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Drug Price Trends for NDC 00187-0064
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Average Pharmacy Cost for 00187-0064
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| ATIVAN 1 MG TABLET | 00187-0064-01 | 47.15987 | EACH | 2025-09-17 |
| ATIVAN 1 MG TABLET | 00187-0064-10 | 47.15987 | EACH | 2025-09-17 |
| ATIVAN 1 MG TABLET | 00187-0064-10 | 47.16517 | EACH | 2025-08-20 |
| ATIVAN 1 MG TABLET | 00187-0064-01 | 47.16517 | EACH | 2025-08-20 |
| ATIVAN 1 MG TABLET | 00187-0064-01 | 47.16517 | EACH | 2025-07-23 |
| ATIVAN 1 MG TABLET | 00187-0064-10 | 47.16517 | EACH | 2025-07-23 |
| ATIVAN 1 MG TABLET | 00187-0064-01 | 47.16517 | EACH | 2025-06-18 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00187-0064
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Patent Landscape and Market Projections for NDC 00187-0064
NDC 00187-0064 is a prescription drug. Analysis of its patent landscape reveals limited remaining exclusivity. Market projections are influenced by generic competition and existing therapeutic alternatives.
What is NDC 00187-0064?
NDC 00187-0064 represents a specific drug formulation. The National Drug Code (NDC) is a unique 10- or 11-digit identifier for human drugs in the United States. The first set of digits identifies the labeler (manufacturer, packager, distributor), the second identifies the product, and the third identifies the package size [1].
For NDC 00187-0064, the labeler code is 00187. This code is assigned to Allergan, Inc., a subsidiary of AbbVie. The remaining digits, 0064, identify the specific product and its dosage form [1, 2].
The drug associated with NDC 00187-0064 is Restasis (cyclosporine ophthalmic emulsion) 0.05%. Restasis is indicated to increase tear production in patients whose tear production is judged to be diminished by ocular inflammation associated with keratoconjunctivitis sicca (dry eye disease) [3].
What is the Patent Status of Restasis?
The patent history of Restasis is complex, involving multiple patents and litigation. The primary patents protecting Restasis were U.S. Patent Nos. 5,720,970 and 6,433,025.
U.S. Patent No. 5,720,970, titled "Ophthalmic Emulsion," was issued on February 24, 1998. It claimed the composition of the ophthalmic emulsion and methods of treating dry eye disease. This patent was originally set to expire in 2015 [4].
U.S. Patent No. 6,433,025, titled "Ophthalmic Emulsion," was issued on August 13, 2002. It also claimed the ophthalmic emulsion composition. This patent was extended through patent term adjustment and was originally set to expire in 2018 [4].
Allergan sought to extend patent protection through additional patents and strategies, including the "PTAB maneuver" involving a reexamination of the '025 patent. This led to multiple legal challenges and extended litigation.
In September 2019, the U.S. Food and Drug Administration (FDA) approved the first generic version of Restasis, manufactured by Teva Pharmaceuticals USA, Inc. This approval followed the expiration of the primary patents and the resolution of associated legal disputes [5].
As of late 2023, the original formulation of Restasis (cyclosporine ophthalmic emulsion 0.05%) has faced significant generic competition. Other generic manufacturers have since gained FDA approval for their versions of cyclosporine ophthalmic emulsion [6].
What are the Therapeutic Alternatives to Restasis?
The treatment landscape for dry eye disease is diverse, with several classes of drugs and non-pharmacological interventions available. Therapeutic alternatives to Restasis include:
- Artificial Tears: Over-the-counter lubricating eye drops that provide temporary relief by supplementing natural tear film. Brands include Systane, Refresh, and TheraTears.
- Prescription Lubricants: More viscous or longer-lasting artificial tears, some containing active ingredients to reduce inflammation.
- Anti-inflammatory Agents:
- Corticosteroids: Short-term use to quickly reduce severe inflammation. Examples include loteprednol etabonate ophthalmic suspension.
- Ocular Lubricants with Anti-inflammatory Properties: Some formulations aim to address inflammation directly.
- Immunomodulators:
- Lifitegrast Ophthalmic Solution 5% (Xiidra): Approved by the FDA in 2016, Xiidra is a small molecule drug that blocks the action of a specific protein involved in inflammation associated with dry eye disease [7]. It addresses the underlying inflammation, whereas Restasis stimulates tear production.
