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NINLARO Drug Patent Profile

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

Ninlaro is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and twenty-four patent family members in forty-six countries.

The generic ingredient in NINLARO is ixazomib citrate. One supplier is listed for this compound. Additional details are available on the ixazomib citrate profile page.

DrugPatentWatch^® Generic Entry Outlook for Ninlaro

Ninlaro was eligible for patent challenges on November 20, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 20, 2029. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for NINLARO

International Patents:	224
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	48
Drug Prices:	Drug price information for NINLARO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NINLARO
What excipients (inactive ingredients) are in NINLARO?	NINLARO excipients list
DailyMed Link:	NINLARO at DailyMed

See drug prices for NINLARO

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

NDA:

208462

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 NINLARO

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

Sponsor	Phase
Genentech, Inc.	Phase 1/Phase 2
Rajshekhar Chakraborty, MD	Phase 1/Phase 2
Takeda	Phase 4

See all NINLARO clinical trials

Pharmacology for NINLARO

Drug Class	Proteasome Inhibitor
Mechanism of Action	Proteasome Inhibitors

Paragraph IV (Patent) Challenges for NINLARO

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 NINLARO

NINLARO is protected by nine US patents.

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
Takeda Pharms Usa	NINLARO	ixazomib citrate	CAPSULE;ORAL	208462-001	Nov 20, 2015		RX	Yes	No
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

Expired US Patents for NINLARO

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

International Patents for NINLARO

When does loss-of-exclusivity occur for NINLARO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

France

Georgia, Republic of

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Malaysia

Netherlands

New Zealand

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

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

See the table below for additional patents covering NINLARO around the world.

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1244827	硼酸酯化合物及其醫藥組合物 (BORONATE ESTER COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS THEREOF)
Poland	1660507
Taiwan	I498333

Supplementary Protection Certificates for NINLARO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2178888	C02178888/01	Switzerland		PRODUCT NAME: IXAZOMIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65959 03.02.2017
2178888	CA 2017 00014	Denmark		PRODUCT NAME: IXAZOMIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER IXAZOMIBCITRAT; REG. NO/DATE: EU/1/16/1094 20161123

NINLARO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NINLARO

Introduction

NINLARO (ixazomib), developed by Takeda Pharmaceutical Co., is a groundbreaking oral proteasome inhibitor that has significantly impacted the treatment landscape for multiple myeloma. Here, we delve into the market dynamics and financial trajectory of NINLARO, highlighting its performance, competitive position, and future prospects.

Market Approval and Initial Launch

NINLARO was the first orally active proteasome inhibitor to reach the market, gaining FDA approval in 2015 for the treatment of adult patients with multiple myeloma who have received at least one prior therapy, in combination with lenalidomide and dexamethasone[5].

Early Adoption and Market Share

Following its launch, NINLARO quickly gained traction. By just a few months after its introduction in the U.S., it captured a significant market share, with one in five new patients receiving second-line treatment for multiple myeloma being prescribed the drug. This was the highest market share for any new multiple myeloma therapy at the time[1].

Global Expansion

NINLARO's approval extended beyond the U.S., with approvals in Canada, Israel, Venezuela, and a filing in Japan. The EU's Committee for Medicinal Products for Human Use (CHMP) also reversed an earlier decision to reject NINLARO, paving the way for a potential launch in early 2017[1].

Financial Performance

Initial Sales

In the first six months of its fiscal year, NINLARO generated ¥13 billion (approximately $125 million) in sales, contributing significantly to the growth of Takeda's U.S. business. Despite a limited label claim, NINLARO accounted for one-third of the growth in the U.S. market[1].

Growth Trajectory

By FY 2019, NINLARO's sales had grown to $721 million, representing a 24.7% increase from the previous year. This growth continued into the first quarter of FY 2020, with sales increasing by another 25.3% to $213 million. The COVID-19 pandemic played a role in this growth, as NINLARO's oral administration was more convenient than injectable competitors[2].

