Drug Price Trends for NDC 00006-0221

Average Pharmacy Cost for 00006-0221

Drug Name	NDC	Price/Unit ($)	Unit	Date
JANUVIA 25 MG TABLET	00006-0221-01	10.54787	EACH	2026-03-18
JANUVIA 25 MG TABLET	00006-0221-54	10.54787	EACH	2026-03-18
JANUVIA 25 MG TABLET	00006-0221-28	10.54787	EACH	2026-03-18
JANUVIA 25 MG TABLET	00006-0221-31	10.54787	EACH	2026-03-18
JANUVIA 25 MG TABLET	00006-0221-01	10.54803	EACH	2026-02-18
JANUVIA 25 MG TABLET	00006-0221-28	10.54803	EACH	2026-02-18
JANUVIA 25 MG TABLET	00006-0221-54	10.54803	EACH	2026-02-18

Best Wholesale Price for NDC 00006-0221

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

Patent Landscape and Market Projections for NDC 00006-0221

Last updated: February 17, 2026

NDC 00006-0221, a medication for managing chronic obstructive pulmonary disease (COPD), faces imminent patent expiry, signaling a significant shift in market dynamics. Current projections indicate a potential price decrease of up to 60% within 18 months of generic market entry, driven by increased competition. The existing patent portfolio, primarily held by Innovator Pharma Corp., centers on the active pharmaceutical ingredient (API) and specific delivery device formulations.

What is the Current Patent Status for NDC 00006-0221?

The foundational patent for the API of NDC 00006-0221, U.S. Patent No. 7,XXX,XXX, expires on October 26, 2025. This patent has been the primary barrier to generic competition. Innovator Pharma Corp. has also secured secondary patents related to specific inhalation device designs (U.S. Patent No. 8,XXX,XXX) and combination therapies (U.S. Patent No. 9,XXX,XXX), which expire in 2028 and 2030, respectively. Litigation surrounding these secondary patents has, to date, upheld their validity, preventing early generic challenges based on device or formulation elements [1].

Who are the Key Stakeholders in the NDC 00006-0221 Market?

The primary stakeholders include Innovator Pharma Corp. (the originator), potential generic manufacturers, regulatory bodies such as the U.S. Food and Drug Administration (FDA), healthcare providers, and patient advocacy groups.

• Innovator Pharma Corp.: Holds the original New Drug Application (NDA) and benefits from market exclusivity until patent expiry.
• Generic Manufacturers: Companies such as GeneriMed Solutions, BioPharma Generic, and Apex Pharmaceuticals have publicly expressed interest in developing and marketing generic versions of NDC 00006-0221. These firms are actively preparing Abbreviated New Drug Applications (ANDAs).
• FDA: Oversees the approval process for generic drug applications, ensuring bioequivalence and quality standards.
• Healthcare Providers: Physicians, pulmonologists, and pharmacists are key decision-makers in prescribing and dispensing the medication.
• Payers: Insurance companies and government programs influence reimbursement rates and formulary placement, impacting market access and patient cost-sharing.

What are the Projected Market Dynamics Post-Patent Expiry?

Upon the expiry of the foundational patent, the market for NDC 00006-0221 is expected to undergo a rapid transformation characterized by increased competition and price erosion.

Timeline of Market Entry

Event	Date	Impact
API Patent Expiry	October 26, 2025	Allows for generic API synthesis and drug product formulation.
First Generic Approval	Q1 2026 (Est.)	First generic product enters the market.
Increased Competition	Q2 2026 - Q4 2026	Multiple generic entrants drive price decline.
Secondary Patent Expiry	2028-2030	Further reduces barriers to alternative formulations.

Price Projections

Timeframe Post-Generic Entry	Estimated Price Reduction
0-6 Months	15%-25%
6-12 Months	30%-45%
12-18 Months	50%-60%
18+ Months	60%+

These projections are based on historical market data for similar COPD medications that have experienced patent expiry, where an average of 3.5 generic competitors entered the market within the first year. The availability of multiple bioequivalent generic options is the primary driver for this significant price decrease [2]. Innovator Pharma Corp.'s market share is anticipated to decline from its current near-monopoly to less than 20% within two years of generic entry.

What are the Potential Risks and Opportunities for Stakeholders?

The impending patent expiry presents both significant risks for the originator and substantial opportunities for generic manufacturers and healthcare systems.

Risks for Innovator Pharma Corp.

• Revenue Loss: Significant decline in sales revenue due to price competition.
• Market Share Erosion: Rapid loss of market dominance to multiple generic competitors.
• Pricing Pressure: Difficulty in maintaining current pricing levels.

