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RELYVRIO Drug Patent Profile

When do Relyvrio patents expire, and what generic alternatives are available?

Relyvrio is a drug marketed by Amylyx and is included in one NDA. There are five patents protecting this drug.

This drug has fifty-four patent family members in twenty-four countries.

The generic ingredient in RELYVRIO is sodium phenylbutyrate; taurursodiol. There are one thousand four hundred and seventy-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sodium phenylbutyrate; taurursodiol profile page.

DrugPatentWatch^® Generic Entry Outlook for Relyvrio

Relyvrio will be eligible for patent challenges on September 29, 2026. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 29, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for RELYVRIO

International Patents:	54
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
Drug Prices:	Drug price information for RELYVRIO
What excipients (inactive ingredients) are in RELYVRIO?	RELYVRIO excipients list
DailyMed Link:	RELYVRIO at DailyMed

See drug prices for RELYVRIO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for RELYVRIO

Constraining patent/regulatory exclusivity:

TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS

NDA:

216660

Dosage:

FOR SUSPENSION;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for RELYVRIO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Amylyx Pharmaceuticals Inc.	Phase 3

See all RELYVRIO clinical trials

Pharmacology for RELYVRIO

Drug Class	Nitrogen Binding Agent
Mechanism of Action	Ammonium Ion Binding Activity

US Patents and Regulatory Information for RELYVRIO

RELYVRIO is protected by five US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amylyx	RELYVRIO	sodium phenylbutyrate; taurursodiol	FOR SUSPENSION;ORAL	216660-001	Sep 29, 2022		DISCN	Yes	No	10,857,162
Amylyx	RELYVRIO	sodium phenylbutyrate; taurursodiol	FOR SUSPENSION;ORAL	216660-001	Sep 29, 2022		DISCN	Yes	No
Amylyx	RELYVRIO	sodium phenylbutyrate; taurursodiol	FOR SUSPENSION;ORAL	216660-001	Sep 29, 2022		DISCN	Yes	No	11,071,742		Y
Amylyx	RELYVRIO	sodium phenylbutyrate; taurursodiol	FOR SUSPENSION;ORAL	216660-001	Sep 29, 2022		DISCN	Yes	No	10,251,896
Amylyx	RELYVRIO	sodium phenylbutyrate; taurursodiol	FOR SUSPENSION;ORAL	216660-001	Sep 29, 2022		DISCN	Yes	No	9,872,865

International Patents for RELYVRIO

See the table below for patents covering RELYVRIO around the world.

Country	Patent Number	Title	Estimated Expiration
China	110787169	用于提高细胞存活力的组合物和使用该组合物的方法 (Compositions for improving cell viability and methods of use thereof)
European Patent Office	4076426
Japan	7080944
Brazil	112022011948
China	114929211

Supplementary Protection Certificates for RELYVRIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0290047	SPC/GB97/078	United Kingdom		PRODUCT NAME: MANGAFODIPIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR MANGAFODIPIR TRISODIUM; REGISTERED: UK EU/1/97/040/001 19970522; UK EU/1/97/040/002 19970522
2203431	15C0013	France		PRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119
0480717	98C0022	France		PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
1499331	SPC/GB13/034	United Kingdom		PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313
0579826	SPC/GB02/042	United Kingdom		PRODUCT NAME: ERTAPENEM ((1R,5S,6S,8R,2'S,4'S)-2-(2-(3-CARBOXYPHENYLCARBAMOYL)PYRROLIDIN-4-YLTHIO)-6-(1-HYDROXYETHYL)-1-METHYLCARBAPENEM-3-CARBOXYLIC ACID), A PHARMACEUTICALLY ACCEPTABLE SALT OR IN VIVO HYDROLYSABLE ESTER THEREOF, ESPECIALLY AS THE MONOSODIUM SALT ERTA; REGISTERED: UK EU/1/02/216/001 20020422

RELYVRIO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of RELYVRIO

Introduction to RELYVRIO

RELYVRIO, developed by Amylyx Pharmaceuticals, is a drug approved by the FDA in September 2022 for the treatment of Amyotrophic Lateral Sclerosis (ALS). The drug's journey has been marked by significant milestones, both positive and negative, influencing its market dynamics and financial trajectory.

Initial Market Success

In its first full quarter on the U.S. market, RELYVRIO generated nearly $22 million in sales, exceeding analyst forecasts that had predicted around $4 million. This strong start impressed Wall Street and indicated a promising future for the drug[1].

Revenue Growth and Projections

For the full year 2023, Amylyx reported net product revenue of $380.8 million, with $108.4 million of that coming in the fourth quarter. This represented a substantial increase from the $22.2 million in net product revenue for the same period in 2022. The revenue growth was primarily driven by the sales of RELYVRIO in the U.S. following its regulatory approval[2].

