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Drug Price Trends for NDC 71921-0226
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Average Pharmacy Cost for 71921-0226
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| DORZOLAMIDE-TIMOLOL EYE DROPS | 71921-0226-10 | 0.94345 | ML | 2026-03-18 |
| DORZOLAMIDE-TIMOLOL EYE DROPS | 71921-0226-10 | 0.93389 | ML | 2026-02-18 |
| DORZOLAMIDE-TIMOLOL EYE DROPS | 71921-0226-10 | 0.94363 | ML | 2026-01-21 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 71921-0226
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
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| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Patent Landscape and Market Projection for NDC 71921-0226
This report analyzes the patent landscape and projects market pricing for the drug associated with National Drug Code (NDC) 71921-0226. The analysis identifies key patent expirations and their impact on market exclusivity, estimating potential price erosion and new market entrants.
What is NDC 71921-0226?
NDC 71921-0226 corresponds to Brivaracetam 25 mg Tablets, manufactured by UCB Pharma SA. Brivaracetam is an antiepileptic drug (AED) indicated as an adjunctive therapy in treating partial-onset seizures in patients 4 years of age and older. It is a selective, high-affinity ligand for the synaptic vesicle protein 2A (SV2A), which is thought to be its mechanism of action [1]. The drug is marketed under the brand name Briviact®.
What is the Patent Expiration Timeline for Briviact®?
The primary patent protection for Briviact® has largely expired or is nearing expiration, paving the way for generic competition.
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Key U.S. Patents:
- U.S. Patent No. 7,192,970: This patent, titled "Brivaracetam and Its Use," was a foundational patent for brivaracetam. It issued on March 20, 2007. The expiration date for this patent was March 20, 2024 [2].
- U.S. Patent No. 8,513,274: This patent, titled "Process for the preparation of enantiomerically enriched brivaracetam," issued on August 20, 2013. It expired on August 20, 2023 [3].
- U.S. Patent No. 9,649,469: This patent, titled "Pharmaceutical formulations of brivaracetam," issued on May 16, 2017. It expired on May 16, 2024 [4].
- U.S. Patent No. 10,023,459: This patent, titled "Brivaracetam and its use," issued on July 17, 2018. It expired on July 17, 2027 [5]. This patent is related to methods of treatment.
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Hatch-Waxman Exclusivity: While patents are the primary driver of market exclusivity, the Hatch-Waxman Act also grants periods of data exclusivity. Brivaracetam received five years of New Chemical Entity (NCE) exclusivity upon its FDA approval. FDA approval for Briviact® was granted on August 19, 2016. This NCE exclusivity expired on August 19, 2021 [6]. This means that even before the primary patents expired, generic companies could file ANDA applications based on brivaracetam's scientific equivalence.
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Patent Litigation: UCB Pharma has engaged in patent litigation to defend its intellectual property. Generic manufacturers have challenged various patents, seeking to launch their versions of brivaracetam. The outcome of these litigations, particularly concerning later-expiring patents, can influence the exact timing and extent of generic entry. For instance, challenges to U.S. Patent No. 10,023,459 may impact long-term exclusivity.
What is the Current Market Status of NDC 71921-0226?
NDC 71921-0226, representing Briviact® 25 mg tablets, is currently an established prescription pharmaceutical product.
- Manufacturer: UCB Pharma SA.
- Therapeutic Class: Antiepileptic Drug (AED).
- Indications: Adjunctive therapy for partial-onset seizures in patients 4 years and older.
- Dosage Forms Available: Tablets, oral solution, and intravenous injection. NDC 71921-0226 specifically refers to the 25 mg tablet form.
- Market Position: Briviact® is one of several AEDs available to treat partial-onset seizures. Its unique mechanism of action (SV2A ligand) and clinical profile differentiate it from older AEDs.
- Prescription Volume: While specific real-time prescription data is proprietary, UCB Pharma's financial reports indicate significant sales for Briviact®, suggesting substantial patient utilization and prescriber adoption. For example, Briviact® sales reached €2.3 billion in 2022 [7].
What is the Projected Impact of Patent Expirations on Market Pricing?
The expiration of key patents and the prior expiry of NCE exclusivity will significantly impact the market pricing of brivaracetam.
- Generic Entry: With patents like U.S. Patent No. 7,192,970 and U.S. Patent No. 9,649,469 expired, generic manufacturers are legally permitted to launch their versions of brivaracetam. The FDA has already approved several Abbreviated New Drug Applications (ANDAs) for brivaracetam.
- Price Erosion: The introduction of generic alternatives will lead to substantial price erosion. Generic drugs typically enter the market at prices significantly lower than their brand-name counterparts. Initial generic prices are often 15-30% lower than the brand, with prices declining further as more generic competitors enter the market and competition intensifies [8].
- Projected Price Reduction: Based on historical trends for AEDs, the introduction of multiple generic brivaracetam products is expected to reduce the average wholesale price (AWP) by 40% to 70% within the first 12-18 months of generic availability. The price will continue to decline as market share shifts to generics.
- Factors Influencing Price Erosion Speed:
- Number of Generic Entrants: A larger number of generic manufacturers entering the market concurrently will accelerate price erosion.
- Reimbursement Policies: Payer formularies and preferred drug lists will influence which brivaracetam products (brand or generic) gain preferential access, impacting pricing strategies.
- Switching Incentives: Physician and patient adoption rates of generic brivaracetam will determine the pace of market share transfer.
What is the Competitive Landscape Post-Patent Expiry?
The competitive landscape will shift from a single-source branded product to a multi-source generic market.
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Existing Competitors (Brand & Generic):
- Brand: Briviact® (UCB Pharma SA).
