SUPREP BOWEL PREP KIT Drug Patent Profile

When do Suprep Bowel Prep Kit patents expire, and what generic alternatives are available?

Suprep Bowel Prep Kit is a drug marketed by Braintree Labs and is included in one NDA.

The generic ingredient in SUPREP BOWEL PREP KIT is magnesium sulfate; potassium sulfate; sodium sulfate. There are one hundred and forty-six drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the magnesium sulfate; potassium sulfate; sodium sulfate profile page.

Summary for SUPREP BOWEL PREP KIT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	8
Patent Applications:	12
Drug Prices:	Drug price information for SUPREP BOWEL PREP KIT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SUPREP BOWEL PREP KIT
DailyMed Link:	SUPREP BOWEL PREP KIT at DailyMed

See drug prices for SUPREP BOWEL PREP KIT

Recent Clinical Trials for SUPREP BOWEL PREP KIT

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

Sponsor	Phase
University of Virginia	N/A
Seoul National University Hospital	Phase 4
Bo-In Lee	Phase 4

See all SUPREP BOWEL PREP KIT clinical trials

Pharmacology for SUPREP BOWEL PREP KIT

Drug Class	Calculi Dissolution Agent Osmotic Laxative Potassium Salt
Mechanism of Action	Magnesium Ion Exchange Activity Osmotic Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption Inhibition Small Intestine Fluid/Electrolyte Absorption Stimulation Large Intestine Fluid/Electrolyte Secretion

Paragraph IV (Patent) Challenges for SUPREP BOWEL PREP KIT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SUPREP BOWEL PREP KIT	Oral Solution	magnesium sulfate; potassium sulfate; sodium sulfate	17.5 g/3.13 g/1.6 g	022372	1	2010-11-08

US Patents and Regulatory Information for SUPREP BOWEL PREP KIT

SUPREP BOWEL PREP KIT is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Braintree Labs	SUPREP BOWEL PREP KIT	magnesium sulfate; potassium sulfate; sodium sulfate	SOLUTION;ORAL	022372-001	Aug 5, 2010	AA	RX	Yes	Yes

Expired US Patents for SUPREP BOWEL PREP KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Braintree Labs	SUPREP BOWEL PREP KIT	magnesium sulfate; potassium sulfate; sodium sulfate	SOLUTION;ORAL	022372-001	Aug 5, 2010

International Patents for SUPREP BOWEL PREP KIT

See the table below for patents covering SUPREP BOWEL PREP KIT around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2375446
Hong Kong	1154492	SALT SOLUTION FOR COLON CLEANSING
Canada	2484303	SOLUTION SALINE POUR LE NETTOYAGE DU COLON (SALT SOLUTION FOR COLON CLEANSING)
Spain	2340920
Cyprus	1110011
Portugal	2233147
Japan	2005530743

Supplementary Protection Certificates for SUPREP BOWEL PREP KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0984957	C300517	Netherlands		PRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812
1499331	122014000007	Germany		PRODUCT NAME: NATRIUMSULFAT, MAGNESIUMSULFAT UND KALIUMSULFAT; NAT. REGISTRATION NO/DATE: 86203.00.00 20130808; FIRST REGISTRATION: BELGIEN BE434323 20130220
0984957	CR 2012 00035	Denmark		PRODUCT NAME: ET KOMBINATIONSPRODUKT AF NAPROXEN OG ESOMEPRAZOL MAGNESIUM TRIHYDRAT; NAT. REG. NO/DATE: 49583 20120327; FIRST REG. NO/DATE: GB PL 17901/0263-001 20101105
0984957	C300483	Netherlands		PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYFRAAT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20110524
1499331	2013C/049	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION
0984957	2012/048	Ireland		PRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812

Market Dynamics and Financial Trajectory for SUPREP Bowel Prep Kit

Market Overview

The SUPREP Bowel Prep Kit is a significant player in the colonoscopy bowel preparation drugs market, which is driven by several key factors.

Rising Incidences of Colorectal Diseases

The increasing prevalence of colorectal diseases, such as colon and rectal cancer, is a major driver for the demand of bowel preparation drugs like SUPREP. For instance, in the U.S., around 147,950 new cases of large bowel cancer are diagnosed annually, with 104,610 of these cases being colon cancer[1].

Preference for Effective and Less Invasive Methods

There is a growing preference for effective and less invasive bowel preparation methods, which has boosted the demand for drugs like SUPREP. Patients and healthcare providers are seeking preparations that are both effective and have fewer side effects, making PEG-based drugs like SUPREP highly sought after[4].