Competitive Landscape

Market Position

NINLARO competes in the proteasome inhibitors market, which includes other notable drugs like Velcade (bortezomib) and Kyprolis (carfilzomib). As of 2018, NINLARO commanded over 11% of the proteasome inhibitors volume share, while Velcade dominated with over 54% of the market[4].

Comparative Efficacy

Clinical studies have shown that the NINLARO treatment combination (NINLARO + lenalidomide + dexamethasone) significantly prolongs progression-free survival (PFS) compared to lenalidomide and dexamethasone alone. Patients on the NINLARO combination experienced a PFS of 20.6 months, compared to 14.7 months for those on the two-drug combination[3][5].

Future Prospects

Projected Sales

Takeda's CEO, Christophe Weber, has expressed strong confidence in NINLARO's potential, predicting it will become a "$3 billion-plus product" and a cornerstone in multiple myeloma treatment. This projection is supported by ongoing Phase III trials aimed at moving NINLARO into first-line treatment[1].

Market Expansion

NINLARO's growth is also driven by its convenience and the ongoing research in diverse patient populations. The drug is expected to witness considerable growth during the forecast period, contributing to the overall expansion of the proteasome inhibitors market[4].

Challenges and Opportunities

Patent Expiry of Velcade

Takeda faces a significant challenge with the impending loss of U.S. patent protection for Velcade, its flagship multiple myeloma drug. However, NINLARO's strong performance is positioned to fill this revenue gap, ensuring continued growth for Takeda in the multiple myeloma market[1].

Competitive Pressure

The multiple myeloma market is highly competitive, with drugs like Darzalex (daratumumab) from Johnson & Johnson posing stiff competition. However, NINLARO's unique oral administration and proven efficacy profile help it maintain a strong market position[1].

Conclusion

NINLARO has established itself as a pivotal treatment in the multiple myeloma landscape, driven by its efficacy, convenience, and strong market adoption. With projected sales exceeding $3 billion and ongoing clinical trials to expand its use into first-line treatment, NINLARO is set to become one of the leading drugs in its class.

Key Takeaways

• Market Approval: NINLARO was the first oral proteasome inhibitor approved for multiple myeloma treatment.
• Early Adoption: It quickly gained significant market share in the U.S. and globally.
• Financial Performance: NINLARO showed strong sales growth, contributing substantially to Takeda's revenue.
• Competitive Landscape: NINLARO competes with Velcade and Kyprolis but has a unique advantage due to its oral administration.
• Future Prospects: Projected to become a $3 billion-plus product, with ongoing trials for first-line treatment.

FAQs

Q: What is NINLARO used for? A: NINLARO (ixazomib) is used for the treatment of adult patients with multiple myeloma who have received at least one prior therapy, in combination with lenalidomide and dexamethasone.

Q: How does NINLARO compare to other proteasome inhibitors? A: NINLARO is the first oral proteasome inhibitor and has shown significant efficacy in prolonging progression-free survival compared to other treatments like Velcade and Kyprolis.

Q: What are the key financial milestones for NINLARO? A: By FY 2019, NINLARO's sales reached $721 million, and it continued to grow by 25.3% in the first quarter of FY 2020.

Q: What challenges does Takeda face with NINLARO? A: Takeda faces the challenge of Velcade's patent expiry but is well-positioned with NINLARO to fill the revenue gap.

Q: What are the future prospects for NINLARO? A: NINLARO is projected to become a $3 billion-plus product, with ongoing Phase III trials aimed at expanding its use into first-line treatment.

Sources

1. FiercePharma: Takeda CEO says new myeloma drug Ninlaro will be 'significantly bigger than Velcade'[1].
2. PharmaLive: Takeda 2020: The incredible growing/shrinking pharma[2].
3. Ninlaro.com: Results with NINLARO® (ixazomib)[3].
4. Biospace: Proteasome Inhibitors Market Size Worth $1.7 Billion by 2023[4].
5. Health Canada: Summary Basis of Decision for Ninlaro[5].