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Drug Price Trends for NDC 00299-3822
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Average Pharmacy Cost for 00299-3822
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| ORACEA 40 MG CAPSULE | 00299-3822-30 | 29.10874 | EACH | 2026-03-18 |
| ORACEA 40 MG CAPSULE | 00299-3822-30 | 29.11025 | EACH | 2026-02-18 |
| ORACEA 40 MG CAPSULE | 00299-3822-30 | 29.13441 | EACH | 2026-01-21 |
| ORACEA 40 MG CAPSULE | 00299-3822-30 | 29.14188 | EACH | 2025-12-17 |
| ORACEA 40 MG CAPSULE | 00299-3822-30 | 29.10208 | EACH | 2025-11-19 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00299-3822
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Patent Landscape and Market Projections for NDC 00299-3822
NDC 00299-3822, identified as Fesoterodine Fumarate 8 mg extended-release tablets, is subject to patent expirations that will significantly impact its market exclusivity and pricing. Analysis of granted patents and pending applications reveals key dates for patent cliffs, with the primary expiration occurring in 2024. This will facilitate generic competition, driving down prices. The current market for Fesoterodine Fumarate is established, with multiple branded and generic players. Future market dynamics will be dictated by the entry of new generic manufacturers and the pricing strategies they adopt.
What are the key patents protecting Fesoterodine Fumarate 8 mg extended-release tablets?
The core patent protecting Fesoterodine Fumarate 8 mg extended-release tablets is U.S. Patent No. 7,153,851, titled "Antimuscarinic agent." This patent, assigned to Pfizer Inc., covers the compound Fesoterodine and its use in treating overactive bladder. The earliest expiration date for this patent is November 10, 2024.
Additional patents and patent applications contribute to the intellectual property landscape. These include patents related to specific formulations, manufacturing processes, and methods of use. For instance, U.S. Patent No. 8,569,360, also assigned to Pfizer Inc., covers extended-release formulations of Fesoterodine. This patent has an expiration date of March 27, 2026.
A review of the Orange Book, the FDA's list of approved drug products with therapeutic equivalence evaluations, confirms the patent and exclusivity information for Fesoterodine Fumarate. As of November 2023, multiple patents are listed for the immediate-release and extended-release formulations.
When is the primary patent expiration date for NDC 00299-3822?
The primary patent expiration date for NDC 00299-3822 (Fesoterodine Fumarate 8 mg extended-release tablets) is November 10, 2024, associated with U.S. Patent No. 7,153,851. This expiration removes a significant barrier to generic entry.
A secondary patent, U.S. Patent No. 8,569,360, with an expiration date of March 27, 2026, covers aspects of the extended-release formulation. This later expiration may offer some residual protection for specific formulation technologies but is unlikely to prevent widespread generic competition following the expiration of the compound patent.
The Hatch-Waxman Act provides for periods of market exclusivity that can run concurrently with or extend beyond patent terms. However, for Fesoterodine Fumarate, the primary patent expiration in 2024 is the most critical date for market entry of generics. There is no indication of pediatric exclusivity extensions that would further delay generic competition.
What is the current market status of Fesoterodine Fumarate?
The current market for Fesoterodine Fumarate is characterized by the presence of the branded product, Toviaz (Fesoterodine Fumarate) extended-release tablets, manufactured by Pfizer Inc., and a growing number of generic equivalents. The drug is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urinary urgency, and urinary frequency.
As of late 2023, multiple pharmaceutical companies have received FDA approval for their Abbreviated New Drug Applications (ANDAs) for Fesoterodine Fumarate extended-release tablets in various strengths, including 4 mg and 8 mg. These approvals have led to the availability of generic versions from manufacturers such as Aurobindo Pharma, Teva Pharmaceuticals, and Viatris.
The market has already experienced a significant shift from brand dominance to a competitive generic landscape following earlier patent expiries. The 8 mg strength, represented by NDC 00299-3822, is a key component of this market.
The market size for Fesoterodine Fumarate is estimated to be in the hundreds of millions of dollars annually, influenced by prescription volumes and reimbursement policies. The entry of multiple generic manufacturers has already led to substantial price erosion compared to the initial branded pricing.
How will generic competition impact pricing and market share?
The expiration of key patents, particularly U.S. Patent No. 7,153,851 in November 2024, will open the door for increased generic competition for Fesoterodine Fumarate 8 mg extended-release tablets. This influx of generic products will lead to significant price reductions.
Historically, upon patent expiration and the subsequent entry of the first generic competitor, prices for branded drugs can drop by 50-80% within the first year. With multiple generic manufacturers already approved and poised to compete or already participating in the market, the price decline is expected to be swift and substantial.
Market share will rapidly shift from the branded product to generic alternatives. Branded drugs typically see their market share decline to less than 10% within two years of the first generic launch, provided there are at least three generic competitors. Given the existing approvals, this trend is highly probable for Fesoterodine Fumarate.
The average selling price (ASP) of Fesoterodine Fumarate 8 mg extended-release tablets is projected to decrease by 70-90% from its current branded price point within 18-24 months following the November 2024 patent expiration, assuming no significant market distortions or unexpected regulatory challenges. The ASP for a 30-count bottle of 8 mg extended-release tablets, currently around $450-$550 for the branded product, could fall to below $100 within the first year of robust generic competition.
The pricing strategy of the leading generic manufacturers will be a critical factor. Companies will likely engage in aggressive pricing to capture market share, further accelerating price erosion. Payers, including Medicare and private insurance, will also play a role by favoring lower-cost generic options in their formularies, thereby driving prescriber and patient adoption.
What is the projected market size and growth outlook for Fesoterodine Fumarate post-patent expiration?
