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-seven patent family members in twenty-five 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. 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:	57
US Patents:	5
Applicants:	1
NDAs:	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

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
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			Y
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
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			Y

International Patents for RELYVRIO

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

Country	Patent Number	Title	Estimated Expiration
South Korea	102223250
European Patent Office	2978419	COMPOSITIONS POUR AMÉLIORER LA VIABILITÉ DE CELLULES ET PROCÉDÉS POUR LEUR UTILISATION (COMPOSITIONS FOR IMPROVING CELL VIABILITY AND METHODS OF USE THEREOF)
Japan	2019123721	細胞生存率を向上させるための組成物およびその使用方法 (COMPOSITIONS FOR IMPROVING CELL VIABILITY AND METHODS OF USE THEREOF)
Australia	2022221410
China	118949048	胆汁酸和苯丁酸化合物的组合物 (Compositions of bile acid and phenylbutyric acid compounds)
Japan	2023085274
Slovenia	2978419

Supplementary Protection Certificates for RELYVRIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2563920	CA 2019 00001	Denmark		PRODUCT NAME: A COMPOUND COMPRISING A MODIFIED OLIGONUCLEOTIDE HAVING A NUCLEOBASE SEQUENCE CONSISTING OF 20 LINKED NUCLEOSIDES ACCORDING TO EP B1 2563920 CLAIM 1 (SEQ ID NO: 80), ...SPECIFICALLY INOTERSEN; AND ITS DERIVATIVES, INCLUDING SODIUM SALTS ...; REG. NO/DATE: EU/1/18/1296 20180710
2380576	2020/043	Ireland		PRODUCT NAME: DEOXYCHOLIC ACID SODIUM SALT; NAT REGISTRATION NO/DATE: PA2103/003/001 20170602; FIRST REGISTRATION NO/DATE: SE/H/1547/001/DC 20160729
3141251	301099	Netherlands		PRODUCT NAME: A MEDICINAL PRODUCT CONSISTING OF A COMBINATION OF A FIRST DOSE PHARMACEUTICAL COMPOSITION AND A SECOND DOSE PHARMACEUTICAL COMPOSITION, THE FIRST DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, SODIUM SULPHATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE AND THE SECOND DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, ASCORBIC ACID, SODIUM ASCORBATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE; NATIONAL REGISTRATION NO/DATE: RVG 120195 20171114; FIRST REGISTRATION: IS IS/1/17/083/01 20171016
3347352	2290051-8	Sweden		PRODUCT NAME: LENACAPAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR LENACAPAVIR SODIUM; REG. NO/DATE: EU/1/22/1671 20220819
2465580	SPC/GB21/030	United Kingdom		PRODUCT NAME: CABOTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING CABOTEGRAVIR SODIUM.; REGISTERED: UK EU/1/20/1481 (NI) 20201221; UK PLGB 35728/0055-57 20201221
0290047	97C0108	Belgium		PRODUCT NAME: MANGAFODIPIR TRISODIUM (ANHYDROUS) CORRESP. MANGAFODIPIR; REGISTRATION NO/DATE: EU/1/97/040/001 19970522
0957929	SPC/GB06/021	United Kingdom		PRODUCT NAME: PEGAPTANIB, PREFERABLY IN THE FORM OF ITS SODIUM SALT; REGISTERED: UK EU/1/05/325/001 20060201

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.