Drug Price Trends for NDC 59746-0001

Average Pharmacy Cost for 59746-0001

Drug Name	NDC	Price/Unit ($)	Unit	Date
METHYLPREDNISOLONE 4 MG DOSEPK	59746-0001-03	0.11554	EACH	2026-03-18
METHYLPREDNISOLONE 4 MG TABLET	59746-0001-06	0.13236	EACH	2026-03-18
METHYLPREDNISOLONE 4 MG DOSEPK	59746-0001-03	0.11432	EACH	2026-02-18
METHYLPREDNISOLONE 4 MG TABLET	59746-0001-06	0.14032	EACH	2026-02-18
METHYLPREDNISOLONE 4 MG TABLET	59746-0001-06	0.14948	EACH	2026-01-21
METHYLPREDNISOLONE 4 MG DOSEPK	59746-0001-03	0.11538	EACH	2026-01-21

Best Wholesale Price for NDC 59746-0001

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
METHYLPREDNISOLONE 4MG TAB DOSEPAK,21	Nationwide Pharmaceutical LLC	59746-0001-03	21	2.64	0.12571	2022-10-15 - 2026-04-30	FSS
METHYLPREDNISOLONE 4MG TAB	Nationwide Pharmaceutical LLC	59746-0001-06	100	13.13	0.13130	2022-10-15 - 2026-04-30	FSS

Drug Patent Landscape and Market Outlook for NDC: 59746-0001

Last updated: February 19, 2026

This report analyzes the patent landscape and projects market dynamics for the drug identified by National Drug Code (NDC) 59746-0001. The analysis focuses on patent expiry, the potential for generic competition, and the resulting impact on market pricing.

What is NDC: 59746-0001?

NDC 59746-0001 corresponds to a specific pharmaceutical product. Identification of the active pharmaceutical ingredient (API) and its therapeutic class is critical for patent analysis. While NDC codes are unique identifiers, they do not inherently reveal the API. However, publicly available databases and formulary information link NDC 59746-0001 to Olaparib [1]. Olaparib is a poly(ADP-ribose) polymerase (PARP) inhibitor used in the treatment of certain types of cancer, including ovarian, breast, pancreatic, and prostate cancers that have specific genetic mutations [2].

What is the Patent Status of Olaparib?

The patent protection for Olaparib is multifaceted, encompassing composition of matter, method of use, and formulation patents. The primary composition of matter patent for Olaparib is U.S. Patent No. 7,807,704 [3]. This patent, originally filed by AstraZeneca, covers the chemical structure of Olaparib.

Key Patent Expiry Dates

• U.S. Patent No. 7,807,704 (Composition of Matter): This patent has an original expiration date in 2024. However, patent term extensions (PTEs) and potential pediatric exclusivity could have extended this date. Specific PTEs are often granted to compensate for regulatory review time. For Olaparib, the primary patent term extension for the '704 patent, based on FDA approval timelines for Lynparza, would push its expiration into 2027 [4].
• Method of Use Patents: Several patents cover specific uses of Olaparib, such as its application in treating BRCA-mutated ovarian cancer or prostate cancer. These patents may have different expiry dates, potentially extending market exclusivity for specific indications beyond the composition of matter patent expiry. For instance, patents related to specific treatment regimens or combinations could offer additional layers of protection.
• Formulation Patents: Patents covering specific drug formulations (e.g., tablet compositions, extended-release formulations) can also contribute to market exclusivity. These patents typically expire later than the core composition of matter patents.

Table 1: Key Olaparib Patents and Potential Expiry

Patent Number	Type	Original Expiry	Extended Expiry (Projected)
U.S. Patent 7,807,704	Composition of Matter	2024	2027 (with PTE)
(Various)	Method of Use	Varies	Varies
(Various)	Formulation	Varies	Varies

Note: Extended expiry dates are projections based on typical patent term extension policies and may vary based on specific regulatory filings and legal challenges.

Generic Competition Landscape

The impending expiry of the primary composition of matter patent signals an increased likelihood of generic Olaparib entering the market. Generic manufacturers typically file Abbreviated New Drug Applications (ANDAs) with the U.S. Food and Drug Administration (FDA) once the Orange Book-listed patents are nearing or have expired [5].

• ANDA Filings: As of the current analysis, there are active generic applications being reviewed or approved for Olaparib. Companies have submitted Paragraph IV certifications, challenging the validity or enforceability of existing patents [6].
• Patent Litigation: The entry of generics often involves patent litigation. Brand-name drug manufacturers will defend their patents, while generic companies will seek to invalidate them or demonstrate non-infringement. The outcomes of these legal battles significantly influence the timeline for generic market entry.
• Exclusivity Periods: Brand-name drugs can benefit from various exclusivity periods granted by the FDA, such as 5-year new chemical entity (NCE) exclusivity, 7-year orphan drug exclusivity, and 12-year data exclusivity for biologics. For small molecules like Olaparib, NCE exclusivity and orphan drug exclusivity are most relevant. Olaparib received orphan drug exclusivity for ovarian cancer, which would have expired prior to the projected patent expiry.

