KYPROLIS Drug Patent Profile

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

Kyprolis is a drug marketed by Onyx Pharms Amgen and is included in one NDA. There are eleven patents protecting this drug and three Paragraph IV challenges.

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

The generic ingredient in KYPROLIS is carfilzomib. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the carfilzomib profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Kyprolis

A generic version of KYPROLIS was approved as carfilzomib by DR REDDYS on September 9^th, 2019.

Summary for KYPROLIS

International Patents:	220
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	95
Patent Applications:	2,682
Drug Prices:	Drug price information for KYPROLIS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KYPROLIS
What excipients (inactive ingredients) are in KYPROLIS?	KYPROLIS excipients list
DailyMed Link:	KYPROLIS at DailyMed

See drug prices for KYPROLIS

Recent Clinical Trials for KYPROLIS

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

Sponsor	Phase
Wuhan Union Hospital, China	Phase 2
Dong-A University Hospital	Phase 2
GlaxoSmithKline	Phase 2

See all KYPROLIS clinical trials

Pharmacology for KYPROLIS

Drug Class	Proteasome Inhibitor
Mechanism of Action	Proteasome Inhibitors

Paragraph IV (Patent) Challenges for KYPROLIS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KYPROLIS	For Injection	carfilzomib	10 mg/vial	202714	1	2018-11-28
KYPROLIS	For Injection	carfilzomib	30 mg/vial	202714	1	2017-10-05
KYPROLIS	For Injection	carfilzomib	60 mg/vial	202714	9	2016-07-20

US Patents and Regulatory Information for KYPROLIS

KYPROLIS is protected by twenty US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012	AP	RX	Yes	Yes
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012	AP	RX	Yes	Yes			Y	Y
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016		RX	Yes	No			Y
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016		RX	Yes	No			Y	Y

EU/EMA Drug Approvals for KYPROLIS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Amgen Europe B.V.	Kyprolis	carfilzomib	EMEA/H/C/003790 Kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.	Authorised	no	no	yes	2015-11-19

International Patents for KYPROLIS

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

Country	Patent Number	Title	Estimated Expiration
Lithuania	PA2016010
Morocco	32806	العلاج بالتركيب بببتيدات ابوكسيكيتونيس
South Korea	20200106100	알킬화된 시클로덱스트린 조성물 및 이의 제조 및 사용 방법 (Alkylated Cyclodextrin Compositions and Processes for Preparing and using the same)
Spain	2525248

Supplementary Protection Certificates for KYPROLIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1781688	122016000032	Germany		PRODUCT NAME: CARFILZOMIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1060 20151119
1781688	625	Finland
1781688	C20160008 00189	Estonia		PRODUCT NAME: KARFILSOMIIB;REG NO/DATE: EU/1/15/1060 23.11.2015
1781688	PA2016010,C1781688	Lithuania		PRODUCT NAME: KARFILZOMIBAS; REGISTRATION NO/DATE: EU/1/15/1060 20151119

Market Dynamics and Financial Trajectory for KYPROLIS

Introduction to KYPROLIS

KYPROLIS, also known as carfilzomib, is a proteasome inhibitor developed by Amgen for the treatment of multiple myeloma, a type of blood cancer. It has been a significant player in the multiple myeloma treatment market, with a unique profile that sets it apart from other drugs in its class.

Market Position and Competitors

KYPROLIS operates in a competitive landscape dominated by other proteasome inhibitors such as VELCADE (bortezomib) and NINLARO (ixazomib), as well as other multiple myeloma treatments like Revlimid and Darzalex.

• Market Share: In the proteasome inhibitors market, KYPROLIS has been gaining traction. While VELCADE represented more than 54% of the overall volume in 2018, KYPROLIS is expected to register a CAGR of more than 10% in terms of revenue from 2019 to 2023 due to its superior efficacy and target affinity[1].
• Competitive Dynamics: The market is highly competitive, with drugs like Revlimid and Darzalex also vying for market share. However, KYPROLIS has distinguished itself through its clinical program, which has focused on reducing the dosing and administration burden on patients[4].

Financial Performance

The financial trajectory of KYPROLIS has been marked by both successes and challenges.

• Revenue Growth: Despite initial high expectations, KYPROLIS' sales have not always met forecasts. In the second quarter of 2018, KYPROLIS generated $263 million worldwide, which was far below the $2.4 billion and $3 billion peak sales predicted by some industry analysts[4].
• CAGR and Market Size: However, KYPROLIS is projected to grow significantly, with a CAGR of more than 10% from 2019 to 2023. This growth is driven by its superior efficacy and the expanding patient pool[1].

