Details for Patent: 12,350,475

Which drugs does patent 12,350,475 protect, and when does it expire?

Patent 12,350,475 protects BYNFEZIA PEN and is included in one NDA.

Summary for Patent: 12,350,475

Title:	Method of injecting octreotide acetate into the body
Abstract:	A method of providing and/or injecting octreotide acetate to a subject in need thereof includes storing the octreotide acetate in a cartridge of a multi-use multi-dose injector provided with a variable dose setter and actuator. The injector includes a needle configured for subcutaneous administration of the octreotide acetate, the octreotide acetate having a concentration of 2,500 μg/mL. The method further includes permitting setting of a dose of the octreotide acetate by rotation of the variable dose setter. The injector is configured to provide at least one audible feedback during the rotation. The method further includes operating the actuator to deliver the octreotide acetate from the cartridge through the needle to treat the subject. The injector is provided with multiple surface portions.
Inventor(s):	Satyashodhan Babasaheb Patil, Sudeep Kumar Agrawal, Subhas Balaram Bhowmick, Prashant Kane
Assignee:	Sun Pharmaceutical Industries Ltd
Application Number:	US18/085,095
Patent Claim Types: see list of patent claims	Use; Delivery; Dosage form;

Scope and Claims Analysis and US Patent Landscape for U.S. Patent No. 12,350,475 (Octreotide Acetate, Multi-Use Multi-Dose Injector, Audible/Tactile Dose Setting, Dose-Indexing, Chromatic Indicator Surfaces)

U.S. Patent No. 12,350,475 is directed to method-of-treatment steps for acromegaly, carcinoid tumors, and vasoactive intestinal peptide (VIP) tumors, combined with tightly specified user-interface and dosing mechanics for an octreotide acetate cartridge-based, multi-use, multi-dose, subcutaneous injector. The independent claim’s enforceable scope is anchored on (i) a ~2,500 μg/mL octreotide acetate concentration, (ii) a variable-dose setter with audible feedback during dose setting, (iii) chromatic/achromatic surface coding of an actuator, dose setter portion, and injector-body terminal portion, (iv) rotational dose setting with reset capability for correcting overdosing, and (v) additional injector safety and dose-indication configurations (in dependent claims). Independent claim 15 adds a multi-session “up to about 1,500 μg” dosing workflow with sequential delivery to different injection sites, including selecting a maximum dose setting, injecting, then turning to an indicated dose for the second site.

Below is a claim-by-claim scope map and the likely patentability and infringement posture based on the claim language supplied, plus a structured U.S. landscape view for the octreotide-acetate injector and dose-setting UI/handling feature space.

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What patents protect octreotide acetate self-injection for acromegaly and carcinoid tumors in the US?

How the claims in 12,350,475 structure the protection

The patent is written as a method-of-treating claim but is effectively a combined “device-using” method claim. The method steps are inseparable from the injector structural/functional limitations embedded in the claim. Core protected elements are:

1. Therapeutic subject matter (functional): treating one or more of acromegaly, carcinoid tumors, or VIP tumors by providing and/or injecting octreotide acetate.
2. Drug form (numerical concentration constraint): octreotide acetate at about 2,500 μg/mL.
3. Delivery system architecture: storing octreotide acetate in a cartridge of a multi-use multi-dose injector with:
   • a variable dose setter and an actuator,
   • a needle configured for subcutaneous administration.
4. Dose selection behavior (functional UI/controls):
   • dose setting permitted via rotating the variable dose setter,
   • audible feedback during dose setting (claim 1) or during rotation (claim 15),
   • re-setting to correct for overdosing (claim 1),
   • mechanical dose selection also described in dependent language (claim 14: rotation plus axial displacement).
5. **Human factors / coded surfaces (chromatic/achromatic):
   • a visible surface of the actuator has a first chromatic/achromatic value,
   • at least a portion of the variable dose setter has a second value,
   • a terminal portion of the injector body has a third value,
   • and their relative spatial relationship is constrained (e.g., the variable dose setter surrounds the actuator portion in claim 1; and in claim 15 the first surface portion surrounds the second surface portion with the third surface portion proximate).
6. Dose indication scheme (dependent claims):
   • indicia only at prescribed doses without markings between them,
   • specified dose set including 50, 100, 150, 200 μg (claim 3),
   • window-display activation by turning the injector until the indicium appears,
   • post-injection zero value appearing in the window.
7. Cartridge/insufficient content lockout (dependent claims):
   • a visible plunger position between the needle and a first indicium,
   • rotation prevented if insufficient octreotide remains.
8. Priming requirement (dependent claim 8).
9. Dose upper bound limitation (dependent claim 9): maximum dose setting of 200 μg.
10. Multi-use cap (dependent claim 10).
11. One-hand needle cover insertion (dependent claim 11).
12. Session workflow with site switching and maximum-first injection (claim 15):
    • daily dose up to about 1,500 μg split across a first and second session,
    • first session includes turning to maximum, delivering to a first injection site, turning to an indicium, delivering to a second site,
    • audible feedback during rotation is retained.

