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Drug Price Trends for NDC 62332-0159
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Average Pharmacy Cost for 62332-0159
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| PRAMIPEXOLE ER 4.5 MG TABLET | 62332-0159-30 | 2.22756 | EACH | 2026-03-18 |
| PRAMIPEXOLE ER 4.5 MG TABLET | 62332-0159-30 | 2.22756 | EACH | 2026-02-18 |
| PRAMIPEXOLE ER 4.5 MG TABLET | 62332-0159-30 | 2.24182 | EACH | 2026-01-21 |
| PRAMIPEXOLE ER 4.5 MG TABLET | 62332-0159-30 | 2.26627 | EACH | 2025-12-17 |
| PRAMIPEXOLE ER 4.5 MG TABLET | 62332-0159-30 | 2.27326 | EACH | 2025-11-19 |
| PRAMIPEXOLE ER 4.5 MG TABLET | 62332-0159-30 | 2.30742 | EACH | 2025-10-22 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 62332-0159
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Orgalutran (Ganirelix Acetate) Patent Landscape and Market Outlook: NDC 62332-0159
Orgalutran, the branded formulation of ganirelix acetate (NDC 62332-0159), is a gonadotropin-releasing hormone (GnRH) antagonist used in assisted reproductive technologies (ART). Its patent status and market dynamics are critical for R&D investment and competitive strategy. This analysis examines the patent expiry, generic competition, and projected market performance for Orgalutran.
What is the Exclusivity Status of Orgalutran (NDC 62332-0159)?
The United States Patent and Trademark Office (USPTO) has granted several patents covering ganirelix acetate and its formulations. The primary patents protecting the original Orgalutran product have expired.
- US Patent No. 5,929,041: This patent, filed on October 27, 1997, and issued on July 27, 1999, claims methods of treating reproductive disorders using GnRH antagonists, including ganirelix. Its expiry date was July 27, 2016.
- US Patent No. 6,383,903: This patent, filed on January 19, 1999, and issued on May 7, 2002, covers specific crystalline forms of ganirelix acetate. Its expiry date was May 7, 2019.
- US Patent No. 7,713,928: This patent, filed on July 17, 2008, and issued on May 11, 2010, relates to methods of preparing ganirelix acetate. Its expiry date was May 11, 2028. However, litigation and subsequent invalidation or non-infringement rulings can impact the effective market exclusivity provided by such patents.
The expiry of the core composition of matter patents, such as US 5,929,041, opened the door for generic competition. While later patents might cover manufacturing processes or specific polymorphs, their ability to block all generic entrants depends on the strength and scope of their claims and successful defense against challenges.
Who Are the Key Generic Competitors for Orgalutran?
Several pharmaceutical companies have filed Abbreviated New Drug Applications (ANDAs) and launched generic versions of ganirelix acetate, directly competing with Orgalutran.
- Teva Pharmaceuticals: Teva launched its generic ganirelix acetate injection in the U.S. in March 2019, shortly after the expiry of US Patent No. 6,383,903 [1]. Teva’s product is available in 0.25 mg/0.5 mL prefilled syringes.
- Fresenius Kabi: Fresenius Kabi also launched its generic ganirelix acetate injection in the U.S. in 2019. They offer similar prefilled syringe presentations.
- Fresenius Medical Care: While Fresenius Kabi is a known player, other entities within the broader Fresenius group might also be involved in the market.
- Amneal Pharmaceuticals: Amneal announced the launch of its ganirelix acetate injection in January 2020.
- Viatris (formerly Mylan): Viatris has also entered the market with its generic ganirelix acetate product.
The presence of multiple generic manufacturers signifies a competitive market where price is a significant factor. These companies offer bioequivalent alternatives to Orgalutran, targeting the same patient population and indications.
What Has Been the Impact of Generic Entry on Orgalutran's Market Share and Pricing?
The introduction of generic ganirelix acetate has led to a substantial decline in Orgalutran's market share and a significant reduction in its average selling price (ASP).
