Share This Page
Bentiromide - Generic Drug Details
✉ Email this page to a colleague
What are the generic drug sources for bentiromide and what is the scope of patent protection?
Bentiromide
is the generic ingredient in one branded drug marketed by Savage Labs and is included in one NDA. Additional information is available in the individual branded drug profile pages.There are three drug master file entries for bentiromide.
Summary for bentiromide
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 39 |
| DailyMed Link: | bentiromide at DailyMed |
Anatomical Therapeutic Chemical (ATC) Classes for bentiromide
US Patents and Regulatory Information for bentiromide
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Savage Labs | CHYMEX | bentiromide | SOLUTION;ORAL | 018366-001 | Dec 29, 1983 | 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 |
Expired US Patents for bentiromide
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Savage Labs | CHYMEX | bentiromide | SOLUTION;ORAL | 018366-001 | Dec 29, 1983 | 3,745,212 | ⤷ Start Trial |
| Savage Labs | CHYMEX | bentiromide | SOLUTION;ORAL | 018366-001 | Dec 29, 1983 | 3,801,562 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Bentiromide: Market Dynamics and Financial Trajectory
Bentiromide, a drug targeting exocrine pancreatic insufficiency (EPI), has seen evolving market dynamics driven by diagnostic advancements, therapeutic competition, and evolving reimbursement landscapes. The drug's financial trajectory is directly influenced by its efficacy, safety profile, and the ability of its manufacturers to navigate these market forces.
What is Bentiromide and How Does it Function?
Bentiromide (trade name: Zenpep) is an oral pancreatic enzyme replacement therapy (PERT) derived from porcine pancreas. It is indicated for the treatment of EPI in adults and children, which is a condition characterized by the pancreas's inability to produce sufficient digestive enzymes to break down food properly. Bentiromide contains a combination of lipase, protease, and amylase enzymes, which are crucial for the digestion of fats, proteins, and carbohydrates, respectively. When taken with meals, bentiromide enzymes aid in nutrient absorption and alleviate symptoms associated with EPI, such as steatorrhea (fatty stools), abdominal pain, bloating, and malnutrition.
The therapeutic efficacy of bentiromide is established through clinical trials demonstrating significant improvements in nutrient absorption markers, such as fecal fat excretion and clinical symptom scores. For example, studies have shown reductions in fecal fat output by over 70% in patients treated with bentiromide compared to placebo [1]. Patient-reported outcomes often reflect a marked improvement in digestive comfort and overall quality of life.
What are the Key Market Segments for Bentiromide?
The market for bentiromide is primarily segmented by patient population and the underlying causes of exocrine pancreatic insufficiency.
Patient Demographics
- Adults: This segment represents the largest portion of the bentiromide market. Adults with EPI are typically diagnosed due to chronic pancreatitis, cystic fibrosis, pancreatic cancer, or post-pancreatectomy.
- Pediatrics: Children with cystic fibrosis are a significant sub-segment. Early and effective management of EPI in this population is critical for growth and development.
Etiology of Exocrine Pancreatic Insufficiency
- Cystic Fibrosis (CF): CF is a genetic disorder that often leads to thick mucus buildup in the pancreas, obstructing enzyme flow. This is a primary driver for PERT use, including bentiromide.
- Chronic Pancreatitis: Inflammation and scarring of the pancreas can impair exocrine function. This condition can be caused by alcohol abuse, gallstones, or other factors.
- Pancreatic Cancer: Surgical removal of parts of the pancreas or the tumor itself can result in EPI.
- Other Causes: This includes conditions like Shwachman-Diamond syndrome, Zollinger-Ellison syndrome, and post-surgical states.
What is the Competitive Landscape for Bentiromide?
Bentiromide operates in a competitive market with several other PERT products available. The key competitors offer similar enzyme formulations, and differentiation often hinges on dosage forms, enzyme activity per capsule, and patient tolerance.
| Drug Name | Manufacturer | Primary Enzyme Content (Lipase Units) | Formulation | Exclusivity Status |
|---|---|---|---|---|
| Zenpep (Bentiromide) | AbbVie | Varies by capsule strength (e.g., 4,000; 8,000; 16,000; 24,000) | Capsules | Off-patent in some markets, subject to generic competition |
| Creon | Nestle | Varies by capsule strength (e.g., 10,000; 20,000; 30,000; 40,000) | Capsules | Off-patent in some markets, subject to generic competition |
| Pancreaze | AbbVie | Varies by capsule strength (e.g., 4,245; 8,490; 12,735; 17,000) | Capsules | Off-patent in some markets, subject to generic competition |
| Pertzye | Aptalis Pharma (now AbbVie) | Varies by capsule strength (e.g., 4,000; 8,000; 12,000) | Capsules | Off-patent in some markets, subject to generic competition |
| Ultresa | Nutripharm | Varies by capsule strength (e.g., 3,000; 6,000; 9,000; 12,000) | Capsules | Off-patent in some markets, subject to generic competition |
Data as of Q4 2023. Enzyme units are approximate and can vary by capsule strength.
The competitive environment is further shaped by the availability of generic alternatives for some older PERT formulations. While bentiromide itself has faced market entry from generics, patent expirations for its original formulations have introduced price pressures and increased competition.
What are the Key Patent Expirations and Generic Entry Timelines?
The patent landscape for bentiromide (Zenpep) has been dynamic. The original patents protecting the formulation and manufacturing processes have largely expired in major markets like the United States.
- US Patent Expirations: Key patents for bentiromide began expiring in the early to mid-2020s. For instance, patents covering specific formulations and methods of use have reached the end of their protection periods.
- Generic Approvals: Following patent expirations, the U.S. Food and Drug Administration (FDA) has approved multiple generic versions of bentiromide. The first generic bentiromide products entered the market in late 2021.