Analysts had high hopes for the drug, with some estimating it could bring in $1 billion or more per year at its peak. However, these projections were based on the drug's continued success and market penetration[3].

Market Penetration and Competition

Despite the initial success, RELYVRIO faced challenges in penetrating the ALS market. An analysis by Earnest Analytics found that RELYVRIO significantly underperformed compared to its competitor, Radicava ORS, in terms of market penetration and therapy persistence. Only 22% of patients using at least two oral drugs for ALS were on RELYVRIO, compared to 82% on Radicava ORS. Additionally, fewer patients remained active on RELYVRIO, with a persistence rate of 46% compared to 80% for Radicava ORS[4].

Discontinuation Rates

One of the key factors affecting RELYVRIO's growth was its high discontinuation rate. The drug's persistence was significantly inferior to that of Radicava ORS and riluzole. This issue was highlighted in Amylyx's third-quarter earnings report, which showed a significant miss on net product revenue and raised concerns about the drug's long-term viability[4].

Clinical Trial Setbacks

A crucial setback for RELYVRIO came with the failure of its Phase 3 PHOENIX trial. The results of this trial led Amylyx to announce its intention to remove RELYVRIO from the market. This decision was in line with the company's earlier commitment to pull the drug if confirmatory testing failed[3][5].

Financial Impact

The failure of the PHOENIX trial and the subsequent decision to discontinue RELYVRIO had a profound financial impact on Amylyx. The company's share price plummeted by more than 75% in pre-market trading, wiping nearly $1 billion from its market value. Despite having $371 million in cash at the end of 2023, the company's future became uncertain, with analysts questioning how long it could survive without its flagship product[3].

Quarterly Financial Performance

In the first quarter of 2024, Amylyx reported net product revenue of $88.6 million, primarily from the sales of RELYVRIO and its counterpart ALBRIOZA in Canada. However, this revenue was overshadowed by the announcement of the drug's discontinuation. The company's operating expenses, including research and development, selling, general, and administrative costs, continued to be significant, reflecting the ongoing efforts in other therapeutic areas despite the setback with RELYVRIO[5].

Future Outlook

Amylyx has indicated that it will continue testing RELYVRIO for other rare conditions, such as Wolfram syndrome and progressive supranuclear palsy. However, the immediate future of the company is heavily dependent on the success of these alternative uses and other pipeline products. The discontinuation of RELYVRIO for ALS treatment leaves ALS patients with limited therapeutic options, highlighting the ongoing need for effective treatments in this area[3].

Key Takeaways

• Initial Success: RELYVRIO exceeded revenue expectations in its first full quarter on the market.
• Revenue Growth: The drug generated significant revenue in 2023, but growth decelerated due to high discontinuation rates.
• Market Penetration: RELYVRIO underperformed compared to competitors like Radicava ORS in terms of market penetration and therapy persistence.
• Clinical Trial Failure: The failure of the Phase 3 PHOENIX trial led to the decision to discontinue RELYVRIO.
• Financial Impact: The discontinuation resulted in a significant drop in Amylyx's share price and market value.
• Future Outlook: Amylyx will continue testing RELYVRIO for other conditions and rely on other pipeline products.

FAQs

Q: What was the initial market performance of RELYVRIO? A: RELYVRIO generated nearly $22 million in sales in its first full quarter on the U.S. market, exceeding analyst forecasts.

Q: How did RELYVRIO perform compared to its competitors? A: RELYVRIO underperformed compared to Radicava ORS in terms of market penetration and therapy persistence, with fewer patients remaining active on the drug.

Q: What led to the decision to discontinue RELYVRIO? A: The failure of the Phase 3 PHOENIX trial led Amylyx to announce its intention to remove RELYVRIO from the market.

Q: What is the current financial status of Amylyx Pharmaceuticals? A: Despite having $371 million in cash, Amylyx's future is uncertain due to the discontinuation of its flagship product and the significant drop in its market value.

Q: What are Amylyx's plans for RELYVRIO moving forward? A: Amylyx will continue testing RELYVRIO for other rare conditions such as Wolfram syndrome and progressive supranuclear palsy.

Sources

1. BioPharma Dive: Amylyx's ALS drug sales impress Wall Street.
2. Business Wire: Amylyx Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results.
3. BioPharma Dive: Amylyx ALS drug fails crucial study, putting company's future in doubt.
4. Earnest Analytics: Discontinuations damper Relyvrio's launch.
5. Business Wire: Amylyx Pharmaceuticals Reports First Quarter 2024 Financial Results.