Details for Patent: 10,137,167

Which drugs does patent 10,137,167 protect, and when does it expire?

Patent 10,137,167 protects NOCDURNA and is included in one NDA.

This patent has ninety-three patent family members in eighteen countries.

Summary for Patent: 10,137,167

Title:	Methods comprising desmopressin
Abstract:	The present disclosure is directed to reducing nocturnal voids by administering a dose of desmopressin over a minimum treatment period compared to before administration, and maintaining or improving the reduction of nocturnal voids over the minimum treatment period.
Inventor(s):	Bjarke Mirner Klein, Jens Peter Norgaard
Assignee:	Ferring BV
Application Number:	US14/143,866
Patent Claim Types: see list of patent claims	Use; Dosage form;

Executive summary US 10,137,167 claims a specific desmopressin treatment algorithm for male nocturia/nocturnal polyuria that is triggered by a serum sodium threshold (≥130 mmol/L), uses an orodispersible desmopressin dose (25/50/100 μg) taken once daily shortly before bedtime (0.8 to 3 hours; exemplified around ~1 hour), includes an initial ~28-day period with serum sodium measurement and a continuation for a second contiguous period (at least 28 days, up to ~1 year) only if sodium remains ≥130 mmol/L, and requires that nocturnal void reduction over the second period is in view of the first-period response. Dependent claims further narrow to acetate salt, a particular orodispersible composition (desmopressin acetate + gelatin + mannitol + citric acid), and dose timing/nocturnal void quantification and selected continuation durations. The protected subject matter is not the generic concept of desmopressin for nocturia, but the combination of (i) male patient, (ii) orodispersible desmopressin dose regimen and timing without water, (iii) sodium-threshold and sodium re-measurement gating, and (iv) a treatment-extension logic linked to first-period efficacy.

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What is US Patent 10,137,167 scope and what do its claims cover?

Short answer: The patent covers a method for further reducing nocturnal voids in male patients with nocturia/nocturnal polyuria using daily orodispersible desmopressin under a serum sodium threshold (≥130 mmol/L), with sodium monitoring after an initial ~28-day titration-like period and extension of dosing only while sodium stays ≥130 mmol/L and based on the first-period nocturnal void reduction.

Claim 1: Core independent method claim scope

Claim 1 is a multi-step, patient-selection and regimen-optimization claim. It requires all limitations below:

1. Patient and indication

   • “male patient in need” of further reducing nocturnal voids.
   • Claim 4 narrows this further to patients with nocturia or nocturnal polyuria.

2. Serum sodium threshold gating

   • The patient has a serum sodium level of at least 130 mmol/L at the time of administering the first-period dose.

3. Drug form and dose

   • Orodispersible dose of desmopressin.
   • Dose is chosen from 25 μg, 50 μg, 100 μg.

4. Dose timing relative to bedtime

   • Taken once daily.
   • Taken 0.8 to 3 hours prior to bedtime.
   • Claim 13 adds “approximately 1 hour prior.”
   • Claim 12 adds “without water.”

5. Treatment period 1

   • A “first treatment period” of about 28 days.
   • During this first period, dosing occurs “prior to bedtime” once daily.

6. Serum sodium re-measurement after period 1

   • “Measuring the patient’s serum sodium level after the first treatment period.”

7. Treatment period 2 extension with sodium threshold

   • “Continuing to administer” prior-to-bedtime orodispersible desmopressin over a second contiguous treatment period of at least 28 days to about 1 year.
   • Continuation is conditioned on the male patient having serum sodium level of at least 130 mmol/L.

8. Efficacy-based relationship requirement

   • The reduction in nocturnal voids over the second period is “further reduced in view of the reduction … over the first treatment period.”
   • The first-period reduction is “determined based on the patient’s nocturnal voids before administration” for the first period.
   • This is a functional/relationship limitation: the method requires that, operationally, continuation is tied to a meaningful reduction observed during the first ~28 days and that further reduction during the second period is in view of that first-period reduction.

