Magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate - Generic Drug Details

What are the generic drug sources for magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate and what is the scope of freedom to operate?

Magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate is the generic ingredient in one branded drug marketed by Braintree Labs and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate has one patent family member in one country.

One supplier is listed for this compound.

Summary for magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate

International Patents:	1
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	5
DailyMed Link:	magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate

Constraining patent/regulatory exclusivity:

NEW PRODUCT

Dosage:

FOR SOLUTION;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate

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

Sponsor	Phase
Jinling Hospital, China	N/A
Beijing Hospital	Phase 3
Zhongshan Hospital Xiamen University	Phase 3

See all magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate

A06AD	Osmotically acting laxatives
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

A06AD	Osmotically acting laxatives
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

A12BA	Potassium
A12B	POTASSIUM
A12	MINERAL SUPPLEMENTS
A	Alimentary tract and metabolism

A12CA	Sodium
A12C	OTHER MINERAL SUPPLEMENTS
A12	MINERAL SUPPLEMENTS
A	Alimentary tract and metabolism

A12CA	Sodium
A12C	OTHER MINERAL SUPPLEMENTS
A12	MINERAL SUPPLEMENTS
A	Alimentary tract and metabolism

A12CC	Magnesium
A12C	OTHER MINERAL SUPPLEMENTS
A12	MINERAL SUPPLEMENTS
A	Alimentary tract and metabolism

B05CB	Salt solutions
B05C	IRRIGATING SOLUTIONS
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

B05XA	Electrolyte solutions
B05X	I.V. SOLUTION ADDITIVES
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

B05XA	Electrolyte solutions
B05X	I.V. SOLUTION ADDITIVES
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

B05XA	Electrolyte solutions
B05X	I.V. SOLUTION ADDITIVES
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

V04CC	Tests for bile duct patency
V04C	OTHER DIAGNOSTIC AGENTS
V04	DIAGNOSTIC AGENTS
V	Various

US Patents and Regulatory Information for magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Braintree Labs	SUFLAVE	magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	215344-001	Jun 15, 2023		RX	Yes	Yes
Braintree Labs	SUFLAVE	magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	215344-001	Jun 15, 2023		RX	Yes	Yes

International Patents for magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2024256873

Supplementary Protection Certificates for magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1020461	300482	Netherlands		PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17091/0263 - 0001 20101105
0984957	1290006-4	Sweden		PRODUCT NAME: ACETYLSALICYLSYRA OCH ESOMEPRAZOLMAGNESIUMTRIHYDRAT; NAT. REG. NO/DATE: MTNR 44371 20110930; FIRST REG.: PT 5402359MFL 20110812
1411900	2011C/016	Belgium		PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
0124495	SPC/GB01/006	United Kingdom		PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
1499331	13C0055	France		PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: BE - 434323 20130220
1499331	122014000007	Germany		PRODUCT NAME: NATRIUMSULFAT, MAGNESIUMSULFAT UND KALIUMSULFAT; NAT. REGISTRATION NO/DATE: 86203.00.00 20130808; FIRST REGISTRATION: BELGIEN BE434323 20130220

Market Dynamics and Financial Trajectory for the Drug: Magnesium Sulfate; Polyethylene Glycol 3350; Potassium Chloride; Sodium Chloride; Sodium Sulfate

Introduction

The combination of magnesium sulfate, polyethylene glycol 3350 (PEG-3350), potassium chloride, sodium chloride, and sodium sulfate is commonly used in bowel cleansing preparations, particularly before colonoscopy. This article delves into the market dynamics and financial trajectory of these drugs, highlighting key trends, usage patterns, and market shifts.

Market Overview

The market for bowel cleansing agents has seen significant changes over the past decade, driven by shifts in prescription patterns, generic market penetration, and consumer preferences.

Prescription Trends

From 2002 to 2011, the number of prescriptions for PEG-3350 products doubled, from approximately 5.2 million to 10.4 million prescriptions per year. This increase was largely driven by the growing need for colonoscopies and the preference for PEG-3350 based products due to their efficacy and safety profile[1].

Generic vs. Brand Name Products

The market has witnessed a substantial increase in the use of generic PEG-3350 products. In 2011, generic polyethylene glycol 3350 accounted for 65% of the prescription market, while MiraLAX and its generic equivalents dominated the over-the-counter (OTC) segment with 63% market share[1].

Sales and Distribution Data

Total Sales

In 2011, approximately 24.1 million bottles of PEG-3350 products were distributed in the US, representing a 25% decrease from 2007. However, this decline was offset by a significant increase in OTC sales, which rose by 124% during the same period[1].

Prescription vs. OTC

Prescription sales of PEG-3350 products decreased by 46% from 2007 to 2011, while OTC sales surged. MiraLAX, an OTC product, peaked in 2009 with 98% of the OTC market share but saw a 28% decline by 2011 due to increased competition from generic products[1].

