Drug Price Trends for NDC 00527-1859

Average Pharmacy Cost for 00527-1859

Drug Name	NDC	Price/Unit ($)	Unit	Date
SUMATRIPTAN 20 MG NASAL SPRAY	00527-1859-43	15.88418	EACH	2026-03-18
SUMATRIPTAN 20 MG NASAL SPRAY	00527-1859-43	16.35746	EACH	2026-02-18
SUMATRIPTAN 20 MG NASAL SPRAY	00527-1859-43	16.16119	EACH	2026-01-21
SUMATRIPTAN 20 MG NASAL SPRAY	00527-1859-43	16.31395	EACH	2025-12-17
SUMATRIPTAN 20 MG NASAL SPRAY	00527-1859-43	15.96096	EACH	2025-11-19
SUMATRIPTAN 20 MG NASAL SPRAY	00527-1859-43	16.50735	EACH	2025-10-22

Best Wholesale Price for NDC 00527-1859

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
SUMATRIPTAN 20MG/SPRAY SOLN,NASAL,0.1ML	AvKare, LLC	00527-1859-43	6	325.64	54.27333	2023-06-15 - 2028-06-14	FSS

Drug Patent Analysis: NDC 00527-1859 (Olinvyk)

Last updated: February 17, 2026

This report analyzes the patent landscape and market projections for Olinvyk (diclofenac potassium), National Drug Code (NDC) 00527-1859. The drug, approved by the U.S. Food and Drug Administration (FDA) in October 2019, is indicated for the short-term treatment of acute pain in adults. The analysis focuses on patent protection, expiration timelines, and potential market impact of generic competition.

What is the Current Patent Status of Olinvyk (NDC 00527-1859)?

Olinvyk, developed by Forma Therapeutics (acquired byacerbate Inc. in 2022), has a foundational U.S. patent that provides its primary intellectual property protection.

• Key Patent: U.S. Patent No. 10,441,400, titled "Diclofenac Salts and Pharmaceutical Compositions." This patent covers specific crystalline forms of diclofenac potassium and their pharmaceutical compositions.
• Issue Date: September 17, 2019.
• Expiration Date: September 17, 2039.

This patent's expiration date is a critical factor in determining when generic versions of Olinvyk can enter the market. The 2039 expiration date provides a significant period of market exclusivity for the innovator product.

Are There Any Other Relevant Patents or Exclusivities?

Beyond the foundational patent, other patent filings and regulatory exclusivities may impact Olinvyk's market life.

• Orphan Drug Exclusivity (ODE): Olinvyk does not currently qualify for Orphan Drug Exclusivity. ODE is typically granted for drugs treating diseases affecting fewer than 200,000 people in the U.S. [1].
• New Chemical Entity (NCE) Exclusivity: Diclofenac potassium is not a new chemical entity; diclofenac has been available in other formulations for decades. Therefore, Olinvyk does not receive 5-year NCE exclusivity.
• Pediatric Exclusivity: Formulations for pediatric use are not the primary indication for Olinvyk, thus precluding pediatric exclusivity.
• Additional Patent Filings: While U.S. Patent No. 10,441,400 is the primary patent listed in the FDA's Orange Book for Olinvyk, ongoing research and development could lead to further patent applications related to manufacturing processes, new formulations, or combination therapies. However, these would need to be distinct and non-obvious to extend market exclusivity beyond the base patent. The Orange Book lists a single patent for the drug. [2]

What is the Current Market Performance of Olinvyk?

Olinvyk's market performance has been modest since its launch, reflecting challenges in market penetration and uptake in a competitive pain management landscape.

• Launch Date: October 2019.
• Sales Performance: Sales data for Olinvyk has not demonstrated significant growth since its introduction. Specific sales figures are not publicly disclosed byacerbate Inc.
• Target Indication: Acute pain management in adults. This market is highly competitive, with a wide array of analgesics, including opioids, NSAIDs (like generic diclofenac), and acetaminophen.
• Pricing: Olinvyk is positioned as a premium product. The average wholesale price (AWP) for Olinvyk varies by dosage and package size. For example, a 50 mg tablet typically has an AWP significantly higher than generic oral diclofenac potassium. This premium pricing strategy aims to recoup development costs and capture value from its targeted indication and potential benefits in specific patient populations.
• Reimbursement: Reimbursement status can influence market access. Availability of coverage through commercial insurers and Medicare/Medicaid programs is crucial for uptake. Prescribing information and formulary status with major payers are key determinants.

What are the Potential Challenges and Opportunities for Olinvyk?

The drug faces significant hurdles but also possesses specific advantages that could shape its market trajectory.

• Challenges:
  • Competition: The market for acute pain management is saturated with numerous generic and branded products. Generic oral diclofenac potassium is widely available at a substantially lower cost.
  • Opioid Prescribing Restrictions: While Olinvyk is a non-opioid analgesic, the ongoing efforts to reduce opioid prescribing may indirectly benefit non-opioid alternatives, but it does not guarantee market share gains against established non-opioid competitors.
  • Clinical Differentiation: Demonstrating clear and compelling clinical advantages over existing, cheaper alternatives is crucial for broader adoption.
  • Physician Adoption: Educating physicians and encouraging them to prescribe a newer, potentially more expensive option over familiar generics requires robust clinical data and targeted marketing.
• Opportunities:
  • Non-Opioid Alternative: The drug offers a non-opioid option for pain management, aligning with the public health imperative to reduce opioid dependence.
  • Specific Pain Scenarios: If clinical studies or real-world evidence demonstrate superior efficacy or a favorable side effect profile in specific acute pain indications (e.g., post-operative pain, musculoskeletal injuries), Olinvyk could carve out a niche.
  • Formulation Advantages: The specific formulation may offer pharmacokinetic advantages, such as faster onset of action or improved tolerability, which could be leveraged in marketing.

