US Patent 5,744,501 Landscape: What Claims Cover, What the Estate Likely Reaches, and Where Generic or Licensing Risk Sits

US Patent 5,744,501 is directed to a method for treating “Late Luteal Phase Dysphoric Disorder” (LLPDD) by administering an effective amount of a serotonin re-uptake blocker (SRB), with dependent claim coverage narrowing to specific SRBs including sertraline, fluoxetine, and fluvoxamine. The claim set is method-of-treatment in the US. That claim structure typically creates a narrower, indication- and dosing-context-driven infringement envelope than chemical-formulation patents, but it can still create meaningful exclusivity leverage where the label, clinical practice, and any FDA-recognized indication language align with the claimed therapeutic class and condition.

What patents protect late luteal phase dysphoric disorder using SSRIs like sertraline, fluoxetine, and fluvoxamine?

Answer: US 5,744,501 protects a US method-of-treatment claim combination: (i) a patient with LLPDD and (ii) administration of an effective amount of a serotonin re-uptake blocker. The patent’s claim 2 locks the SRB selection to a closed list (fluoxetine, zimelidine, fluvoxamine, sertraline, indalpine, citalopram, femoxetine, paroxetine, alaproclate, plus salts), and claims 3 to 5 pick sertraline, fluoxetine, and fluvoxamine specifically.

How the claims are structured for enforceability

The five claims you provided are all method claims, not product claims. Practically, that means:

Infringement theory is induced to medical use, not manufacturing chemistry.
Scope tracks both the indication and the SRB selection.
Dependent claims narrow the SRB identity to named molecules (or salts). That matters for claim charts against generic SSRIs not listed or other serotonin-modulating agents not categorized as “serotonin re-uptake blockers.”

Claim-by-claim scope (practical reading)

Claim 1

Core elements
1. “method for treatment of Late Luteal Phase Dysphoric Disorder”
2. administering an effective amount of a “serotonin re-uptake blocker”
3. to a patient in need
Scope drivers
- “Late Luteal Phase Dysphoric Disorder” is the clinical condition anchor. If a payer or label frames the disorder under a different nomenclature, enforcement becomes harder. If “LLPDD” aligns with later terminology such as late luteal phase dysphoria or premenstrual dysphoric disorder concepts, enforcement depends on the patent’s own definitions and the court’s claim construction approach.
- “Serotonin re-uptake blocker” is likely intended to capture SSRIs (and related agents with reuptake inhibition), but claim 2 turns that into a list.

Claim 2

Adds limitation: SRB is from a listed group of active ingredients and salts.
This claim is a key “fence” claim because it is closed to the enumerated molecules. An accused regimen using an SRB not listed would not meet claim 2 unless doctrine of equivalents applies and a court accepts functional equivalence for “serotonin re-uptake blocker” while still satisfying the claim language constraining the SRB identity through claim 2.

Claims 3–5

Single-molecule embodiments:
- Claim 3: sertraline
- Claim 4: fluoxetine
- Claim 5: fluvoxamine

These create a straightforward infringement path for any medical use where:

the patient has LLPDD as understood in claim construction, and
the prescriber administers sertraline (or fluoxetine, fluvoxamine) in an effective amount.

What the claim set does not cover (based on your claim text)

Because the independent claim 1 uses “serotonin re-uptake blocker” and claim 2 lists specific molecules, the patent does not inherently cover:

non-reuptake serotonin modulators unless courts interpret them as “serotonin re-uptake blockers”
non-listed SSRIs in claim 2 if “serotonin re-uptake blocker” is constrained by the dependent claim
formulations per se (no direct composition claims are shown in your provided claim set)
manufacturing methods

That said, method-of-treatment claims can still be asserted against clinical practice using listed SSRIs.

When does US 5,744,501 lose exclusivity, and what does the expiration risk look like for SSRIs used off-label?

Answer: The provided materials include only claims, not filing date, priority, patent term adjustment, or prosecution history. Without the bibliographic data, the exact US expiration date cannot be computed with precision here. The enforcement window for method claims follows standard US utility patent term mechanics, but an accurate “date-to-date” exclusivity timeline requires the patent’s filing and priority information.

Patent term mechanics that typically control method claims like this

US utility patents generally expire 20 years from the earliest non-provisional filing date (subject to adjustments).
Method claims do not generally extend term beyond the base utility patent.
If there are continuation applications, their claims could create a broader or shifting “patent family” landscape.

Timeline gap: No bibliographic data was provided in the prompt, and the response must not fabricate exact dates.

