ZYTIGA Drug Patent Profile

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

Zytiga is a drug marketed by Janssen Biotech and is included in one NDA.

The generic ingredient in ZYTIGA is abiraterone acetate. There are twenty-five drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the abiraterone acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zytiga

A generic version of ZYTIGA was approved as abiraterone acetate by APOTEX on October 31^st, 2018.

Summary for ZYTIGA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	115
Patent Applications:	1,604
Drug Prices:	Drug price information for ZYTIGA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZYTIGA
What excipients (inactive ingredients) are in ZYTIGA?	ZYTIGA excipients list
DailyMed Link:	ZYTIGA at DailyMed

See drug prices for ZYTIGA

Recent Clinical Trials for ZYTIGA

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

Sponsor	Phase
Merck Sharp & Dohme LLC	Phase 3
Orion Corporation, Orion Pharma	Phase 3
Han Xu, M.D., Ph.D., Non-Investigator, IRB Chair	Phase 2/Phase 3

See all ZYTIGA clinical trials

Pharmacology for ZYTIGA

Drug Class	Cytochrome P450 17A1 Inhibitor
Mechanism of Action	Cytochrome P450 17A1 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors

Paragraph IV (Patent) Challenges for ZYTIGA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZYTIGA	Tablets	abiraterone acetate	500 mg	202379	1	2017-08-23
ZYTIGA	Tablets	abiraterone acetate	250 mg	202379	13	2015-04-28

US Patents and Regulatory Information for ZYTIGA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Biotech	ZYTIGA	abiraterone acetate	TABLET;ORAL	202379-001	Apr 28, 2011	AB	RX	Yes	No
Janssen Biotech	ZYTIGA	abiraterone acetate	TABLET;ORAL	202379-002	Apr 14, 2017	AB	RX	Yes	Yes

Expired US Patents for ZYTIGA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Biotech	ZYTIGA	abiraterone acetate	TABLET;ORAL	202379-001	Apr 28, 2011	5,604,213

EU/EMA Drug Approvals for ZYTIGA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mylan Ireland Limited	Abiraterone Mylan	abiraterone acetate	EMEA/H/C/005368 Abiraterone Mylan is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT).the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.	Authorised	yes	no	no	2021-08-20
Krka, d.d., Novo mesto	Abiraterone Krka	abiraterone acetate	EMEA/H/C/005649 Abiraterone Krka is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) (see section 5.1)the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1)the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.	Authorised	yes	no	no	2021-06-24

International Patents for ZYTIGA

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

Country	Patent Number	Title	Estimated Expiration
Israel	257681	שיטות והרכבים לטיפול בסרטן (Methods and compositions for treating cancer)
Singapore	49321	Synthesis of 17-(3-pyridyl) steroids
Spain	2869343
Portugal	2061561
United Kingdom	2265624	17-substituted steroids useful in cancer treatment

Supplementary Protection Certificates for ZYTIGA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0633893	1190040-4	Sweden		PRODUCT NAME: ABIRATERON OCH SYRAADDITIONSSALTER OCH 3-ESTRAR DAERAV, SPECIELLT ABIRATERON-ACETAT; REG. NO/DATE: EU/1/11/714/001 20110905
0633893	2012/003	Ireland		PRODUCT NAME: ZYTIGA (ABIRATERONE) "ABIRATERONE AND ACID ADDITION SALTS AND 3-ESTERS THEREOF, ESPECIALLY ABIRATERONE ACETATE"; REGISTRATION NO/DATE: EU/1/11/714/001 20110905
0633893	C300508	Netherlands		PRODUCT NAME: ABIRATERON ALSMEDE ZUURADDITIEZOUTEN EN 3-ESTERS ERVAN, IN HET BIJZONDER ABIRATERONACETAAT; NAT. REGISTRATION NO/DATE: EU/1/11/714/001 20110905; FIRST REGISTRATION:
0633893	C00633893/01	Switzerland		PRODUCT NAME: ABIRATERONI ACETAS; REGISTRATION NUMBER/DATE: SWISSMEDIC 62084 20.09.2011
0633893	SPC/GB11/063	United Kingdom		PRODUCT NAME: ABIRATERONE AND ACID ADDITION SALTS AND 3-ESTERS THEREOF ESPECIALLY ABIRATERONE ACETATE; REGISTERED: UK EU/1/11/714/001 20110905

ZYTIGA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Zytiga (Abiraterone Acetate)

Overview of Zytiga

Zytiga, also known as abiraterone acetate, is a CYP17 inhibitor used in the treatment of metastatic prostate cancer. It is indicated in combination with prednisone for various stages of the disease, including castration-resistant prostate cancer and high-risk castration-sensitive prostate cancer[1][3].