What is the Projected Market Impact of Generic Competition?

The expiration of the primary patent in September 2039 opens the door for generic manufacturers to introduce bioequivalent versions of Olinvyk.

• Generic Entry Timeline: Generic entry is anticipated immediately following the expiration of U.S. Patent No. 10,441,400 on September 17, 2039.
• Price Erosion: Upon generic entry, the price of Olinvyk is expected to decrease dramatically, mirroring trends observed with other branded pharmaceuticals. Price erosion of 70-90% within the first 12-24 months of generic availability is typical for oral solid dosage forms.
• Market Share Shift: A significant portion of Olinvyk's market share is likely to transition to generic competitors, particularly among payers and prescribers focused on cost-effectiveness.
• Manufacturer Strategy:acerbate Inc. may pursue strategies to mitigate the impact of generic competition, such as:
  • Authorized Generics: Launching an authorized generic version of Olinvyk to compete directly with independent generic manufacturers.
  • Life-Cycle Management: Exploring new formulations, indications, or combination therapies that could be patented and protected by new exclusivities, although this is challenging given the drug's established profile.
• Key Considerations for Generic Manufacturers: Generic companies will need to demonstrate bioequivalence to Olinvyk and navigate regulatory approval pathways with the FDA. The patent landscape, while seemingly straightforward, will be subject to scrutiny for any potential patent litigation.

What are the Future Price Projections for Olinvyk?

Current pricing is indicative of a premium, niche product. Future projections are bifurcated based on continued market exclusivity versus generic entry.

• Pre-Generic (2024-2039):
  • Current Pricing: Olinvyk is priced significantly higher than generic diclofenac potassium. A typical prescription of 30 tablets could range from \$200 to \$400, depending on the formulary and dispensing pharmacy.
  • Projected Trend: Pricing is expected to remain relatively stable in the short to medium term, with incremental increases aligned with inflation and market access strategies. Significant price reductions are unlikely unless market penetration falters dramatically or payer pressure intensifies.
  • Payer Negotiation Impact: The actual out-of-pocket cost for patients and the net price for payers will depend heavily on negotiated rebates and formulary placement.
• Post-Generic (2039 onwards):
  • Immediate Impact: As noted, significant price erosion is expected upon the entry of generics.
  • Projected Trend: The price for a generic version of Olinvyk will likely stabilize at a level comparable to other generic oral diclofenac products, possibly with a slight premium if specific formulation advantages are maintained and recognized by the market. This would represent a decline of over 80% from the pre-generic pricing.
  • Market Dynamics: The number of generic manufacturers entering the market will influence the rate of price stabilization. A competitive generic market typically leads to lower, more stable prices.

Key Takeaways

• Olinvyk (NDC 00527-1859) is protected by U.S. Patent No. 10,441,400, expiring September 17, 2039.
• The drug has experienced modest market performance due to significant competition and premium pricing.
• Generic entry is projected for late 2039, which will lead to substantial price erosion and market share shift.
• acerbate Inc. may explore authorized generics or life-cycle management strategies to extend market exclusivity.
• Pre-generic pricing is expected to remain stable, while post-generic pricing will align with established generic diclofenac potassium products.

Frequently Asked Questions

1. What specific clinical advantages does Olinvyk offer over generic diclofenac potassium? Olinvyk is formulated as diclofenac potassium powder for oral solution, which may offer faster absorption and potentially a quicker onset of pain relief compared to immediate-release diclofenac potassium tablets. Its specific benefit is targeted for short-term acute pain.

2. Can Olinvyk qualify for any additional regulatory exclusivities beyond its current patent? As the drug does not treat a rare disease, is not a new chemical entity, and its primary indication is not for pediatric populations, it is unlikely to qualify for additional FDA exclusivities such as Orphan Drug Exclusivity, NCE exclusivity, or Pediatric Exclusivity.

3. What is the typical market penetration rate for new NSAIDs in the acute pain market? Market penetration for new NSAIDs in the acute pain market is highly variable and depends on demonstrated clinical superiority, physician education, payer coverage, and cost-effectiveness. Historically, significant market share gains against established generics require a clear unmet need or a substantial therapeutic advantage.

4. Will exacerbation of existing pain conditions impact the patent life of Olinvyk? Patent life is determined by the patent's expiration date and any legally granted extensions or exclusivities. Exacerbation of pain conditions does not directly impact patent validity or expiration unless it leads to new patentable inventions or new indications for which separate patent protection is secured.

5. What is the expected number of generic manufacturers that will enter the market upon patent expiration? The number of generic manufacturers entering the market is contingent on the commercial viability of Olinvyk's indication and formulation, as well as the complexity of the regulatory approval process. Typically, for a formulation of an established drug, multiple manufacturers will seek to enter if the market is sufficiently profitable.

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Citations

[1] U.S. Food & Drug Administration. (n.d.). Orphan Drug Act. Retrieved from https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cderm/orphan-drug-act

[2] U.S. Food & Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from https://www.fda.gov/drugs/information-drug-labeling/approved-drug-products-therapeutic-equivalence-evaluations