Details for Patent: 11,802,115

Which drugs does patent 11,802,115 protect, and when does it expire?

Patent 11,802,115 protects BYLVAY and is included in one NDA.

This patent has fifty-eight patent family members in thirty-three countries.

Summary for Patent: 11,802,115

Title:	Pharmaceutical formulation of odevixibat
Abstract:	The invention relates to a pharmaceutical formulation, e.g. a paediatric formulation, of odevixibat, which comprises a plurality of small particles. The formulation may be used in the treatment of liver diseases such as bile acid-dependent liver diseases, and particularly cholestatic liver diseases such as biliary atresia, progressive familial intrahepatic cholestasis (PFIC), Alagille syndrome (ALGS) and paediatric cholestatic pruritus. The invention also relates to a process for the preparation of the pharmaceutical formulation.
Inventor(s):	Eva Byröd, Per-Göran Gillberg, Anna-Maria Tivert, Rikard Bryland, Ann-Charlotte Dahlquist, Jessica Elversson, Nils Ove Gustafsson, Robert Lundqvist, Ingvar Ymen, Martin Bohlin
Assignee:	Eva Byroed Consulting AB , Tivert Konsult AB , Albireo AB
Application Number:	US16/477,160
Patent Claim Types: see list of patent claims	Formulation; Compound;

US Patent 11,802,115: Odevixibat Formulation Claims, Patent Scope, and Generic Entry Risk

US Patent No. 11,802,115 protects a multiparticulate pediatric formulation of odevixibat, the active ingredient in Bylvay. Its core limitation is a population of small coated particles containing a substantially uniform, low-concentration layer of odevixibat, with tightly controlled drug-particle size. The patent is formulation-specific. It does not broadly cover every odevixibat product, every odevixibat crystal form, or every method of treating cholestatic disease.

The strongest infringement risk applies to an oral generic that reproduces the claimed pellet architecture, aqueous wet-milled coating process, particle-size controls, and low-drug-load coating. A product using a different dosage form, a drug-loaded core, a substantially different coating process, or a different particle-size profile may avoid one or more claim limitations.

What does US Patent 11,802,115 protect?

The patent protects a pharmaceutical formulation comprising multiple coated particles. Each particle must satisfy the following principal requirements:

Claim element	Independent claim 1 requirement
Dosage-form structure	A plurality of particles
Particle size	About 0.1 to about 1.5 mm
Particle architecture	Core surrounded by a coating layer
Active ingredient	Odevixibat or a pharmaceutically acceptable salt
Drug loading	About 0.1% to about 5.0% w/w per particle
Polymer	Coating contains a film-forming polymer
Dose uniformity	Each particle substantially contains the same amount of odevixibat
Drug-particle size	Odevixibat agglomerates in the coating have a d90 below 15 micrometers

Claim 1 is an apparatus-like formulation claim. It is infringed by the composition and physical characteristics of the finished product, regardless of whether the manufacturer uses the same manufacturing process.

The claim is directed to a low-dose multiparticulate system. It is particularly suited to pediatric administration because particles can be delivered in a sachet or mixed with soft food or liquid without requiring a conventional tablet.

How narrow is independent claim 1?

Claim 1 has several cumulative limitations. A competing formulation must satisfy all material limitations to fall within its literal scope.

Particle population

The formulation must contain multiple particles, not a single tablet matrix or a conventional capsule filled with a homogeneous powder. The particles must be between approximately 0.1 and 1.5 mm.

The phrase "about" creates a numerical range of interpretation rather than an absolute boundary. The enforceable scope would depend on the specification, prosecution history, measurement method, and whether the accused product is materially equivalent to the claimed range.

Drug-containing coating

The odevixibat must be in a coating layer surrounding a core. A formulation in which odevixibat is distributed throughout the core would not literally satisfy the claimed architecture.

The coating contains a film-forming polymer. This limitation distinguishes the product from an uncoated powder or a simple physical blend of odevixibat and excipients.

Low drug loading

The coating must contain odevixibat at 0.1% to 5.0% by weight based on the total weight of each particle. Claims 2 through 4 narrow the range to:

• 0.5% to 2.0% w/w;
• approximately 0.5% w/w; and
• approximately 1.5% w/w.