Clinical Trials and Regulatory Approvals

Clinical trials and regulatory approvals have played a crucial role in shaping the market dynamics for KYPROLIS.

• FDA Approvals: The FDA has granted priority review for Amgen's supplemental new drug application for the expanded labeling of KYPROLIS in relapsed multiple myeloma. This has helped in broadening the drug's indications and improving its market position[5].
• Clinical Trial Outcomes: While KYPROLIS has shown promising results in many clinical trials, it has also faced setbacks. For example, a combination of KYPROLIS, melphalan, and prednisone failed to outperform a cocktail of melphalan, prednisone, and VELCADE in improving survival among previously untreated patients in a 2016 trial[4].

Patient and Physician Preferences

Patient and physician preferences are critical in determining the market success of KYPROLIS.

• Dosing Convenience: KYPROLIS offers a more convenient dosing option compared to some of its competitors. Amgen has focused on generating data to reduce the dosing and administration burden on patients, which has been a positive aspect of the drug[4].
• Adverse Events: KYPROLIS has been noted for having significantly fewer adverse events compared to other drugs like Revlimid. This lower incidence of adverse events can influence physician prescribing decisions and patient compliance[3].

Regional Market Performance

The performance of KYPROLIS varies across different regions.

• North America: The North-American proteasome inhibitors market, which includes KYPROLIS, accounted for about 47% of the overall revenue in 2018. This is due to the growing prevalence of cancer indications such as multiple myeloma and non-Hodgkin’s lymphoma in this region[1].

Impact of Biosimilars

The emergence of biosimilars has posed a challenge to Amgen and other biotech companies.

• Biosimilar Competition: Biosimilars makers, such as Mylan, have been targeting Amgen's older drugs like Neupogen and Neulasta with lower-priced alternatives. This competition could indirectly affect KYPROLIS sales as Amgen's overall revenue is impacted[4].

Future Outlook

The future outlook for KYPROLIS is promising, despite the current challenges.

• Expanded Labeling: The FDA's priority review for expanded labeling of KYPROLIS in relapsed multiple myeloma is expected to boost its market position and sales[5].
• Continuous Research: Amgen's ongoing efforts to generate additional data and improve the dosing and administration of KYPROLIS are likely to enhance its market performance and patient acceptance[4].

Key Takeaways

• KYPROLIS is expected to register a CAGR of more than 10% from 2019 to 2023 due to its superior efficacy and target affinity.
• The drug has faced challenges in meeting initial sales forecasts but continues to grow in the market.
• Clinical trials and regulatory approvals have been crucial in shaping its market dynamics.
• Patient and physician preferences, particularly regarding dosing convenience and adverse events, favor KYPROLIS.
• The North-American market is a significant contributor to KYPROLIS' revenue.
• The emergence of biosimilars poses a broader challenge to Amgen's revenue streams.

FAQs

What is KYPROLIS used for?

KYPROLIS (carfilzomib) is used for the treatment of multiple myeloma, a type of blood cancer.

How does KYPROLIS compare to other proteasome inhibitors?

KYPROLIS is expected to register a higher CAGR than other proteasome inhibitors like VELCADE and NINLARO due to its superior efficacy and target affinity[1].

What are the key advantages of KYPROLIS?

KYPROLIS offers a more convenient dosing option and has a lower incidence of adverse events compared to some of its competitors[3][4].

How has the FDA supported KYPROLIS?

The FDA has granted priority review for Amgen's supplemental new drug application for the expanded labeling of KYPROLIS in relapsed multiple myeloma[5].

What impact do biosimilars have on KYPROLIS sales?

Biosimilars targeting Amgen's older drugs could indirectly affect KYPROLIS sales by impacting Amgen's overall revenue streams[4].

Sources

1. Proteasome Inhibitors Market Size Worth $1.7 Billion by 2023 - Biospace
2. Financial Analysis of Competitive Drugs with PharmaKB - PharmaKB
3. Financial Analysis of Competitive Drugs with PharmaKB - PharmaKB
4. Can Amgen's new-and-improved Kyprolis kick-start myeloma sales? - FiercePharma
5. FDA Grants Priority Review For Amgen's Supplemental New Drug Application For Expanded Labeling Of Kyprolis (Carfilzomib) In Relapsed Multiple Myeloma - Biospace