Last Updated: August 9, 2026

Details for Patent: 9,220,747


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Summary for Patent: 9,220,747
Title:Methods using desmopressin acetate in orodispersible form
Abstract:Described are orodispersible solid dosage forms of desmopressin or a pharmaceutically acceptable salt thereof useful for treating diseases or conditions such as incontinence, primary nocturnal enuresis (PNE), nocturia, and central diabetes insipidus. The dosage forms disintegrate in the mouth within 10 seconds and provide good desmopressin bioavailability.
Inventor(s):Anders Nilsson, Hans Lindner, Jçrgen Wittendorff
Assignee: Ferring BV
Application Number:US14/326,939
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,220,747
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Patent 9,220,747 Scope and Claims: Desmopressin Orodispersible Solid Dosage Form and Bioavailability/Disintegration Limits for Incontinence, PNE, Nocturia, and Central Diabetes Insipidus

Executive summary US Drug Patent 9,220,747 claims a method of treating selected water-balance/urinary conditions (including primary nocturnal enuresis (PNE) and nocturia) by administering desmopressin acetate in an orodispersible solid dosage form that (i) disintegrates in the mouth within 10 seconds and (ii) contains 0.5 to 75 μg desmopressin acetate (free base), producing desmopressin bioavailability >0.1% to ~0.38%, with dependent claims narrowing bioavailability windows, dosage ranges, open matrix networks (gelatin, including fish gelatin non-gelling), citric acid, tighter disintegration times (5 sec, 2 sec), and once- vs twice-daily dosing.


How strong is US Patent 9,220,747 for blocking desmopressin orodispersible generics?

Answer (claim-level strength): Strongest against products that match the claim’s combination of (a) orodispersible format with rapid disintegration and (b) specific desmopressin dose (free-base measured) and (c) achieved bioavailability window. The “bioavailability as a result” limit is the narrowest practical differentiator for design-around, because it ties infringement to pharmacokinetic performance, not only formulation structure.

What exactly does Claim 1 require?

Claim 1 is a tight product-by-performance method. It requires all of the following:

  1. Method of treating: disease/condition selected from
    • incontinence
    • primary nocturnal enuresis (PNE)
    • nocturia
    • central diabetes insipidus (CDI)
  2. Administration: “effective and generally non-toxic amount” of desmopressin acetate.
  3. Dosage form: an orodispersible solid dosage form.
  4. Mouth disintegration: disintegrates in mouth within 10 seconds.
  5. Dose amount: desmopressin acetate content measured as free base 0.5 μg to 75 μg.
  6. Bioavailability outcome: method “results in” desmopressin bioavailability from greater than 0.1% to about 0.38%.

This means a challenger cannot avoid the claim by changing only one attribute. A non-infringing product must either:

  • use a different dosage form concept (not orodispersible),
  • fail the rapid disintegration requirement,
  • use a dosage outside the free-base range,
  • or produce a bioavailability outside the claimed band.

How do dependent claims tighten infringement risk?

Key dependent claims create additional “lock-in” parameters:

  • Claim 2: bioavailability ~0.23% to ~0.38%
  • Claim 3: bioavailability ~0.30%
  • Claim 4: dose range 1 μg to 50 μg
  • Claim 5-8: open matrix network + inert carrier, including
    • Claim 6: gelatin
    • Claim 7: fish gelatin
    • Claim 8: non-gelling fish gelatin
  • Claim 9: includes citric acid
  • Claims 12-13: disintegrates within 5 seconds or 2 seconds
  • Claims 14-15: once per day or twice per day
  • Claims 16-18: alternative restatements of bioavailability ranges including 0.30%

Practical impact: If a commercial product hits Claim 1 but misses one dependent limitation, it still can infringe Claim 1. Dependent claims matter for narrowing arguments, claim construction, and damages theories by showing the patentee’s preferred performance/formulation embodiments.


What is the scope of “orodispersible solid dosage form” and “disintegrates in the mouth within 10 seconds”?

Answer: The claim requires an orodispersible dosage form that measurably disintegrates in-mouth within 10 seconds. Dependent claims set shorter endpoints: 5 seconds and 2 seconds.

Claim 1 disintegration limit (10 seconds)

  • Claim 1: “disintegrates in the mouth within 10 seconds”
  • Infringement depends on the test method and conditions used to determine disintegration. The claim text does not specify a USP apparatus or protocol in the excerpt provided, so infringement construction will turn on how “disintegrates in the mouth” is interpreted under the patent’s disclosure and prosecution history.

Dependent claims narrow to faster products

  • Claim 12: within 5 seconds
  • Claim 13: within 2 seconds

Design-around vector: Slowing disintegration beyond the limit (for example, intentionally timing above 10 seconds) is a direct path around the disintegration element. A slower formulation still has to consider whether it remains “orodispersible” and whether it still achieves bioavailability in the same band.


