patients treated with omadacycline saw an improvement in at least 50% of their NTM symptoms, and 56.4% had negative sputum cultures for MABc at day 84[4].

Market Expansion into NTM

The success in NTM-PD treatment indicates a significant market opportunity for omadacycline. Key opinion leaders have expressed positive views on its development for NTM-PD, given the lack of novel, effective therapies in this area. GlobalData estimates suggest that oral omadacycline for NTM-PD could launch in the US in 2029 and in the EU in 2030, with a potential to treat approximately one-quarter of NTM patients by 2033[4].

Regulatory and Safety Considerations

FDA Approval and Labeling

Omadacycline tosylate, marketed as Nuzyra, has been approved by the FDA for the treatment of ABSSSI and CABP. The FDA label highlights its efficacy and safety profile, including potential side effects such as tooth discoloration, inhibition of bone growth, and hypersensitivity reactions[5].

Safety Profile

Clinical trials have shown that omadacycline has a safety profile consistent with other tetracyclines. Common adverse events include gastrointestinal symptoms, and while some patients discontinued treatment due to adverse events, the overall safety profile is favorable[4].

Geographical Market Segments

The omadacycline market is segmented geographically into North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. Each region presents unique market dynamics influenced by local healthcare systems, regulatory environments, and the prevalence of antibiotic-resistant infections[1].

Key Takeaways

• Market Growth: The omadacycline market is expected to grow significantly, reaching USD 1.3 billion by 2031.
• Drivers: Increasing antibiotic resistance, broad-spectrum efficacy, and increased healthcare spending are key drivers.
• Economic Impact: Omadacycline can reduce hospital LOS and shift care to outpatient settings, potentially saving costs.
• Clinical Success: Positive clinical trial results, especially in NTM-PD, indicate strong market potential.
• Regulatory and Safety: FDA-approved with a favorable safety profile, though with some common adverse events.

FAQs

What is the projected market size of omadacycline by 2031?

The omadacycline market is projected to reach USD 1.3 billion by 2031, growing at a CAGR of 25% from 2024 to 2031[1].

What are the primary applications of omadacycline?

Omadacycline is primarily used to treat acute bacterial skin and skin structure infections (ABSSSI), community-acquired bacterial pneumonia (CABP), skin infections, urinary tract infections, and intra-abdominal infections[1].

How does omadacycline impact hospital length of stay (LOS)?

Omadacycline can reduce hospital LOS by enabling the shift of care from inpatient to outpatient settings, which can lead to significant cost savings[3].

What is the safety profile of omadacycline?

Omadacycline has a safety profile consistent with other tetracyclines, with common adverse events including gastrointestinal symptoms. However, it is generally well-tolerated[4].

What is the potential of omadacycline in treating NTM-PD?

Omadacycline has shown promising results in treating nontuberculous mycobacteria pulmonary disease (NTM-PD), with higher response rates compared to placebo and a favorable safety profile. It is expected to launch in the US in 2029 and in the EU in 2030[4].

Sources

1. Market Research Intellect: "Global Omadacycline Market Size and Projections"
2. DrugBank Online: "Omadacycline tosylate"
3. AHDB Online: "Budget Impact Model of Omadacycline on Replacing a Proportion of Existing Treatment Options"
4. Clinical Trials Arena: "Positive Phase II top-line data highlights omadacycline's potential in NTM market"
5. FDA: "NUZYRA (omadacycline) - Label"