Product Usage and Demographics

Pediatric Population

In the pediatric population (ages 0-16), MiraLAX and its generic equivalents accounted for nearly all prescriptions, with 99% of the pediatric prescriptions in 2011. This highlights the dominance of these products in pediatric care[1].

Adult Population

Adults (ages 17 and older) accounted for 87% of the total prescriptions for PEG-3350 products during the review period, indicating a broader usage base among adults[1].

Financial Trajectory

Revenue Trends

The revenue from PEG-3350 products has been influenced by the shift towards generic and OTC products. Despite a decline in prescription sales, the overall market has remained robust due to increased OTC sales and the growing demand for bowel cleansing agents.

Market Share

In 2011, MiraLAX and its generic equivalents held the largest market share in both prescription and OTC segments. Other products like Moviprep, HalfLytely, and Nulytely also had significant market presence but at lower percentages[1].

Product Formulations and Indications

Bowel Cleansing

The combination of PEG-3350 with electrolytes like sodium chloride, sodium bicarbonate, and potassium chloride is indicated for bowel cleansing prior to colonoscopy. These formulations are designed to ensure adequate hydration and electrolyte balance during the cleansing process[4].

Dosage and Administration

The typical dosage involves reconstituting a powder with water to create a 4-liter solution. This solution contains specific amounts of PEG-3350, sodium chloride, sodium bicarbonate, and potassium chloride, ensuring effective bowel cleansing without significant electrolyte imbalances[4].

Adverse Reactions and Safety

Common Adverse Reactions

Nausea, abdominal fullness, and bloating are the most common adverse reactions, occurring in up to 50% of patients. Other less frequent reactions include abdominal cramps, vomiting, and anal irritation. Rare cases of allergic reactions such as urticaria and anaphylaxis have also been reported[4].

Pediatric Safety

In pediatric patients, especially those under 2 years old, careful monitoring is recommended due to the risk of hypoglycemia and dehydration. Hypokalemia has also been reported in a few cases[4].

Market Drivers and Challenges

Drivers

• Increasing Demand for Colonoscopies: The growing awareness and need for colon cancer screening have driven the demand for effective bowel cleansing agents.
• Generic Market Penetration: The availability of generic PEG-3350 products has made these treatments more accessible and affordable.
• Consumer Preference: The preference for OTC products has contributed to the market growth, especially for MiraLAX and its generic equivalents.

Challenges

• Competition: The market is highly competitive, with multiple brands and generic options available.
• Regulatory Scrutiny: Products must adhere to strict regulatory standards, including those related to residual solvents and manufacturing processes[3].
• Side Effects: Common adverse reactions and the need for careful monitoring in pediatric patients can affect market perception and usage.

Future Outlook

The market for bowel cleansing agents is expected to continue growing, driven by the increasing need for colonoscopies and the expanding generic market. However, manufacturers must navigate the challenges of competition, regulatory compliance, and managing adverse reactions to maintain market share.

Key Takeaways

• The market for PEG-3350 based bowel cleansing agents has seen significant growth driven by prescription and OTC sales.
• Generic products have become increasingly dominant, especially in the prescription segment.
• MiraLAX and its generic equivalents hold a substantial market share in both prescription and OTC markets.
• The products are indicated for bowel cleansing prior to colonoscopy and must be carefully monitored for adverse reactions, especially in pediatric patients.
• The future outlook is positive, but manufacturers must address competition, regulatory compliance, and side effect management.

FAQs

Q: What is the primary indication for PEG-3350 based bowel cleansing agents?

A: The primary indication is for bowel cleansing prior to colonoscopy.

Q: How have prescription trends for PEG-3350 products changed over the years?

A: Prescription sales for PEG-3350 products have doubled from 2002 to 2011, despite a decline in brand name prescriptions.

Q: What is the market share of MiraLAX in the OTC segment?

A: MiraLAX and its generic equivalents accounted for 63% of the OTC market share in 2011.

Q: What are the common adverse reactions associated with PEG-3350 based bowel cleansing agents?

A: Common adverse reactions include nausea, abdominal fullness, bloating, abdominal cramps, vomiting, and anal irritation.

Q: Are PEG-3350 based bowel cleansing agents safe for pediatric use?

A: Yes, but they require careful monitoring, especially in children under 2 years old, due to the risk of hypoglycemia, dehydration, and hypokalemia.

Sources

1. FDA Document: Sales Distribution Data and Outpatient Retail Prescription Data for Polyethylene Glycol 3350 Products[1].
2. RxList: Suclear (Sodium, Potassium, Magnesium and PEG-3350) - Drug Information[2].
3. FDA Document: Final Labeling/Labels for Suclear (Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate; and PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride)[3].
4. Drugs.com: PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - Package Insert / Prescribing Info[4].