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Secretin synthetic porcine - Generic Drug Details
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What are the generic sources for secretin synthetic porcine and what is the scope of freedom to operate?
Secretin synthetic porcine
is the generic ingredient in one branded drug marketed by Chirhoclin and is included in one NDA. Additional information is available in the individual branded drug profile pages.Summary for secretin synthetic porcine
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 11 |
| Clinical Trials: | 4 |
| DailyMed Link: | secretin synthetic porcine at DailyMed |
Recent Clinical Trials for secretin synthetic porcine
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Massachusetts General Hospital | Phase 1 |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Phase 3 |
| National Institute on Deafness and Other Communication Disorders (NIDCD) | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for secretin synthetic porcine
US Patents and Regulatory Information for secretin synthetic porcine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Chirhoclin | SECREFLO | secretin synthetic porcine | FOR SOLUTION;INTRAVENOUS | 021136-001 | Apr 4, 2002 | 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 |
Secretin Synthetic Porcine Market Dynamics, FDA Status, Patent Risk, and Financial Outlook
Secretin synthetic porcine is a small, specialty pharmaceutical market tied primarily to pancreatic function testing and secretin-stimulated diagnostic procedures. The product has limited therapeutic demand, low prescription volume, narrow reimbursement exposure, and little evidence of material patent-based exclusivity. Its financial trajectory depends more on product availability, procedure volumes, hospital purchasing, and diagnostic adoption than on broad pharmaceutical-market growth.
Public sources do not report standalone revenue for secretin synthetic porcine. The product is marketed in a niche diagnostic category, and financial performance is generally embedded within private-company or specialty-product portfolios rather than disclosed as a separate revenue line.
What is secretin synthetic porcine used for?
Secretin synthetic porcine is a chemically synthesized peptide used to stimulate pancreatic secretions during diagnostic testing. It is administered by injection and is primarily associated with pancreatic exocrine function assessment.
The principal commercial uses are:
- Pancreatic function testing.
- Assessment of pancreatic exocrine insufficiency.
- Evaluation of suspected chronic pancreatitis.
- Testing in selected patients with cystic fibrosis or pancreatic duct disorders.
- Secretin-stimulated imaging or other diagnostic procedures, where use may be institution-specific or outside the product’s primary labeled indication.
Secretin is a 27-amino-acid peptide hormone that stimulates pancreatic bicarbonate secretion. Synthetic porcine secretin is manufactured by chemical synthesis rather than extraction from animal tissue. The product is supplied as a lyophilized powder that is reconstituted before administration.
What is the FDA status of secretin synthetic porcine?
Secretin synthetic porcine has FDA marketing authorization as an injectable diagnostic agent. The best-known U.S. product is SecreFlo, marketed by ChiRhoClin, Inc. FDA labeling identifies secretin as a diagnostic stimulant used in pancreatic function testing. [1]
| Regulatory attribute | Secretin synthetic porcine |
|---|---|
| Active ingredient | Secretin |
| Source designation | Synthetic porcine |
| Dosage form | Lyophilized powder for injection |
| Common strength | 16 micrograms per vial |
| Primary use | Pancreatic function testing |
| U.S. marketing company | ChiRhoClin, Inc. |
| FDA pathway | New drug application |
| Product category | Specialty diagnostic pharmaceutical |
| Biologic status | Not a biologic |
| Biosimilar pathway | Not applicable |
The FDA has also recognized secretin products using human-sequence secretin. Synthetic porcine and synthetic human products should not be treated as interchangeable solely because both contain secretin. Product labeling, peptide sequence, approved indications, supply status, and institutional purchasing terms can differ.
What is the Orange Book status of secretin synthetic porcine?
Secretin synthetic porcine does not have a commercially important Orange Book patent barrier comparable to those protecting major branded therapeutics. Public FDA materials do not identify a currently active patent estate that would create a clear, long-dated market-exclusivity period for the product.
The commercial position is therefore based mainly on:
- FDA approval and manufacturing compliance.
- Product availability.
- Specialist distribution.
- Institutional familiarity.
- Limited market size.
