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Last Updated: December 27, 2024

AKPENTOLATE Drug Patent Profile


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Which patents cover Akpentolate, and what generic alternatives are available?

Akpentolate is a drug marketed by Rising and is included in two NDAs.

The generic ingredient in AKPENTOLATE is cyclopentolate hydrochloride. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cyclopentolate hydrochloride profile page.

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Summary for AKPENTOLATE
Drug patent expirations by year for AKPENTOLATE

US Patents and Regulatory Information for AKPENTOLATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rising AKPENTOLATE cyclopentolate hydrochloride SOLUTION/DROPS;OPHTHALMIC 040164-001 Jan 13, 1997 AT RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Rising AKPENTOLATE cyclopentolate hydrochloride SOLUTION/DROPS;OPHTHALMIC 040165-001 Jan 13, 1997 AT RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

AKPENTOLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for AK-Pentolate

Overview of AK-Pentolate

AK-Pentolate, or cyclopentolate hydrochloride ophthalmic solution, is an anticholinergic medication used to dilate pupils (mydriasis) and paralyze accommodation (cycloplegia) in the eye. It is commonly used in ophthalmic examinations and treatments[4].

Market Context: U.S. Ophthalmic Drugs Market

The U.S. ophthalmic drugs market, within which AK-Pentolate operates, is experiencing significant growth. Here are some key market dynamics:

  • Market Size and Growth: The U.S. ophthalmic drugs market was valued at USD 15.53 billion in 2023 and is expected to grow at a CAGR of 7.4% from 2024 to 2030. This growth is driven by an increasing prevalence of eye-related disorders and a rising aging population[1].

  • Segmentation: The market is segmented into various therapeutic areas, including retinal disorders, glaucoma, and dry eye disease. The retinal disorders segment held the largest revenue share of 36.7% in 2023, driven by conditions such as diabetic retinopathy and age-related macular degeneration (AMD)[1].

Competitive Landscape

  • Key Players: The ophthalmic drugs market is dominated by several key players, including pharmaceutical companies like Regeneron Pharmaceuticals, Iveric Bio, and Harrow. These companies are actively involved in new product launches and strategic initiatives to address a broader population suffering from ocular diseases[1].

  • Product Launches and Approvals: Frequent approvals and new product launches are crucial for market growth. For instance, Regeneron Pharmaceuticals received FDA approval for EYLEA HD (aflibercept) for treating wet AMD, wet age-related macular edema, and diabetic retinopathy in August 2023[1].

Financial Trajectory

Revenue Growth

  • Overall Market Growth: The revenue growth in the ophthalmic drugs market is driven by new product launches, increasing awareness about ophthalmic disorders, and expanded healthcare coverage. This growth is expected to continue, with the market anticipated to reach significant heights by 2030[1].

  • Generic vs. Branded Drugs: While branded drugs currently hold the largest share, the generic drugs segment is expected to show the fastest growth due to the increasing expiry rate of branded drug patents and the cost-effectiveness of generic drugs. This shift could impact the financial trajectory of specific products like AK-Pentolate if generic alternatives become more prevalent[1].

Cost and Pricing Dynamics

  • Net Price Growth: The net price growth for prescription medicines, including ophthalmic drugs, is influenced by a combination of factors such as low net price increases of branded and generic medicines and the impact of losses of exclusivity. This can result in a net negative driver for price growth, which may affect the revenue of specific drugs[3].

  • Healthcare Coverage: The increasing coverage of ophthalmic drugs under healthcare plans has significantly decreased out-of-pocket expenditures on these drugs over the last decade. This trend is expected to continue, potentially stabilizing or increasing the demand for ophthalmic medications like AK-Pentolate[1].

Technological Advancements and Strategic Collaborations

  • Technological Advancements: Technological advancements and strategic collaborations are propelling the growth of the ophthalmic drugs market. For example, new product launches and clinical trials, such as Aldeyra Therapeutics' plans for reproxalap for dry eye disease, indicate a constant pace of development in the market[1].

  • Company Performance: Pharmaceutical companies like Santen Pharmaceutical have shown strong financial performance, with significant year-over-year growth in revenue and operating profit. This is attributed to strong sales momentum, cost optimization, and structural reforms[2].

Challenges and Opportunities

  • Product Recalls and Efficacy: The rising prevalence of product recalls due to insufficient evidence of product efficacy compels manufacturers to improve their medications. This can be both a challenge and an opportunity for companies to enhance their products and regain market trust[1].

  • Awareness and Education: Increasing awareness about ophthalmic disorders through campaigns by organizations like the American Academy of Ophthalmology is expected to boost the overall market. This increased awareness can drive demand for diagnostic and therapeutic products, including AK-Pentolate[1].

Key Takeaways

  • Growing Market: The U.S. ophthalmic drugs market is growing steadily, driven by an aging population and increasing prevalence of eye-related disorders.
  • Segment Growth: The retinal disorders segment is a significant contributor to the market, with anti-VEGF agents and treatments for conditions like AMD and diabetic retinopathy leading the way.
  • Financial Dynamics: Revenue growth is influenced by new product launches, generic drug penetration, and healthcare coverage.
  • Technological Advancements: Continuous innovation and strategic collaborations are crucial for market growth.
  • Challenges and Opportunities: Product efficacy and awareness campaigns play significant roles in shaping the market trajectory.

FAQs

Q: What is the current size and growth rate of the U.S. ophthalmic drugs market? A: The U.S. ophthalmic drugs market was valued at USD 15.53 billion in 2023 and is expected to grow at a CAGR of 7.4% from 2024 to 2030[1].

Q: Which segment holds the largest revenue share in the ophthalmic drugs market? A: The retinal disorders segment held the largest revenue share of 36.7% in 2023[1].

Q: How do generic drugs impact the ophthalmic drugs market? A: Generic drugs are expected to show the fastest growth due to the increasing expiry rate of branded drug patents and their cost-effectiveness[1].

Q: What role do technological advancements play in the ophthalmic drugs market? A: Technological advancements and strategic collaborations are key drivers of market growth, with new product launches and clinical trials contributing significantly[1].

Q: How does healthcare coverage affect the demand for ophthalmic drugs? A: Increasing healthcare coverage has significantly decreased out-of-pocket expenditures on ophthalmic drugs, stabilizing or increasing demand for these medications[1].

Sources

  1. Grand View Research: U.S. Ophthalmic Drugs Market Size | Industry Report, 2030
  2. Santen Pharmaceutical: Q1 FY2023 Financial Results
  3. PhRMA: Understanding the Drivers of Drug Expenditure in the U.S.
  4. RxList: AK-Pentolate (Cyclopentolate Hydrochloride Ophthalmic Solution)

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