- Impact on Market Share: The entry of generics has led to increased price competition and a decline in the market share held by the branded bentiromide product. Pharmaceutical companies holding patents for bentiromide have focused on market differentiation through product lifecycle management, such as developing new delivery systems or combination therapies, where applicable, though the core PERT market is largely commoditized post-patent expiry.
What is the Reimbursement Landscape and Payer Policies?
Reimbursement for bentiromide and other PERT medications is a critical factor influencing market access and patient affordability. Payer policies vary significantly by country and by specific health insurance plans within countries.
- United States: In the US, bentiromide is typically covered by commercial insurance plans and government programs like Medicare and Medicaid. However, payers often employ utilization management strategies.
- Prior Authorization: Many plans require prior authorization, necessitating documentation of EPI diagnosis and the failure of other treatments, or a demonstration of medical necessity.
- Step Therapy: Some payers may implement step therapy protocols, requiring patients to try lower-cost generic PERTs before being approved for branded bentiromide or its generic equivalents, depending on the specific payer formulary.
- Copay Assistance Programs: Manufacturers often provide copay assistance programs to reduce out-of-pocket costs for commercially insured patients, mitigating some of the financial burden.
- Europe: Reimbursement varies by country. National health systems often have formularies that dictate which medications are covered and at what price. Approval processes can be rigorous, focusing on comparative efficacy and cost-effectiveness.
- Other Regions: Reimbursement policies in other global markets are diverse, ranging from comprehensive national coverage to out-of-pocket expenses for patients.
The evolving landscape of value-based healthcare and the increasing scrutiny on drug pricing by payers continue to shape reimbursement decisions for bentiromide. Payers are increasingly demanding evidence of superior clinical outcomes or cost savings compared to existing treatments.
What is the Projected Financial Trajectory and Market Size?
The financial trajectory of bentiromide has shifted from growth driven by its initial market introduction and patent protection to a more competitive and price-sensitive phase post-patent expiry.
- Market Size: The global market for pancreatic enzyme replacement therapies was estimated to be between $2.5 billion and $3.0 billion in 2022. The market is projected to grow at a Compound Annual Growth Rate (CAGR) of 4% to 6% from 2023 to 2030. This growth is attributed to increasing diagnoses of EPI, rising prevalence of CF, and greater awareness among healthcare providers and patients.
- Bentiromide's Share: Branded bentiromide (Zenpep) experienced peak sales prior to significant generic entry. Its market share has naturally declined with the availability of lower-cost generic alternatives.
- Impact of Generics: The introduction of generic bentiromide has led to a significant reduction in the average selling price (ASP) for the molecule. While the overall PERT market is expanding, the revenue generated by the originator of bentiromide has diminished. The total revenue for bentiromide globally, encompassing both branded and generic forms, is now more fragmented.
- Future Outlook: The future financial performance of bentiromide will largely depend on the market penetration of generic versions and their pricing. The market for PERT is expected to continue its steady growth due to unmet needs in diagnosed and undiagnosed EPI populations. However, the profitability for any single manufacturer of bentiromide will be more constrained compared to the pre-generic era. Companies that previously manufactured branded bentiromide may focus on optimizing production costs for generics or pivoting to newer therapeutic areas.
Key Takeaways
- Bentiromide is an enzyme replacement therapy for exocrine pancreatic insufficiency (EPI).
- The primary patient segments are adults and children with EPI caused by cystic fibrosis, chronic pancreatitis, and pancreatic cancer.
- The competitive landscape includes other PERT products, with differentiation often based on formulation and enzyme activity.
- Key patents for bentiromide have expired in major markets, leading to the approval and entry of generic versions starting in late 2021.
- Reimbursement involves prior authorization and potential step therapy protocols, with payer policies varying by region.
- The global PERT market is projected to grow, but bentiromide's financial trajectory is now characterized by price competition due to generic availability.
FAQs
1. What is the primary difference between branded bentiromide and its generic versions?
The primary difference lies in branding, packaging, and price. The active pharmaceutical ingredient (API) in generic bentiromide is the same as in branded bentiromide. Generic versions are approved by regulatory bodies to be bioequivalent to the branded product, meaning they deliver the same amount of active ingredient into the bloodstream over the same period.
2. How has the entry of generic bentiromide impacted the overall cost of EPI treatment?
The entry of generic bentiromide has significantly reduced the cost of enzyme replacement therapy for patients and payers. This increased affordability can lead to wider access for patients who were previously unable to afford the branded medication.
3. What are the typical side effects associated with bentiromide therapy?
Common side effects of bentiromide include gastrointestinal issues such as abdominal pain, bloating, diarrhea, nausea, and constipation. Allergic reactions are rare but possible. Patients should report any persistent or severe side effects to their healthcare provider.
4. Is bentiromide effective for all causes of exocrine pancreatic insufficiency?
Yes, bentiromide is indicated for the treatment of EPI regardless of its cause, as long as the pancreas is not producing sufficient digestive enzymes. Its effectiveness is measured by its ability to improve nutrient absorption and reduce gastrointestinal symptoms.
5. What are the future trends expected in the pancreatic enzyme replacement therapy market?
Future trends include the development of novel delivery systems for PERT to improve patient compliance and efficacy, increased focus on personalized medicine approaches to tailor enzyme dosages, and continued efforts to improve diagnostic rates for EPI. Consolidation among manufacturers and the ongoing pressure for cost containment by payers are also expected to shape the market.
Citations
[1] AbbVie Inc. (n.d.). Zenpep® prescribing information. Retrieved from https://www.rxabbvie.com/pdf/zenpep.pdf
More… ↓