What is the strongest infringement path under US 5,744,501: generic entry, label language, or prescribing practice?

Answer: For method claims of this type, infringement is most plausibly tied to prescribing and dispensing practice for LLPDD using the listed SSRIs at therapeutic (“effective amount”) dosing.

How generic entry changes risk

A generic launch does not eliminate liability for the claimed method, because:

generic SSRIs can still infringe if the method claim is practiced (patient diagnosis + effective administration).
however, proving method use and patient eligibility is typically more complex than product composition proof.

What typically matters for enforcement in LLPDD contexts

How clinicians diagnose and document LLPDD (or renamed variants).
Whether the regimen is presented or used specifically for “late luteal phase dysphoric disorder.”
What evidence exists in medical records to show the prescriber was treating LLPDD with the listed SSRI.

Which SSRIs are explicitly covered by the dependent claims, and which are outside the fence?

Answer: The dependent claim 2 expressly lists: fluoxetine, zimelidine, fluvoxamine, sertraline, indalpine, citalopram, femoxetine, paroxetine, alaproclate, and pharmaceutically acceptable salts.

Closed-list effect in a claim chart

A typical infringement chart against an accused regimen would treat claim 2 as satisfied only if:

the administered drug is one of the listed active ingredients (or salt form), and
the patient has LLPDD, and
an effective amount is administered.

That makes the “outside the fence” category clear for any reuptake blocker not enumerated in claim 2.

How does US 5,744,501 compare with other late luteal phase dysphoric disorder or premenstrual dysphoric disorder patents?

Answer: Based on claim structure alone, US 5,744,501 is a classic early-generation SSRI method-of-treatment patent focusing on patient indication and drug selection rather than:

sustained-release formulation engineering,
fixed-dose combination regimens,
device or delivery system constraints.

Typical adjacent patent clusters in this therapeutic area (what you would usually see)

Even though you did not provide additional patents, the litigation and patent landscapes for LLPDD/PMDD-style indications commonly include:

method-of-use patents tied to specific SSRIs and dosage schedules
dose-frequency or titration regimen claims
formulation claims for delayed-release or controlled-release SSRI delivery
combination claims (for example SSRI plus hormonal interventions) if supported
use in specific patient subpopulations

US 5,744,501, as stated in your claim set, belongs to the method-of-treatment-with-an-SSRI cluster and reads as narrower than formulation and regimen engineering portfolios.

What patent litigation affects US 5,744,501 and how often do parties reach settlements in SSRI PMDD/LLPDD disputes?

Answer: No litigation history, assignments, or enforcement record was supplied. Without case captions, docket numbers, settlement terms, or a patent assertion dataset, an accurate statement about litigation affecting 5,744,501 cannot be produced.

What is the Orange Book status of US 5,744,501 and which FDA products would be relevant?

Answer: Orange Book status depends on whether the method patent is listed against an NDA/BLA for a specific drug product and whether it is tied to an indication that matches the claimed LLPDD treatment. The prompt provides only claim text and does not include the patent’s listed NDA/BLA numbers or the listed drug(s).

Orange Book linkage mechanics relevant to a method patent

For a method-of-use patent to appear, it must be listed against a drug product with a qualifying patent listing category (and tied to an approval that covers the claimed method). If the claimed method is not in the approved labeling at the time of listing, it may not show up for Orange Book purposes.

Status gap: no bibliographic listing information was provided.

How strong is the patent estate for US 5,744,501 given the claim breadth?

Answer: Strength is primarily tied to:

the closed-list limitation in claim 2
the indication anchor of LLPDD
lack of formulation or manufacturing claims (as shown in your provided claim set)

Strength factors that improve enforceability

Claims 3–5 create clean, molecule-specific embodiments (sertraline, fluoxetine, fluvoxamine).
Method claims are valuable where prescribing practice aligns with the claimed condition and drug.
The “effective amount” language supports practical infringement because therapeutic dosing is the intended use.

Strength factors that constrain breadth

Claim 2 limits SSRIs to a defined set. That narrows the range of potential accused agents.
“Late Luteal Phase Dysphoric Disorder” is a more specific label than broader conditions like “depression” or “mood disorders,” which can limit infringement if care providers treat under different diagnostic frameworks.

Practical litigation posture

If asserted, the patentee’s case would hinge on showing the method claim is practiced for LLPDD with one of the listed SSRIs.
Defense would focus on diagnosis terminology, label language vs practice, and whether the administered drug qualifies as the claimed “serotonin re-uptake blocker” within the claim set.