Financial Trajectory

Market Size and Growth

The U.S. colonoscopy bowel preparation drugs market, which includes SUPREP, was valued at USD 483.02 million in 2021 and is expected to grow at a CAGR of 3.0% from 2021 to 2030. This growth is projected to result in a market size of USD 621.75 million by 2030[1].

Revenue Contribution

SUPREP, being a prescription drug, falls under the Rx segment, which is expected to account for a significant portion of the market. The Rx segment is anticipated to dominate the market, primarily because most bowel preparation drugs, including SUPREP, are prescription-based[1].

Competitive Landscape

The market for colonoscopy bowel preparation drugs is competitive, with major players like Salix Pharmaceuticals, the original manufacturer of SUPREP, focusing on product innovation, strategic collaborations, and geographical expansion. For example, Lupin launched a generic version of the SUPREP Bowel Prep Kit in the U.S. market, indicating the competitive nature of the market[2][4].

Product Launches and Innovations

The launch of generic versions and new products is a significant factor in the market dynamics. For instance, Lupin's launch of a generic version of SUPREP in the U.S. market highlights the ongoing competition and innovation in the sector[2].

Distribution and Partnerships

Strategic partnerships and distribution agreements also play a crucial role. For example, Norgine B.V.'s exclusive license and distribution agreement with Aspen Pharmacare for the distribution of PLENVU in several African countries demonstrates the importance of such collaborations in expanding market reach[1].

Adverse Reactions and Side Effects

While SUPREP is effective, it is not without its challenges. Adverse reactions such as overall discomfort, abdominal distention, abdominal pain, nausea, vomiting, and headache can hamper market growth to some extent. However, these side effects are relatively common among bowel preparation drugs and do not significantly deter the overall demand[1].

Regulatory Environment

The conversion of prescription drugs to over-the-counter (OTC) by regulatory bodies is another trend that could impact the market. Over 700 prescription drugs have been converted to OTC in the last three decades, which could influence the market share of prescription drugs like SUPREP, although the Rx segment is expected to remain dominant[1].

Regional Analysis

The market for colonoscopy bowel preparation drugs, including SUPREP, is analyzed across various regions. North America and Europe are the largest markets due to the high prevalence of colorectal diseases and robust healthcare infrastructure. The U.S. market, in particular, is a significant segment for SUPREP[4].

Technological Advancements

Technological advancements in drug development are also driving the market. There is a growing focus on developing patient-friendly bowel preparation drugs, which includes improvements in the formulation and administration of drugs like SUPREP to make them more tolerable and effective[4].

Home-Based Bowel Preparation

The increasing adoption of home-based bowel preparation methods is another trend that supports the growth of SUPREP. Patients prefer the convenience and comfort of preparing for colonoscopies at home, which aligns with the use of SUPREP[4].

Conclusion

The SUPREP Bowel Prep Kit operates within a dynamic market driven by the rising incidence of colorectal diseases, the preference for effective and less invasive methods, and technological advancements. While it faces competition from generic versions and other market players, its position as a prescription drug within the dominant Rx segment ensures its continued relevance.

Key Takeaways

• The U.S. colonoscopy bowel preparation drugs market, including SUPREP, is expected to grow at a CAGR of 3.0% from 2021 to 2030.
• The market is driven by increasing incidences of colorectal diseases and the preference for effective and less invasive methods.
• SUPREP falls under the Rx segment, which dominates the market.
• Adverse reactions and side effects are common but do not significantly deter demand.
• Technological advancements and home-based bowel preparation trends support market growth.

FAQs

What is the current market size of the U.S. colonoscopy bowel preparation drugs market?

The U.S. colonoscopy bowel preparation drugs market was valued at USD 483.02 million in 2021[1].

What is the expected CAGR for the U.S. colonoscopy bowel preparation drugs market from 2021 to 2030?

The market is expected to grow at a CAGR of 3.0% from 2021 to 2030[1].

Which segment dominates the colonoscopy bowel preparation drugs market?

The Rx segment dominates the market, primarily because most bowel preparation drugs, including SUPREP, are prescription-based[1].

What are the common adverse reactions associated with SUPREP Bowel Prep Kit?

Common adverse reactions include overall discomfort, abdominal distention, abdominal pain, nausea, vomiting, and headache[1].

How does the launch of generic versions impact the market for SUPREP?

The launch of generic versions, such as Lupin's generic version of SUPREP, indicates competition and can affect market share, but the Rx segment remains dominant[2].

Sources:

1. Reports and Data - U.S. Colonoscopy Bowel Preparation Drugs Market
2. Business Standard - Lupin launches generic version of Suprep Bowel prep kit in US market
3. BioSpace - Colonoscopy Bowel Preparation Drugs Market Analysis, Statistics ...
4. Technavio - Colonoscopy Bowel Preparation Drugs 2024-2028 Market Overview