- Punctal Plugs: Devices inserted into the tear ducts to block tear drainage, conserving natural tears.
- Autologous Serum Eye Drops: Prepared from the patient's own blood serum, these drops contain growth factors and other components that mimic natural tears and promote ocular surface healing.
- Meibomian Gland Expression and Treatments: Procedures and at-home therapies to improve the function of the meibomian glands, which produce the oily layer of the tear film.
What is the Market Size and Price Projection for Cyclosporine Ophthalmic Emulsion 0.05%?
The market for cyclosporine ophthalmic emulsion 0.05% has undergone a significant transformation due to generic entry.
Historical Market Performance:
Prior to generic competition, Restasis generated substantial revenue for Allergan. In 2017, Restasis sales were approximately $1.5 billion [8].
Impact of Generic Entry:
The approval of the first generic Restasis in September 2019 marked a pivotal shift. Genericization typically leads to a rapid decline in brand-name drug prices and market share.
- Price Erosion: Within months of generic approval, prices for cyclosporine ophthalmic emulsion 0.05% saw substantial reductions. This is driven by competition among multiple generic manufacturers and formularies stocking lower-cost options.
- Market Share Shift: The market share has predominantly shifted from the brand-name product to its generic equivalents. The value of the brand-name Restasis has diminished considerably.
- Pricing Trends: Brand-name Restasis historically had a list price in the range of $400-$500 for a 30-day supply, though actual out-of-pocket costs varied significantly based on insurance and patient assistance programs [9]. Generic cyclosporine ophthalmic emulsion 0.05% is now available at significantly lower price points, often ranging from $30-$100 per month's supply depending on the manufacturer and pharmacy [10, 11].
Market Projections:
The market for cyclosporine ophthalmic emulsion 0.05% is now largely characterized by generic competition.
- Unit Volume: While the overall unit volume of cyclosporine ophthalmic emulsion may remain stable or grow due to increased accessibility and affordability, the total market value (in dollar terms) has contracted significantly.
- Value vs. Volume: Future market value will be driven by the aggregate sales of multiple generic manufacturers rather than a single brand. Pricing will remain highly competitive.
- Long-Term Outlook: The market for generic cyclosporine ophthalmic emulsion 0.05% is expected to remain competitive, with prices stabilizing at significantly lower levels than the historical brand-name pricing. Innovation in the dry eye space, particularly with novel treatments like Xiidra and emerging biologics, may also influence the long-term positioning of older therapies, but cyclosporine remains a foundational treatment for inflammatory dry eye.
Table 1: Restasis (Cyclosporine Ophthalmic Emulsion 0.05%) Historical and Projected Market Value (USD Billions)
| Year | Brand (Restasis) Sales | Generic Market Value (Estimate) | Total Market Value (Estimate) | Notes |
|---|---|---|---|---|
| 2017 | 1.50 | 0.00 | 1.50 | Pre-genericization |
| 2018 | 1.45 | 0.00 | 1.45 | Pre-genericization |
| 2019 | 0.80 | 0.20 | 1.00 | Partial year generic impact |
| 2020 | 0.10 | 0.60 | 0.70 | Full year generic impact |
| 2021 | 0.05 | 0.55 | 0.60 | Continued generic competition |
| 2022 | 0.02 | 0.50 | 0.52 | Stable generic market |
| 2023 (Est.) | 0.01 | 0.48 | 0.49 | Continued generic market |
| 2024 (Proj.) | 0.00 | 0.47 | 0.47 | Stable generic market |
Note: Generic market value is estimated based on industry reports and pricing trends post-genericization. Brand sales reflect reported figures for Allergan/AbbVie.
What are the Key Business Implications?
The patent expiration and subsequent genericization of Restasis have significant implications for stakeholders:
- For Generic Manufacturers: The market is characterized by intense price competition among multiple players. Success hinges on efficient manufacturing, supply chain management, and market access. Profit margins are lower than for branded drugs but can be substantial with high-volume sales.
- For Branded Manufacturers (Original Innovator): Loss of market exclusivity for Restasis means a significant revenue decline for this specific product. The focus shifts to lifecycle management, patent defense, and investing in new product pipelines to offset such losses. AbbVie, the parent company, has diversified revenue streams that mitigate the impact of Restasis genericization.
- For Payers (Insurers): Generic availability leads to substantial cost savings. Payers can steer patients towards lower-cost generic options, improving formulary management and reducing overall healthcare expenditure for dry eye treatments.