Key Takeaways

US 5,744,501 is a method-of-treatment patent for LLPDD using a serotonin re-uptake blocker, with dependent claims narrowing to a closed list of specific SSRIs and salts.
Claim 1 covers the overall method concept (LLPDD + effective amount of an SRB).
Claim 2 narrows SRB identity to enumerated active ingredients: fluoxetine, zimelidine, fluvoxamine, sertraline, indalpine, citalopram, femoxetine, paroxetine, alaproclate, and salts.
Claims 3–5 provide molecule-specific coverage for sertraline, fluoxetine, and fluvoxamine, creating straightforward infringement targets if the LLPDD method is practiced.
No expiration date, Orange Book listing, or litigation/settlement record can be stated from the prompt’s information limited to the claim text.

FAQs

1) Does US 5,744,501 cover generic versions of fluoxetine or sertraline?
The patent’s claims target method-of-treatment. If the generic product is administered to treat LLPDD with an “effective amount” of the listed drug, method-practice infringement risk can persist regardless of brand vs generic.

2) What happens if a clinician treats LLPDD using an SSRI not listed in claim 2?
On the text provided, claim 2 is a closed list. Use of a non-enumerated SSRI would not satisfy claim 2, and claim 1 would turn on whether that agent qualifies as a “serotonin re-uptake blocker” as construed alongside the dependent claim structure.

3) Are formulation changes (immediate vs delayed release) within the scope of US 5,744,501?
The provided claims are method claims centered on treating LLPDD with an effective amount of an SRB. Formulation specifics are not included in the claim text you provided.

4) If LLPDD is diagnosed under a different name, does that avoid infringement?
Potentially, depending on claim construction and evidence that the patient met the claim’s LLPDD definition. The claim set as provided is indication-specific.

5) Can a patent listing for an SSRI method of use survive generics entering the market?
Method patents can remain enforceable after generic launch if the claimed method is still practiced. The key question is whether the claimed method is performed, not whether the product is branded.

References

United States Patent 5,744,501, claims 1–5 (as provided in the prompt).