These dependent claims create fallback positions if the broader 0.1% to 5.0% range is challenged for lack of novelty, obviousness, written description, or enablement.

Uniformity between particles

The claim requires that each particle "substantially" contain the same amount of odevixibat. This is a functional and quantitative limitation. It is likely to require analytical testing of particle-to-particle drug distribution.

The patent's commercial objective is dose uniformity when a patient receives a portion of the multiparticulate dose. A generic product with substantial pellet-to-pellet variation could fall outside this limitation, although the meaning of "substantially" would be determined through the patent specification and technical evidence.

Odevixibat agglomerate size

The coating must contain odevixibat agglomerates with a d90 particle-size distribution below 15 micrometers. Claim 16 narrows this limitation to below 12 micrometers.

This is one of the most technically important limitations. It targets the dispersed state of odevixibat in the coating suspension and the resulting coating layer. A generic manufacturer would need to characterize:

• the measurement technique;
• whether the measurement is performed on the wet suspension, dried coating, or isolated odevixibat;
• the definition of an agglomerate;
• the sampling method; and
• whether the reported d90 is volume-based, number-based, or measured by another convention.

Those issues may determine whether a product meets the claim even when its nominal formulation is similar.

What do claims 2 through 16 add?

What drug-loading ranges are protected?

Claims 2 through 4 protect narrower drug-loading levels. They are commercially relevant because a product using approximately 0.5% or 1.5% odevixibat per particle may infringe a narrower claim even if the broader claim is invalidated.

The claims are nested:

Claim	Added limitation
2	0.5% to 2.0% w/w odevixibat
3	Approximately 0.5% w/w
4	Approximately 1.5% w/w

Is a drug-free core required?

Claim 5 specifies that the core does not contain odevixibat. This narrows the product to a core-shell structure in which the active ingredient is confined to the coating.

Claim 6 specifies microcrystalline cellulose as the core material. A generic using sugar spheres, starch, silica, or another inert carrier could avoid claim 6 while potentially remaining within claim 1.

What manufacturing process is covered?

Claims 7 through 9 add process-derived product limitations:

• the coating is prepared by spraying a homogeneous aqueous odevixibat suspension onto the cores;
• the suspension is prepared by wet milling; and
• the suspension contains no odevixibat agglomerates larger than 200 micrometers.

These claims are narrower than claim 1. They create potential infringement exposure for a manufacturer using fluid-bed or pan coating with an aqueous, wet-milled suspension.

A dry-powder coating process, solvent-based process, high-shear dispersion process without wet milling, or coating process using preformed drug particles may avoid one or more of claims 7 through 9. Such a process may still infringe claim 1 if the final product satisfies the structural and particle-size limitations.

Does the patent cover surfactant-free formulations?

Claim 10 requires that the coating layer does not contain a surfactant. A formulation with a surfactant may avoid claim 10, but it would not necessarily avoid claim 1.

The distinction is important in design-around analysis. Surfactant use is a dependent-claim issue, while the core claim does not require a surfactant-free coating.

What particle sizes are protected?

Claim 11 narrows the particle size to approximately 0.1 to approximately 1.0 mm. This range is relevant to pediatric sprinkle formulations and may capture a commercial product whose pellets are smaller than the full 1.5 mm upper boundary.

Are odevixibat crystal forms protected?

Claims 12 through 14 cover crystalline forms within the multiparticulate formulation:

• crystalline hydrate of odevixibat;
• crystal modification 1; and
• crystal modification 1 with XRPD peaks at approximately 5.6, 6.7, and/or 12.1 degrees 2-theta using CuKalpha1 radiation.

These claims do not appear to claim crystal modification 1 in isolation. They require its presence in the formulation of claim 1. The XRPD claim is vulnerable to disputes over polymorph identification, instrument calibration, sample preparation, peak intensity, and whether the claimed peaks are sufficiently distinctive.

Is the patent limited to pediatric use?

Claim 15 expressly identifies the formulation as a pediatric formulation. This limitation reinforces the commercial relationship between the patent and the pediatric presentation of odevixibat, but it does not convert the broader claims into method-of-use claims.

What is the likely patent term and expiration framework?

US Patent 11,802,115 B2 issued on October 31, 2023. Its enforceable term is generally calculated as 20 years from the earliest effective nonprovisional or PCT filing date, subject to patent-term adjustment and any applicable terminal disclaimer. The issue date is not the expiration date.