Key takeaways on enforceable scope

• The chromatic/achromatic surface coding is a differentiating technical limitation. Many prior art injector concepts include windows, audible clicks, or dose dials, but claim language forces a specific three-zone visual coding scheme and spatial arrangement.
• The cartridge-based multi-use / multi-dose injector is central. The claim is not merely about measuring a dose; it is about how the drug is stored and dispensed through a reusable device.
• The concentration constraint (about 2,500 μg/mL) narrows the drug-and-formulation match. It is not stated as “any concentration,” so accused devices using a materially different concentration may avoid that specific element even if the UI mechanics remain similar.

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What is the independent claim scope of U.S. Patent 12,350,475?

Claim 1: Dose setting with audible feedback, chromatic surfaces, and overdosing correction

Claim 1 covers a treatment method that requires all of the following, in combination:

• Administer octreotide acetate (about 2,500 μg/mL) subcutaneously to a subject with acromegaly/carcinoid/VIP tumors.
• Store octreotide acetate in a cartridge of a multi-use multi-dose injector.
• Dose setter is variable, and dose is set by rotating the variable dose setter.
• Injector provides at least one audible feedback during setting of the dose.
• Injector has an actuator and injector body with three chromatic/achromatic values:
  • first: visible surface of actuator,
  • second: a portion of the variable dose setter,
  • third: a terminal portion of the injector body.
• The variable dose setter portion surrounds at least a portion of the actuator.
• The terminal injector-body portion is proximate to the variable dose setter portion.
• The rotating dose setter comprises re-setting to correct for overdosing.

Immediate implications for infringement To infringe claim 1, an accused product must match:

• the specific “dose setting with audible feedback” implementation (audible signals during setting/rotation),
• the multi-zone chromatic/achromatic coding and their spatial relationship,
• and the “re-setting to correct overdosing” behavior (not merely allowing dose adjustment; it must be usable for resetting after an overdosing event or to correct overdosing).

Claim 15: Daily split-session workflow with maximum-first injection and second-site delivery

Claim 15 is a second independent method claim adding a distinct operational workflow and restricting certain injector surface geometry:

• Still requires: treating acromegaly/carcinoid/VIP tumors by providing and/or injecting octreotide acetate; cartridge storage; multi-use multi-dose; subcutaneous needle; about 2,500 μg/mL.
• Adds: audible feedback during rotation.
• Adds three surface portions with first surrounding second; third proximate to first.
• Adds a session workflow: injector operating to provide a daily dose of up to about 1,500 μg, split into first and second sessions.
• First session requires:
  • turn dose setter to maximum,
  • deliver a first injection to a first injection site at maximum,
  • turn dose setter to an indicium for a dose,
  • deliver a second injection to a second injection site.

Immediate implications for infringement Claim 15 is likely easier to distinguish against devices whose label-directed daily dosing is not structured as “maximum-first then turn to indicium for a second site” under the claimed delivery mechanics. The claim is not just about dose splitting. It locks in the sequence and specific interaction with the dose setter window/indicia.

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What do the dependent claims add to coverage and how do they change the infringement risk?

Claim 2 and 3: Indicia only at prescribed doses, including a 50/100/150/200 μg set

• Claim 2: indicia only at prescribed doses settable via the variable dose setter, with no markings between prescribed doses.
• Claim 3: prescribed doses are 50, 100, 150, 200 μg.

Risk posture: If an accused injector uses tick-marks or intermediate markings, or the dose options differ (e.g., 75 μg steps, 25 μg steps, or a different max), it can avoid these limitations even if it uses audible feedback and chromatic zones.

Claim 4 and 5: Window-display logic and zero-value after completion

• Claim 4: turn injector until the indicium corresponding to a prescribed dose appears in a window.
• Claim 5: after injection completion, a zero value appears in the window.

Risk posture: UI differences in what the window displays post-injection and how dose selection is confirmed can carve out these dependent claims.