Title:	Method for treating late luteal phase dysphoric disorder
Abstract:	There is disclosed a method for treating Late Luteal Phase Dysphoric Disorder with administration of a nontoxic dose of a serotonin re-uptake blocker. Preferably, the serotonin re-uptake blocker is fluoxetine or norfluoxetine.
Inventor(s):	Michael J. Norden
Assignee:	Individual
Application Number:	US08/815,462
Patent Claim Types: see list of patent claims	Use;
Patent landscape, scope, and claims:	US Patent 5,744,501 Landscape: What Claims Cover, What the Estate Likely Reaches, and Where Generic or Licensing Risk Sits US Patent 5,744,501 is directed to a method for treating “Late Luteal Phase Dysphoric Disorder” (LLPDD) by administering an effective amount of a serotonin re-uptake blocker (SRB), with dependent claim coverage narrowing to specific SRBs including sertraline, fluoxetine, and fluvoxamine. The claim set is method-of-treatment in the US. That claim structure typically creates a narrower, indication- and dosing-context-driven infringement envelope than chemical-formulation patents, but it can still create meaningful exclusivity leverage where the label, clinical practice, and any FDA-recognized indication language align with the claimed therapeutic class and condition. What patents protect late luteal phase dysphoric disorder using SSRIs like sertraline, fluoxetine, and fluvoxamine? Answer: US 5,744,501 protects a US method-of-treatment claim combination: (i) a patient with LLPDD and (ii) administration of an effective amount of a serotonin re-uptake blocker. The patent’s claim 2 locks the SRB selection to a closed list (fluoxetine, zimelidine, fluvoxamine, sertraline, indalpine, citalopram, femoxetine, paroxetine, alaproclate, plus salts), and claims 3 to 5 pick sertraline, fluoxetine, and fluvoxamine specifically. How the claims are structured for enforceability The five claims you provided are all method claims, not product claims. Practically, that means: Infringement theory is induced to medical use, not manufacturing chemistry. Scope tracks both the indication and the SRB selection. Dependent claims narrow the SRB identity to named molecules (or salts). That matters for claim charts against generic SSRIs not listed or other serotonin-modulating agents not categorized as “serotonin re-uptake blockers.” Claim-by-claim scope (practical reading) Claim 1 Core elements “method for treatment of Late Luteal Phase Dysphoric Disorder” administering an effective amount of a “serotonin re-uptake blocker” to a patient in need Scope drivers “Late Luteal Phase Dysphoric Disorder” is the clinical condition anchor. If a payer or label frames the disorder under a different nomenclature, enforcement becomes harder. If “LLPDD” aligns with later terminology such as late luteal phase dysphoria or premenstrual dysphoric disorder concepts, enforcement depends on the patent’s own definitions and the court’s claim construction approach. “Serotonin re-uptake blocker” is likely intended to capture SSRIs (and related agents with reuptake inhibition), but claim 2 turns that into a list. Claim 2 Adds limitation: SRB is from a listed group of active ingredients and salts. This claim is a key “fence” claim because it is closed to the enumerated molecules. An accused regimen using an SRB not listed would not meet claim 2 unless doctrine of equivalents applies and a court accepts functional equivalence for “serotonin re-uptake blocker” while still satisfying the claim language constraining the SRB identity through claim 2. Claims 3–5 Single-molecule embodiments: Claim 3: sertraline Claim 4: fluoxetine Claim 5: fluvoxamine These create a straightforward infringement path for any medical use where: the patient has LLPDD as understood in claim construction, and the prescriber administers sertraline (or fluoxetine, fluvoxamine) in an effective amount. What the claim set does not cover (based on your claim text) Because the independent claim 1 uses “serotonin re-uptake blocker” and claim 2 lists specific molecules, the patent does not inherently cover: non-reuptake serotonin modulators unless courts interpret them as “serotonin re-uptake blockers” non-listed SSRIs in claim 2 if “serotonin re-uptake blocker” is constrained by the dependent claim formulations per se (no direct composition claims are shown in your provided claim set) manufacturing methods That said, method-of-treatment claims can still be asserted against clinical practice using listed SSRIs. When does US 5,744,501 lose exclusivity, and what does the expiration risk look like for SSRIs used off-label? Answer: The provided materials include only claims, not filing date, priority, patent term adjustment, or prosecution history. Without the bibliographic data, the exact US expiration date cannot be computed with precision here. The enforcement window for method claims follows standard US utility patent term mechanics, but an accurate “date-to-date” exclusivity timeline requires the patent’s filing and priority information. Patent term mechanics that typically control method claims like this US utility patents generally expire 20 years from the earliest non-provisional filing date (subject to adjustments). Method claims do not generally extend term beyond the base utility patent. If there are continuation applications, their claims could create a broader or shifting “patent family” landscape. Timeline gap: No bibliographic data was provided in the prompt, and the response must not fabricate exact dates. What is the strongest infringement path under US 5,744,501: generic entry, label language, or prescribing practice? Answer: For method claims of this type, infringement is most plausibly tied to prescribing and dispensing practice for LLPDD using the listed SSRIs at therapeutic (“effective amount”) dosing. How generic entry changes risk A generic launch does not eliminate liability for the claimed method, because: generic SSRIs can still infringe if the method claim is practiced (patient diagnosis + effective administration). however, proving method use and patient eligibility is typically more complex than product composition proof. What typically matters for enforcement in LLPDD contexts How clinicians diagnose and document LLPDD (or renamed variants). Whether the regimen is presented or used specifically for “late luteal phase dysphoric disorder.” What evidence exists in medical records to show the prescriber was treating LLPDD with the listed SSRI. Which SSRIs are explicitly covered by the dependent claims, and which are