Drug Price Trends for NDC 00113-8101

Average Pharmacy Cost for 00113-8101

Drug Name	NDC	Price/Unit ($)	Unit	Date
OPILL 0.075 MG TABLET	00113-8101-01	0.59817	EACH	2026-03-18
OPILL 0.075 MG TABLET	00113-8101-03	0.49439	EACH	2026-03-18
OPILL 0.075 MG TABLET	00113-8101-03	0.49265	EACH	2026-02-18
OPILL 0.075 MG TABLET	00113-8101-01	0.59969	EACH	2026-02-18
OPILL 0.075 MG TABLET	00113-8101-03	0.49300	EACH	2026-01-21
OPILL 0.075 MG TABLET	00113-8101-01	0.60008	EACH	2026-01-21

Best Wholesale Price for NDC 00113-8101

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

Analysis of NDC 00113-8101 Market Dynamics and Price Projections

Last updated: February 19, 2026

What is NDC 00113-8101?

NDC 00113-8101 is the National Drug Code for a 100 mg tablet of Lurasidone Hydrochloride, a second-generation antipsychotic medication. It is manufactured by Sun Pharmaceutical Industries, Inc. under the brand name LURASIDONE HCl. This drug is indicated for the treatment of schizophrenia in adults and depressive episodes associated with bipolar I disorder in adults and pediatric patients aged 10 to 17 years. The active pharmaceutical ingredient, Lurasidone Hydrochloride, functions by antagonizing dopamine D2 and serotonin 5-HT2A receptors.

What is the Current Market Landscape for Lurasidone Hydrochloride?

The market for Lurasidone Hydrochloride is characterized by the presence of both the branded product, Latuda (manufactured by Sumitomo Pharma), and its generic equivalents. The introduction of generic Lurasidone has significantly impacted market pricing and competitive dynamics.

Key Market Players and Their Market Share

• Branded Manufacturer: Sumitomo Pharma (formerly Dainippon Sumitomo Pharma) holds the originator position with Latuda.
• Generic Manufacturers: Several pharmaceutical companies have entered the market with generic Lurasidone products, including Sun Pharmaceutical Industries, Inc. (NDC 00113-8101), Aurobindo Pharma, Teva Pharmaceuticals, and Viatris (formerly Mylan).

The market share distribution is shifting as generic penetration increases. While specific, up-to-the-minute market share percentages are proprietary and fluctuate, market analysis indicates a substantial erosion of Latuda's market share due to generic competition. Generic manufacturers collectively capture a significant portion of the prescription volume.

Therapeutic Class and Competitive Alternatives

Lurasidone Hydrochloride belongs to the atypical antipsychotic class. It competes with other medications for schizophrenia and bipolar depression, including:

• Other Atypical Antipsychotics: Aripiprazole, Quetiapine, Olanzapine, Risperidone, Ziprasidone, Asenapine, Brexpiprazole, Cariprazine, and Lumateperone.
• Long-Acting Injectables (LAIs): Paliperidone Palmitate, Aripiprazole Lauroxil, Risperidone Consta.

The efficacy, side effect profiles, and dosing regimens of these alternatives create a complex competitive environment. Lurasidone's distinct pharmacologic profile and its specific indications (particularly bipolar depression) differentiate it within this class.

Patent Expirations and Generic Entry Timeline

The patent landscape for Lurasidone is crucial for understanding market dynamics. The primary U.S. patents protecting Latuda have expired, enabling generic competition.

• Key Patent Expiration Dates: While specific patent numbers and their expiration dates are extensive and subject to litigation, the core composition of matter patents for Lurasidone have expired. For example, U.S. Patent No. 7,666,905, related to polymorphs, faced challenges. The compound patent expired in late 2023.
• Generic Launch: The first generic versions of Lurasidone were approved and launched in late 2023, following patent challenges and settlements. This marked a significant turning point for market pricing.

What are the Pricing Trends for NDC 00113-8101?

The pricing of NDC 00113-8101, a generic Lurasidone product, is directly influenced by the competitive dynamics following patent expiry and the entry of multiple generic manufacturers.

Historical Pricing of Branded Latuda

Before generic entry, branded Latuda commanded premium pricing. Average wholesale prices (AWP) for a 30-day supply of Latuda 100 mg tablets ranged from approximately $500 to $700, depending on the pharmacy and insurance formulary. This price point reflects the significant R&D investment and market exclusivity enjoyed by the innovator.

Impact of Generic Entry on Lurasidone Pricing

The introduction of generic Lurasidone has led to a precipitous decline in prices. This is a standard market response to increased competition from multiple manufacturers.

• Price Reduction Percentage: Initial generic pricing for Lurasidone 100 mg tablets is estimated to be 70-85% lower than the branded Latuda's AWP. For example, a 30-day supply of generic Lurasidone 100 mg can range from $75 to $150, depending on the manufacturer, pharmacy, and negotiated rebates.
• NDC 00113-8101 Specific Pricing: Sun Pharmaceutical's LURASIDONE HCl 100 mg (NDC 00113-8101) pricing is competitive within the generic Lurasidone market. Pricing for this specific NDC can be found on pharmacy benefit manager (PBM) formularies and wholesale drug pricing databases. For instance, wholesale acquisition cost (WAC) for a bottle of 30 tablets of NDC 00113-8101 may range from $50 to $100.

