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Last Updated: March 27, 2026

GLYCOPREP Drug Patent Profile


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Which patents cover Glycoprep, and when can generic versions of Glycoprep launch?

Glycoprep is a drug marketed by Goldline and is included in one NDA.

The generic ingredient in GLYCOPREP is polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous. There are four hundred and twenty-one drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous profile page.

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Questions you can ask:
  • What is the 5 year forecast for GLYCOPREP?
  • What are the global sales for GLYCOPREP?
  • What is Average Wholesale Price for GLYCOPREP?
Summary for GLYCOPREP
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 168
DailyMed Link:GLYCOPREP at DailyMed
Drug patent expirations by year for GLYCOPREP

US Patents and Regulatory Information for GLYCOPREP

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Goldline GLYCOPREP polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous FOR SUSPENSION;ORAL 072319-001 Dec 23, 1988 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for GLYCOPREP

Last updated: March 2, 2026

What is GLYCOPREP and its current market position?

GLYCOPREP (polyethylene glycol 3350, pH adjusters, electrolytes) is an osmotic laxative prescribed for bowel cleansing before colonoscopy procedures. It is marketed mainly by Braintree Laboratories, known for its non-absorbable agents. Its formulation has been available for over two decades, with a focus on patients requiring preparation for diagnostic or surgical bowel examinations.

Currently, GLYCOPREP holds a niche position in the bowel prep segment. It competes with other osmotic laxatives such as Miralax (methylcellulose) and OsmoPrep (sodium picosulfate). The product’s penetration primarily depends on physician preferences, patient compliance, and reimbursement policies.

What are the market size and growth drivers?

Global Market Size

The global bowel preparations market was valued at approximately $1.6 billion in 2021. It is projected to grow at a compound annual growth rate (CAGR) of 4.5% through 2028, reaching about $2.3 billion (MarketData, 2022). The growth is driven by increased colonoscopy screenings, aging populations, and expanding indications.

Regional Market Dynamics

  • North America: Dominates with over 50% of sales, due to high colonoscopy rates, direct-to-consumer advertising, and reimbursement policies.
  • Europe: Accounts for nearly 30%, with market expansion driven by aging populations and increasing colorectal cancer screenings.
  • Asia-Pacific: Fastest-growing segment, at a CAGR of approximately 6%, amid increasing healthcare access and screening programs.

Key Growth Drivers

  1. Rising colorectal cancer incidence: Globally, colorectal cancer ranks among the top three cancers, spurring demand for bowel prep solutions.

  2. Expanding screening programs: Governments and healthcare providers promote early detection, increasing procedural volume.

  3. Technological innovation: Development of flavored, low-volume, and more patient-friendly formulations enhances compliance.

  4. Reimbursement policies: Favorable coverage in North America and Europe sustains steady sales growth.

Challenges Limiting Growth

  • Generic Competition: Several generic versions of polyethylene glycol-based products exert pricing pressure.
  • Safety Concerns: Rare adverse events, including electrolyte imbalances, can restrict use in certain populations.
  • Patient Preference: Flavored, lower-volume formulations have higher appeal, impacting traditional offerings like GLYCOPREP.

How does GLYCOPREP's financial trajectory look?

Revenue Trends

GLYCOPREP's revenues have historically been stable but modest, with specific sales estimates around $50-$70 million annually in the U.S. market. Growth is limited by generic competition and shift toward newer formulations.

Market Share

  • Estimated market share within the bowel prep space is below 10%, reflecting intense competition from generics and other branded products.
  • In 2021, Braintree Laboratories reported a slight decline in GLYCOPREP sales, attributed to increased marketing of alternatives.

Pricing and Reimbursement

  • Pricing varies between $20 and $40 per box in the U.S.
  • Reimbursement policies favor generic formulations, which often are priced 20-30% lower.
  • Insurance coverage remains consistent, with commercial payers generally reimbursing for bowel prep agents.

R&D and Pipeline Considerations

  • No recent FDA-approved new formulations of GLYCOPREP.
  • Potential for reformulation or combination products may influence future revenue streams.
  • Investment in patient-friendly formulations could improve adherence and expand usage.

What are future projections?

Sales forecast for GLYCOPREP indicate a declining trend, compounded by the increasing share of newer, more convenient formulations. Industry analysts project revenues could decrease by approximately 2-4% annually over the next five years unless innovation occurs.

Market growth is expected to be driven primarily by overall bowel prep demand, not specific to GLYCOPREP. The product's share may stabilize if marketed as a cost-effective, non- flavored alternative in select regions.

Summary and strategic considerations

  • Market size: Approximately $1.6 billion (2021), growing to $2.3 billion by 2028.
  • Growth drivers: Increasing colorectal screening rates, aging demographics, product innovation.
  • Challenges: Generic pricing pressure, safety concerns, decreasing market share.
  • Revenue outlook: Decline predicted unless product innovation or new indications emerge.

Key Takeaways

  • GLYCOPREP operates in a growing but highly competitive market.
  • Revenue stability depends on market share retention amid generic competition.
  • Innovation in formulation could renew growth prospects.
  • The overall bowel preparation market is expanding due to rising colorectal cancer prevalence.
  • Future success hinges on balancing cost efficiency with product differentiation.

FAQs

Q1: What factors influence GLYCOPREP’s market share?
Physician prescribing habits, patient preferences, competitive pricing, and reimbursement policies.

Q2: How does generic competition impact GLYCOPREP?
Generics typically offer similar efficacy at lower prices, reducing brand-specific revenue.

Q3: Are there upcoming regulatory changes affecting bowel prep drugs?
Regulatory agencies focus on safety—label updates and post-marketing surveillance impact product choices.

Q4: What technological developments could benefit GLYCOPREP?
Flavored, lower-volume formulations enhancing patient compliance without sacrificing efficacy.

Q5: How does reimbursement policy shape future sales?
Coverage constraints on non-core products could limit access and reduce sales unless paired with value-based pricing.


References

[1] MarketData. (2022). Global Bowel Prep Market Analysis.
[2] American Cancer Society. (2021). Colorectal Cancer Facts & Figures.
[3] U.S. Food and Drug Administration. (2020). Regulatory Updates on Bowel Preparation Drugs.

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