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LIVMARLI Drug Patent Profile

Which patents cover Livmarli, and what generic alternatives are available?

Livmarli is a drug marketed by Mirum and is included in one NDA. There are seven patents protecting this drug.

This drug has one hundred and fourteen patent family members in twenty-two countries.

The generic ingredient in LIVMARLI is maralixibat chloride. One supplier is listed for this compound. Additional details are available on the maralixibat chloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Livmarli

Livmarli will be eligible for patent challenges on September 29, 2025. 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 July 24, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for LIVMARLI

International Patents:	114
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	16
Patent Applications:	52
Drug Prices:	Drug price information for LIVMARLI
What excipients (inactive ingredients) are in LIVMARLI?	LIVMARLI excipients list
DailyMed Link:	LIVMARLI at DailyMed

See drug prices for LIVMARLI

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

Constraining patent/regulatory exclusivity:

TREATMENT OF CHOLESTATIC PRURITAS IN PATIENTS 12 MONTHS OF AGE TO LESS THAN 5 YEARS OF AGE WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)

NDA:

214662

Dosage:

SOLUTION;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.

Pharmacology for LIVMARLI

Drug Class	Ileal Bile Acid Transporter Inhibitor
Mechanism of Action	Ileal Bile Acid Transporter Inhibitors Organic Anion Transporting Polypeptide 2B1 Inhibitors

US Patents and Regulatory Information for LIVMARLI

LIVMARLI is protected by fourteen US patents and ten FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF CHOLESTATIC PRURITAS IN PATIENTS 12 MONTHS OF AGE TO LESS THAN 5 YEARS OF AGE WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC).

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
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-001	Sep 29, 2021		RX	Yes	Yes	10,512,657
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-001	Sep 29, 2021		RX	Yes	Yes
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-002	Jul 24, 2024		RX	Yes	Yes
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-001	Sep 29, 2021		RX	Yes	Yes	11,260,053
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-001	Sep 29, 2021		RX	Yes	Yes	11,376,251
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-002	Jul 24, 2024		RX	Yes	Yes	10,512,657
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-002	Jul 24, 2024		RX	Yes	Yes	11,229,661

EU/EMA Drug Approvals for LIVMARLI

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mirum Pharmaceuticals International B.V.	Livmarli	Maralixibat chloride	EMEA/H/C/005857 Livmarli is indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 2 months of age and older.	Authorised	no	no	yes	2022-12-09

International Patents for LIVMARLI

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20210137466	담즙정체성 간 질환을 갖는 소아 대상체에서 성장을 증가시키는 방법
Norway	2023023
South Korea	102051031
Hong Kong	1248117	用於治療小兒膽汁淤積性肝病的膽汁酸再循環抑制劑 (BILE ACID RECYCLING INHIBITORS FOR TREATMENT OF PEDIATRIC CHOLESTATIC LIVER DISEASES)
Canada	3129827	REPONSE DEPENDANT DU GENOTYPE ET DE LA DOSE A UN ASBTI CHEZ DES PATIENTS AYANT UNE DEFICIENCE DE POMPE D'EXPORTATION DE SEL BILIAIRE (GENOTYPE AND DOSE-DEPENDENT RESPONSE TO AN ASBTI IN PATIENTS WITH BILE SALT EXPORT PUMP DEFICIENCY)
Canada	3129735	PROCEDES POUR AUGMENTER LA CROISSANCE CHEZ DES SUJETS PEDIATRIQUES AYANT UNE MALADIE HEPATIQUE CHOLESTATIQUE (METHODS FOR INCREASING GROWTH IN PEDIATRIC SUBJECTS HAVING CHOLESTATIC LIVER DISEASE)
European Patent Office	2995317	INHIBITEURS DE RECYCLAGE D'ACIDE BILIAIRE ET SATIOGÈNES POUR LE TRAITEMENT DU DIABÈTE, DE L'OBÉSITÉ ET DES CONDITIONS GASTRO-INTESTINALES INFLAMMATOIRES (BILE ACID RECYCLING INHIBITORS AND SATIOGENS FOR TREATMENT OF DIABETES, OBESITY, AND INFLAMMATORY GASTROINTESTINAL CONDITIONS)

Supplementary Protection Certificates for LIVMARLI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2771003	CA 2023 00017	Denmark		PRODUCT NAME: MARALIXIBAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER MARALIXIBATCHLORID; REG. NO/DATE: EU/1/22/1704 20221212
2771003	2390017-8	Sweden		PRODUCT NAME: MARALIXIBAT, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR MARALIXIBAT CHLORIDE; REG. NO/DATE: EU/1/22/1704 20221212
2771003	301234	Netherlands		PRODUCT NAME: MARALIXIBAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER MARALIXIBATCHLORIDE; REGISTRATION NO/DATE: EU/1/22/1704 20221212
2771003	CR 2023 00017	Denmark		PRODUCT NAME: MARALIXIBAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER MARALIXIBATCHLORID; REG. NO/DATE: EU/1/22/1704 20221212
2771003	23C1022	France		PRODUCT NAME: MARALIXIBAT, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE MARALIXIBAT, EN PARTICULIER LE CHLORURE DE MARALIXIBAT; REGISTRATION NO/DATE: EU/1/22/1704 20221212
2771003	122023000029	Germany		PRODUCT NAME: MARALIXIBAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE MARALIXIBATCHLORID; REGISTRATION NO/DATE: EU/1/22/1704 20221209
2771003	21/2023	Austria		PRODUCT NAME: MARALIXIBAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE MARALIXIBATCHLORID; REGISTRATION NO/DATE: EU/1/22/1704 (MITTEILUNG) 20221212

LIVMARLI Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for LIVMARLI

Introduction

LIVMARLI, developed by Mirum Pharmaceuticals, is a groundbreaking medication approved for the treatment of cholestatic pruritus in patients with rare liver diseases such as Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC). Here, we delve into the market dynamics and financial trajectory of LIVMARLI, highlighting its significant growth, regulatory milestones, and future prospects.

