PILOCARPINE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for pilocarpine hydrochloride and what is the scope of freedom to operate?

Pilocarpine hydrochloride is the generic ingredient in six branded drugs marketed by Alcon, Sandoz, Amneal, Rising, Somerset Theraps Llc, Orasis Pharms, Abbvie, Aurobindo Pharma Ltd, Impax Labs, Innogenix, Lannett Co Inc, Padagis Us, and Concordia, and is included in thirteen NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pilocarpine hydrochloride has fifty-six patent family members in twenty-four countries.

There are seven drug master file entries for pilocarpine hydrochloride. Fifteen suppliers are listed for this compound.

Summary for PILOCARPINE HYDROCHLORIDE

International Patents:	56
US Patents:	6
Tradenames:	6
Applicants:	13
NDAs:	13
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	50
Patent Applications:	6,184
What excipients (inactive ingredients) are in PILOCARPINE HYDROCHLORIDE?	PILOCARPINE HYDROCHLORIDE excipients list
DailyMed Link:	PILOCARPINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for PILOCARPINE HYDROCHLORIDE

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

Sponsor	Phase
ZonMw: The Netherlands Organisation for Health Research and Development	Phase 3
Maastricht University Medical Center	Phase 3
Ocuphire Pharma, Inc.	Phase 3

See all PILOCARPINE HYDROCHLORIDE clinical trials

Pharmacology for PILOCARPINE HYDROCHLORIDE

Drug Class	Cholinergic Receptor Agonist
Mechanism of Action	Cholinergic Agonists Cholinergic Muscarinic Agonists

Anatomical Therapeutic Chemical (ATC) Classes for PILOCARPINE HYDROCHLORIDE

N07AX	Other parasympathomimetics
N07A	PARASYMPATHOMIMETICS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

S01EB	Parasympathomimetics
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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
Orasis Pharms	QLOSI	pilocarpine hydrochloride	SOLUTION;OPHTHALMIC	217836-001	Oct 17, 2023		RX	Yes	Yes	10,639,297		Y
Orasis Pharms	QLOSI	pilocarpine hydrochloride	SOLUTION;OPHTHALMIC	217836-001	Oct 17, 2023		RX	Yes	Yes	11,129,812
Sandoz	ISOPTO CARPINE	pilocarpine hydrochloride	SOLUTION;OPHTHALMIC	200890-003	Jun 22, 2010	AT	RX	Yes	Yes
Abbvie	VUITY	pilocarpine hydrochloride	SOLUTION;OPHTHALMIC	214028-001	Oct 28, 2021		RX	Yes	Yes	11,285,134

International Patents for PILOCARPINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
South Korea	20220162876	안과용 약학 조성물 및 이와 관련된 용도 (OPHTHALMIC PHARMACEUTICAL COMPOSITIONS AND USES RELATING THERETO)
Australia	2023226732	Ophthalmic pharmaceutical compositions and uses relating thereto
Russian Federation	2019107585
Australia	2019261598	Use of pilocarpine hydrochloride for the treatment of ocular conditions

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.