Practical claim coverage implications

• You must do both sodium monitoring points: baseline at the start of the first period (to ensure ≥130) and reassessment after ~28 days (to allow continuation under the same threshold).
• You must use orodispersible desmopressin (not a different route/dosage form) and use one of the enumerated microgram dose levels in claim 1.
• The claim is not simply “titrate and monitor”; it locks the regimen to the two contiguous periods (about 28 days, then at least 28 days up to ~1 year), with sodium threshold gating for period 2 and a requirement that second-period further reduction is in view of first-period response.

Claim 2: Salt form scope

Claim 2 limits claim 1 to:

• “dose of desmopressin free base … in the form of the acetate salt of desmopressin.”

This restricts infringement theory for products using a different salt (or free base) versus desmopressin acetate.

Claim 3: Composition scope for a specific orodispersible formulation

Claim 3 requires an orodispersible dosage form comprising:

• desmopressin acetate
• gelatin
• mannitol
• citric acid

This is a classic formulation-dependent bottleneck. It narrows coverage sharply to a product matching that compositional recipe (or at least the claimed components in the claimed way). If a competitor’s orodispersible technology substitutes key excipients or changes the matrix system, it may be outside this dependent claim.

Claim 4: Indication narrowing

Claim 4 narrows patient population to:

• nocturia or nocturnal polyuria.

If a competitor uses desmopressin under a different clinical framing that is not nocturia/nocturnal polyuria, they may try to avoid this limitation. In practice, most nocturia registries and labeling overlap.

Claims 5, 6, 7-11: Quantification and continuation duration selections

• Claim 5: the reduction in nocturnal voids ranges from about 1 to 2 nocturnal voids compared to baseline before first dosing.
  • This is quantification that can be used as an infringement/facts-and-measures defense point.
• Claim 6: the second contiguous period is from about 8 weeks to about 1 year.
• Claims 7-11: set out discrete second-period durations:
  • Claim 7 lists: 8, 12, 20, 28, 52 weeks.
  • Claim 8 selects about 8 weeks.
  • Claim 9 selects about 20 weeks.
  • Claim 10 selects about 52 weeks.
  • Claim 11 selects about 1 year.

Operationally, these dependent claims provide multiple “entry points” for different clinical schedules while staying within the same core design: sodium threshold gating and orodispersible pre-bed desmopressin dosing.

Claims 12-13: Administration details

• Claim 12: dose is taken without water.
• Claim 13: dose is taken approximately 1 hour prior to bedtime.

If a competitor’s label or patient instructions require taking with water, they may attempt to avoid these dependent limitations. If the competitor’s instructions permit “without water” as part of standard administration, it remains a risk.

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Which elements in US 10,137,167 are most likely to drive infringement analysis?

Short answer: The highest-value infringement levers are the serum sodium threshold and re-measurement gating, two contiguous treatment periods with extension up to ~1 year, and use of an orodispersible desmopressin dose taken 0.8 to 3 hours pre-bed once daily (without water if pursuing dependent claims).

Element-by-element “design-around” sensitivity

1. Orodispersible vs other dosage forms
   • Central in claim 1 and also in claim 3.
2. Dose strength selection (25/50/100 μg)
   • Claim 1 is limited to those doses as the chosen dose.
3. Timing window (0.8 to 3 hours)
   • Dependent narrowing at ~1 hour in claim 13.
   • A different timing outside 0.8 to 3 hours is a potential non-infringement route, though clinical practice may drift into the window.
4. Serum sodium ≥130 mmol/L at baseline and after 28 days
   • This is a strong gating limitation.
   • A competitor could attempt protocols using a different sodium threshold for continuation or using different sodium monitoring schedules, though claim 1’s requirement is specific: baseline must be ≥130; after first ~28 days sodium must be ≥130 to continue.
5. “Further reduced … in view of” first-period reduction
   • This “relationship” requirement can become a factual and protocol-specific infringement battleground.
6. Nocturnal void reduction quantified (1 to 2)
   • This is only in claim 5, but it gives another dependent-claim fence.
7. Formulation composition (gelatin, mannitol, citric acid)
   • Only in claim 3; it is a likely design-around handle if a different orodispersible formulation is used.

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What patents likely intersect US 10,137,167 claims (desmopressin for nocturia, sodium monitoring, orodispersible formulations)?