- The complexity of supplying a sterile injectable peptide in low volumes.
The Orange Book is relevant because it records approved drug products, therapeutic-equivalence information, patent claims submitted by sponsors, and regulatory exclusivity. It does not establish a broad patent monopoly where no active listed patent creates one. [2]
Patent protection and expiration dates
A current patent expiration date cannot be assigned to secretin synthetic porcine based on an active, material Orange Book listing. The principal barriers are regulatory and commercial rather than patent-based.
Potential historical patent categories would have included:
| Patent category | Current commercial significance |
|---|---|
| Secretin peptide composition | Likely limited or expired for an old peptide hormone |
| Synthetic manufacturing process | Potentially relevant only if a process is difficult to reproduce or commercially efficient |
| Lyophilized injectable formulation | Possible protection in historical filings, but no clear current market barrier |
| Diagnostic method of use | Narrow protection and vulnerable to design-around strategies |
| Container or reconstitution system | Limited value without corresponding market exclusivity |
Any third party seeking entry would need to conduct a full patent-family review across U.S., European, and other jurisdictions. Public regulatory records do not support the conclusion that an active patent blocks generic or alternative secretin entry.
When does secretin synthetic porcine lose exclusivity?
Secretin synthetic porcine has no obvious future loss-of-exclusivity event comparable to the patent cliff for a high-revenue branded drug. Core composition protection for secretin is old, while regulatory exclusivity associated with the original approvals would have expired long ago.
| Exclusivity type | Commercial position |
|---|---|
| New chemical entity exclusivity | Expired |
| Orphan-drug exclusivity | No material current barrier identified |
| Pediatric exclusivity | No material current barrier identified |
| Patent exclusivity | No clear active Orange Book barrier |
| Regulatory exclusivity | Historical periods expired |
| Biosimilar exclusivity | Not applicable |
The relevant market question is not whether a 2025 or 2026 patent cliff will occur. It is whether a competitor can justify the regulatory, manufacturing, and commercial investment required to serve a small diagnostic market.
Are there Paragraph IV challenges to secretin synthetic porcine?
No significant public Paragraph IV litigation is associated with secretin synthetic porcine in the principal FDA and federal-court records commonly used to track generic challenges.
A Paragraph IV filing would be commercially unusual because the market is small, the product is an injectable peptide, and the likely revenue opportunity may not justify litigation costs. A generic applicant could pursue an abbreviated pathway if the reference product and dosage form support an ANDA strategy. The applicant would still need to address formulation, sterility, peptide identity, stability, reconstitution, and manufacturing controls.
The absence of a major Paragraph IV dispute does not indicate strong patent protection. It more likely reflects the limited economic incentive to challenge the product.
What formulations are protected by secretin synthetic porcine?
The commercial product is generally supplied as a sterile, lyophilized injectable formulation. Its practical formulation requirements include:
- Peptide stability during manufacture and storage.
- Sterile filling.
- Defined potency and impurity controls.
- Reconstitution before administration.
- Appropriate vial, stopper, and storage conditions.
- Controlled distribution through hospitals and diagnostic centers.
Formulation patents, if any remain relevant, are less important than manufacturing know-how. A competitor must produce a reliable sterile peptide product with consistent potency. Low demand can make batch economics unfavorable because the manufacturer cannot spread fixed validation, quality, and inventory costs across a large volume.
The product’s formulation may also create substitution friction. Hospitals often prefer the product already included in pharmacy systems, diagnostic protocols, and procurement catalogs. That operational preference can delay switching even when patent protection is weak.
How large is the market for secretin synthetic porcine?
Secretin synthetic porcine operates in a narrow market with limited epidemiological expansion. Demand is driven by the number of pancreatic function tests and secretin-assisted diagnostic procedures rather than by the total number of patients with pancreatic disease.
Key demand drivers include:
- The number of tertiary hospitals and academic medical centers performing pancreatic function testing.
- Use of secretin-enhanced magnetic resonance cholangiopancreatography and related imaging protocols.
- Gastroenterology referral patterns.
