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Last Updated: December 22, 2024

ISOPTO CARPINE Drug Patent Profile


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When do Isopto Carpine patents expire, and when can generic versions of Isopto Carpine launch?

Isopto Carpine is a drug marketed by Sandoz and is included in one NDA.

The generic ingredient in ISOPTO CARPINE is pilocarpine hydrochloride. There are twelve drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the pilocarpine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Isopto Carpine

A generic version of ISOPTO CARPINE was approved as pilocarpine hydrochloride by PADAGIS US on November 16th, 2004.

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Summary for ISOPTO CARPINE
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 74
Patent Applications: 4,022
What excipients (inactive ingredients) are in ISOPTO CARPINE?ISOPTO CARPINE excipients list
DailyMed Link:ISOPTO CARPINE at DailyMed
Drug patent expirations by year for ISOPTO CARPINE

US Patents and Regulatory Information for ISOPTO CARPINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz ISOPTO CARPINE pilocarpine hydrochloride SOLUTION;OPHTHALMIC 200890-001 Jun 22, 2010 AT RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sandoz ISOPTO CARPINE pilocarpine hydrochloride SOLUTION;OPHTHALMIC 200890-002 Jun 22, 2010 AT RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sandoz ISOPTO CARPINE pilocarpine hydrochloride SOLUTION;OPHTHALMIC 200890-003 Jun 22, 2010 AT RX Yes Yes ⤷  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

ISOPTO CARPINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ISOPTO CARPINE

Introduction to ISOPTO CARPINE

ISOPTO CARPINE, also known as pilocarpine hydrochloride ophthalmic solution, is a miotic agent used to control intraocular pressure in various ophthalmic conditions, including chronic simple glaucoma, acute angle-closure glaucoma, and the prevention of postoperative elevated intraocular pressure (IOP)[1][4].

Therapeutic Indications

ISOPTO CARPINE is indicated for several key ophthalmic conditions:

  • Reduction of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
  • Management of acute angle-closure glaucoma.
  • Prevention of postoperative elevated IOP associated with laser surgery.
  • Induction of miosis[1][4].

Market Size and Growth

The global ophthalmic drugs market, within which ISOPTO CARPINE operates, is projected to grow significantly. By 2033, the market is expected to reach USD 85.6 billion, growing at a Compound Annual Growth Rate (CAGR) of 8.3% from 2023 to 2033. This growth is driven by the increasing prevalence of eye-related ailments such as glaucoma, dry eye disease, and other ocular disorders[3].

Segment Dominance

Product Type

Prescription drugs, which include ISOPTO CARPINE, hold a substantial market share of 63.5% in 2023, driven by the increased prevalence of conditions like Age-related Macular Degeneration (AMD) and diabetic retinopathy[3].

Drug Class

Anti-glaucoma drugs, the category to which ISOPTO CARPINE belongs, claim a significant market share of 31.9% in 2023, dominated by the rising cases of glaucoma globally[3].

Dosage Form

Eye drops, the form in which ISOPTO CARPINE is administered, command a dominant market position with a 41.8% share in 2023. This is fueled by the over-the-counter (OTC) availability, patient compliance, and new product launches[3].

Route of Administration

Topical administration, the method used for ISOPTO CARPINE, holds a dominant market position at 57% in 2023, favored for self-administration, non-intrusiveness, and patient compliance[3].

Distribution Channel

Hospital pharmacies dominate the distribution channel with a 60.4% market share in 2023, driven by the high prevalence of chronic eye diseases and increasing healthcare spending in developing nations. Online pharmacies are expected to grow at the fastest rate during the projection period due to increasing internet penetration and e-prescriptions[3].

Regional Analysis

North America holds a dominant market position, capturing more than 44% of the market share and valued at USD 16.9 billion in 2023. The region's growth is influenced by the rising prevalence of eye diseases, advancements in ophthalmology technology, and the growing elderly population. The Asia-Pacific region is also expected to witness high growth due to an increase in ocular disease instances and rising consumer awareness of therapeutic efficacy[3].

Financial Trajectory

Spending on pilocarpine hydrochloride, the active ingredient in ISOPTO CARPINE, has seen significant increases over the years. The financial trajectory of the drug is positively influenced by the growing demand for ophthalmic medications and the expanding market size of the global ophthalmic drugs sector[2].

Key Factors Driving Market Growth

  • Increasing Prevalence of Eye Diseases: Conditions such as glaucoma, dry eye disease, and other ocular disorders are driving the demand for ophthalmic medications.
  • Rising Geriatric Population: The growing elderly population is a significant factor contributing to the market growth.
  • Research & Development Initiatives: Continuous R&D efforts to develop novel ophthalmic drugs and medications are stimulating market growth.
  • Strategic Initiatives by Major Players: Implementation of strategic initiatives by major market players is further fueling market expansion[3].

Challenges and Considerations

  • Adverse Effects: ISOPTO CARPINE can cause adverse reactions such as miosis, blurred vision, and difficulty in dark adaptation, which may affect the ability to drive and use machines[4].
  • Regulatory Requirements: While the drug has been approved for various indications, post-market risk evaluation and mitigation strategies are essential to ensure patient safety[1].

Conclusion

ISOPTO CARPINE operates within a robust and growing market for ophthalmic drugs. The drug's therapeutic indications, coupled with the increasing demand for ophthalmic medications, position it for continued financial growth. The market dynamics, driven by factors such as the rising prevalence of eye diseases and the growing geriatric population, ensure a strong financial trajectory for ISOPTO CARPINE.

Key Takeaways

  • ISOPTO CARPINE is used to control intraocular pressure in various ophthalmic conditions.
  • The global ophthalmic drugs market is projected to reach USD 85.6 billion by 2033.
  • Anti-glaucoma drugs, including ISOPTO CARPINE, hold a significant market share.
  • Topical administration and eye drops are dominant in the market.
  • North America and the Asia-Pacific region are key markets for ophthalmic drugs.
  • Increasing prevalence of eye diseases and R&D initiatives drive market growth.

FAQs

What are the primary indications for ISOPTO CARPINE?

ISOPTO CARPINE is indicated for the reduction of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma, management of acute angle-closure glaucoma, prevention of postoperative elevated IOP, and induction of miosis[1][4].

How does ISOPTO CARPINE work?

ISOPTO CARPINE works by contracting the ciliary muscle, which opens the trabecular meshwork spaces to facilitate the outflow of aqueous humor, thus lowering intraocular pressure[1].

What are the common adverse effects of ISOPTO CARPINE?

Common adverse effects include miosis, blurred vision, and difficulty in dark adaptation. These effects can impact the ability to drive and use machines[4].

What is the market size of the global ophthalmic drugs market?

The global ophthalmic drugs market is expected to be worth around USD 85.6 billion by 2033, growing at a CAGR of 8.3% from 2024 to 2033[3].

Which region dominates the ophthalmic drugs market?

North America holds a dominant market position, capturing more than 44% of the market share, followed by the Asia-Pacific region which is expected to witness high growth[3].

Cited Sources

  1. FDA Clinical Review for NDA 200-890: "CLINICAL REVIEW for NDA 200-890 - FDA"
  2. Drug Patent Watch: "Pilocarpine hydrochloride - Generic Drug Details"
  3. Market.US Report: "Ophthalmic Drugs Market Size, Share | CAGR of 8.3%"
  4. Novartis ISOPTO CARPINE PI: "ISOPTO CARPINE ophthalmic solution"

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