outside the fence? Answer: The dependent claim 2 expressly lists: fluoxetine, zimelidine, fluvoxamine, sertraline, indalpine, citalopram, femoxetine, paroxetine, alaproclate, and pharmaceutically acceptable salts. Closed-list effect in a claim chart A typical infringement chart against an accused regimen would treat claim 2 as satisfied only if: the administered drug is one of the listed active ingredients (or salt form), and the patient has LLPDD, and an effective amount is administered. That makes the “outside the fence” category clear for any reuptake blocker not enumerated in claim 2. How does US 5,744,501 compare with other late luteal phase dysphoric disorder or premenstrual dysphoric disorder patents? Answer: Based on claim structure alone, US 5,744,501 is a classic early-generation SSRI method-of-treatment patent focusing on patient indication and drug selection rather than: sustained-release formulation engineering, fixed-dose combination regimens, device or delivery system constraints. Typical adjacent patent clusters in this therapeutic area (what you would usually see) Even though you did not provide additional patents, the litigation and patent landscapes for LLPDD/PMDD-style indications commonly include: method-of-use patents tied to specific SSRIs and dosage schedules dose-frequency or titration regimen claims formulation claims for delayed-release or controlled-release SSRI delivery combination claims (for example SSRI plus hormonal interventions) if supported use in specific patient subpopulations US 5,744,501, as stated in your claim set, belongs to the method-of-treatment-with-an-SSRI cluster and reads as narrower than formulation and regimen engineering portfolios. What patent litigation affects US 5,744,501 and how often do parties reach settlements in SSRI PMDD/LLPDD disputes? Answer: No litigation history, assignments, or enforcement record was supplied. Without case captions, docket numbers, settlement terms, or a patent assertion dataset, an accurate statement about litigation affecting 5,744,501 cannot be produced. What is the Orange Book status of US 5,744,501 and which FDA products would be relevant? Answer: Orange Book status depends on whether the method patent is listed against an NDA/BLA for a specific drug product and whether it is tied to an indication that matches the claimed LLPDD treatment. The prompt provides only claim text and does not include the patent’s listed NDA/BLA numbers or the listed drug(s). Orange Book linkage mechanics relevant to a method patent For a method-of-use patent to appear, it must be listed against a drug product with a qualifying patent listing category (and tied to an approval that covers the claimed method). If the claimed method is not in the approved labeling at the time of listing, it may not show up for Orange Book purposes. Status gap: no bibliographic listing information was provided. How strong is the patent estate for US 5,744,501 given the claim breadth? Answer: Strength is primarily tied to: the closed-list limitation in claim 2 the indication anchor of LLPDD lack of formulation or manufacturing claims (as shown in your provided claim set) Strength factors that improve enforceability Claims 3–5 create clean, molecule-specific embodiments (sertraline, fluoxetine, fluvoxamine). Method claims are valuable where prescribing practice aligns with the claimed condition and drug. The “effective amount” language supports practical infringement because therapeutic dosing is the intended use. Strength factors that constrain breadth Claim 2 limits SSRIs to a defined set. That narrows the range of potential accused agents. “Late Luteal Phase Dysphoric Disorder” is a more specific label than broader conditions like “depression” or “mood disorders,” which can limit infringement if care providers treat under different diagnostic frameworks. Practical litigation posture If asserted, the patentee’s case would hinge on showing the method claim is practiced for LLPDD with one of the listed SSRIs. Defense would focus on diagnosis terminology, label language vs practice, and whether the administered drug qualifies as the claimed “serotonin re-uptake blocker” within the claim set. Key Takeaways US 5,744,501 is a method-of-treatment patent for LLPDD using a serotonin re-uptake blocker, with dependent claims narrowing to a closed list of specific SSRIs and salts. Claim 1 covers the overall method concept (LLPDD + effective amount of an SRB). Claim 2 narrows SRB identity to enumerated active ingredients: fluoxetine, zimelidine, fluvoxamine, sertraline, indalpine, citalopram, femoxetine, paroxetine, alaproclate, and salts. Claims 3–5 provide molecule-specific coverage for sertraline, fluoxetine, and fluvoxamine, creating straightforward infringement targets if the LLPDD method is practiced. No expiration date, Orange Book listing, or litigation/settlement record can be stated from the prompt’s information limited to the claim text. FAQs 1) Does US 5,744,501 cover generic versions of fluoxetine or sertraline? The patent’s claims target method-of-treatment. If the generic product is administered to treat LLPDD with an “effective amount” of the listed drug, method-practice infringement risk can persist regardless of brand vs generic. 2) What happens if a clinician treats LLPDD using an SSRI not listed in claim 2? On the text provided, claim 2 is a closed list. Use of a non-enumerated SSRI would not satisfy claim 2, and claim 1 would turn on whether that agent qualifies as a “serotonin re-uptake blocker” as construed alongside the dependent claim structure. 3) Are formulation changes (immediate vs delayed release) within the scope of US 5,744,501? The provided claims are method claims centered on treating LLPDD with an effective amount of an SRB. Formulation specifics are not included in the claim text you provided. 4) If LLPDD is diagnosed under a different name, does that avoid infringement? Potentially, depending on claim construction and evidence that the patient met the claim’s LLPDD definition. The claim set as provided is indication-specific. 5) Can a patent listing for an SSRI method of use survive generics entering the market? Method patents can remain enforceable after generic launch if the claimed method is still practiced. The key question is whether the claimed method is performed, not whether the product is branded. References United States Patent 5,744,501, claims 1–5 (as provided in the prompt). More… ↓ ⤷ Start Trial

Details for Patent: 5,744,501

Summary for Patent: 5,744,501