The patent number and claims alone do not establish the final expiration date. The controlling records are the front page of the patent, the USPTO Patent Center file history, and any terminal-disclaimer or patent-term-adjustment information. A commercial freedom-to-operate review should use the USPTO term calculation rather than an expiration date inferred from the grant date.

What is the FDA and Orange Book status of odevixibat?

Bylvay is an FDA-approved odevixibat product marketed by Ipsen following its acquisition of Albireo. FDA approved Bylvay for pruritus associated with cholestatic liver disease, including the original pediatric indication for progressive familial intrahepatic cholestasis and later expansion to Alagille syndrome. The product is an oral multiparticulate formulation supplied for pediatric dosing [FDA, 2021; FDA, 2023].

The Orange Book question is narrower than the patent question. A patent may protect a formulation without being listed in the Orange Book. Listing depends on whether the patent claims an approved drug substance, drug product, or method of use within FDA listing rules.

For an ANDA strategy, a sponsor should determine whether US 11,802,115 is listed against the relevant Bylvay reference product and whether the listing identifies a drug-product or method-of-use category. If listed, a Paragraph IV certification could trigger Hatch-Waxman litigation. If not listed, the patent may still support a separate infringement action under 35 U.S.C. § 271(e)(2) only if the statutory listing and certification framework applies to the relevant product and patent.

When does odevixibat lose exclusivity?

Odevixibat has several distinct exclusivity layers:

Exclusivity type	Relevance
FDA regulatory exclusivity	Depends on the approved indication, pediatric status, orphan-drug status, and approval history
Formulation patent exclusivity	Potentially extends through the term of US 11,802,115, subject to term adjustment
Method-of-use patents	May restrict treatment indications even after formulation claims expire
Drug-substance or crystal-form patents	May create separate barriers if valid and unexpired
Pediatric exclusivity	Can add six months to qualifying listed exclusivity or patent periods under the Pediatric Exclusivity provision

There is no biosimilar pathway for odevixibat because it is a small-molecule drug. The relevant competitor pathway is an ANDA for a generic, not a 351(k) biosimilar application.

Which companies are likely to challenge the formulation patent?

The most likely challengers are generic companies with pediatric oral-pellet capabilities, including manufacturers experienced in multiparticulate coating, fluid-bed processing, and ANDA development. The claim set creates a higher technical barrier than a simple active-ingredient patent because the challenger must address both bioequivalence and detailed formulation characteristics.

Potential challenge routes include:

1. Paragraph IV certification against any Orange Book listing.
2. Declaratory-judgment litigation if a listing or product launch creates a justiciable controversy.
3. Non-infringing ANDA design using a different core, drug-loading level, particle-size distribution, or coating process.
4. Invalidity challenges based on prior art involving coated pellets, wet-milled suspensions, pediatric multiparticulates, and uniform low-dose drug deposition.

A Paragraph IV challenge would typically expose the first filer to a potential 180-day generic exclusivity period, subject to statutory forfeiture rules and the patent-listing status.

How strong is the patent estate for Bylvay?

US 11,802,115 is strongest against a generic that copies the commercial product's physical architecture. Its strengths are:

• multiple independent technical variables;
• narrow particle-size and agglomerate-size controls;
• product claims that do not depend solely on manufacturing testimony;
• dependent claims covering commercially plausible drug-load levels;
• crystal-form and pediatric-formulation fallback claims.

Its weaknesses are:

• substantial reliance on relative terms such as "about" and "substantially";
• possible difficulty proving particle-to-particle uniformity;
• measurement sensitivity for d90 agglomerate size;
• potential design-around options using a different core or coating process;
• possible prior art in pharmaceutical pellet coating and wet milling.

The patent is less effective against a tablet, capsule, liquid formulation, or formulation in which odevixibat is uniformly distributed through a matrix rather than deposited in a coating layer.

What generic launch scenarios exist?

Scenario 1: Direct copy of the Bylvay multiparticulate

This presents the highest infringement exposure. The product may satisfy claims 1, 2, 5, 6, 7, 8, 9, 11, and 15, depending on formulation data and manufacturing disclosures.

