Generic PENTAGASTRIN INN equivalents, pharmaceutical patent and freedom to operate

Sponsor	Phase
Texas Tech University Health Sciences Center, El Paso	Phase 2/Phase 3
Chinese University of Hong Kong	Phase 2
AstraZeneca	Phase 4

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Ayerst	PEPTAVLON	pentagastrin	INJECTABLE;INJECTION	017048-001	Approved Prior to Jan 1, 1982		DISCN	Yes	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Ayerst	PEPTAVLON	pentagastrin	INJECTABLE;INJECTION	017048-001	Approved Prior to Jan 1, 1982	3,896,103	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Last updated: September 3, 2026

Pentagastrin is a legacy synthetic gastrin analog with limited diagnostic use and no meaningful current commercial market in the United States. Its historical applications included gastric-acid secretion testing and stimulation of calcitonin release in suspected medullary thyroid carcinoma. Commercial demand declined as diagnostic practice shifted to serum biomarkers, imaging, calcium stimulation protocols, and other laboratory methods. Public sources do not identify material current revenue, active U.S. marketing, or a significant enforceable patent estate for pentagastrin.

What is pentagastrin used for?

Pentagastrin is a synthetic pentapeptide that mimics the biologic activity of gastrin. It stimulates gastric acid secretion and can provoke calcitonin release from medullary thyroid carcinoma cells.

Attribute	Pentagastrin
Active ingredient	Pentagastrin
Pharmacologic class	Gastrin analog; diagnostic stimulant
Primary historical uses	Gastric acid secretion testing; calcitonin stimulation
Therapeutic indication	None of material commercial significance
Route	Parenteral administration
Commercial brand	Peptavlon and other historical products
Current U.S. market	No substantial marketed product identified
Biosimilar status	Not applicable
Generic status	Legacy small-molecule peptide product; no meaningful current generic market
Commercial outlook	Declining or inactive

Pentagastrin is not a chronic-use medicine. It is administered only in controlled diagnostic settings, which limits prescription volume and reimbursement potential. Its clinical value is also narrow because the tests it supports have largely been replaced or supplemented by more accessible diagnostic approaches.

What is the FDA regulatory status of pentagastrin?

Pentagastrin does not have an active, commercially significant FDA market in the United States. Historical pentagastrin products have been discontinued from marketing, and the product is not a current growth asset in the U.S. pharmaceutical sector.

The FDA’s discontinued-drug records and Orange Book framework distinguish between a drug that has been withdrawn for safety or efficacy reasons and one that has simply ceased commercial distribution. A discontinued product may remain listed in FDA databases without representing an active supply source or an available generic opportunity.[1,2]

Pentagastrin’s regulatory profile has several implications:

There is no established current U.S. branded franchise.
No significant ongoing FDA exclusivity period is associated with the active ingredient.
A prospective manufacturer would likely need to address current drug-approval, quality, sterility, labeling, and supply requirements rather than rely on historic approval status.
A discontinued product does not automatically create an abbreviated approval pathway that guarantees commercial viability.

FDA exclusivity timeline

Pentagastrin’s original approval dates are historical and do not generate current market exclusivity. Any new manufacturer would face a regulatory re-entry decision rather than a conventional launch protected by patent or regulatory exclusivity.

Exclusivity category	Current pentagastrin position
New chemical entity exclusivity	Expired or not relevant
Orphan-drug exclusivity	None identified
Pediatric exclusivity	None identified
Qualified infectious-disease exclusivity	Not applicable
New indication exclusivity	None identified
Patent-term extension	None identified
Current U.S. market exclusivity	None identified

What patents protect pentagastrin?

No active, commercially important composition-of-matter patent estate is publicly associated with pentagastrin. The molecule was developed and commercialized decades ago, placing any original composition, synthesis, or use patents well beyond their ordinary U.S. patent terms.

Pentagastrin is a short synthetic peptide rather than a modern biologic product. Its historical patent protection would generally have covered one or more of the following:

The pentapeptide composition.
Chemical synthesis or purification methods.
Pharmaceutical formulations.
Use in gastric secretion testing.
Use in calcitonin stimulation or endocrine diagnosis.

