When do the patents on REGONOL expire, and when will REGONOL go generic?

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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
Sandoz	REGONOL	pyridostigmine bromide	INJECTABLE;INJECTION	017398-001	Approved Prior to Jan 1, 1982	AP	RX	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

Last updated: July 19, 2026

REGONOL drug investment fundamentals and IP/exclusivity risk analysis (FDA, Orange Book, generic entry, litigation, revenue exposure)

Executive summary: REGONOL’s investment profile hinges on whether it has (1) an FDA-approved NDA/BLA with Orange Book-listed patents, (2) active Hatch-Waxman exclusivities (NCE, 3-year, 5-year, pediatric) or granted stays, and (3) a defendable patent estate covering its marketed indication, formulation, and manufacturing process. Without verified drug identity (active ingredient, dosage form, applicant, NDA/BLA number, FDA approval date, and Orange Book listing), no defensible valuation, timeline, or litigation risk ranking can be produced.

What is REGONOL and what active ingredient does it contain?

REGONOL’s fundamentals analysis depends on the drug’s regulated identity: active ingredient, strength(s), dosage form (tablet, capsule, injection, transdermal, etc.), route of administration, and the approved therapeutic indication(s). Each of these elements determines the applicable exclusivity regime, the relevant patent families in the Orange Book, and the competitive set of generics/biosimilars.

Which FDA application does REGONOL map to (NDA or ANDA precursor)?

Investment-grade analysis requires the underlying FDA application number (NDA/BLA), holder, approval pathway (505(b)(1), 505(b)(2), 505(j), 351(a)), and approval date. Those facts drive:

Orange Book patent publication matching to the approved drug product.
Timelines for 180-day generic exclusivity triggers.
Risk of Paragraph IV challenges and associated automatic stays.
Whether exclusivity is tied to an NCE or to a new formulation or indication.

Does REGONOL have multiple strengths or dosage forms that split IP coverage?

Portfolio risk often diverges by dosage form. Reformulations can have separate Orange Book entries (drug substance vs drug product vs method-of-use).

What patents protect REGONOL, and how many are listed for the marketed product?

Patent estate mapping determines whether REGONOL is defendable against generic entry and whether the risk is litigation-led (Paragraph IV) or design-around-led (non-infringement/invalidity based on formulation/process changes).

How many Orange Book patents cover REGONOL and which claim types dominate?

For investment analysis, you separate patents by functional role:

Drug substance composition claims
Drug product formulation claims
Method-of-use (indication) claims
Manufacturing/process claims

Each category changes the likelihood of “easy” generic entry. For example, method-of-use claims can allow partial market entry if generics “carve out” the protected indication, subject to labeling carve-out feasibility and FDA regulatory constraints.

Who are the assignees and likely licensors for REGONOL’s patent families?

Ownership and licensing structure drives dealability and enforcement leverage. Common investor-relevant indicators:

Primary assignee vs exclusive licensee
Whether patents are consolidated to a single enforcement entity
Jurisdiction scope (US-only vs global family members)

When does REGONOL lose exclusivity (NCE, pediatric, and 5-year/3-year exclusivity)?

Exclusivity timing sets the earliest viable generic/biosimilar entry point independent of patent expiry.

What is REGONOL’s exclusivity clock for FDA marketing protection?

Investment scenarios usually model two clocks:

Hatch-Waxman exclusivity (3-year, 5-year, NCE) that blocks generic approval even if patents are later challenged.
Orange Book patent expiration (and potential post-grant or litigation stays).

When is the earliest generic entry date based on exclusivity and patent expiry?

A credible estimate requires the FDA exclusivity start and type, plus Orange Book expiration dates. Those dates determine:

The “first approval” window for ANDA entry.
Whether a Section viii (b)(3) certification strategy is likely.
The expected duration of price pressure post-entry.

When do REGONOL’s specific Orange Book patents expire?

Patent expiry dates are the core of generic entry modeling.

What are the top-expiring patents and what are their claim scopes?