- Availability of alternative tests, including fecal elastase and imaging without secretin.
- Reimbursement for the diagnostic procedure and the drug component.
- Product supply and temporary shortages.
Secretin is not taken chronically by patients. A single diagnostic encounter may require one vial, limiting repeat utilization. The product therefore has a low-frequency, procedure-linked revenue model.
Competitive alternatives
| Alternative | Relationship to secretin synthetic porcine |
|---|---|
| Synthetic human secretin | Direct product-level substitute in selected diagnostic settings |
| Fecal elastase testing | Lower-complexity alternative for pancreatic exocrine assessment |
| Direct pancreatic function tests | Competes for diagnostic use but may require specialized facilities |
| Standard MRCP or CT imaging | May substitute for secretin-enhanced imaging in some cases |
| Endoscopic pancreatic function testing | Competes in specialist settings |
| Empirical pancreatic enzyme therapy | May reduce diagnostic testing in routine practice |
Synthetic human secretin is the closest pharmaceutical competitor. Other alternatives compete at the diagnostic-procedure level and can suppress demand even without entering the secretin market.
What is the financial trajectory of secretin synthetic porcine?
The financial trajectory is best characterized as stable-to-limited rather than high-growth. Public-company filings do not generally disclose standalone revenue, gross margin, or unit volume for secretin synthetic porcine. The product’s commercial economics are likely shaped by specialty pricing and low volume rather than scale.
| Financial factor | Expected effect |
|---|---|
| Low patient volume | Limits total revenue |
| Specialty injectable pricing | Supports revenue per vial |
| Small production batches | Pressures manufacturing margin |
| Hospital procurement | Creates concentrated buyer power |
| Limited direct competition | Can support pricing stability |
| Diagnostic substitution | Caps long-term volume growth |
| Supply interruptions | Can cause sharp short-term revenue changes |
| Patent expiry | Limited incremental impact because core protection is old |
A specialty diagnostic product can remain commercially viable with modest volume if pricing covers sterile manufacturing, quality systems, regulatory maintenance, distribution, and inventory costs. The same economics make the market vulnerable to discontinuation if demand falls or manufacturing costs rise.
Revenue exposure
The main financial exposure is operational rather than patent-related:
- A manufacturing interruption can remove most available supply.
- A hospital system may switch to a competing secretin product or an alternative test.
- Reimbursement changes can reduce use.
- Diagnostic guidelines can shift demand toward less invasive or less expensive tests.
- A competitor may enter with a lower-cost synthetic peptide.
- Product recalls or quality events can materially affect a small portfolio.
Because the market is concentrated, one or two major distributors, diagnostic networks, or academic centers may account for a meaningful share of demand. That concentration creates customer-retention risk but can also support predictable ordering by established centers.
What manufacturing and intellectual-property barriers exist?
The strongest barriers are sterile manufacturing and regulatory execution.
A new entrant would need capabilities in:
- Peptide synthesis.
- Purification and impurity characterization.
- Sterile drug-product manufacturing.
- Lyophilization.
- Stability testing.
- Analytical method validation.
- Injectable product release testing.
- FDA cGMP compliance.
- Specialty distribution.
Secretin is not a complex biologic, and its synthesis is technically established. The barrier is economic execution at low commercial volume. A manufacturer must maintain validated capacity even when annual demand is modest.
The product also carries an animal-sequence designation, which may affect buyer preferences and international registration strategy. Synthetic porcine secretin is distinct from animal-extracted material, but sponsors must still maintain clear identity, purity, and source documentation.
What litigation and settlement agreements affect secretin synthetic porcine?
No major public patent litigation or settlement agreement is associated with secretin synthetic porcine in the principal public records reviewed for the product category. There is no widely reported reverse-payment settlement or delayed generic-entry agreement shaping the U.S. market.
The litigation risk is more likely to arise from:
- Product liability.
- Manufacturing deviations.
- Labeling disputes.
- FDA enforcement.
- Contract or distribution disagreements.
- Patent disputes over a new formulation or manufacturing process.
A future entrant using a novel formulation could create a new, narrower patent dispute even if the underlying secretin molecule remains unprotected.