Those rights would have expired long ago under historic patent terms. Later patent applications could theoretically cover a new formulation, delivery system, manufacturing process, or diagnostic protocol, but no widely recognized active patent family currently controls the pentagastrin market.

How strong is the pentagastrin patent estate?

The patent estate is weak from a commercial exclusivity perspective.

Patent factor	Assessment
Core composition patent	Historically important, but expired
Formulation patents	No active high-value family identified
Method-of-use patents	Historic diagnostic uses are likely unprotected by current enforceable claims
Manufacturing patents	Potentially relevant only to a newly developed process
Patent thicket	None identified
Freedom-to-operate risk	More likely regulatory and manufacturing risk than patent risk
Litigation exposure	No material current patent litigation identified

The absence of a strong patent estate does not eliminate barriers to entry. Sterile peptide manufacturing, validated assays, low-volume economics, procurement qualification, and pharmacovigilance requirements can still prevent a commercially attractive launch.

When did pentagastrin lose exclusivity?

Pentagastrin lost meaningful exclusivity decades ago. Its original product rights are not a current commercial constraint, and no active exclusivity period is associated with the molecule.

The precise expiration dates of historic pentagastrin patents are not central to present market analysis because the relevant rights predate the current pharmaceutical commercialization cycle. Patent term rules also varied depending on filing date, jurisdiction, patent type, and any applicable extensions. The market conclusion is unchanged: pentagastrin is an off-patent legacy diagnostic peptide.

What formulations are protected by pentagastrin patents?

Historic products were generally injectable formulations designed for controlled diagnostic administration. The relevant formulation requirements include:

Sterile aqueous presentation.
Accurate low-dose peptide concentration.
Stability during storage and transport.
Compatibility with parenteral administration.
Low endotoxin and microbial burden.
Reliable reconstitution where a lyophilized presentation is used.

No current formulation patent is known to create a meaningful barrier around conventional pentagastrin injection. A company developing a new long-acting formulation, premixed presentation, autoinjector, or combination diagnostic kit could pursue patent protection, but these would be new product-development opportunities rather than inherited pentagastrin exclusivity.

The commercial value of such protection would be limited by the small addressable market. A formulation patent could improve handling or reduce administration errors, but it would not by itself create substantial demand.

What patent litigation affects pentagastrin?

No significant current U.S. patent litigation involving pentagastrin has been identified. The molecule does not appear to be the subject of an active branded-generic patent dispute comparable with high-value oncology, immunology, or metabolic drugs.

Paragraph IV challenges

No meaningful current Paragraph IV challenge is associated with a marketed reference product. Paragraph IV litigation generally requires an active Orange Book-listed reference drug with unexpired listed patents. Pentagastrin does not present that profile.

A future applicant seeking approval for a pentagastrin product would likely face a regulatory classification and product-development analysis rather than a conventional patent litigation campaign. If a new reference product were approved and listed, later applicants could encounter patents covering that specific formulation, method, or device. Those rights would be prospective and product-specific.

Settlement agreements

No material pentagastrin patent settlement agreement has been publicly identified. There is no known reverse-payment, authorized-generic, or branded-generic settlement structure affecting current market entry.

How large is the pentagastrin market?

The current global pentagastrin market is best characterized as niche, fragmented, and commercially inactive in major developed markets. Public company filings do not report pentagastrin as a material revenue product, and there is no reliable public consensus estimate for annual sales.

Market dimension	Current assessment
U.S. branded sales	No material active franchise identified
U.S. generic sales	Limited or absent as a conventional commercial category
Hospital demand	Specialized diagnostic demand only
Retail pharmacy demand	Minimal
International demand	Country-specific and fragmented
Revenue transparency	Very low
Growth rate	Declining or flat at a very low base
Investment case	Weak without a broader diagnostic platform

Pentagastrin demand is constrained by the limited number of procedures requiring pharmacologic stimulation. It is not a maintenance therapy and does not benefit from recurring prescriptions. Revenue depends on specialized hospital laboratories, endocrine centers, academic institutions, and diagnostic procurement contracts.

