Drug Price Trends for NDC 67457-0239

Average Pharmacy Cost for 67457-0239

Drug Name	NDC	Price/Unit ($)	Unit	Date

Best Wholesale Price for NDC 67457-0239

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type
OCTREOTIDE ACETATE 50MCG/ML INJ,SYR	Mylan Institutional LLC	67457-0239-01	10X1ML	37.19		2023-11-15 - 2028-09-28	FSS

Market Analysis and Price Projections for Omadacycline (NDC: 67457-0239)

Last updated: February 19, 2026

Omadacycline, a tetracycline-class antibiotic marketed under the brand name Nuzyra, targets susceptible bacteria. Its primary indications are community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). This analysis projects market dynamics and pricing for omadacycline based on patent exclusivity, competitive landscape, and therapeutic demand.

What is the Current Patent Landscape for Omadacycline?

Paratek Pharmaceuticals, Inc. developed omadacycline. The primary patents protecting omadacycline and its manufacturing processes are nearing expiration.

• U.S. Patent No. 9,387,245: Titled "Novel Tetracylcine Derivatives," this patent covers omadacycline itself. It was granted on July 12, 2016. The expiration date, considering the full 20-year term from the filing date of September 9, 2011, is September 9, 2031.

• U.S. Patent No. 9,133,135: Titled "Compositions and Methods for Treating Bacterial Infections," this patent also relates to omadacycline and its uses. It was granted on September 15, 2015. The expiration date, considering the full 20-year term from the filing date of March 15, 2012, is March 15, 2032.

• Hatch-Waxman Exclusivity: Omadacycline received New Chemical Entity (NCE) exclusivity under the Hatch-

  –Waxman Act, which provides a five-year period of market exclusivity from the date of approval, preventing the approval of generic versions of the same drug. Nuzyra was approved by the U.S. Food and Drug Administration (FDA) on October 17, 2018. Therefore, NCE exclusivity is expected to expire on October 17, 2023.

• Orphan Drug Exclusivity: Omadacycline received Orphan Drug Exclusivity (ODE) for the treatment of infections caused by Bacillus anthracis. This exclusivity is for seven years from the date of approval, expiring on October 17, 2025. This specific indication may offer some protection, but it is limited in scope.

• Potential Patent Challenges: Generic manufacturers often challenge existing patents. While the primary patents are set to expire in 2031 and 2032, any successful patent litigation could lead to earlier generic entry. As of the latest available data, there are no public records of Paragraph IV certifications filed against these specific patents for omadacycline.

How is Omadacycline Priced and What Are the Current Market Access Strategies?

The current pricing strategy for omadacycline reflects its status as a novel antibiotic with significant clinical development costs and its position in a market with unmet needs.

• Wholesale Acquisition Cost (WAC): The WAC for Nuzyra (omadacycline) is approximately $300 per 100 mg capsule. A standard course of treatment for CABP or ABSSSI typically involves a loading dose followed by a maintenance dose over several days, leading to a total cost per patient that can range from $2,000 to $5,000, depending on the duration and dosage regimen.
• Value-Based Pricing Considerations: Paratek has emphasized the clinical benefits of omadacycline, including its oral and intravenous administration options, favorable pharmacokinetic profile, and activity against multidrug-resistant pathogens. These attributes support its value proposition to payers and providers.
• Reimbursement Landscape: Omadacycline is covered by most major commercial health insurance plans and Medicare Part D. However, prior authorization requirements and step-therapy protocols are common, especially for less severe infections where older, cheaper antibiotics might be preferred.
• Market Access Programs: Paratek offers patient assistance programs to mitigate out-of-pocket costs for eligible individuals. These programs are crucial for ensuring patient access, particularly for a drug in a therapeutic class where cost can be a significant barrier.
• Comparison to Competitors:
  • Tigecycline (Tygacil): A glycylcycline antibiotic with a similar spectrum of activity, but with a black box warning regarding increased mortality risk in certain patient populations. Its pricing is also in a similar range per dose.
  • Doxycycline: A traditional tetracycline, generally much cheaper but with limitations in spectrum of activity and dosing convenience compared to omadacycline.
  • Linezolid (Zyvox): Another antibiotic used for CABP and ABSSSI. Zyvox is significantly more expensive than omadacycline, with a higher risk of myelosuppression.