Claim 6 and 7: Cartridge indicia coding and insufficient-content rotation lockout

• Claim 6: first indicium closer to needle than variable dose setter differs visually from second indicia farther away.
• Claim 7: when insufficient octreotide is stored:
  • plunger is visible at a position between needle and first indicium, and
  • rotation of the variable dose setter is prevented.

Risk posture: This is a safety lockout feature with precise sight-line elements. Competitors using different low-volume inhibition logic or that still allow rotation can avoid these dependent limitations.

Claim 8: Priming

Adds a requirement to prime before delivering one of a plurality of prescribed doses.

Risk posture: If an accused device is designed so that “priming” is not part of the method workflow or is not required (or is not implemented with the claim’s method logic), it may avoid claim 8.

Claim 9: Maximum dose setting of 200 μg

Risk posture: If the accused device supports >200 μg max settings, or if the “maximum dose setting” is not 200 μg, claim 9 narrows away.

Claim 10: Re-attachable cap for multi-use

Adds a cap feature.

Claim 11: One-hand needle cover insertion

Injector held in one hand, needle insertable into a needle cover without using the other hand.

Risk posture: This is a specific ergonomic/kinematic capability. If a product requires two hands or uses a different safety mechanism, it can avoid claim 11.

Claims 12, 13: Ordering of chromatic values

• Claim 12: second value lower than first.
• Claim 13: third value higher than each of first and second.

Risk posture: These are unusual ordering constraints. They likely map to specific color luminance or intensity definitions. If an accused injector uses non-ordinal coding (e.g., distinct colors without a defined “higher/lower” relation), it may not meet these dependent comparisons.

Claim 14: Rotation plus axial displacement

Dose setting includes rotation and axially displacing the variable dose setter.

Risk posture: If the dose dial is purely rotational with no axial displacement, claim 14 is a carve-out.

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How does the patent landscape look for octreotide acetate injectors using multi-dose cartridges and dose dials?

What this patent’s claim mix implies about its novelty drivers

Even without reviewing the file history, the claim drafting indicates likely novelty anchors:

• the combination of (a) three-zone chromatic/achromatic coding with a defined spatial relationship plus (b) audible feedback during dose setting plus (c) “re-setting to correct overdosing.”
• the “device-using method” structure for a classic therapeutic field (octreotide acetate for endocrine tumors), paired with a UI/human factors injector.

That mix tends to target incremental improvements that may have been overlooked in earlier injector generations: standardized dose selection without interim markings, dose-window confirmation behavior, and lockout/visibility logic when cartridge content is insufficient.

Likely categories of prior art to search in the US

A full US freedom-to-operate or landscape review around this patent would typically examine:

1. Octreotide acetate delivery device patents: cartridge or reservoir-based reusable injectors, subcutaneous needle assemblies, needle covers, and multi-dose mechanics.
2. Dose dials with audible feedback: clicker mechanisms, sound-producing ratchets, and acoustic feedback during rotation.
3. Dose windows and indicia schemes: “zero upon completion,” selection without intermediate marks, and view logic tied to a rotating dial.
4. Cartridge end-of-dose lockouts: plunger visibility and prevention of further dose dial rotation.
5. Human-factors color coding: chromatic or luminance-coded surfaces and spatially arranged visual cues.

What is likely at stake commercially

If competitors design around the chromatic/achromatic surface coding and audible feedback during rotation, they can still face exposure if they meet the remaining limits, especially:

• the concentration requirement,
• the cartridge multi-use multi-dose architecture, and
• the overdosing correction reset capability.

If they instead change the dose set, max dose, session workflow, or indicia marking density, they can reduce coverage under dependent claims and potentially reduce the probability of meeting all elements of claim 1 or claim 15.

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Which claim elements are the best “design-around” levers?

Highest-leverage design-around features

1. Change the drug concentration: claim language requires “about 2,500 μg/mL.”
2. Remove or change the chromatic/achromatic three-surface coding with the claimed spatial relationships.
3. Eliminate audible feedback during dose setting/rotation or implement audible signals only after injection (or only at a stage not covered by “during setting”).
4. Remove “re-setting to correct overdosing” as a user-permitted function (or implement a different correction workflow not meeting the claim’s re-setting mechanic).
5. Change the dose indicia scheme:
   • use intermediate markings, different prescribed dose set, or a different window logic.
6. Modify max dose beyond 200 μg to avoid claim 9 (dependent).
7. Change lockout logic for insufficient cartridge so rotation remains possible or the plunger visibility geometry differs.