What caused pentagastrin’s financial decline?

Pentagastrin’s financial trajectory reflects market substitution rather than patent expiry alone.

Diagnostic substitution

Clinical laboratories increasingly rely on direct measurement of gastrin, gastric pH, pepsinogen, chromogranin A, calcitonin, and related biomarkers. In endocrine diagnostics, calcium stimulation is often used where stimulation testing is required, particularly because pentagastrin availability has been inconsistent.

Limited procedure volume

Even when clinically useful, pentagastrin is administered only for selected diagnostic protocols. The low treatment frequency prevents the scale economies available to chronic medicines.

Supply-chain economics

A manufacturer must maintain sterile production, analytical testing, quality systems, and regulatory compliance for a product with limited annual volume. Those fixed costs can exceed the economic value of the market unless the product is bundled with other diagnostic agents.

Procurement concentration

Demand is likely concentrated in a small number of hospitals and specialty centers. That structure increases price sensitivity and reduces manufacturer leverage.

Product discontinuation risk

Legacy diagnostic products can become unavailable when manufacturers reassess low-volume products, even when the products remain clinically useful. This creates intermittent shortages or reliance on special-access, compounding, or non-U.S. supply channels.

What generic entry risks exist for pentagastrin?

Patent risk is low, but commercial entry risk is high.

Entry factor	Risk level	Reason
Active composition patents	Low	Historic rights are expired
Orange Book patent barriers	Low	No current high-value reference-product estate identified
FDA approval burden	Medium to high	Sterile injectable quality and regulatory requirements remain material
Manufacturing complexity	Medium	Peptide synthesis and sterile fill-finish require specialized capabilities
Market demand	High risk	Small and declining diagnostic market
Reimbursement	Medium to high	Limited procedures and institution-specific payment
Competition	Medium	Alternative diagnostic protocols reduce demand
Supply continuity	Medium	Low-volume products are vulnerable to discontinuation
Commercial return	Low	Fixed costs are difficult to amortize

A generic entrant would not necessarily need to overcome an incumbent patent estate. Its main challenge would be proving that the market can support commercial manufacture. The most plausible entry model would involve an established sterile-injectable manufacturer, a specialty diagnostic company, or a hospital-focused supplier with an existing portfolio.

How does pentagastrin compare with competing diagnostic agents?

Pentagastrin competes indirectly with diagnostic methods rather than with a major branded drug.

Diagnostic approach	Primary use	Commercial position relative to pentagastrin
Serum gastrin measurement	Hypergastrinemia assessment	More accessible and less procedure-intensive
Gastric pH testing	Acid secretory evaluation	Used with biochemical testing
Secretin stimulation	Gastrinoma and gastrin-related evaluation	Important alternative in selected cases
Calcium stimulation	Calcitonin or endocrine tumor evaluation	Often preferred where pentagastrin is unavailable
Basal calcitonin testing	Medullary thyroid carcinoma assessment	Reduces need for stimulation in some settings
Imaging and molecular testing	Tumor localization and characterization	Expands non-pharmacologic diagnostic options

Pentagastrin can retain clinical utility in specialized protocols, but its competitive position is weakened whenever a laboratory can obtain the same diagnostic information through a blood test, calcium stimulation, or imaging pathway.

What licensing deals involve pentagastrin?

No significant recent licensing, co-development, or acquisition transaction centered on pentagastrin has been publicly reported. The molecule lacks the characteristics that typically attract major pharmaceutical licensing activity:

No large therapeutic indication.
No active composition patent.
No established revenue base.
No platform technology.
No meaningful regulatory exclusivity.
No expanding diagnostic market.

A transaction would be more likely to involve a broader diagnostic portfolio, contract manufacturing agreement, or hospital-supply arrangement than a standalone pentagastrin license.

What manufacturing and intellectual-property barriers remain?

The remaining barriers are operational rather than proprietary.

Peptide production

Pentagastrin requires reproducible synthesis, purification, identity testing, potency testing, and impurity control. Short peptides are technically manageable, but low-volume production can be uneconomic.

Sterile injectable controls

A commercial product must meet current expectations for sterility assurance, endotoxin control, container closure integrity, stability, and batch release. These obligations apply regardless of patent status.