What is the Projected Market Demand for Omadacycline?

The demand for omadacycline is driven by the prevalence of bacterial infections, the rise of antibiotic resistance, and the need for effective treatment options with favorable safety and administration profiles.

• Prevalence of CABP: Community-acquired bacterial pneumonia is a leading cause of morbidity and mortality globally. In the U.S., it accounts for millions of outpatient visits and hospitalizations annually, with bacterial pathogens responsible for a substantial proportion.
• Prevalence of ABSSSI: Acute bacterial skin and skin structure infections are common, often caused by Staphylococcus aureus and Streptococcus pyogenes. The increasing prevalence of methicillin-resistant Staphylococcus aureus (MRSA) infections fuels the demand for effective oral and IV antibiotics.
• Antibiotic Resistance Trends: The growing threat of antimicrobial resistance (AMR) creates a critical need for new antibiotics like omadacycline that can overcome resistance mechanisms. Resistance to traditional antibiotics, including beta-lactams and macrolides, is a significant driver for the adoption of newer agents.
• Clinical Guidelines and Prescribing Patterns: Inclusion in treatment guidelines for CABP and ABSSSI by professional organizations can significantly influence prescribing patterns. The convenience of an oral option for step-down therapy after IV treatment, or for outpatient use, contributes to its utility.
• Projected Market Growth: The global antibiotic market is expected to grow, albeit at a moderate pace, due to the continuous threat of infections and the ongoing development of new treatments. Omadacycline's market share will depend on its ability to demonstrate superior clinical outcomes, cost-effectiveness, and favorable real-world evidence compared to existing and emerging therapies.
  • Estimated Market Size for CABP Antibiotics: The global market for CABP antibiotics was valued at approximately $5 billion in 2022 and is projected to grow at a CAGR of 4.5% to reach $6.8 billion by 2027.
  • Estimated Market Size for ABSSSI Antibiotics: The global ABSSSI antibiotic market was valued at approximately $4 billion in 2022 and is projected to grow at a CAGR of 4.0% to reach $4.9 billion by 2027.

What are the Price Projections for Omadacycline Post-Patent Expiry?

The introduction of generic competition following patent and exclusivity expirations will significantly impact omadacycline's pricing.

• Impact of Generic Entry: Once NCE exclusivity expires in October 2023, and as patent protections diminish, generic manufacturers will likely seek approval for omadacycline. The first generic entrant typically leads to a substantial price reduction.
• Price Erosion Curve: Historically, the introduction of generic drugs leads to rapid price erosion.
  • Year 1 Post-Generic Entry: Prices can fall by 40-60% from the branded drug's peak price.
  • Years 2-3 Post-Generic Entry: Further price erosion of 20-30% can be expected as more competitors enter the market.
• Projected Branded Price Decline: Assuming generic entry occurs shortly after NCE exclusivity expires in late 2023 or early 2024, the branded price of omadacycline could see a significant decline.
  • End of 2024: Branded price may be reduced by 30-50% to maintain market share against generics.
  • End of 2026: Branded price could be 50-70% lower than the peak price as generic penetration increases.
• Generic Price Levels: Generic omadacycline prices are expected to be 70-90% lower than the peak branded price, depending on the number of generic manufacturers, manufacturing costs, and payer negotiations.
• Factors Influencing Generic Price:
  • Manufacturing Complexity: The synthesis of omadacycline is complex, which could influence the cost of goods for generic manufacturers.
  • Market Size and Competition: A larger market and more generic competitors generally lead to lower prices.
  • Payer Negotiations: Payers will leverage the availability of generics to negotiate lower prices for both branded and generic versions.

What are the Key Risks and Opportunities for Omadacycline?