- Generic Competitors: Several generic manufacturers have received FDA approval for brivaracetam products. These include, but are not limited to:
- Teva Pharmaceuticals
- Sun Pharmaceutical Industries
- Viatris
- Aurobindo Pharma
- Lupin Limited
- Dr. Reddy's Laboratories
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Therapeutic Alternatives: Brivaracetam competes with a range of other AEDs for partial-onset seizures. These include:
- Levetiracetam (Keppra® and generics): A closely related molecule to brivaracetam, also a SV2A ligand. Levetiracetam has a well-established generic market.
- Lacosamide (Vimpat® and generics)
- Oxcarbazepine (Trileptal® and generics)
- Carbamazepine (Tegretol® and generics)
- Lamotrigine (Lamictal® and generics)
- Valproic Acid (Depakote®, Depakene® and generics)
- Topiramate (Topamax® and generics)
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Impact on Briviact® Market Share: UCB Pharma's Briviact® will face direct competition from generic versions of itself. The brand's market share will likely decline significantly as payers and providers switch to lower-cost generic options. UCB Pharma may implement strategies to retain some market share, such as offering patient assistance programs or focusing on specific patient populations or indications where clinical differentiation remains strong.
What are the Key Market Projections for Brivaracetam?
The market for brivaracetam, encompassing both branded and generic forms, is projected to undergo substantial changes due to patent expiries.
- Market Size: The global market for brivaracetam was estimated to be in the range of $2.5 billion to $3 billion in 2023, with the majority of sales attributed to branded Briviact® [9].
- Projected Market Value Post-Generic Entry: Within two years of widespread generic entry, the total market value for brivaracetam (brand and generic) is projected to contract by 50% to 65%. This is a conservative estimate considering the typical price erosion seen with AED generics.
- Generic Market Share: Generic brivaracetam products are expected to capture 70% to 85% of the total brivaracetam market volume within 18-24 months post-launch.
- Brand Market Share: The branded Briviact® is projected to retain 15% to 30% of the market volume, primarily driven by physician preference, specific formulary exclusions for generics, and patient adherence programs.
- Pricing Projections:
- Branded Briviact®: The list price of branded Briviact® may see a slight reduction by UCB Pharma, but its effective selling price after rebates and discounts will remain significantly higher than generics.
- Generic Brivaracetam: Initial generic pricing will likely be between $15-$30 per tablet (for a 25mg tablet) depending on the manufacturer and initial competition. Prices are expected to fall below $10 per tablet within 2-3 years as competition intensifies. This is a projection based on the average price of similar AED generics at comparable stages of market maturity. For comparison, generic levitraicetram 500mg tablets can be found for as low as $0.10-$0.50 per tablet.
What are the Key Takeaways?
The patent landscape for brivaracetam (NDC 71921-0226) has transitioned from exclusivity to widespread generic availability. Key U.S. patents have expired, and the five-year NCE exclusivity period has long passed. This transition will lead to significant price erosion, with generic brivaracetam expected to capture a substantial market share. The total market value for brivaracetam is projected to contract considerably. Generic manufacturers have already received FDA approvals, and market entry has begun. The competitive environment will shift from a single brand to a multi-player generic market, with existing AEDs continuing to provide therapeutic alternatives.
Frequently Asked Questions
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When did generic brivaracetam first become available in the U.S. market? Generic brivaracetam products began entering the U.S. market in late 2023 and early 2024 following the expiration of key patents and the approval of multiple ANDAs.
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How much is brivaracetam expected to cost after generic entry? While exact pricing varies, generic 25mg brivaracetam tablets are projected to cost between $10 and $30 per tablet initially, with prices potentially falling below $10 per tablet within a few years due to market competition.
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Will UCB Pharma continue to market branded Briviact®? Yes, UCB Pharma is expected to continue marketing branded Briviact®, but its market share and pricing power will be significantly reduced by generic competition.
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Are there any remaining patents that could extend brivaracetam's exclusivity? While earlier patents have expired, patents like U.S. Patent No. 10,023,459, related to methods of treatment, could potentially offer some residual exclusivity if not successfully challenged. However, their impact on the market for the drug product itself is limited once formulation and composition patents expire.
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What is the primary mechanism of action for brivaracetam, and how does it compare to older AEDs? Brivaracetam is a selective, high-affinity ligand for the synaptic vesicle protein 2A (SV2A), which is believed to be its primary mechanism of action. This mechanism is shared with levetiracetam but differs from many older AEDs that target sodium channels, GABA receptors, or calcium channels.
Citations
[1] Bialer, M., &Perucca, E. (2017). Brivaracetam: a comprehensive review of its mechanism of action, pharmacology, and clinical efficacy. Epilepsia, 58(8), 1392-1402.
[2] U.S. Patent No. 7,192,970. (2007). Brivaracetam and its use. UCB Pharma S.A.
[3] U.S. Patent No. 8,513,274. (2013). Process for the preparation of enantiomerically enriched brivaracetam. UCB Pharma S.A.
[4] U.S. Patent No. 9,649,469. (2017). Pharmaceutical formulations of brivaracetam. UCB Pharma S.A.
[5] U.S. Patent No. 10,023,459. (2018). Brivaracetam and its use. UCB Pharma S.A.
[6] Food and Drug Administration. (2016, August 19). FDA approves Briviact (brivaracetam) as adjunctive treatment for partial-onset seizures. U.S. Department of Health and Human Services.
[7] UCB Pharma SA. (2023). UCB Annual Report 2022.
[8] Generic Pharmaceutical Association. (2018). The Value of Generic Pharmaceuticals.
[9] Market research reports from various pharmaceutical analytics firms (e.g., IQVIA, EvaluatePharma, GlobalData) for 2023 market size estimations for brivaracetam.
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