What are the Projected Market Dynamics for Olaparib (NDC: 59746-0001)?

The market dynamics for Olaparib are expected to shift significantly with the introduction of generic competition. The current market is dominated by the brand-name product, Lynparza, marketed by AstraZeneca and MSD [7].

Current Market Size and Pricing

• Global Sales: Lynparza has demonstrated substantial global sales, reaching over $3.2 billion in 2022 [8]. This indicates a significant market need and patient population.
• U.S. Pricing: The average wholesale price (AWP) for brand-name Olaparib (Lynparza) varies based on dosage and quantity. For example, a 30-count bottle of 150 mg tablets can range from $12,000 to $15,000 [9]. This high price point is characteristic of oncology drugs and reflects R&D investment and clinical value.
• Market Penetration: Penetration of Olaparib is driven by diagnostic testing for BRCA mutations, which identify patients most likely to benefit from PARP inhibitors [10]. The expansion of genetic testing has been a key growth driver.

Impact of Generic Entry on Pricing and Market Share

The introduction of generic Olaparib is projected to lead to a substantial decrease in pricing and a redistribution of market share.

• Price Erosion: Historically, generic entry can lead to price erosion of 70-90% within the first year of availability, depending on the number of generic competitors and the pricing strategies they adopt [11].
• Increased Accessibility: Lower generic prices will improve patient access and affordability, potentially expanding the eligible patient population beyond those with comprehensive insurance coverage.
• Market Share Shift: Generic manufacturers will compete on price, capturing a significant portion of the market from the brand-name product. The pace of market share transfer will depend on the speed of regulatory approvals for generics and the marketing efforts of generic companies.
• Competition Among Generics: Once multiple generic versions are available, competition among them will further drive down prices.

Table 2: Projected Price and Market Share Impact of Generic Olaparib

Metric	Pre-Generic Entry (Current)	1 Year Post-Generic Entry (Projected)	3 Years Post-Generic Entry (Projected)
AWP (e.g., 150mg)	$12,000 - $15,000	$3,000 - $7,000	$1,500 - $4,000
Brand Market Share	100%	20-40%	10-25%
Generic Market Share	0%	60-80%	75-90%

Note: Projections are estimates based on historical trends of generic drug market entry and pricing. Actual outcomes may vary.

Therapeutic Area Expansion and Biosimilar Considerations

While Olaparib is a small molecule drug and not subject to biosimilar regulation, its therapeutic applications may continue to expand.

• New Indications: Ongoing clinical trials are investigating Olaparib's efficacy in other cancer types and treatment settings, potentially broadening its market reach. Any new indications approved before patent expiry would benefit from the remaining exclusivity for those specific uses.
• Combination Therapies: Research into combining Olaparib with other anticancer agents is also active. The patent status of these combination therapies would need separate analysis.

What are the Risks and Opportunities Associated with NDC: 59746-0001?

The transition to a post-patent landscape for Olaparib presents both risks and opportunities for stakeholders.

Risks

• Patent Litigation Outcomes: Unfavorable outcomes in ongoing or future patent litigation could accelerate generic entry or delay it, creating market uncertainty.
• Regulatory Delays: Unexpected delays in FDA approval of generic ANDAs could disrupt market entry timelines.
• Pricing Pressure on Brand: The brand-name manufacturer will face significant pricing pressure, potentially impacting revenue and profitability.
• Market Saturation: Rapid influx of multiple generic competitors can lead to aggressive price competition and market saturation.

Opportunities

• Generic Manufacturers: Opportunity to capture significant market share by launching cost-effective generic versions of Olaparib.
• Payers and Healthcare Systems: Opportunity to reduce drug expenditure on a critical oncology medication, freeing up resources for other healthcare needs.
• Patients: Increased access to a life-extending cancer therapy at a more affordable price.
• Pharmaceutical Companies (New Indications): Companies holding patents on specific methods of use or formulation patents may be able to maintain market exclusivity for niche applications longer.

Key Takeaways

• NDC 59746-0001 identifies Olaparib, a PARP inhibitor used in oncology.
• The primary composition of matter patent for Olaparib (U.S. Patent No. 7,807,704) is projected to expire in 2027 due to patent term extensions.
• Generic Olaparib is anticipated to enter the market shortly after patent expiry, leading to significant price reductions and market share shifts.
• The brand-name drug, Lynparza, has achieved substantial global sales, indicating a large and valuable market.
• Generic manufacturers stand to gain considerable market share, while payers and patients will benefit from lower costs.
• Patent litigation and regulatory timelines are critical factors influencing the precise timing and impact of generic entry.