Scenario 2: Same therapeutic dose, different particle architecture

A generic could use a drug-loaded core, matrix pellets, granules outside the claimed size range, or a capsule containing a non-coated blend. This reduces literal infringement risk but creates separate bioequivalence and FDA product-quality issues.

Scenario 3: Same coated-particle architecture, different drug dispersion

A manufacturer could avoid claims 7 through 9 by using a different suspension-preparation process or a nonaqueous coating system. Claim 1 remains the principal risk if the final particles retain the claimed dimensions, loading, polymer, uniformity, and d90 characteristics.

Scenario 4: Different crystal form or amorphous odevixibat

This may avoid claims 12 through 14 but would not necessarily avoid claim 1. Solid-state differences could also affect stability, dissolution, exposure, and bioequivalence.

What patent litigation or settlement issues matter?

The critical litigation dates are the date of any Paragraph IV notice, the filing of an infringement action within 45 days, the resulting 30-month stay, and any later settlement or launch agreement. A settlement could include a licensed entry date, a no-challenge clause, authorized-generic terms, or manufacturing restrictions.

The patent itself does not establish that litigation, a Paragraph IV notice, or a settlement has occurred. Those events require review of PACER, FDA Orange Book records, ANDA litigation filings, and any public company disclosures.

Key Takeaways

• US 11,802,115 is a formulation patent, not a broad odevixibat composition-of-matter patent.
• Claim 1 requires small coated particles, low drug loading, a film-forming polymer, substantial dose uniformity, and odevixibat agglomerates with d90 below 15 micrometers.
• Claims 2 through 4 protect commercially relevant 0.5% and 1.5% drug-load embodiments.
• Claims 7 through 9 target aqueous spraying and wet milling, while claim 10 targets surfactant-free coatings.
• Claims 12 through 14 add crystalline hydrate and crystal modification 1 limitations.
• A generic using a different dosage form or drug-loaded core has a stronger design-around position.
• Odevixibat is a small molecule, so generic competition proceeds through the ANDA pathway rather than biosimilar regulation.
• The final patent expiration date requires USPTO term data and cannot be derived from the issue date alone.
• Orange Book listing, Paragraph IV activity, litigation, and settlements are separate factual questions from the scope of the granted claims.

FAQs

Does US 11,802,115 cover all Bylvay products?

No. It covers formulations meeting the claimed coated-particle structure and quantitative limitations. It does not automatically cover every odevixibat dosage form or every Bylvay-related method of use.

Can a generic avoid the patent by using larger particles?

Potentially. Particles outside the claimed approximate size ranges may avoid literal infringement, but the effect of "about," measurement variability, and the doctrine of equivalents would require technical and legal analysis.

Does using a surfactant avoid all claims?

No. It may avoid claim 10, which requires a surfactant-free coating. It does not by itself avoid claim 1.

Is crystal modification 1 protected independently?

The cited claims protect crystal modification 1 when incorporated into the claimed multiparticulate formulation. They do not, on their face, claim the crystal form independently of that formulation.

Can a generic use the same odevixibat dose in a tablet?

A tablet may avoid the particle and coating limitations of claim 1. It would still require FDA approval through the applicable abbreviated or supplemental pathway and would face separate patent, bioequivalence, labeling, and formulation evaluations.

References

1. U.S. Patent No. 11,802,115 B2. (2023). Pharmaceutical formulation comprising odevixibat. United States Patent and Trademark Office.

2. U.S. Food and Drug Administration. (2021). FDA approves first drug to treat itching from a rare liver disease in pediatric patients. FDA.

3. U.S. Food and Drug Administration. (2023). Bylvay prescribing information. FDA.

4. U.S. Food and Drug Administration. (2023). Approved drug products with therapeutic equivalence evaluations. FDA.

5. U.S. Congress. (1984). Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585.

6. U.S. Patent and Trademark Office. (2024). Patent term adjustment and patent term calculation resources. USPTO.

Drugs Protected by US Patent 11,802,115

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-001	Jul 20, 2021		RX	Yes	No			Y
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-003	Jul 20, 2021		RX	Yes	Yes			Y
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-002	Jul 20, 2021		RX	Yes	No			Y
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-004	Jul 20, 2021		RX	Yes	Yes			Y

International Family Members for US Patent 11,802,115

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2019290337
Australia	2019290338
Brazil	112020024461
Brazil	112020024479