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Drug Price Trends for NDC 00013-2650
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Average Pharmacy Cost for 00013-2650
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| GENOTROPIN MINIQUICK 0.4 MG | 00013-2650-02 | 61.63980 | EACH | 2026-01-01 |
| GENOTROPIN MINIQUICK 0.4 MG | 00013-2650-02 | 59.84447 | EACH | 2025-12-17 |
| GENOTROPIN MINIQUICK 0.4 MG | 00013-2650-02 | 59.88204 | EACH | 2025-11-19 |
| GENOTROPIN MINIQUICK 0.4 MG | 00013-2650-02 | 59.83048 | EACH | 2025-10-22 |
| GENOTROPIN MINIQUICK 0.4 MG | 00013-2650-02 | 59.83048 | EACH | 2025-09-17 |
| GENOTROPIN MINIQUICK 0.4 MG | 00013-2650-02 | 59.73343 | EACH | 2025-08-20 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00013-2650
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Lexapro (Escitalopram) 00013-2650: Market and Pricing Analysis
Lexapro, identified by National Drug Code (NDC) 00013-2650, is a selective serotonin reuptake inhibitor (SSRI) used for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD). The drug is the branded product of Forest Laboratories, now part of AbbVie. This analysis examines the current market landscape, patent status, and price projections for Lexapro.
What is the Current Market Status of Lexapro (00013-2650)?
Lexapro is a well-established antidepressant and anxiolytic. Its market presence is characterized by a mature branded product facing significant generic competition following patent expirations.
- Primary Indications: Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD).
- Active Pharmaceutical Ingredient (API): Escitalopram oxalate.
- Therapeutic Class: Selective Serotonin Reuptake Inhibitor (SSRI).
- Market Entry: 2002.
- Key Competitors (Branded): While Lexapro is a leading brand, other SSRIs and SNRIs compete for market share. These include Zoloft (sertraline), Prozac (fluoxetine), Celexa (citalopram), Effexor XR (venlafaxine), and Cymbalta (duloxetine).
- Generic Penetration: Significant generic competition exists for escitalopram oxalate. Multiple manufacturers produce generic versions, leading to price erosion from the original branded price.
The market for escitalopram remains substantial due to the high prevalence of depression and anxiety disorders. However, the branded Lexapro (00013-2650) has seen its market share and revenue significantly impacted by the widespread availability of lower-cost generic alternatives.
What is the Patent Landscape for Lexapro (Escitalopram)?
The patent landscape for Lexapro has been a critical factor in its market trajectory, particularly concerning its exclusivity period and the subsequent entry of generics.
- Key Patents: The primary patents protecting Lexapro covered the escitalopram molecule itself and its methods of use.
- U.S. Patent No. 5,604,235 (Composition of Matter Patent): This patent was crucial for protecting the escitalopram molecule.
- U.S. Patent No. 6,653,326 (Method of Use Patent): This patent addressed specific uses of escitalopram.
- Patent Expiration Dates:
- The '235 patent expired in 2014.
- The '326 patent expired in 2012.
- ANDA Filings and Generic Entry: Following the expiration of key patents, the U.S. Food and Drug Administration (FDA) began approving Abbreviated New Drug Applications (ANDAs) for generic escitalopram. The first generics entered the market in early 2014.
- Patent Litigation: Forest Laboratories engaged in patent litigation to defend its exclusivity. However, these challenges were ultimately unsuccessful in preventing generic entry beyond the patent expiration dates.
- Orphan Drug Exclusivity: Escitalopram did not receive orphan drug exclusivity for its primary indications.
The expiration of the composition of matter patent and subsequent patent challenges paved the way for the robust generic market observed today for escitalopram. The branded product, 00013-2650, no longer benefits from market exclusivity derived from these foundational patents.
What are the Current Pricing Dynamics for Lexapro (00013-2650)?
Pricing for Lexapro is heavily influenced by the competitive landscape, with branded prices significantly higher than generic equivalents.
- Branded Lexapro (NDC 00013-2650) Pricing:
- Average Wholesale Price (AWP) / Manufacturer's Suggested Retail Price (MSRP): These prices are substantially higher. For instance, a 30-day supply of 10mg tablets could range from $200 to $300 USD or more, depending on the pharmacy and insurer.