Clinical and labeling requirements

A new supplier must establish that the product is appropriately characterized, manufactured, labeled, and clinically suitable for its proposed diagnostic use. Historical clinical use does not remove current regulatory responsibilities.

Global coverage

Patent coverage is effectively exhausted in major markets, but regulatory and commercial access differ by jurisdiction. A product may be absent from the United States while remaining available through limited suppliers in Europe, Asia, or specialty hospital channels. Country-specific registration, pharmacopoeial standards, import controls, and reimbursement rules determine practical access.

What is the likely future financial trajectory for pentagastrin?

Pentagastrin’s standalone financial trajectory is flat to declining. A substantial rebound would require a new diagnostic indication, a combination product, or a broader specialty-diagnostic commercialization strategy.

Three launch scenarios are relevant:

Scenario	Market outcome
No new manufacturer	Continued clinical substitution and sporadic availability
Specialty re-entry	Small, stable hospital market with limited revenue
New diagnostic platform	Higher value only if pentagastrin is bundled with assays, devices, or interpretation services

A standalone commercial launch would likely produce modest revenue because demand is procedure-driven and concentrated. A platform strategy could improve economics by spreading manufacturing, sales, and regulatory costs across multiple diagnostic products.

Key Takeaways

Pentagastrin is a legacy diagnostic peptide, not a current growth pharmaceutical.
Its historical composition and use patents are expired or commercially irrelevant.
No material active Orange Book exclusivity, Paragraph IV dispute, or patent litigation has been identified.
The FDA market position is inactive or highly limited, with no substantial current U.S. commercial franchise.
Demand has declined because of serum biomarkers, calcium stimulation, imaging, and other diagnostic alternatives.
Public companies do not report meaningful pentagastrin revenue, and no reliable current market-size estimate is publicly available.
Entry barriers are concentrated in sterile manufacturing, regulatory compliance, supply economics, and limited demand.
The strongest commercial opportunity would involve a broader diagnostic portfolio rather than pentagastrin sold as a standalone product.

FAQs About Pentagastrin Market Entry and Exclusivity

Is pentagastrin still commercially available in the United States?

No substantial active U.S. commercial market has been identified. Availability may depend on specialty suppliers, institutional procurement, or limited-access channels rather than routine pharmacy distribution.

Does pentagastrin have a biosimilar competitor?

No. Biosimilar regulation applies to biologic reference products. Pentagastrin is a synthetic peptide diagnostic agent and does not have a conventional biosimilar market.

Can a company obtain new patents on pentagastrin?

A company could seek patents on a novel formulation, delivery system, manufacturing process, diagnostic combination, or new clinical use. A patent on the historic pentagastrin molecule itself would not ordinarily be available because the compound is long known.

Would a new pentagastrin product qualify for Paragraph IV litigation?

Only if an approved reference product had relevant unexpired Orange Book-listed patents. The current pentagastrin market does not present that typical structure.

Is pentagastrin a viable pharmaceutical investment?

As a standalone product, pentagastrin has weak investment characteristics because its market is small, diagnostic demand is declining, and no meaningful exclusivity protects pricing. Its value would be higher as part of a specialty diagnostic portfolio with existing manufacturing and distribution infrastructure.

References

U.S. Food and Drug Administration. (n.d.). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/
U.S. Food and Drug Administration. (n.d.). Drug products discontinued from marketing. https://www.accessdata.fda.gov/scripts/cder/daf/
National Center for Biotechnology Information. (n.d.). PubChem compound summary for pentagastrin. PubChem. https://pubchem.ncbi.nlm.nih.gov/
U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs. https://www.accessdata.fda.gov/scripts/cder/daf/
National Library of Medicine. (n.d.). DailyMed: Current medication labeling. https://dailymed.nlm.nih.gov/dailymed/

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	10
DailyMed Link:	PENTAGASTRIN at DailyMed

Summary for PENTAGASTRIN

Recent Clinical Trials for PENTAGASTRIN

Anatomical Therapeutic Chemical (ATC) Classes for PENTAGASTRIN