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Last Updated: December 22, 2024

PILOCARPINE HYDROCHLORIDE Drug Patent Profile


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When do Pilocarpine Hydrochloride patents expire, and what generic alternatives are available?

Pilocarpine Hydrochloride is a drug marketed by Amneal, Rising, Somerset Theraps Llc, Aurobindo Pharma Ltd, Impax Labs, Innogenix, Lannett Co Inc, and Padagis Us. and is included in eight NDAs.

The generic ingredient in PILOCARPINE HYDROCHLORIDE 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 Pilocarpine Hydrochloride

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

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Summary for PILOCARPINE HYDROCHLORIDE
US Patents:0
Applicants:8
NDAs:8
Finished Product Suppliers / Packagers: 9
Raw Ingredient (Bulk) Api Vendors: 74
Clinical Trials: 50
Patent Applications: 4,022
What excipients (inactive ingredients) are in PILOCARPINE HYDROCHLORIDE?PILOCARPINE HYDROCHLORIDE excipients list
DailyMed Link:PILOCARPINE HYDROCHLORIDE at DailyMed
Drug patent expirations by year for PILOCARPINE HYDROCHLORIDE
Recent Clinical Trials for PILOCARPINE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
ZonMw: The Netherlands Organisation for Health Research and DevelopmentPhase 3
Maastricht University Medical CenterPhase 3
Ocuphire Pharma, Inc.Phase 3

See all PILOCARPINE HYDROCHLORIDE clinical trials

Pharmacology for PILOCARPINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for PILOCARPINE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
VUITY Ophthalmic Solution pilocarpine hydrochloride 1.25% 214028 1 2022-12-30

US Patents and Regulatory Information for PILOCARPINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride SOLUTION;OPHTHALMIC 214193-001 Sep 21, 2020 AT RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Padagis Us PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride TABLET;ORAL 076746-001 Nov 16, 2004 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Somerset Theraps Llc PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride SOLUTION;OPHTHALMIC 210384-001 Nov 25, 2019 AT RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Rising PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride SOLUTION;OPHTHALMIC 204398-001 Sep 27, 2017 AT RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Impax Labs PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride TABLET;ORAL 077248-001 Mar 31, 2006 AB 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

PILOCARPINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Pilocarpine Hydrochloride

Introduction to Pilocarpine Hydrochloride

Pilocarpine hydrochloride is a medication widely used in the treatment of various ocular conditions, including glaucoma, dry eye syndrome, and presbyopia. Its market dynamics are influenced by a complex interplay of factors, including increasing prevalence of ocular disorders, advancements in ophthalmic medicine, and economic considerations.

Market Size and Growth Projections

The pilocarpine hydrochloride market has experienced significant growth in recent years and is projected to continue this trend. The global pilocarpine market was valued at USD 1 billion in 2023 and is expected to reach USD 1.64 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 6.2% from 2024 to 2031[4].

Drivers of Market Growth

Increasing Prevalence of Ocular Disorders

The rising incidence of ocular disorders such as glaucoma and dry eye syndrome is a major driver of the pilocarpine hydrochloride market. As the global population ages, the demand for medications that manage intraocular pressure and promote tear production increases[4].

Aging Population

The aging population worldwide is more susceptible to age-related eye conditions, leading to a growing demand for pilocarpine as a therapeutic agent. This demographic shift is a significant factor in the market's expansion[4].

Advancements in Ophthalmic Medicine

Ongoing advancements in ophthalmic medicine, including the development of novel formulations and drug delivery systems for pilocarpine, enhance its efficacy, tolerability, and patient compliance. These innovations drive market growth by offering better treatment options for patients[4].

Regulatory Approvals and Clinical Endorsements

Regulatory approvals and clinical endorsements by healthcare authorities and professional organizations contribute to the market expansion and adoption of pilocarpine hydrochloride. These endorsements validate the safety and effectiveness of the medication, increasing its acceptance among healthcare providers and patients[4].

Financial Trajectory

Revenue and Spending Trends

Spending on pilocarpine hydrochloride has seen significant increases over the years. For instance, spending on generic pilocarpine hydrochloride rose from $116,092 in 2009 to $2.2 million in 2013, indicating a substantial surge in demand and revenue[2].

