Ixazomib citrate - Generic Drug Details

What are the generic drug sources for ixazomib citrate and what is the scope of freedom to operate?

Ixazomib citrate is the generic ingredient in one branded drug marketed by Takeda Pharms Usa and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ixazomib citrate has one hundred and eighty-seven patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for ixazomib citrate

International Patents:	187
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	37
Patent Applications:	1,926
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ixazomib citrate
DailyMed Link:	ixazomib citrate at DailyMed

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

Dosage:

CAPSULE;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 ixazomib citrate

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

Sponsor	Phase
AIDS Malignancy Consortium	Phase 2
Sun Yat-sen University	Phase 2
Takeda	Phase 2

See all ixazomib citrate clinical trials

Pharmacology for ixazomib citrate

Drug Class	Proteasome Inhibitor
Mechanism of Action	Proteasome Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ixazomib citrate

L01XG	Proteasome inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for IXAZOMIB CITRATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NINLARO	Capsules	ixazomib citrate	2.3 mg, 3 mg and 4 mg	208462	1	2019-11-20

US Patents and Regulatory Information for ixazomib citrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-002	Nov 20, 2015		RX	Yes	No			Y	Y
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-003	Nov 20, 2015		RX	Yes	Yes			Y	Y
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-001	Nov 20, 2015		RX	Yes	No			Y	Y
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-002	Nov 20, 2015		RX	Yes	No			Y	Y
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-001	Nov 20, 2015		RX	Yes	No			Y	Y

Expired US Patents for ixazomib citrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-002	Nov 20, 2015
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-001	Nov 20, 2015
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-003	Nov 20, 2015
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-003	Nov 20, 2015
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-002	Nov 20, 2015

International Patents for ixazomib citrate

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2730581
South Korea	20140107483
South Korea	101474831
New Zealand	582693	Boron-containing proteasome inhibitors
Taiwan	201433317	Boronate ester compounds and pharmaceutical compositions thereof

Supplementary Protection Certificates for ixazomib citrate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2178888	1790016-8	Sweden		PRODUCT NAME: IXAZOMIB AND PHARMACEUTICALLY ACCEPTABLE SALTS AND ESTERS THEREOF, SUCH AS IXAZOMIB CITRATE; REG. NO/DATE: EU/1/16/1094 20161123
2178888	PA2017010,C2178888	Lithuania		PRODUCT NAME: IKSAZOMIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA IR ESTERIS, TOKS KAIP IKSAZOMIBO CITRATAS; REGISTRATION NO/DATE: EU/1/16/1094 20161121
2178888	17C1011	France		PRODUCT NAME: IXAZOMIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET SES ESTERS TELS QUE LE CITRATE D'IXAZOMIB; REGISTRATION NO/DATE: EU/1/16/1094 20161123
2178888	C20170014 00227	Estonia		PRODUCT NAME: IKSASOMIIB;REG NO/DATE: EU/1/16/1094 23.11.2016
2178888	132017000051594	Italy		PRODUCT NAME: IXAZOMIB E SUOI SALI ED ESTERI FARMACEUTICAMENTE ACCETTABILI, COME IXAZOMIB CITRATO(NINLARO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1094/001-003, 20161123

Market Dynamics and Financial Trajectory for IXAZOMIB CITRATE

Last updated: March 4, 2026

IXAZOMIB CITRATE, marketed as Ninlaro, is an oral proteasome inhibitor approved for multiple myeloma treatment. It entered the U.S. market in 2015 and has maintained regulatory approvals in other regions. The drug faces competitive pressures from other proteasome inhibitors and evolving treatment protocols.

Market Size and Growth Potential

The global multiple myeloma market is projected to grow from $20.5 billion in 2021 to over $30 billion by 2028, at a compound annual growth rate (CAGR) of approximately 6%. IXAZOMIB CITRATE accounts for an estimated 15-20% of the proteasome inhibitor segment, which itself represents roughly 40% of the total multiple myeloma market.

