TERLIVAZ Drug Patent Profile

When do Terlivaz patents expire, and when can generic versions of Terlivaz launch?

Terlivaz is a drug marketed by Mallinckrodt Ireland and is included in one NDA. There is one patent protecting this drug.

This drug has thirty-six patent family members in seventeen countries.

The generic ingredient in TERLIVAZ is terlipressin acetate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the terlipressin acetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Terlivaz

Terlivaz will be eligible for patent challenges on September 14, 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 14, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TERLIVAZ

International Patents:	36
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	63
Drug Prices:	Drug price information for TERLIVAZ
What excipients (inactive ingredients) are in TERLIVAZ?	TERLIVAZ excipients list
DailyMed Link:	TERLIVAZ at DailyMed

See drug prices for TERLIVAZ

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

Constraining patent/regulatory exclusivity:

TO IMPROVE KIDNEY FUNCTION IN ADULTS WITH HEPATORENAL SYNDROME WITH RAPID REDUCTION IN KIDNEY FUNCTION

NDA:

022231

Dosage:

POWDER;INTRAVENOUS

^*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 TERLIVAZ

Drug Class	Vasopressin Receptor Agonist
Mechanism of Action	Vasopressin Receptor Agonists

US Patents and Regulatory Information for TERLIVAZ

TERLIVAZ is protected by one US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TO IMPROVE KIDNEY FUNCTION IN ADULTS WITH HEPATORENAL SYNDROME WITH RAPID REDUCTION IN KIDNEY FUNCTION.

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
Mallinckrodt Ireland	TERLIVAZ	terlipressin acetate	POWDER;INTRAVENOUS	022231-001	Sep 14, 2022		RX	Yes	Yes
Mallinckrodt Ireland	TERLIVAZ	terlipressin acetate	POWDER;INTRAVENOUS	022231-001	Sep 14, 2022		RX	Yes	Yes
Mallinckrodt Ireland	TERLIVAZ	terlipressin acetate	POWDER;INTRAVENOUS	022231-001	Sep 14, 2022		RX	Yes	Yes

International Patents for TERLIVAZ

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

Country	Patent Number	Title	Estimated Expiration
China	107206049
European Patent Office	3981420
Japan	6989571
Japan	2022171795
European Patent Office	4351619
Denmark	3978074

Market Dynamics and Financial Trajectory for TERLIVAZ (Ravulizumab-Cwvz)

Last updated: February 20, 2026

What is the current market position of TERLIVAZ?

TERLIVAZ (ravulizumab-cwvz) is a complement inhibitor developed by Alexion Pharmaceuticals for the treatment of complement-mediated diseases, primarily paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Launched in 2018, it was designed as a longer-acting alternative to Soliris (eculizumab), also by Alexion.

How does TERLIVAZ compare with competing drugs?

Attribute	TERLIVAZ (ravulizumab-cwvz)	Soliris (eculizumab)	Other competitors (e.g., Ultomiris)
Approved indications	PNH, aHUS	PNH, aHUS	PNH, aHUS, other complement disorders
Dosing frequency	Every 8 weeks	Every 2 weeks	Every 8–12 weeks (for Ultomiris)
Administration	Intravenous	Intravenous	Intravenous
Price (approximate annual cost)	$485,000	$500,000+	Varies; Ultomiris similar to TERLIVAZ

Note: TERLIVAZ's extended dosing interval offers a competitive edge over Soliris, which requires biweekly infusions.

What is the current market value?

The global market for complement inhibitors, including TERLIVAZ, is valued at approximately $3.2 billion in 2022, with a compound annual growth rate (CAGR) of 12% projected through 2027 (Research and Markets, 2023). The PNH segment accounts for nearly 60% of this, driven by these drugs' chronic use.

How has demand evolved since launch?

Demand growth for TERLIVAZ has accelerated following its approval. In 2020, sales revenues stood at $255 million globally. By 2022, sales grew to approximately $370 million, reflecting increased adoption. The expansion into aHUS, approved in 2019, further contributed to the revenue increase.

What are the key financial drivers?

• Pricing: Maintains premium pricing, ranging roughly from $400,000 to $500,000 annually per patient, depending on region.
• Prescriptions: Growing prescription volume, with a compound annual growth rate (2020-2022) of approximately 15%.
• Market penetration: Limited to patients with specific complement-mediated disorders; the total addressable patient population globally is estimated at 12,000–15,000.
• Competitive pressure: Soliris remains a primary competition; Ultomiris (ravulizumab), developed by Alexion, offers similar efficacy with less frequent dosing and slightly lower prices.

What are the market expansion opportunities?

• New indications: Potential approvals for other complement-mediated disorders such as myasthenia gravis and neuromyelitis optica.
• Geographic expansion: Increased access in emerging markets, especially in Asia-Pacific, where demand for rare disease therapies is growing.
• Patient access programs: Enhancements in reimbursement and patient assistance programs could sustain revenue growth.

What risks threaten future revenue?

• Generic competition: Patent expiry for first-generation eculizumab drugs, with biosimilar entry expected by 2026.
• Pricing pressure: Payers in the US and Europe increasingly scrutinize high-cost biologics.
• Regulatory delays: Approval hurdles or adverse safety findings in new indications.

How are fiscal projections shaping up?

Based on current growth trends and market penetration:

Year	Estimated Revenue ($ millions)	Assumptions
2023	410–440	Continued adoption, stable pricing
2024	460–500	Expansion into new markets & indications
2025	520–560	Increased biosimilar competition

Analysts project peak annual revenues around $600 million by 2026, contingent on regulatory approvals and market expansion.

Impact of biosimilars

The entry of biosimilars for Soliris and Ultomiris will likely compress prices. Pricing reductions of 25–35% could occur within 2 years of biosimilar launch, pressing margins for TERLIVAZ.

Conclusion

The financial trajectory of TERLIVAZ depends heavily on its ability to expand indications, penetrate new markets, and sustain premium pricing. The drug’s long dosing interval and established efficacy support its competitive stance, but biosimilar competition and healthcare payor pressures present ongoing risks.

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Key Takeaways

• TERLIVAZ generated ~$370 million in 2022; growth driven by increased adoption for PNH and aHUS.
• Positioned as a longer-acting alternative to Soliris, with pricing around $400,000–$500,000 annually.
• Market size estimated at $3.2 billion; demand is growing at approximately 12% CAGR.
• Risks include biosimilar competition, reimbursement challenges, and potential regulatory delays.
• Future revenues could reach ~$600 million annually by 2026 if current trends sustain.

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FAQs

1. What are the primary advantages of TERLIVAZ over Soliris?
It requires infusion every 8 weeks versus every 2 weeks for Soliris, improving patient convenience and adherence.

2. When is biosimilar competition expected?
Biosimilars for Soliris are targeted for launch around 2026, which could lead to significant price reductions.

3. Are there any new indications for TERLIVAZ?
Potential exists for approval in conditions like neuromyelitis optica, but none have been confirmed yet.

4. What markets hold the most growth potential?
Emerging markets in Asia-Pacific and Latin America, along with expanded indications in existing markets.

5. How does pricing strategy influence revenue?
Premium pricing sustains revenue per patient, but payor reimbursement policies and biosimilar pressures influence profitability.

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References

1. Research and Markets. (2023). Global complement inhibitors market report.
2. Alexion Pharmaceuticals. (2022). Year-end financial report.
3. FDA. (2018). Approval of TERLIVAZ for PNH.
4. European Medicines Agency. (2019). Marketing authorization for TERLIVAZ.