Investors track:

The last-to-expire drug product/formulation patents
Whether method-of-use patents extend beyond composition patents
Whether multiple patents share near-term expiries (cluster risk) that accelerates generic entry probability

Is there a patent life extension mechanism for REGONOL (PTE/PTE1, PTA effects)?

Patent term adjustment and extensions can shift the effective exclusivity landscape. For valuation, the question is whether those extensions meaningfully extend market protection after the baseline patent expiry.

What is the Orange Book status of REGONOL for each NDC?

Orange Book status is NDC-specific. A product can have:

Different patent coverage across strengths
Different formulation or dosage form listings
Different certification histories (if ANDAs are on file)

Which NDCs carry the most restrictive patent coverage?

For commercial exposure, the “most protected” NDC often determines whether competitors can offer meaningful substitute supply or only smaller-labeled entries.

Which companies have filed ANDAs or Paragraph IV challenges to REGONOL?

Paragraph IV filings are the best observable signal of imminent generic risk.

What Paragraph IV certification basis is used (IV vs I/II/III)?

The certification type indicates whether challengers are contesting:

Patent infringement
Patent validity
Patent enforceability

Are there settlements that limit the generic launch date?

Settlement agreements can impose “reverse payment” or covenant-not-to-sue structures that delay launch. Investment relevance comes from:

Entered date
Carve-outs and labeling restrictions
“All-calls” or “partial-calls” structure limiting exclusivity of the first filer

What patent litigation affects REGONOL, and what is the current case posture?

Litigation posture drives the probability of:

Enforced exclusivity through court stays
Early market entry via non-infringement positions
Case dismissal based on covenant or license

Key litigation events investors monitor

Investment-grade monitoring typically captures:

Complaint filing date and venue
Markman dates and claim construction outcomes (if publicly available)
Trial dates and appeal posture
Injunction status or denial of preliminary injunction

Which courts have jurisdiction and what is the typical appeal timeline?

US patent litigation is time- and venue-sensitive. A fast-moving case can make a valuation hinge on outcomes within 6 to 18 months.

How does REGONOL’s IP strength compare with the closest branded competitors?

Competitive comparison should evaluate:

Patent estate breadth (drug substance + formulation + method-of-use)
Number of Orange Book patents and whether they are staggered or clustered
Relative exclusivity duration
Litigation intensity (frequency of Paragraph IV and historical outcomes)

Is REGONOL a platform drug or a single-asset product at risk?

A platform drug with multiple indications and dosage forms tends to sustain share even through partial generic encroachment, depending on labeling and substitution dynamics.

What formulations are protected for REGONOL, and can generics design around them?

Formulation patents often decide whether generic manufacturers must switch excipients, particle size, release profile, or manufacturing conditions.

Do formulation patents cover release kinetics, stability, or bioavailability?

Key technical differentiators that can reduce generic interchangeability:

Modified-release mechanisms
Solid-state forms (polymorphs, hydrates, solvates)
Bioavailability or food-effect claims (if method-of-use)

Is there evidence of bioequivalence challenges or substitution barriers?

If REGONOL has narrow therapeutic index characteristics (or clinical endpoints tied to specific exposures), the FDA and payers may scrutinize generic substitutions.

What generic entry risks exist for REGONOL (label carve-outs, design-around, launch sequencing)?

Generic entry risk is rarely one-dimensional.

What is the likely labeling strategy for ANDA challengers?

Generics can sometimes avoid infringement by:

Carve-out from protected indication(s)
Narrowing patient population language
Omitting protected dosing or administration directions

If labeling carve-out is feasible, investors model earlier erosion limited to specific clinical use patterns.

Does 180-day exclusivity apply to early filers?

The first Paragraph IV ANDA holder can lock in 180-day exclusivity, affecting who enters first and how fast price drops propagate.

Is there any biosimilar risk for REGONOL?

Biosimilar risk applies only if REGONOL is a biologic (BLA-approved product). If REGONOL is an NDA small molecule, biosimilar analysis is not applicable.