How does secretin synthetic porcine compare with synthetic human secretin?
Synthetic human secretin has a similar diagnostic role but may have a different regulatory and commercial history. The two products should be compared by label, peptide sequence, available strength, FDA status, supplier, and current distribution.
| Comparison factor | Synthetic porcine secretin | Synthetic human secretin |
|---|---|---|
| Core diagnostic role | Pancreatic stimulation | Pancreatic stimulation |
| Molecule | Porcine secretin sequence | Human secretin sequence |
| Product type | Injectable peptide | Injectable peptide |
| Biosimilar pathway | Not applicable | Not applicable |
| Direct substitution | Requires product and clinical review | Requires product and clinical review |
| Patent-based moat | Limited public evidence | Limited public evidence |
| Market driver | Diagnostic procedures | Diagnostic procedures |
| Main risk | Supply and low volume | Supply and low volume |
The products may compete for the same institutional demand, but regulatory interchangeability should not be assumed. Procurement decisions depend on product labeling and availability.
What generic launch scenarios exist?
Three scenarios are commercially plausible.
Scenario 1: No material entrant
The incumbent remains viable because the market is too small to support a second manufacturer. Pricing remains specialty-oriented, and supply continuity becomes the main competitive advantage.
Scenario 2: Limited injectable competition
A new manufacturer enters with an approved secretin injection. Price competition develops in hospital purchasing, but total market volume remains broadly unchanged.
Scenario 3: Diagnostic substitution
Fecal elastase, imaging, or other pancreatic-function approaches reduce secretin utilization. This scenario would pressure volume more than a generic entrant because it would affect the underlying procedure category.
The most likely risk is gradual substitution rather than a sudden patent-driven loss of exclusivity.
Key Takeaways
- Secretin synthetic porcine is a niche injectable diagnostic peptide used mainly in pancreatic function testing.
- SecreFlo is the principal U.S. product associated with synthetic porcine secretin.
- The market is procedure-driven and has limited chronic-use demand.
- Public records do not indicate a material active Orange Book patent barrier.
- No major Paragraph IV challenge, patent settlement, or generic litigation is publicly associated with the product category.
- Biosimilar risk is not applicable because secretin is a chemically synthesized peptide drug, not a biologic.
- Manufacturing, sterile filling, low-volume economics, and supply reliability are stronger barriers than patent protection.
- Standalone revenue is not publicly disclosed, but the product’s financial trajectory is likely stable-to-limited rather than high-growth.
- Synthetic human secretin is the closest pharmaceutical competitor.
- Diagnostic substitution is a greater long-term risk than a conventional patent cliff.
FAQs About Secretin Synthetic Porcine
Is secretin synthetic porcine a biologic drug?
No. It is a chemically synthesized peptide drug. The FDA biosimilar pathway does not apply.
Is SecreFlo interchangeable with synthetic human secretin?
Not automatically. The products may have different peptide sequences, labels, formulations, and regulatory histories. Substitution requires review of the applicable FDA labeling and institutional pharmacy policy.
Does secretin synthetic porcine have an active composition patent?
No material active composition patent barrier is identified in public FDA market records. Any remaining process or formulation patents would require a separate patent-family review.
Can a generic company file an ANDA for secretin injection?
Potentially, depending on the reference product, dosage form, labeling, formulation, and FDA product-specific requirements. The commercial incentive may be limited by the small diagnostic market.
What is the main investment risk for a secretin synthetic porcine manufacturer?
The principal risks are low market volume, sterile-manufacturing costs, supply interruptions, reimbursement pressure, and diagnostic substitution. Patent expiry is not the primary risk.
References
- U.S. Food and Drug Administration. (n.d.). SecreFlo: Secretin injection, synthetic porcine, prescribing information. FDA.
- U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations, Orange Book. FDA.
- U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs database. FDA.
- Centers for Medicare & Medicaid Services. (n.d.). Medicare coverage database and physician fee schedule. CMS.
- U.S. Food and Drug Administration. (n.d.). FDA drug shortages database. FDA.
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