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ESOMEPRAZOLE STRONTIUM Drug Patent Profile
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When do Esomeprazole Strontium patents expire, and when can generic versions of Esomeprazole Strontium launch?
Esomeprazole Strontium is a drug marketed by Belcher and is included in one NDA.
The generic ingredient in ESOMEPRAZOLE STRONTIUM is esomeprazole strontium. There are seventy-four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the esomeprazole strontium profile page.
US Patents and Regulatory Information for ESOMEPRAZOLE STRONTIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Belcher | ESOMEPRAZOLE STRONTIUM | esomeprazole strontium | CAPSULE, DELAYED RELEASE;ORAL | 202342-001 | Aug 6, 2013 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Belcher | ESOMEPRAZOLE STRONTIUM | esomeprazole strontium | CAPSULE, DELAYED RELEASE;ORAL | 202342-002 | Aug 6, 2013 | 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 |
Esomeprazole Strontium Investment Scenario & Patent/Regulatory Fundamentals (US + EU + Key Markets)
Esomeprazole strontium is a proton pump inhibitor (PPI) salt form of the established active moiety esomeprazole, used for acid-related gastrointestinal indications. Investment fundamentals are driven less by new clinical efficacy and more by (1) patent and exclusivity positioning for the specific salt, (2) whether any branded product still has regulatory exclusivity in the US/EU, and (3) generic and branded-OR competition intensity for esomeprazole products.
What is esomeprazole strontium and where is it sold?
Esomeprazole strontium is a salt formulation of esomeprazole used to treat conditions such as gastroesophageal reflux disease (GERD) and other acid-related disorders. As a salt, it is typically commercialized as an oral delayed-release or enteric-coated product aligned to esomeprazole’s pharmacology.
Typical product profile
- Drug class: Proton pump inhibitors (PPIs)
- Active moiety: Esomeprazole (as strontium salt)
- Regulatory approach: For most markets, this is a “follow-on” or generic/salt-line product unless a branded originator exists with still-active IP or data exclusivity.
Investment implication
- Base-case: Higher probability of generic-driven price compression unless a specific salt form has enforceable patent coverage or market-specific brand protections.
What patents protect esomeprazole strontium in the US?
A full “what patents protect” view requires Orange Book listings and jurisdiction-specific patent datasets. These are not provided here, and no drug-specific US patent/patent family table can be reliably generated from the information given.
Investment implication
- Without enumerating the Orange Book patent numbers, the only defensible statement is that salt forms often have narrower patent protection than the core esomeprazole compound, creating a lower-cost pathway for ANDA filers when no salt-specific claims remain enforceable.
How strong is the patent estate for esomeprazole strontium?
Salt forms of established APIs (here, esomeprazole) generally have weaker long-duration patent leverage than:
- new molecular entities (new API),
- novel formulations with clear non-obviousness and strong claim scope,
- or long-lived manufacturing-method IP.
Practical screening standard used by investors
- If only compound-scope patents on esomeprazole (not the salt) were originally enforceable, the salt’s remaining IP tends to track that core expiration.
- If salt-specific polymorph/crystal form or manufacturing-process claims exist, they can delay generic entry, but enforcement is claim-specific and jurisdiction-specific.
Investment implication
- For investment underwriting, the critical variable is whether any esomeprazole strontium-specific claims remain unexpired and whether they are listed in the reference-listed drug’s US Orange Book.
When does esomeprazole strontium lose exclusivity?
Answer depends on:
- US data exclusivity/market exclusivity (if applicable to a branded product)
- patent expirations for esomeprazole strontium specifically
- any period of exclusivity arising from regulatory status (e.g., 5-year/3-year exclusivity based on new clinical studies, if a branded NDA exists and qualifies)
No exclusivity timeline is computable from the inputs provided.
Investment implication
- For salt follow-ons, generic entry risk often accelerates once core esomeprazole protections lapse and if salt-specific claims do not extend exclusivity in major markets.
What is the Orange Book status of esomeprazole strontium?
Orange Book status requires the exact US brand/NDC mapping and Orange Book patent listings for the reference listed drug and relevant NDA/ANDA products. That dataset is not included here.
Investment implication
- If the Orange Book shows only generic entries with no active “exclusivity” periods, the asset behaves like a near-term price-taking commodity product.
- If a branded NDA exists with active listed patents covering the salt or formulation, entry timelines become dependent on Paragraph IV outcomes.
What generic entry risks exist for esomeprazole strontium?
Generic risk drivers
- Claim scope: Whether patents cover only the salt and not broader esomeprazole compositions.
- Manufacturing dependency: Whether the generic must reproduce a specific crystal form, polymorph, or process step.
- Bioequivalence: Salt changes rarely overcome regulatory bioequivalence requirements; generic viability is more about IP and manufacturability than clinical differentiation.
Investment implication
- In most salt follow-on cases, the dominant threat is ANDA-led erosion rather than FDA “scientific” barriers.
How does esomeprazole strontium compare with esomeprazole magnesium or esomeprazole (base)?
Salt forms of esomeprazole are typically compared on:
- bioequivalence performance,
- stability and formulation handling,
- patient tolerability profile (often similar),
- and IP coverage tied to salt-specific claims (where they exist).
Investment implication
- If one salt form has stronger IP cover than another in major markets, investors may prefer the salt with the longest enforceable patent tail.
- If all salt forms are genericized, differentiation shifts to supply chain scale, formulary access, pricing contracts, and OTC/brand positioning (if applicable).
What formulations are protected by patents for esomeprazole strontium?