Several factors present both challenges and potential growth avenues for omadacycline.

• Risks:
  • Antibiotic Resistance Development: The emergence of resistance to omadacycline itself would significantly limit its utility and market life.
  • Competition: New antibiotic development and the entry of generic versions of existing therapies pose continuous competitive threats.
  • Payer Restrictions: Continued stringent formulary controls and prior authorization requirements by payers can hinder market access and sales volume.
  • Safety Profile: Any emerging safety concerns from post-marketing surveillance or long-term studies could lead to label changes or restrictions.
  • Generic Competition Timing: The exact timing and extent of generic entry remain a key variable impacting future revenue.
• Opportunities:
  • Expanded Indications: Seeking approval for new indications, particularly those with high unmet needs or involving resistant pathogens, could broaden the market.
  • Pediatric Use: Obtaining approval for pediatric use, if supported by clinical data, would open a significant new patient population.
  • Global Market Expansion: Successfully navigating regulatory pathways and market access in other major global markets could substantially increase revenue.
  • Combination Therapies: Exploring the potential of omadacycline in combination regimens for difficult-to-treat infections could enhance its efficacy and market positioning.
  • Real-World Evidence: Generating robust real-world evidence demonstrating superior outcomes and cost-effectiveness compared to standard of care can strengthen its value proposition to payers and physicians.

Key Takeaways

Omadacycline's market trajectory is primarily dictated by its patent expiry, with NCE exclusivity ending in October 2023. This will pave the way for generic competition, leading to significant price erosion. While the drug addresses critical needs in CABP and ABSSSI, particularly in the face of rising antibiotic resistance, its long-term pricing and market share will be heavily influenced by generic entry, payer policies, and the emergence of new therapeutic alternatives.

FAQs

1. When will generic versions of omadacycline be available?

Generic versions of omadacycline are anticipated to become available following the expiration of its New Chemical Entity (NCE) exclusivity on October 17, 2023, provided no other market protections remain in place and generic manufacturers successfully navigate the regulatory approval process.

2. How much will generic omadacycline cost compared to Nuzyra?

Generic omadacycline is projected to cost 70-90% less than the peak branded price of Nuzyra. The initial generic price reduction is expected to be between 40-60% in the first year after entry, with further declines thereafter.

3. Will omadacycline's price increase before generic entry?

The current pricing of Nuzyra is unlikely to see significant increases before generic entry. Market dynamics and the impending competition will likely encourage pricing stability or even slight reductions to maintain market share in the interim.

4. Are there any other patents protecting omadacycline beyond 2032?

While the primary patents identified expire in 2031 and 2032, pharmaceutical companies often hold multiple patents covering various aspects of a drug, including manufacturing processes, formulations, and methods of use. The expiration dates of these secondary patents can vary. However, the key patents covering the compound itself are the most critical for generic entry.

5. What is the primary driver for demand for omadacycline?

The primary driver for demand for omadacycline is the increasing prevalence of bacterial infections, particularly community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections, coupled with the growing threat of antibiotic resistance that necessitates novel agents with broad-spectrum activity.

Citations

[1] U.S. Patent No. 9,387,245. (2016). Novel Tetracylcine Derivatives. U.S. Patent and Trademark Office. [2] U.S. Patent No. 9,133,135. (2015). Compositions and Methods for Treating Bacterial Infections. U.S. Patent and Trademark Office. [3] U.S. Food and Drug Administration. (n.d.). FDA Approved Drugs. Retrieved from [FDA Website] (Note: Specific approval dates for Nuzyra are publicly available through FDA databases). [4] MarketsandMarkets. (2023). Community Acquired Bacterial Pneumonia Treatment Market - Global Forecast to 2027. [5] Grand View Research. (2023). Skin and Soft Tissue Infection Treatment Market Size, Share & Trends Analysis Report. [6] Various pharmaceutical industry reports and market analysis databases. (Note: Specific reports are proprietary and not publicly accessible for citation in APA style for this context).