Short answer: The patent sits at the intersection of: (i) desmopressin therapeutic use in nocturia/nocturnal polyuria with safety monitoring to mitigate hyponatremia, and (ii) specific administration regimen features (orodispersible format, dosing window pre-bed, without water) and (iii) extension of dosing based on first-period efficacy response under a serum sodium threshold.

Where overlap is most plausible (claim-scope adjacency)

• Therapeutic use patents for desmopressin in nocturia commonly claim dose titration and sodium safety monitoring. US 10,137,167’s differentiation is its specific two-period structure (about 28 days followed by continuation to ~1 year) and the ≥130 mmol/L continuation rule plus an efficacy relationship between first and second periods.
• Formulation patents for orodispersible desmopressin variants often cover excipients and manufacturing to enable rapid oral dispersion. Claim 3’s excipient set (gelatin/mannitol/citric acid) suggests potential overlap with formulation IP, but claim 3 itself is narrow on excipient composition.
• Dosing-timing patents: pre-bed timing windows and “without water” administration are often product-label or administration-tech detail areas. Claim 13 and claim 12 likely correspond to specific administration instructions in clinical studies or product labeling.

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How does US 10,137,167 differ from broader desmopressin nocturia patents?

Short answer: Many upstream patents claim desmopressin efficacy for nocturia and general sodium monitoring. US 10,137,167 adds a hard-edged regimen architecture: baseline sodium ≥130, first ~28-day period, post-period sodium measurement, and continuation for up to ~1 year only while sodium remains ≥130, combined with a claim requirement that second-period further reduction is in view of first-period reduction.

Key differentiators embedded in claim language

• Two-part contiguous period structure with defined approximate lengths.
• Continuation decision tied to sodium level measured after period 1.
• Relationship requirement linking reductions across periods.
• Specific administration details: orodispersible, once daily, and dosing window 0.8 to 3 hours pre-bed.
• Dependent compression points: acetate salt and an excipient-defined orodispersible composition.

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What is the legal strength profile of US 10,137,167 (claim breadth vs narrow fences)?

Short answer: Claim 1 is relatively broad in concept but narrow in operational specifics (serum sodium threshold, orodispersible format, dosing window, two-period structure, male patient). Dependent claims add narrow product/composition and schedule constraints.

Breadth analysis

• Breadth is concentrated in claim 1: it is not limited to a specific excipient recipe. It covers any orodispersible desmopressin achieving the claimed regimen behavior.
• Narrow fences appear in dependent claims:
  • claim 2: acetate salt
  • claim 3: specific excipient composition
  • claim 12-13: without water and ~1 hour timing
  • claims 7-11: discrete continuation durations
  • claim 5: quantified nocturnal void reduction

Litigation relevance

• In infringement suits, plaintiffs often anchor to claim 1 to avoid dependence on specific excipient formulations.
• Defense strategies typically try to create a record that one or more claim-1 limitations are not met: sodium threshold, dosing window, dosage strength selection, dosing form (not orodispersible), or treatment scheduling and measurement logic.

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What generic entry risks exist for competitors vs US 10,137,167?

Short answer: Risk is driven more by how products are used in clinical practice and labeling than by mere formulation equivalence. Even if a generic is therapeutically equivalent, a competitor may still face method-of-use exposure if its label or promoted protocol aligns with claim 1’s sodium-gated, two-period continuation regimen with orodispersible pre-bed dosing in the specified timing window.

Risk multipliers

• If a generic or follow-on product is marketed with instructions matching:
  • once-daily orodispersible desmopressin,
  • administration 0.8 to 3 hours pre-bed (or ~1 hour),
  • baseline sodium screening and sodium re-check after about 28 days,
  • continuation for a second contiguous period (at least 28 days up to about 1 year) only if sodium remains ≥130,
  • and dosing decisions guided by observed nocturnal void reduction across the first and second periods.

Risk reducers

• Protocols that:
  • use a different serum sodium threshold for continuation,
  • decouple or remove the “based on first-period reduction / further reduction in view of first-period reduction” logic,
  • or use a different dosing schedule that is outside the two-period contiguous structure described in claim 1,
  • or change from orodispersible dosing.

(These are conceptual design-around levers grounded in the claim limitations; enforcement still depends on facts and how clinicians follow the regimen.)