Market Expansion and Regulatory Approvals

LIVMARLI has experienced substantial market expansion driven by recent regulatory approvals. In 2023, the FDA approved LIVMARLI for the treatment of cholestatic pruritus in PFIC patients aged 12 months and older, and the European Commission authorized its use for patients three months and older[4].

Global Reach

The international business of LIVMARLI has grown significantly, with reimbursed access now available in 18 countries. This global expansion has been a key driver of revenue growth, contributing to the drug's increasing market presence[1].

Financial Performance

Revenue Growth

LIVMARLI has demonstrated remarkable revenue growth. In 2023, global net product sales of LIVMARLI totaled $141.8 million, representing an 89% increase over 2022 net product sales. This trend continued into 2024, with Q2 net sales of LIVMARLI reaching $47.2 million, a 45% increase from Q2 2023[1][2].

Full-Year Projections

Mirum Pharmaceuticals is guiding for full-year 2024 global net product sales of $310 million to $320 million, with a recent upward revision to $330 million to $335 million based on strong Q3 performance[2][5].

Key Drivers of Revenue Growth

Label Expansion

The recent FDA approval expanding LIVMARLI's label to include patients aged 12 months and older for PFIC has significantly increased the potential patient population. This expansion, combined with European approvals, has enhanced LIVMARLI's competitive position in the PFIC market[3][4].

Payer Reimbursement

Strong payer reimbursement support has been crucial for LIVMARLI's success. In the U.S., eligible patients with commercial insurance often pay as little as $10 out of pocket per prescription, with about 94% of patients approved by their insurance and 98% paying $10 or less per fill[4].

Pipeline and Future Prospects

Ongoing Studies and Approvals

Mirum Pharmaceuticals is conducting several studies and awaiting key regulatory milestones. The Phase 3 EXPAND study for LIVMARLI in additional cholestatic pruritus settings is underway, and the company is expecting interim analyses for volixibat in primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC) in the first half of 2024[1][2].

New Drug Applications

A New Drug Application (NDA) for CHENODAL in cerebrotendinous xanthomatosis (CTX) has been submitted and is under priority review with a PDUFA date of December 28, 2024. This potential approval could further diversify Mirum's product portfolio[2][5].

Financial Health and Cash Position

Mirum Pharmaceuticals maintains a strong financial position, with a cash reserve of $295.4 million as of June 30, 2024. This robust cash position enables the company to continue investing in its pipeline and expanding its commercial footprint[2].

Analyst Projections and Market Sentiment

Analysts have lifted their sales guidance and target prices for Mirum Pharmaceuticals, reflecting the company's strong financial performance and promising pipeline. The company is expected to reach quarterly profitability in 2025, driven by revenue growth from LIVMARLI and the potential success of volixibat[3][5].

Challenges and Risks

While LIVMARLI has shown remarkable growth, Mirum Pharmaceuticals faces challenges such as high operational expenses, intense competition in the PBC market, and regulatory risks associated with drug development and approvals. However, the company's moderate debt level and strong liquidity position mitigate some of these risks[3].

Conclusion

LIVMARLI has established itself as a leading treatment for rare liver diseases, driven by significant market expansion, regulatory approvals, and strong financial performance. With a robust pipeline, ongoing studies, and a solid financial position, Mirum Pharmaceuticals is well-positioned for continued growth and market dominance in the rare disease sector.

Key Takeaways

• Revenue Growth: LIVMARLI's global net product sales grew 89% in 2023 and are expected to reach $310-$320 million in 2024.
• Regulatory Approvals: Recent FDA and European approvals have expanded LIVMARLI's label, increasing its addressable patient population.
• Pipeline: Ongoing studies for volixibat and new drug applications for CHENODAL are key drivers of future growth.
• Financial Health: Mirum Pharmaceuticals maintains a strong cash position, enabling continued investment in its pipeline.
• Market Sentiment: Analysts project quarterly profitability in 2025, driven by LIVMARLI's success and the potential of volixibat.

FAQs

Q: What is LIVMARLI used for?

A: LIVMARLI is used to treat cholestatic pruritus in patients with rare liver diseases such as Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC).

Q: How has LIVMARLI's revenue grown?

A: LIVMARLI's global net product sales grew 89% in 2023 to $141.8 million and are expected to reach $310-$320 million in 2024.

Q: What are the recent regulatory milestones for LIVMARLI?

A: LIVMARLI has been approved by the FDA for PFIC patients aged 12 months and older and by the European Commission for patients three months and older.

Q: What is the current cash position of Mirum Pharmaceuticals?

A: As of June 30, 2024, Mirum Pharmaceuticals has a cash reserve of $295.4 million.

Q: What are the potential future growth drivers for LIVMARLI?

A: Future growth drivers include the Phase 3 EXPAND study, potential approvals for volixibat, and the NDA submission for CHENODAL in CTX.

Sources

1. Biospace: Mirum Pharmaceuticals Reports Fourth Quarter and Year-End 2023 Financial Results and Provides Business Update.
2. Stocktitan: Mirum Pharmaceuticals Reports Second Quarter 2024 Financial Results and Provides Business Update.
3. Investing.com: Mirum Pharmaceuticals' SWOT analysis: liver disease specialist's stock poised for growth.
4. Managed Healthcare Executive: FDA Approves Livmarli for Second Liver Disease Indication.
5. Investing.com: Mirum shares target lifted on raised sales guidance and strong LIVMARLI sales.