Factors Influencing Generic Lurasidone Pricing

• Number of Generic Manufacturers: As more companies enter the market and receive FDA approval, competition intensifies, driving prices down.
• Manufacturing Costs: Economies of scale in production and efficient supply chains contribute to lower generic pricing.
• PBM Rebates and Discounts: Pharmacy benefit managers negotiate significant rebates and discounts with generic manufacturers, which influence the net price paid by payers and pharmacies.
• Distribution Channel: Pricing can vary between retail pharmacies, mail-order pharmacies, and hospital outpatient pharmacies.
• Formulary Placement: Inclusion on key insurance formularies with favorable tier placement is critical for market access and can influence pricing strategies.

What are the Future Price Projections for NDC 00113-8101?

The price trajectory for NDC 00113-8101 is expected to follow established patterns for generic drugs, characterized by initial price drops followed by relative price stabilization, with potential for minor fluctuations.

Short-Term Projections (1-3 Years)

In the short term, expect continued price competition among existing generic manufacturers of Lurasidone.

• Price Stability: While significant price drops have already occurred, minor price erosions of 5-10% per year are possible as manufacturers optimize production and seek market share.
• Increased Volume: As more prescribers and patients become accustomed to generic availability, prescription volumes for generic Lurasidone are projected to increase, supporting overall market value for generics.
• Negotiated Prices: The net prices paid by payers will continue to be driven by negotiated rebate contracts with PBMs, which are typically confidential.

Long-Term Projections (3-5+ Years)

The long-term outlook for NDC 00113-8101 is one of sustained, albeit modest, price competitiveness.

• Price Floor: A price floor will likely be established as manufacturing costs and a baseline profit margin are reached. Further significant declines without substantial innovation or manufacturing process improvements are improbable.
• Market Consolidation: Over time, market consolidation among generic manufacturers could occur, potentially leading to a slight softening of intense price competition. However, the presence of multiple approved generic manufacturers usually maintains a competitive landscape.
• Interchangeability and Therapeutic Equivalency: Lurasidone products are bioequivalent and therapeutically equivalent, allowing for seamless substitution. This reinforces the competitive pricing environment.
• Potential for New Generic Entrants: If manufacturing barriers are low, new generic entrants could emerge, temporarily increasing competition and potentially causing minor price dips.

Factors Affecting Future Pricing

• Regulatory Changes: Any changes in FDA regulations regarding generic drug approval or manufacturing standards could indirectly impact pricing.
• Healthcare Policy: Shifts in U.S. healthcare policy, such as those related to drug pricing negotiations or formulary requirements, could influence market access and pricing.
• Competition from Novel Therapies: The development of entirely new drug classes or novel delivery systems for schizophrenia and bipolar depression could eventually impact the market share and pricing of older generics like Lurasidone. However, this is a longer-term consideration.
• Supply Chain Disruptions: Global supply chain issues, raw material shortages, or geopolitical events could lead to temporary price volatility.

Key Takeaways

• NDC 00113-8101 is a generic Lurasidone Hydrochloride 100 mg tablet manufactured by Sun Pharmaceutical Industries, Inc.
• The market for Lurasidone has transitioned from branded exclusivity (Latuda) to robust generic competition following patent expirations in late 2023.
• Generic entry has resulted in a substantial price reduction for Lurasidone, with prices dropping 70-85% compared to the branded product.
• Pricing for NDC 00113-8101 is competitive within the generic Lurasidone market, with wholesale acquisition costs for a 30-day supply ranging from $50 to $100.
• Short-term price projections indicate continued modest price erosion and increased volume.
• Long-term projections suggest price stabilization at a competitive floor, driven by manufacturing costs and ongoing generic competition, barring significant market shifts.

Frequently Asked Questions

1. How does the pricing of NDC 00113-8101 compare to other generic Lurasidone products? Pricing for NDC 00113-8101 is competitive with other generic Lurasidone products. Variations typically arise from individual manufacturer strategies, rebate negotiations with PBMs, and distribution agreements. Specific pricing comparisons are best obtained through wholesale drug pricing databases or PBM formularies.

2. What is the expected market penetration of generic Lurasidone, including NDC 00113-8101, over the next five years? Generic Lurasidone is expected to capture over 90% of the Lurasidone market within the next three to five years, driven by cost savings and prescriber adoption. NDC 00113-8101 will be a significant contributor to this market share.

3. Are there any specific quality concerns or regulatory actions associated with NDC 00113-8101 or other generic Lurasidone products? As of current reporting, there are no widespread, specific quality concerns or significant regulatory actions unique to NDC 00113-8101 or a majority of generic Lurasidone products that would distinguish them from standard generic drug manufacturing and oversight. All approved generic drugs meet FDA quality standards.

4. Will the price of NDC 00113-8101 be affected by the development of new antipsychotic medications? While the development of novel antipsychotic medications could indirectly influence the overall market for Lurasidone over the long term by shifting treatment paradigms, it is unlikely to have a direct, immediate impact on the pricing of existing generic Lurasidone products like NDC 00113-8101 in the short to medium term.

5. What is the typical duration for a generic drug to reach its price floor after market entry? For many generic drugs, a significant portion of the price reduction occurs within the first 1-2 years of market entry. The price floor is generally established within 3-5 years, by which point competition has stabilized and manufacturing efficiencies have been realized.

Citations

[1] U.S. Food & Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from [FDA Orange Book Website] [2] Sumitomo Pharma Co., Ltd. (2023). Financial Results and Business Update. [3] Generic Pharmaceutical Association. (n.d.). The Value of Generics. Retrieved from [GPhA Website] [4] IQVIA. (2023). Global Medicine Spending and Recommended Therapeutic Class Forecasts. [5] Internal Market Analysis Reports (Proprietary Data Sources).