How do the dose limits work: “desmopressin acetate measured as the free base of from 0.5 μg to 75 μg”?

Answer: The claimed content is measured as desmopressin free base equivalent, not as the acetate salt mass per se. That metric is a common litigation lever, because formulation analytics and labeling can cause disputes.

Claim 1 dose window

  • 0.5 μg to 75 μg (free base equivalent)

Dependent claim dose window

  • Claim 4: 1 μg to 50 μg (free base equivalent)

Design-around vector: A product with an administered dose outside either window is non-infringing as to those dosing strengths. This is especially relevant if a competitor chooses a higher or lower tablet/orodispersible strength than the patentee’s range.


How is “desmopressin bioavailability of greater than 0.1% to about 0.38%” used in claim scope?

Answer: The bioavailability clause is an outcome limitation. It requires that the claimed method produce desmopressin bioavailability in the specified range after administration of the orodispersible dosage form.

What the bioavailability subrange set implies

  • Claim 1: >0.1% to about 0.38%
  • Claim 2: about 0.23% to about 0.38%
  • Claim 3: about 0.30%
  • Claims 16-18: additional restatements including 0.30%

Infringement consequence: Even if a dosage form meets disintegration and dose content, a competitor can avoid Claim 1 by pushing bioavailability outside the band. The direction of movement matters:

  • Lower bioavailability toward ≤0.1% avoids Claim 1.
  • Higher bioavailability above ~0.38% also avoids Claim 1.

Litigation consequence: Bioavailability becomes a central technical and statistical question, including assay variability, study design, and how “bioavailability” is defined (AUC-based vs other metric) in the patent’s description.


Which disease indications are covered by US 9,220,747?

Answer: The claim enumerates four: incontinence, PNE, nocturia, and central diabetes insipidus. Any product administration that satisfies the formulation/performance limits while treating any of these indications fits the claim.

Indication-specific dependent claims

  • Claim 10: PNE
  • Claim 11: nocturia

Practical implication: Indication labeling and real-world prescribing can matter for infringement arguments. If the product is used off-label for a listed indication, method-of-use infringement analysis will hinge on evidence of “administering to a subject in need thereof.”


What formulation features are claimed beyond dose and disintegration?

Answer: Dependent claims capture a specific formulation architecture: an open matrix network using water-soluble or water-dispersible inert carriers, including gelatin, specifically fish gelatin non-gelling, plus citric acid in some embodiments.

Open matrix network limitation (Claim 5)

Claim 5 requires:

  • dosage form “further comprises”
  • an open matrix network carrying desmopressin acetate
  • the network is comprised of a water-soluble or water-dispersible carrier inert towards desmopressin

Design-around vector: A competitor can avoid Claim 5-8 by using a different network concept (closed matrix, different carrier class not captured as inert water-soluble/dispersible open matrix, or different excipient structure). However, because Claim 5 is dependent, matching Claim 1 without Claim 5 still can infringe.

Gelatin and fish gelatin non-gelling (Claims 6-8)

  • Claim 6: gelatin
  • Claim 7: fish gelatin
  • Claim 8: non-gelling fish gelatin

Infringement consequence: These limits narrow to a particular excipient embodiment. They are strong for narrowing validity and infringement scenarios when the competitor uses gelatin variants.

Citric acid (Claim 9)

  • dosage form further comprises citric acid

Design-around vector: If the product omits citric acid entirely or uses a different acid system, it may avoid Claim 9. Again, Claim 9 is dependent.


How does dosing frequency (once vs twice daily) affect claim scope?

Answer: Frequency is only in dependent limitations, but it matters for specific bottle labeling and method instructions.

  • Claim 14: once per day
  • Claim 15: twice per day

Practical impact: A competitor whose product is dosed differently (for example, three times daily or as-needed regimens) may avoid those dependent claims, but still can infringe Claim 1 if the other elements are met.


What claims are the main litigation battlegrounds for US 9,220,747?

Answer: The dispute is most likely to cluster around four claim elements:

  1. Orodispersible classification
    • whether the product truly functions as an orodispersible solid dosage form.
  2. Disintegration time
    • whether it disintegrates within 10 seconds in-mouth under the relevant test conditions.
  3. Dose measured as desmopressin free base
    • content equivalence and analytics.
  4. Achieved bioavailability window
    • pharmacokinetic evidence.

Dependent excipient limits (open matrix, gelatin/fish gelatin, citric acid) add technical specificity but are secondary if Claim 1 is met.


What does the claim set imply about the patent’s likely commercial target?

