United States Patent 10,857,162: Scope, Claims, Expiration, and ALS Patent Landscape

U.S. Patent No. 10,857,162 protects methods of treating amyotrophic lateral sclerosis by administering tauroursodeoxycholic acid, also called taurursodiol or TUDCA, with sodium phenylbutyrate. The core protection is a combination-treatment method using specified weight-based dose ranges. The patent does not claim TUDCA, sodium phenylbutyrate, or a fixed-dose product as chemical compositions.

The patent is associated with Amylyx Pharmaceuticals, Inc., developer of AMX0035, later marketed as Relyvrio in the United States. The patent issued on December 8, 2020, and has a nominal patent-term endpoint in 2037 based on its 2017 priority chain, subject to any patent-term adjustment recorded by the USPTO.[1]

What does U.S. Patent 10,857,162 protect?

The patent’s independent claim covers a method comprising:

Treating at least one ALS symptom in a human subject;
Administering TUDCA at approximately 10 mg/kg to 30 mg/kg; and
Administering sodium phenylbutyrate at approximately 30 mg/kg to 100 mg/kg.

The claim requires the two active ingredients to be administered to the same human subject for ALS-related treatment. It does not require that the ingredients be present in the same container, tablet, sachet, or dosage form.

Claim element	Scope
Disease	Amyotrophic lateral sclerosis or an ALS-associated condition
Patient	Human subject, including a suspected or diagnosed patient under dependent claims
TUDCA dose	About 10 mg/kg to about 30 mg/kg
Sodium phenylbutyrate dose	About 30 mg/kg to about 100 mg/kg
Therapeutic objective	Treatment of at least one ALS symptom
Route	Oral administration under claim 16
Administration frequency	Once daily or twice daily under dependent claims
Dosage form	Separate or single dosage form
Treatment duration	Less than three months, less than six months, or at least six months

The legal center of gravity is the combination of the two compounds in ALS at overlapping dose ranges. Neither compound alone falls within claim 1.

How should the 22 claims be grouped?

The claims fall into five functional groups.

Core combination-treatment claim

Claim 1 is the broadest claim. It covers the coadministration of TUDCA and sodium phenylbutyrate within the stated weight-based dose ranges.

The claim does not expressly require:

A specific pharmaceutical formulation;
A particular salt or polymorph of either compound;
A specific treatment stage;
A biomarker;
A clinical severity threshold;
A particular ALS subtype;
A fixed ratio between the two compounds; or
A demonstrated clinical response.

The phrase “at least one symptom” broadens the treatment objective. A patent-infringement analysis would likely focus on whether the accused regimen is directed to ALS and satisfies the dose limitations, rather than whether the product label uses the same symptom terminology.

Frequency limitations

Claims 2 through 4 and 20 through 22 address once-daily and twice-daily administration.

Claim 2: TUDCA once daily.
Claim 3: sodium phenylbutyrate once daily.
Claim 4: both once daily.
Claim 20: TUDCA twice daily.
Claim 21: sodium phenylbutyrate twice daily.
Claim 22: both twice daily.

These claims narrow claim 1 but do not eliminate the underlying dose limitations. A regimen can potentially fall within claim 1 without satisfying a frequency-dependent claim.

Dosage-form limitations

Claims 5 and 6 distinguish between administration in:

Separate dosage forms; and
A single dosage form.

This structure is important for AMX0035/Relyvrio because the commercial product used a co-packaged formulation containing sodium phenylbutyrate and taurursodiol. Claim 6 is directed to a single dosage form, while claim 5 preserves coverage for regimens using separate products.

The claims do not require a particular excipient, granulation process, particle size, release profile, capsule technology, or powder-to-water reconstitution method. Those characteristics would generally be addressed by separate formulation or composition claims.

Daily-dose limitations

Claims 7 through 12 specify absolute daily quantities:

Claims	TUDCA	Sodium phenylbutyrate
7, 10	0.5-5 g/day	0.5-10 g/day
8, 11	1.5-2.5 g/day	4.5-8.5 g/day
9, 12	1 g twice daily	3 g twice daily

Claims 9 and 12 correspond to the commonly described AMX0035 daily regimen of 2 g taurursodiol and 6 g sodium phenylbutyrate. Claim 19 combines these amounts with oral administration and a single dosage form.

Duration, route, and patient-status limitations

Claims 13 through 18 cover:

Treatment for less than six months;
Treatment for less than three months;
Treatment for at least six months;
Oral administration;
A subject suspected of having ALS; and
A subject diagnosed with an ALS-associated condition.