Secondary levers

• Priming requirement (claim 8) if the accused method omits it.
• Ergonomic “one-hand needle cover insertion” (claim 11).
• Axial displacement during dose setting (claim 14).

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What is the likely litigation and enforcement posture based on claim structure?

How claim 1 and claim 15 may be asserted

Given both are independent and anchored in:

• the same therapeutic context (acromegaly/carcinoid/VIP tumors),
• the same drug concentration constraint,
• and the same multi-use multi-dose cartridge injector architecture,

assertion likely focuses on whether an accused device:

• uses a rotating variable dose setter,
• provides audible feedback during setting/rotation,
• and includes the three-zone chromatic/achromatic coding with the claimed geometry.

Claim 15 adds a workflow for split dosing across injection sites. If a competitor’s label-directed dosing and user workflow differ, it can reduce claim 15 fit even if claim 1 fits.

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Key Takeaways

• U.S. Patent 12,350,475 protects a device-using method for octreotide acetate therapy that is inseparable from a multi-use multi-dose, cartridge-based subcutaneous injector with rotational dose setting and audible feedback, plus a three-zone chromatic/achromatic coding scheme with defined spatial relationships.
• Claim 1’s enforceable scope is strongest where an accused injector reproduces: (i) audible feedback during dose setting, (ii) chromatic/achromatic actuator and dose-setter/body surface coding, and (iii) user-permitted re-setting to correct overdosing, all combined with ~2,500 μg/mL octreotide acetate.
• Dependent claims narrow with dose indicia patterns (no markings between prescribed doses; 50/100/150/200 μg set), window confirmation (including zero after completion), insufficient-content lockout (rotation prevented; plunger position), priming, max dose at 200 μg, and one-hand needle cover insertion.
• Claim 15 adds a two-session daily dosing workflow up to about 1,500 μg, with a maximum-first injection to a first site and subsequent selection for injection to a second site.

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FAQs

1. What specific injector UI limitations matter most for infringement under claim 1?
   Audible feedback during dose setting/rotation, and the three-part chromatic/achromatic coding on actuator, dose setter portion, and injector-body terminal portion with claimed spatial relationships.

2. Does changing the dose range avoid dependent claim coverage?
   Yes, especially for dependent claims that fix prescribed doses (50/100/150/200 μg) and max dose (200 μg), and for claims that depend on the “no markings between” indicia scheme.

3. How does the “zero value appears in the window” feature affect design-around strategies?
   If the window logic does not show a “zero” post-completion or does so differently, claim 5 can be avoided.

4. What does “re-setting the variable dose setter to correct for overdosing” imply about user operation?
   The accused device must permit a user action matching the claimed re-setting correction mechanism tied to overdosing correction, not merely allow general dose adjustment.

5. How does claim 15 differ from claim 1 in practical enforcement?
   Claim 15 adds a split daily dosing workflow with maximum-first injection at a first site followed by dose selection for injection at a second site, and it constrains certain surface-portion relationships.

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References

No external sources were cited because only the claim text supplied by the user was used.

Drugs Protected by US Patent 12,350,475

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Sun Pharm	BYNFEZIA PEN	octreotide acetate	SOLUTION;SUBCUTANEOUS	213224-001	Sep 27, 2024		RX	Yes	Yes	12,350,475					METHOD OF TREATING ACROMEGALY PATIENTS WHO HAVE HAD INADEQUATE RESPONSE TO OR CANNOT BE TREATED WITH SURGICAL RESECTION, PITUITARY IRRADIATION, AND BROMOCRIPTINE MESYLATE AT MAXIMALLY TOLERATED DOSES
Sun Pharm	BYNFEZIA PEN	octreotide acetate	SOLUTION;SUBCUTANEOUS	213224-001	Sep 27, 2024		RX	Yes	Yes	12,350,475					METHOD OF TREATING PROFUSE WATERY DIARRHEA ASSOCIATED WITH VASOACTIVE INTESTINAL PEPTIDE TUMORS (VIPOMAS)-SECRETING TUMORS
Sun Pharm	BYNFEZIA PEN	octreotide acetate	SOLUTION;SUBCUTANEOUS	213224-001	Sep 27, 2024		RX	Yes	Yes	12,350,475					METHOD OF TREATING SEVERE DIARRHEA AND FLUSHING EPISODES ASSOCIATED WITH METASTATIC CARCINOID TUMORS