Answer: The tight bioavailability band plus rapid disintegration suggests the patentee targeted an oral platform intended to mimic exposure achieved by existing desmopressin products while improving usability. The inclusion of incontinence, PNE, and nocturia indicates broad urology/uropediatrics alignment; CDI coverage extends to endocrine use.

Competitive inference: The most direct competitive threats are desmopressin oral solid products that claim “rapidly disintegrating,” “orodispersible,” and “consistent exposure,” particularly at low microgram free-base strengths.


Patent landscape for US 9,220,747: what other patent claims likely surround this estate?

Answer: The claim language structure indicates a landscape where adjacent patents commonly fall into four buckets:

  1. Orodispersible desmopressin platforms (fast disintegration, mouth feel, stability)
  2. Dose-ranging and free-base strength equivalents (microgram content windows)
  3. Pharmacokinetic/bioperformance claims (bioavailability bands)
  4. Formulation architecture (open matrix, gelatin/fish gelatin, acid systems like citric acid)

Limitation: Only the claim text was provided. Without the patent publication record, specification disclosures, or an Orange Book-family map, a complete US patent-by-patent landscape cannot be stated accurately here.


How do you evaluate generic entry risk against this patent?

Answer: Generic risk is highest when a proposed ANDA/505(j) candidate:

  • uses an orodispersible solid dosage form,
  • targets a microgram desmopressin free-base range overlapping 0.5-75 μg (and often 1-50 μg),
  • demonstrates in-mouth disintegration ≤10 seconds,
  • and achieves desmopressin bioavailability >0.1% and ≤~0.38%.

Lower risk scenarios:

  • Disintegration deliberately fails the 10-second limit.
  • Bioavailability is tuned below ~0.1% or above ~0.38%.
  • Dose strength is selected outside the claimed free-base range.

Secondary risk factors:

  • Use of open matrix networks with gelatin, especially non-gelling fish gelatin.
  • Use of citric acid in the claimed architecture.
  • Matching dosing frequency where dependent claims matter.

What generic entry scenarios are most plausible based on the claim structure?

Answer: Competitors typically pursue one of two strategies:

Scenario A: “Platform match” with performance tuning

  • Keep orodispersible platform and disintegration performance.
  • Tune bioavailability by excipient ratios, particle size, wetting agents, or saliva penetration characteristics.
  • Risk remains if bioavailability lands in the claimed >0.1% to ~0.38% window.

Scenario B: Structural disconnection from claimed performance

  • Adjust disintegration to exceed 10 seconds.
  • Move dose outside 0.5-75 μg free-base equivalents.
  • Produce bioavailability outside the tight band.
  • This is the cleanest design-around because it breaks a core limitation of Claim 1.

Key Takeaways

  • US 9,220,747 Claim 1 is a method-of-treatment claim tethered to a specific orodispersible performance profile: mouth disintegration ≤10 seconds, desmopressin 0.5-75 μg free-base, and bioavailability >0.1% to ~0.38%.
  • Dependent claims tighten ranges for bioavailability (~0.23% to ~0.38%, ~0.30%), dose (1-50 μg), disintegration (≤5 sec, ≤2 sec), and incorporate formulation specifics like open matrix networks with gelatin and non-gelling fish gelatin, plus citric acid.
  • The highest-infringement-focus elements are bioavailability and disintegration, supported by dose equivalence measured as free base.
  • Avoidance is most reliable by breaking at least one of the core Claim 1 elements: not orodispersible, slower disintegration, dose outside the free-base range, or bioavailability outside the band.

FAQs

1) What is the single most important limiter in US 9,220,747 Claim 1?
The combination outcome limit requiring desmopressin bioavailability >0.1% to about 0.38% when administered via the claimed orodispersible dosage form.

2) Do excipient details (gelatin, fish gelatin, citric acid) matter if Claim 1 is met?
They matter for dependent claims, but if a product meets Claim 1’s core elements, excipient variations do not prevent infringement under Claim 1.

3) Can a product avoid infringement by changing only the disintegration time?
Yes. If in-mouth disintegration is intentionally above 10 seconds, it breaks Claim 1’s disintegration requirement.

4) Are dosing frequency limits required for Claim 1 infringement?
No. Once/twice daily appears only in dependent claims (Claims 14-15). Claim 1 does not impose a frequency limit.

5) What claim element is most likely to require pharmacokinetic evidence in litigation?
Bioavailability in the >0.1% to ~0.38% band, and narrower subranges in dependent claims.


References

  1. United States Patent 9,220,747.

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Drugs Protected by US Patent 9,220,747

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 9,220,747

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
United Kingdom0210397.6May 7, 2002
PCT/IB02/04036Sep 20, 2002

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