These claims create alternative temporal and patient-status positions. Claims 14 and 15 are not mutually exclusive in every factual setting because a course lasting at least six months cannot also last less than three months, but claim drafting often includes separate duration positions to preserve distinct fallback scope.

What is the scope of claim 19?

Claim 19 is the most commercially specific claim in the issued set. It requires:

TUDCA at 1 gram twice daily;
Sodium phenylbutyrate at 3 grams twice daily;
A single dosage form; and
Oral administration.

This claim maps closely to the commercial AMX0035/Relyvrio treatment concept. It provides a narrower infringement pathway than claim 1 because an accused product or regimen must satisfy the single-dosage-form limitation and the specified dosing schedule.

A key claim-construction issue is whether the two active ingredients must be physically combined in one unit or may be supplied as a single product package containing multiple components. The answer would depend on the specification, prosecution history, and the ordinary meaning of “single dosage form.” A co-packaged product with separate sachets may be treated differently from a powder blend or tablet containing both ingredients.

What patents protect AMX0035 and Relyvrio?

U.S. Patent 10,857,162 is part of a broader AMX0035 patent estate. The estate has included method-of-use and formulation-related filings directed to the combination of taurursodiol and sodium phenylbutyrate.

Patent or patent category	Subject matter	Commercial relevance
U.S. 10,857,162	ALS treatment using TUDCA and sodium phenylbutyrate	Core combination method
Related continuation or divisional patents	Alternative ALS dosing, administration, or treatment limitations	May preserve follow-on method coverage
Formulation patents	Single dosage forms, powder systems, excipients, and product configuration	Relevant to an AMX0035-like product
Method-of-use patents	ALS treatment, symptom reduction, patient populations, and dosing	Relevant to labeled or induced use
International family members	Foreign equivalents and national-phase rights	Geographic enforcement and licensing

Patent-family analysis should distinguish between a patent’s grant date and its enforceable claims. Continuation patents can issue after the original patent and may materially alter the estate even when they share the same earliest priority date.

The product-specific patent position should be confirmed against the current FDA Orange Book and the USPTO Patent Center because listing status, expiration, pediatric extensions, patent-term adjustment, and later continuation grants can change the practical exclusivity picture.[2]

When does U.S. Patent 10,857,162 expire?

The patent traces to a 2017 priority chain. Its nominal 20-year term is therefore expected to end in 2037, subject to patent-term adjustment and any applicable statutory extension.

Event	Date or period
Earliest priority chain	2017
Patent issued	December 8, 2020
Nominal term endpoint	2037
Patent-term adjustment	Must be confirmed in the USPTO patent record
Patent-term extension under Hatch-Waxman	No extension should be assumed without an FDA determination

A 2037 endpoint does not mean every commercial product remains blocked until that date. Enforceability depends on the precise asserted claim, claim construction, validity, ownership, Orange Book listing, and the accused product’s label and conduct.

What is the Orange Book status of the patent?

Relyvrio was approved by the FDA on September 29, 2022, under NDA 217660 for the treatment of ALS in adults.[3] Amylyx later announced that it would withdraw Relyvrio from the market after the PHOENIX confirmatory study failed to meet its primary endpoint. The company announced the withdrawal in 2024, and commercial availability ended during the subsequent withdrawal process.[4]

The Orange Book consequences are material:

A patent may remain legally valid after the branded product is withdrawn.
An Orange Book listing is tied to an approved NDA and listed patent requirements.
Withdrawal of the NDA can affect the practical operation of an ANDA Paragraph IV pathway.
An unmarketed or withdrawn reference product creates regulatory complexity for generic applicants.
Patent enforcement and regulatory exclusivity are separate issues.

The FDA’s Orange Book should be used to confirm whether U.S. 10,857,162 was listed for the NDA, whether it remains listed, and whether related patents were added before withdrawal.[2]

What FDA exclusivity did Relyvrio receive?

Relyvrio received FDA approval through the NDA pathway. The product’s commercial protection was not based solely on U.S. Patent 10,857,162.

Relevant regulatory concepts include:

Protection	Likely relevance
New chemical entity exclusivity	Unlikely to be the main basis because both active ingredients were previously known
Orphan-drug exclusivity	Potentially relevant because ALS has orphan-drug status, subject to the approved indication and exclusivity record
Patent protection	Method-of-use and formulation protection
Pediatric exclusivity	Requires a specific FDA award and should not be presumed
NDA exclusivity	Depends on FDA’s regulatory classification and approval record

Relyvrio’s product consists of previously known active substances. That fact reduces the likelihood that the commercial moat depended on classic new-chemical-entity exclusivity. The principal barriers were the approved combination, clinical evidence, regulatory approval, and patent claims directed to the combination’s use and formulation.