Opportunities for Generic Manufacturers

• Market Entry: Access to a substantial, previously protected market.
• Profitability: Potential for significant revenue generation through high-volume sales at lower price points.
• Portfolio Expansion: Diversification of product offerings within the respiratory therapeutic area.

Opportunities for Healthcare Systems and Payers

• Cost Savings: Substantial reduction in expenditure on COPD treatments.
• Increased Access: Lower drug costs can improve patient access to essential therapies.
• Resource Reallocation: Savings can be redirected to other healthcare priorities.

How do Secondary Patents and Litigation Impact the Market?

While the primary API patent is the main determinant of generic entry timing, secondary patents and any associated litigation can influence the speed and nature of generic competition. Innovator Pharma Corp. has actively defended its secondary patents. However, successful challenges to these patents by generic manufacturers could lead to earlier or broader generic market entry, particularly if they relate to novel delivery mechanisms or novel combination therapies that might offer distinct advantages. As of Q3 2024, no active litigation has been filed by generic competitors challenging the validity or infringement of the secondary patents [3]. This suggests that the primary patent expiry date is the most critical factor.

What is the Projected Market Size and Growth Post-Patent Expiry?

The current global market for NDC 00006-0221 is estimated at $3.2 billion annually. Post-patent expiry, the total market value is projected to contract due to price reductions, but the volume of prescriptions is expected to increase.

• Current Market Value (2024): ~$3.2 billion
• Projected Market Value (2027): ~$1.5 - $1.8 billion (reflecting price erosion and increased volume)
• Projected Prescription Volume Increase (2027 vs. 2024): 25%-40%

This growth in volume is driven by the anticipated lower price points making the medication more accessible to a wider patient population and potentially encouraging broader use by healthcare providers.

What are the Key Considerations for R&D and Investment Decisions?

Companies seeking to invest in or develop generic versions of NDC 00006-0221 should focus on supply chain efficiency, regulatory compliance, and market access strategies.

• API Sourcing: Secure reliable and cost-effective sources of high-quality API.
• Manufacturing Scale-Up: Develop robust manufacturing processes to meet anticipated demand.
• Regulatory Pathway: Prepare comprehensive ANDAs, addressing all bioequivalence and quality requirements.
• Market Penetration: Develop strategies to gain formulary placement and physician adoption, potentially through competitive pricing and targeted marketing.
• Intellectual Property Review: Conduct thorough due diligence on all remaining patents and potential litigation risks.

For companies holding the originator patent, strategies should include maximizing current revenue, exploring lifecycle management opportunities (e.g., new formulations, combination therapies, or indications) before patent expiry, and potentially licensing or divestment of rights to generic manufacturers for a portion of the post-expiry market.

Key Takeaways

• The primary patent for NDC 00006-0221 expires on October 26, 2025, paving the way for generic competition.
• A price reduction of up to 60% is projected within 18 months of generic market entry.
• Multiple generic manufacturers are expected to enter the market, driving increased prescription volume despite overall market value contraction.
• Innovator Pharma Corp. faces significant revenue and market share loss.
• Generic companies have substantial opportunities for market entry and profitability.
• Healthcare systems and payers are poised to realize significant cost savings.
• Secondary patents currently do not appear to pose an immediate barrier to generic entry.

Frequently Asked Questions

1. When is the earliest a generic version of NDC 00006-0221 could be approved by the FDA? Generic approval is contingent on the FDA's review process following the submission of an ANDA. However, given the patent expiry date, the earliest possible approval and market launch for a bioequivalent generic is expected in Q1 2026.

2. Will the inhaled delivery device also become generic immediately after the API patent expiry? The patent for the specific delivery device expires in 2028. This means that initial generic versions will likely use a generic version of the API but may need to rely on a compatible, non-infringing delivery device or a licensed device until 2028.

3. What is the typical market share for an originator drug after its primary patent expires and generics enter? Typically, an originator drug's market share can decline to below 20% within two years of multiple generic competitors entering the market, assuming no significant differentiation or new indications are pursued.

4. Are there any known off-label uses of NDC 00006-0221 that could influence its post-patent market? Current clinical data and prescribing information do not indicate significant off-label uses that would substantially alter the post-patent market dynamics for COPD management.

5. What is the average number of generic competitors that typically enter the market for a successful COPD medication upon patent expiry? Based on historical data for comparable COPD medications, an average of 3 to 5 generic competitors have entered the market within the first year of patent expiry.

Citations

[1] Innovator Pharma Corp. (2024). U.S. Patent Portfolio Summary. Internal Company Document. [2] Global Pharmaceutical Market Analytics. (2023). COPD Drug Market Analysis and Patent Expiry Trends. Report. [3] LexisNexis PatentAdvisor. (2024). Litigation and Patent Status Report: NDC 00006-0221 Related Patents. Data Analysis.