Formulation patents depend on whether the branded or innovator product has:
- enteric coating technologies,
- controlled-release matrices,
- particle size control,
- polymorph/crystal form specifications,
- or specific manufacturing steps.
No formulation-claim catalog is provided, so no formulation-protection table can be produced.
Investment implication
- If no product-specific formulation patents remain, investors should underwrite margins to competitive generics and contract manufacturing economics.
What method-of-use patents exist for esomeprazole strontium?
Method-of-use patents are uncommon for mature PPIs unless a specific new indication, dosing regimen, or combination therapy is claimed.
Investment implication
- If the market is treated as mature GERD/acid indications only, method-of-use IP typically does not create a high-valuation moat.
What patent litigation affects esomeprazole strontium (Paragraph IV, settlements)?
Litigation assessment requires:
- ANDA Paragraph IV filings for the specific US product,
- district court case numbers,
- settlement dates and terms,
- and any stipulations affecting FDA approval timing.
No litigation dataset is provided, so no litigation chronology can be reliably stated.
Investment implication
- If no active litigation exists, the asset typically behaves like a genericized PPIs category.
- If litigation exists with a strong innovator case, expected value shifts to probable stay/trigger outcomes.
What is the FDA regulatory pathway and status for esomeprazole strontium?
Regulatory pathway depends on whether the product is:
- an NDA (originator) or
- an ANDA (generic) using an appropriate reference listed drug.
No NDA/ANDA identifiers are provided, so a pathway and status table cannot be constructed.
Investment implication
- For ANDA products, regulatory risk is usually lower post-bioequivalence and depends on the generic’s ability to navigate listed patents and litigation.
What manufacturing or IP barriers block generic competition for esomeprazole strontium?
For salt-based products, barriers can include:
- proprietary crystallization/polymorph control,
- validated process parameters tied to the claimed invention,
- sourcing of specific intermediates,
- and scale manufacturing yields.
No process-patent or trade-secret evidence is included, so no barrier scoring can be generated from the inputs.
Investment implication
- Without enforceable IP, barriers are mostly operational and scale-related, which increases the likelihood of margin compression across many competitors.
Which companies are the likely competitors and what are their market positions?
Competitor identification requires market access lists, NDC-level roster, and/or regional distribution data. None is provided here.
Investment implication
- Esomeprazole family PPIs typically have many generic entrants; the winner is usually the operator with the lowest landed cost, highest throughput, and best payer/formulary coverage.
Investment scenario: Base case, bear case, and upside case
Base case (most likely for mature salt PPIs)
- Generic availability is widespread.
- Pricing is constrained by multi-supplier competition.
- Growth is volume-led through formulary penetration and contract pricing.
- Margin profile follows generic PPI dynamics (lower gross margin vs branded PPIs).
Bear case
- Continued or accelerated generic entry due to expiry of remaining salt-specific protections.
- Higher competitive rebates and payer pressure.
- Pipeline substitution (other PPIs or different salt forms) shifts volume.
Upside case
- Persistent enforceable IP around a specific salt form (polymorph/crystal form or manufacturing method).
- Limited number of qualified suppliers due to process constraints.
- Branded renewal strategies or stronger regional brand uptake.
No numeric scenario model can be produced because pricing, volumes, and patent/regulatory identifiers are not supplied.
Commercial fundamentals that matter for underwriting
Key KPIs to underwrite
- Expected time to generic competition entry (driven by listed patents and litigation)
- Supply chain economics (API sourcing, salt formation yield, conversion costs)
- Product lifecycle stage (NDC saturation levels)
- Payer and formulary footprint in key geographies
- Contract manufacturing leverage and operational scale
Category anchor
- PPIs are a mature class with high generic penetration; differentiation must come from IP duration, supply-chain cost position, or contract-winning strategy.
What geographic markets should be prioritized for investment exposure?
A geography plan usually weights:
- US ANDA ecosystem and Orange Book-driven entry triggers
- EU member state generics saturation and national tender dynamics
- regulatory enforceability intensity via national courts
- reimbursement and pricing controls
No country-level listings or sales shares are provided, so geography prioritization cannot be quantified.
Key Takeaways
- Esomeprazole strontium is a mature PPI salt profile where investment value typically depends on salt-specific IP tail and the practical risk of generic erosion.
- Patent and exclusivity assessment must be anchored to Orange Book/NDA-ANDA-level listings and any salt-specific claims; those inputs are not provided here, preventing an enforceable timeline or litigation forecast.
- Base-case underwriting should assume competitive pricing pressure unless a branded or salt-specific patent estate remains enforceable in major markets.
- The decisive diligence targets are: listed patents tied to the exact US product/NDC, any active Paragraph IV litigation, and manufacturing/process barriers linked to claimed polymorph or crystallization control.
FAQs
- Is esomeprazole strontium considered interchangeable with other esomeprazole salts for substitution and generics?
- What are the typical legal risks when launching an ANDA for an esomeprazole salt form?
- Do salt-form changes (strontium vs magnesium) create meaningful clinical differentiation for PPIs in reimbursement decisions?
- How do polymorph or crystal-form patents influence manufacturing and generic approval for salt PPIs?
- What underwriting metrics best predict margin durability for generic PPIs like esomeprazole salts?
References
- Food and Drug Administration. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
- U.S. Food and Drug Administration. 505(b)(1), 505(b)(2), and Abbreviated New Drug Application (ANDA) regulatory framework.
- European Medicines Agency. Generic and hybrid applications guideline documents.
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