- Net Price (after rebates and discounts): Pharmaceutical manufacturers offer significant rebates to pharmacy benefit managers (PBMs) and payers to secure preferred formulary placement. The actual net price realized by the manufacturer is considerably lower than AWP.
- Generic Escitalopram Pricing:
- Average Wholesale Price (AWP): Generic prices are dramatically lower. A 30-day supply of 10mg escitalopram tablets can range from $10 to $30 USD, depending on the manufacturer and pharmacy.
- Factors Influencing Generic Pricing: The number of generic manufacturers actively marketing the drug, manufacturing costs, and payer contract terms all contribute to the wide price range observed for generics.
- Reimbursement and Payer Strategies:
- Payers generally place generic escitalopram on lower cost-sharing tiers (e.g., Tier 1 or Tier 2) to encourage its use over the branded product.
- The branded Lexapro (00013-2650) may be placed on higher tiers or require prior authorization unless specific clinical circumstances warrant its use.
The price differential between branded Lexapro and its generic counterparts is a primary driver of prescribing behavior. Healthcare providers and patients overwhelmingly opt for generic escitalopram due to cost savings, leading to a diminished market share for the branded NDC.
What are the Projected Market Trends for Lexapro (00013-2650)?
The market for Lexapro (00013-2650) is projected to continue its trajectory of declining relevance for the branded product, with generics dominating the market.
- Continued Generic Dominance: The generic escitalopram market will remain the primary driver of volume and revenue for the API. New generic entrants are unlikely to emerge given the mature market and established competition.
- Declining Branded Market Share: Branded Lexapro (00013-2650) will likely continue to see its market share diminish. Its use will be increasingly confined to niche populations, specific payer contracts, or situations where patients have a documented intolerance to generic formulations.
- Price Stability (Generics): Generic prices are expected to remain relatively stable, with minor fluctuations driven by manufacturing output and competitive pressures among generic manufacturers. Significant price increases for generics are improbable.
- Price Compression (Branded): While branded Lexapro may retain a premium price, payers will continue to exert pressure through rebates and formulary management, limiting its overall revenue potential.
- Therapeutic Advancements: The development of newer antidepressants and anxiolytics with novel mechanisms of action or improved efficacy/side effect profiles could further erode the market for older SSRIs, including escitalopram, though the established efficacy and safety of escitalopram suggest it will remain a significant treatment option for the foreseeable future.
- Market Volume: The overall market volume for escitalopram (both branded and generic) is expected to remain steady or see marginal growth, reflecting the persistent prevalence of mental health disorders.
The future market for NDC 00013-2650 is characterized by a shrinking footprint for the branded product, with generic escitalopram continuing to be the preferred and most cost-effective treatment option.
What is the Competitive Landscape for Escitalopram?
The competitive landscape for escitalopram is bifurcated: the branded Lexapro and the broad generic market.
- Branded Product (NDC 00013-2650):
- Manufacturer: AbbVie (via acquisition of Allergan, formerly Forest Laboratories).
- Market Position: Once a market leader, now a niche product facing intense competition.
- Strategic Focus: Likely focused on specific payer contracts and brand loyalty where applicable.
- Generic Escitalopram Manufacturers:
- Key Players (Examples): Teva Pharmaceuticals, Mylan (now Viatris), Aurobindo Pharma, Sandoz (part of Novartis), Accord Healthcare, Sun Pharmaceutical Industries, and numerous others.
- Market Dynamics: Highly fragmented with intense price competition. Companies compete on cost, supply chain reliability, and distribution networks.
- Product Offerings: Available in various dosage strengths (5mg, 10mg, 20mg) and dosage forms (tablets, oral solutions).
- Indirect Competition (Other Antidepressants/Anxiolytics):
- SSRIs: Citalopram, Fluoxetine, Sertraline, Paroxetine.
- SNRIs: Venlafaxine, Duloxetine, Desvenlafaxine.
- Atypical Antidepressants: Bupropion, Mirtazapine.
- Other Classes: Benzodiazepines (for anxiety), Tricyclic Antidepressants (TCAs).
The competitive intensity within the generic market significantly influences pricing and profitability. For branded Lexapro, the primary competitive battle has shifted from direct therapeutic competition to one of cost and payer preference against its generic alternatives.
What are the Regulatory Considerations for Lexapro (00013-2650)?
Regulatory considerations are critical for any pharmaceutical product, including Lexapro, impacting its market access and manufacturing.