How strong is the patent estate for TUDCA and sodium phenylbutyrate?

The estate is strongest against a product that reproduces the approved combination and dosing regimen for ALS. It is weaker against products or regimens that materially change one of the claim elements.

Factors supporting enforcement strength

The claims require a defined two-drug combination.
The commercial dosing regimen is close to the claimed amounts.
Oral, single-dosage-form claims target the marketed product configuration.
Treatment of ALS is a clear indication rather than a broad disease-class claim.
Dependent claims provide multiple dosing and duration positions.

Factors that create vulnerability

TUDCA and sodium phenylbutyrate were known compounds.
Prior art may disclose either compound for neurodegenerative, metabolic, or cellular-stress applications.
Combination-treatment claims can face obviousness challenges based on motivation to combine known agents.
Weight-based ranges may be vulnerable if prior clinical or experimental references disclose overlapping doses.
“About” may create claim-construction disputes at the boundaries of the dose ranges.
A generic or competitor could attempt to design around the single-dosage-form claims.
Method claims require proof of use, intent, or induced infringement tied to ALS.

The principal invalidity issues would likely include anticipation, obviousness, written description, enablement, and indefiniteness. The commercial strength of the patent depends heavily on the prosecution record and the prior art considered by the examiner, not on the issued claim text alone.

What Paragraph IV challenges or patent litigation affect the patent?

No major publicly established Paragraph IV challenge or final patent judgment directed specifically to U.S. Patent 10,857,162 should be assumed from the patent number alone.

A generic applicant seeking approval for an equivalent product would need to evaluate:

Whether an approved reference listed drug remains available for an ANDA pathway;
Whether the patent remains listed in the Orange Book;
Whether the applicant can file a Paragraph IV certification;
Whether a 30-month stay could arise from a timely infringement action;
Whether the NDA withdrawal changes the regulatory route; and
Whether the applicant must pursue a different 505(b)(2) or other pathway.

A Paragraph IV certification against a method-of-use patent is especially dependent on the proposed labeling and the scope of any carve-out. If the proposed label excludes ALS use, the generic applicant may reduce inducement risk. If the label retains ALS language or the product is actively promoted for ALS, the patent holder could assert induced infringement.

What generic launch risks exist?

The main generic-launch scenarios are as follows.

Scenario	Patent and regulatory risk
Same TUDCA/sodium phenylbutyrate product for ALS	High method-of-use and formulation risk
Separate TUDCA and sodium phenylbutyrate products	Claim 5 may still apply; single-form claims may not
Different doses outside the claimed ranges	Possible design-around, but “about” and overlapping dependent claims matter
Non-ALS indication	Lower direct claim risk, subject to promotion and actual use
Label carved to exclude ALS	May reduce induced-infringement exposure
Product launched after patent expiry	Patent risk declines, but regulatory and manufacturing issues remain
505(b)(2) product with new formulation	May face listed-patent certifications and clinical requirements
Product after NDA withdrawal	Regulatory pathway may be more complex than a standard ANDA

The patent does not prevent all sales of TUDCA or sodium phenylbutyrate. It targets use of the combination for ALS within specified dose and administration parameters.

What manufacturing and formulation barriers remain?

The patent at issue does not itself establish a broad manufacturing monopoly. Manufacturing risk may arise from separate patents covering:

Co-formulation of the two active ingredients;
Powder or sachet dosage forms;
Stability in the presence of bile acids and phenylbutyrate;
Taste masking;
Reconstitution;
Moisture control;
Packaging;
Manufacturing processes; and
Product-specific specifications.

A competitor could potentially avoid claim 19 by supplying the two compounds as separate dosage forms. That strategy would still require analysis under claim 5 and any related composition or formulation patents.

The active ingredients also have practical manufacturing issues. Sodium phenylbutyrate has a strong odor and taste, while TUDCA presents formulation and palatability considerations. These barriers are commercial and technical rather than necessarily patent-based.

How does this patent compare with competing ALS drugs?

U.S. Patent 10,857,162 protects a combination regimen rather than a single molecular entity. Its competitive position differs from the estates for riluzole and edaravone.