Key Drivers:

• Increased adoption of oral therapies over injectable options.
• Expansion of indications in earlier lines of treatment.
• Rising prevalence of multiple myeloma globally, with 160,000 cases annually.

Constraints:

• Competition from drugs like bortezomib (Velcade) and carfilzomib (Kyprolis).
• Patent expirations, with patent expected to expire by 2028 in key markets.
• Price and reimbursement pressures, especially in Europe and the U.S.

Revenue Trends and Financial Outlook

Since its launch, IXAZOMIB CITRATE has seen steady growth in revenue, but it remains behind leading proteasome inhibitors.

Year	Estimated Global Revenue (USD millions)	Year-over-Year Growth
2016	150	N/A
2017	200	33%
2018	280	40%
2019	370	32%
2020	440	19%
2021	510	16%

Forecast estimates project revenues reaching approximately $700 million globally by 2026. The key growth factors include increased adoption in first-line therapy and expanded indications.

Competitive Landscape

• Bortezomib (Velcade): Market leader, with over 60% market share in proteasome inhibitors.
• Carfilzomib (Kyprolis): Offers higher efficacy in refractory cases but with increased toxicity concern.
• Originator and biosimilars: Liposomal formulations and biosimilars are entering markets, exerting downward pressure on prices.

IXAZOMIB's advantage lies in its oral administration, providing convenience in outpatient settings, which supports patient adherence and potentially enhances long-term revenue streams.

Regulatory and Patent Outlook

• Regulatory status: Approved in the U.S., European Union, and Japan.
• Patent status: Original patents expected to expire by 2028 in major territories. Patent extensions or new indications could alter the patent landscape.
• Pipeline: Trials for combinations with other agents are ongoing, potentially expanding usage and prolonging lifecycle.

Strategic Opportunities and Risks

Opportunities:

• Launching in emerging markets with rising healthcare infrastructure.
• Developing combination regimens to improve efficacy.
• Seeking approval for earlier-line treatment to expand patient populations.

Risks:

• Regulatory delays or rejections for new indications.
• Price controls in European markets could limit revenue.
• Rapid emergence of biosimilars and generics.

Summary of Financial Trajectory

Year	Projected Global Revenue (USD millions)	CAGR (2022-2026)
2022	560	10%
2023	620	11%
2024	680	10%
2025	720	4%
2026	700	-3%

The revenue plateauing after 2024 may reflect patent expirations and increased competition, signalling the need for lifecycle extension strategies.

Key Takeaways

• IXAZOMIB CITRATE has a growing but competitive market, expected to approach $700 million annually by 2026.
• Oral formulation confers distinct advantages, though market share remains limited relative to injectable proteasome inhibitors.
• Patent expiration and biosimilar entry pose significant revenue risks.
• Expansion into early-line therapy and emerging markets offers growth potential.
• Strong competition and reimbursement policies will influence financial outcomes.

FAQs

1. What is the primary competitive advantage of IXAZOMIB CITRATE? It is an oral proteasome inhibitor, offering convenience compared to injectable drugs.

2. When is patent expiration expected? Patent protection is projected to end around 2028 in major markets.

3. What are the major hurdles for market growth? Patent expirations, biosimilar competition, and reimbursement pressures.

4. Are there upcoming regulatory approvals? Trials for combination regimens are ongoing; approvals for new indications could expand usage.

5. Which markets are most promising for expansion? Emerging markets, especially in Asia, and early-line treatment settings.

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References

[1] MarketWatch. (2022). Multiple myeloma drugs market forecast. Retrieved from https://www.marketwatch.com

[2] IQVIA. (2022). Global Oncology Market Report. Retrieved from https://www.iqvia.com

[3] U.S. Food and Drug Administration. (2015). Ninlaro approval announcement. Retrieved from https://www.fda.gov

[4] European Medicines Agency. (2016). IXAZOMIB marketing authorization. Retrieved from https://www.ema.europa.eu