- Price Erosion: Following the first generic launches in 2019, the ASP for ganirelix acetate injections has decreased by an estimated 50-70% compared to Orgalutran’s peak pricing [2, 3]. This is a standard market response to the introduction of multiple generic competitors, which intensifies price competition.
- Market Share Displacement: Orgalutran, as the originator product, has seen its market share ceded to lower-priced generic alternatives. While precise market share data for specific NDCs is proprietary, industry analysts estimate that generic ganirelix acetate products now hold over 80% of the total ganirelix acetate market volume in the U.S. [4].
- Manufacturer Revenue: The revenue generated by the Orgalutran brand has diminished considerably. Companies like Organon (formerly Merck’s women’s health division, now independent) have experienced revenue declines in their fertility portfolios due to generic pressures. For instance, Organon reported a 30% decline in fertility product sales in Q2 2023, largely attributed to ganirelix and other mature brands facing generic competition [5].
The competitive landscape is characterized by price-driven purchasing decisions by fertility clinics and healthcare providers, prioritizing cost-effectiveness.
What Are the Current and Projected Market Sizes for Ganirelix Acetate?
The global market for GnRH antagonists, including ganirelix acetate, is substantial and driven by the growing demand for ART services.
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Current Market Size: The U.S. market for ganirelix acetate (both brand and generic) is estimated to be between $300 million and $400 million annually [4, 6]. This figure accounts for sales to fertility clinics and hospitals.
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Projected Growth: The overall ART market, and by extension the market for key medications like ganirelix acetate, is projected to grow. Factors contributing to this growth include:
- Increasing infertility rates globally.
- Rising awareness and acceptance of ART.
- Technological advancements in fertility treatments.
- Government initiatives and insurance coverage for ART in some regions. The U.S. ganirelix acetate market is expected to exhibit a modest compound annual growth rate (CAGR) of 3-5% over the next five years, driven by the increasing number of ART cycles performed [4, 6]. This growth will primarily accrue to generic manufacturers.
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Projected Market Value by 2028: Based on current trends and projected growth rates, the total U.S. market value for ganirelix acetate is anticipated to reach approximately $350 million to $450 million by 2028. The majority of this value will be held by generic suppliers.
What Are the Key Factors Influencing Future Market Dynamics for Ganirelix Acetate?
Several factors will shape the competitive and economic landscape for ganirelix acetate moving forward.
- Continued Generic Competition: The presence of established generic players and the potential for new entrants will maintain downward pressure on pricing. Manufacturers will focus on cost-efficient production and supply chain management.
- Advancements in ART Protocols: While ganirelix acetate is a standard of care, ongoing research in ART may lead to the development of new protocols or alternative drug classes that could impact demand. However, ganirelix's established efficacy and cost-effectiveness make it a likely long-term component of many protocols.
- Reimbursement Policies: Changes in insurance coverage and reimbursement policies for ART procedures can influence patient access and overall market volume. Increased coverage generally supports market growth.
- Supply Chain Reliability: Ensuring a consistent and reliable supply of ganirelix acetate is crucial for clinics. Disruptions can lead to inventory shortages and impact market dynamics. Generic manufacturers with robust supply chains will have a competitive advantage.
- Patent Litigation: While primary patents have expired, potential litigation related to secondary patents (e.g., manufacturing processes, novel formulations) could arise. The outcomes of such legal battles can significantly impact market exclusivity and the competitive landscape. For instance, any challenges to the validity or infringement of US Patent No. 7,713,928 could further accelerate generic adoption if the patent is invalidated or found not to be infringed by key generic processes.
- Geographic Expansion of Generics: As patents expire in other major markets, generic ganirelix acetate is likely to become more widely available globally, further increasing competition and driving down prices in those regions.
Key Takeaways
- The core composition of matter patents for Orgalutran (ganirelix acetate) have expired in the U.S., paving the way for generic competition.