Profit Margins and Challenges

Despite the growth in revenue, generic drug manufacturers face challenges due to low profit margins. The profit margin for generic drug manufacturers is around 5%, which is significantly lower than the 30% average for brand-name drug manufacturers. This low margin can lead to production challenges and shortages, as companies may find it economically unviable to continue producing these drugs[2].

Impact of Market Dynamics on Pricing

The market dynamics of pilocarpine hydrochloride can lead to fluctuating prices. Initially, as more generic products enter the market, prices tend to drop. However, as fewer manufacturers remain in the market, prices can rise due to reduced competition. This cycle can result in higher prices for consumers and challenges for manufacturers in maintaining profitability[2].

Geographical Segmentation

The pilocarpine hydrochloride market is segmented geographically into regions such as North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. Each region has its own market dynamics influenced by local healthcare infrastructure, regulatory environments, and consumer behavior. The Asia-Pacific region, in particular, is expected to show significant growth due to improving healthcare infrastructure and increasing public awareness of the benefits of pilocarpine therapy[1][4].

Application and Product Type Segmentation

The market is also segmented based on application (eye clinics, hospitals, others) and product type (eye drops, injections). These segments help in understanding the specific needs and trends within different healthcare settings and product formulations. For example, the development of novel eye drop formulations, such as the 1.25% pilocarpine hydrochloride solution for presbyopia, has been well-received and is driving growth in the eye drop segment[3][4].

Challenges and Opportunities

Challenges

  • Low Profit Margins: The low profit margins for generic drug manufacturers pose a significant challenge, leading to potential production shortages and market exits[2].
  • Competition from Alternative Therapies: Competition from alternative therapies such as beta-blockers, prostaglandin analogs, and surgical interventions requires pilocarpine manufacturers to differentiate their products and provide evidence-based clinical positioning[4].

Opportunities

  • Growing Healthcare Infrastructure: Improvements in healthcare infrastructure, especially in developing nations, present opportunities for market expansion[4].
  • Increasing Public Awareness: Rising public awareness of the benefits of pilocarpine therapy contributes to market growth and adoption[4].

Regulatory Environment

The FDA has implemented several measures to address drug shortages, including the establishment of a systematic database to document drug shortages. These efforts have helped in reducing the number of new drug shortages, although challenges persist due to the low profit margins and limited financial resources of generic manufacturers[2].

Key Takeaways

  • The pilocarpine hydrochloride market is expected to grow significantly due to the increasing prevalence of ocular disorders and an aging population.
  • Advancements in ophthalmic medicine and regulatory approvals are driving market growth.
  • Low profit margins for generic manufacturers pose challenges, including potential production shortages.
  • Geographical and application-based segmentation highlights varying market dynamics and opportunities.
  • The market faces competition from alternative therapies, necessitating differentiation strategies.

FAQs

What are the primary drivers of the pilocarpine hydrochloride market?

The primary drivers include the increasing prevalence of ocular disorders, an aging population, and advancements in ophthalmic medicine.

How is the pilocarpine hydrochloride market segmented?

The market is segmented based on type (eye drops, injections), application (eye clinics, hospitals, others), and geographical regions.

What are the challenges faced by generic pilocarpine hydrochloride manufacturers?

Generic manufacturers face low profit margins, which can lead to production challenges and market exits.

How does the regulatory environment impact the pilocarpine hydrochloride market?

The FDA's efforts to document and prevent drug shortages have helped reduce new shortages, but challenges persist due to low profit margins and limited financial resources.

What are the opportunities for growth in the pilocarpine hydrochloride market?

Opportunities include growing healthcare infrastructure, especially in developing nations, and increasing public awareness of the benefits of pilocarpine therapy.

Sources

  1. Market Research Intellect: Global Pilocarpine Hydrochloride Market Size, Trends and Projections.
  2. American Academy of Ophthalmology: The State of Generic Drugs.
  3. ResearchGate: Pilocarpine Hydrochloride Ophthalmic Solution 1.25% - An Innovative Prescription Eye Drop for the Treatment of Presbyopia.
  4. Market Research Intellect: Pilocarpine Market Size, Trends and Projections.

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