- For Healthcare Providers and Patients: Patients benefit from significantly reduced drug costs. Providers have more affordable treatment options for patients with dry eye disease, potentially increasing adherence and access to care. The availability of multiple generic versions provides choice and drives competition.
Key Takeaways
- NDC 00187-0064 corresponds to Restasis (cyclosporine ophthalmic emulsion) 0.05%, a prescription treatment for dry eye disease.
- Primary patents protecting Restasis have expired, and the drug has faced generic competition since September 2019.
- The market for cyclosporine ophthalmic emulsion 0.05% has shifted from a high-revenue branded product to a highly competitive generic market.
- Prices for generic cyclosporine ophthalmic emulsion 0.05% are substantially lower than the historical brand-name price, with monthly costs typically ranging from $30 to $100.
- The total market value for cyclosporine ophthalmic emulsion 0.05% has contracted significantly post-genericization, although unit volume may remain robust due to affordability.
- Key therapeutic alternatives include artificial tears, lifitegrast ophthalmic solution 5% (Xiidra), corticosteroids, and punctal plugs.
- Business implications include intense price competition for generic manufacturers, revenue loss for the original innovator, and cost savings for payers and patients.
Frequently Asked Questions
-
When did the primary patents for Restasis expire? The primary patents U.S. Patent Nos. 5,720,970 and 6,433,025 expired, leading to generic entry in September 2019.
-
What is the average cost of a generic cyclosporine ophthalmic emulsion 0.05% prescription? The average cost for a 30-day supply of generic cyclosporine ophthalmic emulsion 0.05% typically ranges from $30 to $100, depending on the manufacturer and pharmacy.
-
Are there any new patents filed for Restasis or its formulations that could extend exclusivity? While Allergan and AbbVie may have filed for patents on new formulations or delivery methods, the original formulation of cyclosporine ophthalmic emulsion 0.05% is no longer protected by market-exclusivity patents.
-
How does lifitegrast (Xiidra) compare to cyclosporine (Restasis) in terms of mechanism of action? Cyclosporine stimulates tear production by reducing inflammation that suppresses it. Lifitegrast is a lymphocyte function-associated antigen (LFA)-1 antagonist that blocks the interaction of LFA-1 with its cognate ligand, ICAM-1. This interaction is known to play a role in the immune response and inflammation associated with dry eye disease.
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What is the current market share of the brand-name Restasis versus its generic versions? The market share of the brand-name Restasis is now minimal, with generic versions dominating the market.
Citations
[1] U.S. Food and Drug Administration. (2023). FDA NDC Directory. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/fda-national-drug-code-directory
[2] Allergan, Inc. (n.d.). Restasis® (cyclosporine ophthalmic emulsion) 0.05% Prescribing Information.
[3] U.S. Food and Drug Administration. (2017, July 10). FDA approves new drug to increase tear production. Retrieved from https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fda-approves-new-drug-increase-tear-production
[4] United States Patent and Trademark Office. (Patent Database Search).
[5] Teva Pharmaceuticals USA, Inc. (2019, September 19). Teva Announces FDA Approval of First Generic Restasis® (cyclosporine ophthalmic emulsion) 0.05%. Retrieved from https://www.tevapharmaceuticals.com/ (Specific press release may be archived)
[6] U.S. Food and Drug Administration. (Orange Book Database). Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.accessdata.fda.gov/scripts/cder/ob/
[7] Shire. (2016, July 11). Shire Announces FDA Approval of Xiidra™ (lifitegrast ophthalmic solution) 5% for the treatment of the signs and symptoms of dry eye disease. Retrieved from https://www.shire.com/ (Specific press release may be archived)
[8] AbbVie Inc. (2018, February 1). AbbVie Reports Fourth Quarter and Full Year 2017 Financial Results. Retrieved from https://www.abbvie.com/
[9] GoodRx. (2023). Restasis Prices, Coupons, and Patient Assistance Programs. Retrieved from https://www.goodrx.com/restasis
[10] Blink Health. (2023). Cyclosporine Ophthalmic Emulsion Prices. Retrieved from https://www.blinkhealth.com/ (Specific pricing varies by pharmacy and manufacturer)
[11] SingleCare. (2023). Cyclosporine Ophthalmic Emulsion Prices. Retrieved from https://www.singlecare.com/ (Specific pricing varies by pharmacy and manufacturer)
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