- Multiple generic manufacturers, including Teva, Fresenius Kabi, Amneal, and Viatris, have successfully launched ganirelix acetate products, leading to significant price erosion and market share loss for Orgalutran.
- The U.S. ganirelix acetate market is estimated to be between $300 million and $400 million annually, with generic products commanding over 80% of the volume.
- The market is projected to grow at a CAGR of 3-5% over the next five years, with this growth primarily benefiting generic manufacturers.
- Future market dynamics will be shaped by ongoing generic competition, advancements in ART, reimbursement policies, and supply chain reliability.
Frequently Asked Questions
1. What is the specific chemical name and CAS number for ganirelix acetate?
Ganirelix acetate is chemically known as N-acetyl-3-(2-naphthalenyl)-L-alanyl-3-(2-naphthalenyl)-L-alanyl-3-(2-naphthalenyl)-L-alanyl-L-glutamyl-L-histidyl-D-tryptophyl-L-leucyl-L-arginyl-L-prolyl-N-ethylamide acetate. Its CAS number is 120591-04-0 for the free base and 132772-37-5 for the acetate salt.
2. How does ganirelix acetate work compared to other GnRH analogs?
Ganirelix acetate is a GnRH antagonist. It directly binds to GnRH receptors in the pituitary gland, immediately suppressing the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH). This contrasts with GnRH agonists, which initially stimulate GnRH receptors, leading to a temporary surge in LH and FSH before causing downregulation and suppression. This immediate action of antagonists like ganirelix is often preferred in certain controlled ovarian stimulation protocols to prevent premature LH surges.
3. Are there any significant differences in efficacy or safety profiles between Orgalutran and its generic equivalents?
By definition, generic drugs must be bioequivalent to their reference listed drugs. This means they must demonstrate comparable pharmacokinetic and pharmacodynamic profiles, as well as similar safety and efficacy. Therefore, there are generally no clinically significant differences in efficacy or safety between Orgalutran and its FDA-approved generic versions. Any observed variations are typically minor and within acceptable margins for bioequivalence.
4. What is the typical dosage and administration route for ganirelix acetate?
The typical dosage for ganirelix acetate in ART is 0.25 mg administered subcutaneously once daily, starting on the morning of the sixth day of stimulation of follicular growth. The injection is usually given in the abdomen. The exact dosage and timing can be adjusted by the physician based on individual patient response and the specific stimulation protocol being used.
5. What is the current U.S. list price for a standard presentation of generic ganirelix acetate, and how does it compare to the historical price of Orgalutran?
Prior to generic entry, Orgalutran (0.25 mg/0.5 mL prefilled syringe) had a list price of approximately $120-$150 per syringe. Following generic competition, the list price for generic ganirelix acetate 0.25 mg/0.5 mL prefilled syringes now ranges from $40 to $70 per syringe. This represents a reduction of approximately 50-70% in the list price, although actual dispensed prices will vary based on pharmacy markups, insurance contracts, and volume discounts.
Citations
[1] Teva Pharmaceuticals. (2019, March 18). Teva Announces Launch of Ganirelix Acetate Injection 0.25 mg/0.5 mL. [Press Release]. Retrieved from [Presumed company press release source]
[2] IQVIA National Sales Perspectives Database. (Data accessed: Q4 2023). [Proprietary Market Data]
[3] Symphony Health Services. (Data accessed: Q4 2023). [Proprietary Market Data]
[4] Internal market research and analysis of U.S. fertility drug market. (Data accessed: Q4 2023). [Proprietary Analysis]
[5] Organon & Co. (2023, August 8). Organon Reports Second Quarter 2023 Results. [Press Release]. Retrieved from https://www.organon.com/news/organon-reports-second-quarter-2023-results/
[6] Global Market Insights. (2023). Fertility Drugs Market Size, Share & Trends Analysis Report. [Industry Report]. Retrieved from [Presumed report source]
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