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What formulations are protected by US 10,137,167?

Short answer: Claim 3 protects an orodispersible dosage form composed of desmopressin acetate + gelatin + mannitol + citric acid. Claim 1 protects orodispersible desmopressin broadly, without requiring the specific excipient set, so long as the regimen elements are followed.

Formulation-dependent scope map

• Claim 1: any orodispersible desmopressin meeting regimen parameters.
• Claim 2: desmopressin acetate salt.
• Claim 3: desmopressin acetate with gelatin, mannitol, citric acid.

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What method-of-use scenarios likely fall inside or outside the claims?

Short answer: Inside are methods that match claim 1’s regimen and measurement logic. Outside are protocols that violate any required limitation.

Likely inside (fact-pattern fit)

• Male nocturia/nocturnal polyuria patients with baseline sodium ≥130.
• Daily orodispersible desmopressin 25/50/100 μg once daily, taken 0.8 to 3 hours pre-bed.
• Evaluate serum sodium after about 28 days.
• Continue dosing for a contiguous second period of at least 28 days up to ~1 year only if sodium remains ≥130.
• Document that nocturnal void reduction in period 2 is further reduced in view of first-period reduction determined versus pre-treatment baseline.

Likely outside (limitation break points)

• Use of desmopressin in a non-orodispersible form.
• Use of pre-bed timing outside 0.8 to 3 hours (or for dependent claim 13, outside ~1 hour).
• Continuation without the post-first-period sodium measurement and sodium ≥130 gating.
• Continuation regardless of whether sodium is ≥130 after period 1.
• Dosing sequences that do not implement the defined contiguous second treatment period framework (at least 28 days up to ~1 year).

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Key Takeaways

• US 10,137,167 is a method-of-use patent centered on a sodium-threshold controlled, two-period desmopressin regimen for male nocturia/nocturnal polyuria using orodispersible dosing.
• Claim 1’s highest-impact requirements are: (i) baseline serum sodium ≥130, (ii) ~28-day initial period, (iii) sodium re-measurement after period 1, (iv) continuation for ≥28 days to ~1 year only if sodium ≥130, and (v) a functional relationship between first-period and second-period nocturnal void reductions.
• Dependent claims add narrow, infringement-relevant constraints on: acetate salt, specific orodispersible excipient composition (gelatin/mannitol/citric acid), dose timing without water and ~1 hour pre-bed administration, and selected second-period durations.

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FAQs

1. Does US 10,137,167 protect only orodispersible desmopressin or also other routes?
   Claim 1 requires an orodispersible dose; other routes are outside claim 1’s core limitation.

2. What serum sodium number is critical in US 10,137,167?
   The claim uses a ≥130 mmol/L threshold at baseline for period 1 and after period 1 for continuation into the second contiguous period.

3. Is the second-period duration flexible or limited in US 10,137,167?
   Claim 1 allows the second contiguous period of at least 28 days to about 1 year; dependent claims list specific schedules (8/12/20/28/52 weeks and about 1 year).

4. Can a competitor avoid dependent claim 3 by changing excipients in an orodispersible formulation?
   Dependent claim 3 requires specific excipients (gelatin, mannitol, citric acid), so changing that composition targets the dependent-claim fence.

5. If a product is FDA-approved for nocturia, does that automatically mean it infringes?
   Infringement depends on whether the method steps matching claim 1 are performed using the specified regimen elements (sodium gating, timing window, orodispersible dosing, and the two-period structure linked to measured nocturnal void reduction).

Drugs Protected by US Patent 10,137,167

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-002	Jun 21, 2018		DISCN	Yes	No						TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS, COMPRISING MONITORING A PATIENT'S SERUM SODIUM CONCENTRATION

International Family Members for US Patent 10,137,167

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2712622		PA2017001	Lithuania
European Patent Office	2712622		122017000006	Germany
European Patent Office	2712622		LUC00015	Luxembourg
European Patent Office	3225249		300983	Netherlands
European Patent Office	3225249		CA 2019 00023	Denmark
European Patent Office	3225249		2019C/520	Belgium
European Patent Office	2712622		C02712622/01	Switzerland