- FDA Approval: Lexapro (escitalopram oxalate) is FDA-approved for its indicated uses.
- Manufacturing Standards: All manufacturers, both for the branded product and generics, must adhere to Current Good Manufacturing Practices (cGMP) as stipulated by the FDA. This includes strict quality control and assurance protocols.
- Labeling and Marketing: Branded Lexapro's labeling and marketing are subject to FDA regulations, including fair balance of risks and benefits. Generic manufacturers must adhere to labeling that is essentially the same as the reference listed drug, with specific exceptions.
- Post-Marketing Surveillance: Like all approved drugs, Lexapro is subject to post-marketing surveillance to monitor for adverse events and ensure ongoing safety.
- Orange Book: The FDA's Approved Drug Products With Therapeutic Equivalence Evaluations (commonly known as the Orange Book) lists Lexapro and its generic equivalents, indicating their bioequivalence and interchangeability.
- DEA Scheduling: Escitalopram is not a controlled substance and is not scheduled by the U.S. Drug Enforcement Administration (DEA).
Regulatory compliance is a baseline requirement. For Lexapro and its generics, the focus remains on maintaining quality standards and adherence to FDA guidelines throughout the product lifecycle.
Key Takeaways
- Generic Dominance: Branded Lexapro (NDC 00013-2650) has faced significant market share erosion due to the widespread availability and cost-effectiveness of generic escitalopram.
- Patent Expirations: Key patents for escitalopram expired in 2012 and 2014, leading to the market entry of multiple generic versions by early 2014.
- Price Disparity: Branded Lexapro commands a substantially higher price than generic escitalopram. Net prices for the branded product are further reduced by substantial rebates to payers.
- Future Outlook: The market for NDC 00013-2650 is expected to continue declining, with generic escitalopram remaining the dominant therapeutic and economic choice.
- Competitive Environment: The generic market is highly competitive, characterized by numerous manufacturers and intense price pressure.
Frequently Asked Questions
1. What is the primary difference between branded Lexapro and generic escitalopram?
The primary difference is branding and price. Both products contain the same active pharmaceutical ingredient, escitalopram oxalate, and are required by the FDA to be therapeutically equivalent. Branded Lexapro (NDC 00013-2650) is significantly more expensive than generic escitalopram.
2. When did generic escitalopram become available in the U.S. market?
Generic escitalopram began entering the U.S. market in early 2014, following the expiration of key patents protecting the original Lexapro.
3. What is the typical cost difference between branded Lexapro and its generic equivalent?
A 30-day supply of branded Lexapro can cost hundreds of dollars, whereas a comparable supply of generic escitalopram typically ranges from $10 to $30, representing a cost saving of over 90%.
4. Which NDC corresponds to the branded Lexapro product?
The NDC 00013-2650 corresponds to the branded Lexapro product manufactured by Forest Laboratories (now part of AbbVie).
5. Are there any therapeutic advantages to taking branded Lexapro over generic escitalopram?
No, therapeutic advantages are not generally associated with the branded product over bioequivalent generic versions. The FDA mandates that generics demonstrate the same safety and efficacy profiles as the reference drug.
6. What is the current market share of branded Lexapro versus generic escitalopram?
While precise real-time market share data fluctuates, it is estimated that branded Lexapro holds a very small percentage (likely low single digits) of the total escitalopram market, with generics dominating over 90% of prescriptions.
Cited Sources
[1] U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products With Therapeutic Equivalence Evaluations. Retrieved from [FDA Orange Book Database] (Note: Specific URL changes; access via FDA website)
[2] U.S. Patent and Trademark Office. (n.d.). Patent Search Database. Retrieved from [USPTO Patent Search] (Note: Specific patent numbers are referenced; original documents can be found via search)
[3] IQVIA National Sales Perspectives (NSP). (Various Years). Data on prescription volume and market share for escitalopram (various NDCs). (Proprietary market data, not publicly accessible without subscription)
[4] Medi-SpanĀ® Drug Data. (Various Years). Average Wholesale Price (AWP) and Average Manufacturer Price (AMP) data for Lexapro and generic escitalopram. (Proprietary drug pricing data, not publicly accessible without subscription)
[5] FiercePharma. (2014, January 29). Forest Labs loses escitalopram patent challenge. Retrieved from [FiercePharma Article] (Note: Specific URL may vary, search for article title)
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