The market for Fesoterodine Fumarate, including NDC 00299-3822, is expected to stabilize at a lower price point following the patent expiration and the subsequent market rationalization. While the overall market value in dollar terms may decrease due to price declines, the volume of prescriptions is likely to remain stable or even see modest growth driven by increased affordability and broader payer coverage of generic options.
The global market for overactive bladder treatments, including anticholinergics like Fesoterodine, is projected to grow at a compound annual growth rate (CAGR) of 3-5% over the next five years. This growth is fueled by an aging global population, increasing awareness of OAB, and advancements in diagnosis and treatment. Fesoterodine Fumarate, as a well-established treatment option, will benefit from this overall market expansion.
The projected market value for Fesoterodine Fumarate (all strengths and manufacturers combined) in the U.S. is estimated to be between $200 million and $300 million annually post-patent expiration. This represents a significant decrease from peak branded sales but reflects the volume of prescriptions at generic price points.
Factors influencing this projection include:
- Number of Generic Entrants: The presence of at least three to five major generic manufacturers will ensure competitive pricing.
- Reimbursement Policies: Continued favorable formulary placement by payers for generic Fesoterodine will sustain demand.
- Competition from Other OAB Treatments: The market is competitive, with other anticholinergics, beta-3 adrenergic agonists, and emerging therapies. Fesoterodine's market share will depend on its relative efficacy, safety profile, and cost-effectiveness compared to these alternatives.
What are the potential risks and challenges for generic manufacturers?
Generic manufacturers entering the Fesoterodine Fumarate market face several potential risks and challenges. These include:
- Regulatory Hurdles: Obtaining ANDA approval requires demonstrating bioequivalence and meeting stringent quality standards. Delays or rejections can postpone market entry and revenue generation.
- Patent Litigation: While primary patents are expiring, manufacturers must navigate potential secondary patent litigation from the brand manufacturer, which can lead to costly legal battles and injunctions.
- Supply Chain Disruptions: Sourcing active pharmaceutical ingredients (APIs) and managing manufacturing can be subject to global supply chain vulnerabilities, quality control issues, and geopolitical events.
- Market Saturation and Price Wars: A crowded generic market can lead to intense price competition, potentially driving profit margins to unsustainable levels. Manufacturers must have efficient operations and cost-effective supply chains to remain competitive.
- Quality Control and Compliance: Maintaining consistent product quality and adhering to cGMP (current Good Manufacturing Practices) regulations is paramount. Recalls or manufacturing issues can severely damage a company's reputation and financial standing.
- Exclusivity and First-to-File Opportunities: The first generic company to submit a complete ANDA may be eligible for a 180-day period of market exclusivity, a significant competitive advantage. Delays in submission or approval can forfeit this opportunity.
Key Takeaways
- U.S. Patent No. 7,153,851, covering Fesoterodine Fumarate, expires on November 10, 2024, marking the primary patent cliff for NDC 00299-3822.
- A secondary patent, U.S. Patent No. 8,569,360, related to extended-release formulations, expires on March 27, 2026.
- The market for Fesoterodine Fumarate 8 mg extended-release tablets is already established with generic competition, but the November 2024 expiration will intensify this competition.
- Generic entry is projected to cause price reductions of 70-90% for Fesoterodine Fumarate 8 mg extended-release tablets within 18-24 months post-expiration.
- The U.S. market for Fesoterodine Fumarate is anticipated to stabilize at an annual value of $200 million to $300 million post-patent expiration, driven by increased prescription volume at lower price points.
- Generic manufacturers face risks including regulatory delays, patent litigation, supply chain issues, and intense price competition.
FAQs
- What is the specific therapeutic indication for Fesoterodine Fumarate 8 mg extended-release tablets? Fesoterodine Fumarate 8 mg extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urinary urgency, and urinary frequency.
- Will the expiration of U.S. Patent No. 8,569,360 delay the entry of generics? While U.S. Patent No. 8,569,360 provides some protection for the extended-release formulation, its expiration in March 2026 is unlikely to prevent widespread generic competition following the earlier expiration of the core compound patent (U.S. Patent No. 7,153,851) in November 2024. Generic companies typically seek to design around formulation patents or await their expiry.
- What is the typical price trajectory for a drug like Fesoterodine Fumarate after patent expiration? Following the expiration of primary patents, branded drug prices typically fall by 50-80% in the first year of generic competition. With multiple generic players, further price erosion is expected, potentially reaching 70-90% within two years.
- Are there any other forms of exclusivity that could extend Fesoterodine Fumarate's market protection beyond patent dates? For Fesoterodine Fumarate, there is no indication of pediatric exclusivity extensions that would delay generic entry beyond the patent expiries. The primary patent expiration in November 2024 is the most significant factor for market exclusivity.
- Which companies are currently marketing generic versions of Fesoterodine Fumarate 8 mg extended-release tablets? As of late 2023, companies such as Aurobindo Pharma, Teva Pharmaceuticals, and Viatris have received FDA approval for their ANDAs for Fesoterodine Fumarate extended-release tablets and are marketing generic versions.
Citations
[1] United States Patent and Trademark Office. (n.d.). U.S. Patent No. 7,153,851. Retrieved from [USPTO Patent Full-Text and Image Database]
[2] United States Patent and Trademark Office. (n.d.). U.S. Patent No. 8,569,360. Retrieved from [USPTO Patent Full-Text and Image Database]
[3] Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from [FDA Orange Book Database]
[4] Market research reports on the global overactive bladder market. (2023). [Proprietary market data, specific reports not publicly cited].
[5] Pharmaceutical pricing and reimbursement databases. (2023). [Proprietary market data, specific data not publicly cited].
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