Is REGONOL a biologic, and what is the reference product pathway?

If it is biologic, investors also track:

351(k) filings
BLA reference product expiration
Exchangeability and interchangeability status

What is REGONOL’s FDA regulatory status and post-approval milestones?

A fundamentals view must include regulatory posture and manufacturing quality stability.

Has REGONOL faced FDA enforcement actions, REMS changes, or major manufacturing updates?

These factors affect:

Supply reliability
Liability risk and settlement costs
Litigation exposure to product liability

Is REGONOL on a fast track, breakthrough, or special review program?

Program designation can correlate with higher scrutiny on endpoints and labeling.

What is the commercial revenue exposure for REGONOL and how sensitive is it to price erosion?

Investment scenarios should model share loss and pricing trajectory post entry.

How concentrated is revenue in protected indications or payers?

If reimbursement depends on narrow clinical criteria, generic labeling carve-outs can leave a branded moat.

What is the expected price drop after generic entry?

The magnitude varies by:

Number of competitors
Payer formulary position
Substitution rules
Patient switching behavior

How strong is the patent estate for REGONOL in key jurisdictions?

Investors care about whether the enforcement geography matches the commercial markets.

Is the patent family US-heavy or globally distributed?

Global families can support:

License leverage
Multi-jurisdiction settlement pressure
Importation-related injunction leverage

Which jurisdictions matter for launch and supply constraints?

For US-only products, the US patent estate dominates. For international sales, parallel litigation in major markets increases deterrence.

Investment scenario table: generic/biosimilar launch outcomes for REGONOL

Investment outcomes depend on verified FDA and Orange Book facts. Without verified identity, no defensible scenario dates or probabilities can be stated.

Scenario	Core driver	What must be true	Commercial implication
Branded protection holds	Orange Book patents + exclusivity extend	No valid non-infringement path; litigation stays effective	Slower price erosion; continued payer acceptance
At-risk but delayed entry	Near-term patent expiry or exclusivity not yet reached	Challengers lose on key patents or settlement delays launch	Temporary resilience; entry pressure increases later
Fast erosion	Early validity/invalidity outcomes or design-around wins	Patent gaps, weak method/formulation coverage, rapid appellate outcomes	Margin compression; share shift to generics quickly
Partial erosion (label carve-out)	Only non-protected indication remains available	Carve-out feasible and FDA labeling supports it	Branded retains a niche; revenue declines less sharply

Key Takeaways

REGONOL’s investment fundamentals are driven by FDA-verified identity, Orange Book patent coverage by NDC, and the interaction between exclusivity and patent expiry.
Generic risk depends on whether REGONOL has staggered, claim-broad protection (composition + formulation + method-of-use) or clustered, design-around-prone protection.
Valuation should model three pathways: litigation-driven stays, settlement-enforced delays, and label carve-out/ANDA design-around.
Without the active ingredient, FDA application number, and Orange Book listings, no authoritative exclusivity timeline, patent expiry schedule, Paragraph IV status, or litigation posture can be tied to REGONOL.

FAQs

How do Paragraph IV certifications determine the earliest potential generic launch date for a branded product like REGONOL?
What is the difference between NCE exclusivity and 5-year new clinical investigation exclusivity in Hatch-Waxman modeling?
Which Orange Book patent types (drug substance, drug product, method-of-use, manufacturing) most strongly block generic entry?
How do labeling carve-outs affect generic substitution and branded revenue retention after patent expiry?
What litigation events (Markman, preliminary injunction, appeals) most change the probability-weighted outcome for a generic entry scenario?

References (APA)

FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
FDA. Hatch-Waxman Drug Patent Litigation: Overview of the Statutory Scheme. U.S. Food and Drug Administration.
FDA. Purple Book: Lists of Licensed Biological Products. U.S. Food and Drug Administration.

US Patents:	0
Applicants:	1
NDAs:	1

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Summary for REGONOL