Product	Active ingredient	Main protection profile	Competitive relationship
Relyvrio/AMX0035	TUDCA plus sodium phenylbutyrate	Combination method and formulation patents	Direct subject of U.S. 10,857,162
Riluzole/Tiglutik/Exservan	Riluzole	Composition, formulation, and method patents	Established ALS alternative
Radicava/Radicava ORS	Edaravone	Composition, formulation, and method patents	Competing ALS therapy
Investigational ALS therapies	Various	Trial-stage patents and exclusivity	Potential future substitutes

Patent overlap with riluzole or edaravone is limited because U.S. 10,857,162 requires TUDCA and sodium phenylbutyrate. Competitive substitution, however, can reduce the economic value of the patent estate even where no legal overlap exists.

What is the commercial exposure?

Relyvrio generated substantial commercial revenue before its withdrawal. Amylyx reported more than $300 million in 2023 net product revenue, according to company disclosures.[5] The exposure associated with U.S. Patent 10,857,162 was therefore concentrated in the commercial period before withdrawal rather than in a conventional 2037 loss-of-exclusivity event.

The patent’s residual value may include:

Licensing to companies developing mitochondrial or neurodegenerative therapies;
Use in combination-treatment research;
Foreign patent enforcement;
Settlement leverage in any future abbreviated application;
Protection for reformulated or regionally approved products; and
Defensive value against competing combination products.

Withdrawal of the U.S. product materially reduces near-term U.S. revenue exposure. It does not automatically extinguish the patent or eliminate potential foreign rights.

Key Takeaways

U.S. Patent 10,857,162 is a method-of-treatment patent for ALS.
Claim 1 requires both TUDCA and sodium phenylbutyrate in specified weight-based ranges.
The patent does not broadly claim either active ingredient alone.
Claims 5, 6, and 19 address separate versus single dosage forms and are particularly relevant to AMX0035/Relyvrio.
Claims 7 through 12 cover absolute daily doses, including 1 g TUDCA twice daily and 3 g sodium phenylbutyrate twice daily.
The patent issued on December 8, 2020, with a nominal term extending into 2037 based on the 2017 priority chain.
FDA approval of Relyvrio occurred on September 29, 2022, and the product was later withdrawn after the PHOENIX study failed its primary endpoint.
Generic risk depends on the proposed label, product configuration, dose, Orange Book status, and availability of an ANDA pathway.
The main validity risks are obviousness, anticipation, written description, enablement, and construction of “about” dose ranges.
The patent estate is strongest against an ALS product reproducing the commercial two-drug regimen and weakest against non-ALS uses, materially different doses, and separate-product strategies.

FAQs

Does U.S. Patent 10,857,162 cover taurursodiol alone?

No. The independent claim requires taurursodiol or TUDCA to be administered with sodium phenylbutyrate for ALS treatment.

Does the patent cover a TUDCA product used outside ALS?

Not under claim 1 as written. The claim requires treatment of at least one ALS symptom. Separate patents or induced-use theories could produce a different result.

Can a company avoid claim 19 by selling two separate products?

Potentially, but claim 5 separately covers administration of TUDCA and sodium phenylbutyrate as separate dosage forms. The entire claim set and related patents must be reviewed.

Is a patent challenge required after Relyvrio’s withdrawal?

Not necessarily. The appropriate regulatory certification depends on the status of the NDA, Orange Book listings, the proposed product, and the pathway selected by the applicant.

Does the patent block all generic sodium phenylbutyrate products?

No. It targets the specified combination method for ALS. Sodium phenylbutyrate products used for other indications are outside the claim unless another patent or infringement theory applies.

References

United States Patent and Trademark Office. (2020). U.S. Patent No. 10,857,162: Methods of treating amyotrophic lateral sclerosis.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
U.S. Food and Drug Administration. (2022, September 29). FDA approves oral medication for patients with amyotrophic lateral sclerosis.
Amylyx Pharmaceuticals, Inc. (2024, April 4). Amylyx Pharmaceuticals announces withdrawal of AMX0035/Relyvrio in the U.S. and Canada.
Amylyx Pharmaceuticals, Inc. (2024). Annual report on Form 10-K for the year ended December 31, 2023.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Amylyx	RELYVRIO	sodium phenylbutyrate; taurursodiol	FOR SUSPENSION;ORAL	216660-001	Sep 29, 2022		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial				TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014242123	⤷ Start Trial
Australia	2019200658	⤷ Start Trial
Australia	2021201770	⤷ Start Trial
Australia	2022221410	⤷ Start Trial
Australia	2025201758	⤷ Start Trial
Canada	2908683	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 10,857,162

Which drugs does patent 10,857,162 protect, and when does it expire?

Summary for Patent: 10,857,162