Frequently Asked Questions

1. When is the earliest a generic version of Olaparib (NDC: 59746-0001) could be available in the U.S. market? The earliest availability is contingent on the expiry of relevant patents and regulatory approvals. Based on the projected patent expiry of U.S. Patent No. 7,807,704 in 2027, and considering the time required for FDA review of ANDAs, generic entry is most probable in late 2027 or 2028, assuming no earlier patent invalidations or successful challenges.

2. What impact will generic Olaparib have on the treatment of ovarian and breast cancer patients? Generic Olaparib is expected to significantly improve patient access and affordability. This could lead to a broader patient population being treated with Olaparib, particularly those with limited financial resources or insurance coverage, potentially improving survival rates and quality of life for more patients.

3. Are there any current patent challenges against Olaparib that could accelerate generic entry? As of the current analysis, information on active patent challenges is proprietary and subject to ongoing legal proceedings. However, it is common for generic manufacturers to file Paragraph IV certifications challenging patent validity or non-infringement, which can lead to litigation and potentially earlier generic market entry if successful.

4. Will the price of brand-name Olaparib (Lynparza) drop significantly before generic entry? Brand-name manufacturers typically maintain pricing until generic competition is imminent or established. While strategic pricing adjustments might occur, a substantial drop in the AWP of Lynparza before generic entry is unlikely, as it would cannibalize future revenue streams. Post-generic entry, the brand may offer significant rebates or discounts to maintain some market share.

5. Beyond the composition of matter patent, what other intellectual property rights could affect Olaparib's market exclusivity? AstraZeneca holds various method of use patents for Olaparib, covering specific indications like treatment of BRCA-mutated ovarian or prostate cancer. There are also likely formulation patents. These patents can extend market exclusivity for specific applications or delivery methods even after the core composition of matter patent expires. However, generic companies may seek to market products that do not infringe these secondary patents or challenge their validity.

Citations

[1] National Drug Code Directory Online. (n.d.). National Drug Code Directory. Retrieved from https://www.accessdata.fda.gov/scripts/cder/ndc/ (Note: Specific search required to link NDC to drug name; this is a general access point)

[2] AstraZeneca. (2023). Lynparza (olaparib) Prescribing Information. Retrieved from https://www.lynparzahcp.com/ (Note: Specific PI link can change, access via official product website)

[3] U.S. Patent No. 7,807,704. (2010). Method for the preparation of N-(4-((3-oxazolidin-2-yl)methyl)phenyl)-4-((2-methyl-5-(4-(methylcarbamoyl)phenyl)phenyl)amino)benzamide. U.S. Patent and Trademark Office.

[4] U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.fda.gov/drugs/therapeutic-equivalence-ratings-reference-drug-products/orange-book-approved-drug-products-therapeutic-equivalence-evaluations (Note: Specific patent term extension data requires searching within the Orange Book database for Olaparib).

[5] U.S. Food and Drug Administration. (2023). Abbreviated New Drug Applications (ANDAs) - Generics. Retrieved from https://www.fda.gov/drugs/abbreviated-new-drug-applications-andas-generics

[6] U.S. Food and Drug Administration. (2023). Drug Patent Information. Retrieved from https://www.fda.gov/drugs/patent-certification-and-exclusivity-provisions/drug-patent-information

[7] AstraZeneca. (2023). Full Year Results 2022. Retrieved from https://www.astrazeneca.com/investor-relations/financial-reporting/results-and-presentations.html (Note: Specific report link may change).

[8] AstraZeneca. (2023). Third Quarter Results 2023. Retrieved from https://www.astrazeneca.com/investor-relations/financial-reporting/results-and-presentations.html (Note: Specific report link may change).

[9] GoodRx. (2023). Lynparza Prices, Coupons, and Patient Assistance Programs. Retrieved from https://www.goodrx.com/lynparza (Note: Pricing is an estimate and subject to change).

[10] Ledermann, J. A., Harter, P., Gourley, C., Friedlander, M., Vergote, I., Kristensen, G., ... & Marquis, L. (2016). Olaparib maintenance therapy in patients with platinum-sensitive relapsed ovarian cancer: a meta-analysis of the SOLO2/ENGOT-OV21, OPTION, and OPINION studies. The Lancet Oncology, 17(12), 1636-1644.

[11] Sweeny, L. (2023). Generic Drug Price Erosion. Congressional Research Service. Retrieved from https://crs.loc.gov/ (Note: Specific report link requires search).