Market Dynamics

Competitive Landscape

The global abiraterone acetate drugs market is highly competitive, with multiple players and innovative product offerings. The entry of generic versions of Zytiga has significantly impacted the market dynamics. Companies like Hikma Pharmaceuticals PLC and Dr Reddy's Laboratories Limited have launched generic versions of abiraterone acetate, increasing competition and reducing the market share of the original drug[4].

Impact of Generics

The introduction of generic versions of Zytiga has been a major factor in the decline of its sales. For instance, in the second quarter of 2019, U.S. sales of Zytiga slipped by 59% to $198 million due to the onset of generic competition. This decline continued as generics further eroded the market share of the branded drug[2].

Patient Demand and Medical Advancements

Despite the competition, the demand for abiraterone acetate remains strong due to the rising number of patients suffering from prostate cancer. In 2021, approximately 248,530 new cases of prostate cancer were detected in the United States alone. The continuous advancements in medical treatments and the expansion of clinical trials are expected to drive the growth of the global abiraterone acetate market[4].

Regional Market Performance

The North American market is expected to account for a significant revenue share due to the high prevalence of prostate cancer and the availability of advanced R&D infrastructure. The Asia Pacific region is also anticipated to witness rapid growth due to increasing government spending on healthcare and the implementation of health-related schemes to raise awareness and encourage better treatment adoption[4].

Financial Trajectory

Historical Sales Performance

Zytiga's global drug sales have experienced a significant decline in recent years. Between 2020 and 2023, the sales of Zytiga recorded a historical decline with a Compound Annual Growth Rate (CAGR) of 29%. In 2023, the global sales of Zytiga stood at USD 887 million[1].

Quarterly Performance

In the second quarter of 2019, U.S. sales of Zytiga dropped sharply by 59% to $198 million, primarily due to the launch of generic versions. This decline was part of a broader trend where Zytiga's sales were impacted by generic competition, making it a drag on Johnson & Johnson's pharmaceutical unit rather than a growth driver[2].

Forecasted Decline

GlobalData projects that the sales of Zytiga will continue to decline at a significant CAGR, reflecting the ongoing impact of generic competition and the evolving landscape of prostate cancer treatments[1].

Impact on Johnson & Johnson

Overall Pharmaceutical Performance

Despite the decline in Zytiga sales, Johnson & Johnson's pharmaceutical business has shown resilience. The company has seen growth in other segments, such as its oncology group, which grew by 9.8% in the second quarter of 2019. Drugs like Imbruvica, Stelara, and Darzalex have contributed significantly to the company's growth, helping to offset the losses from Zytiga and other declining products[2].

Strategic Outlook

Johnson & Johnson executives remain optimistic about achieving above-market growth through new drug launches and label expansions. The company is focusing on its suite of new drugs and is confident in its ability to navigate patent losses and generic competition[2].

Key Takeaways

• Generic Competition: The introduction of generic versions of Zytiga has significantly reduced its sales and market share.
• Market Demand: The rising number of prostate cancer cases and advancements in medical treatments continue to drive demand for abiraterone acetate.
• Regional Performance: North America and the Asia Pacific region are key markets due to high prevalence rates and healthcare infrastructure.
• Financial Decline: Zytiga's sales have declined sharply, with a historical CAGR of 29% between 2020 and 2023.
• Company Resilience: Johnson & Johnson's pharmaceutical business remains strong despite the decline in Zytiga sales, thanks to growth in other product segments.

FAQs

Q: What is Zytiga used for? A: Zytiga (abiraterone acetate) is used in combination with prednisone for the treatment of metastatic prostate cancer, including castration-resistant prostate cancer and high-risk castration-sensitive prostate cancer[1][3].

Q: Why have Zytiga sales declined? A: Zytiga sales have declined primarily due to the introduction of generic versions, which have eroded the market share of the branded drug[2].

Q: How has Johnson & Johnson's pharmaceutical business been affected by the decline in Zytiga sales? A: Despite the decline in Zytiga sales, Johnson & Johnson's pharmaceutical business has shown growth in other segments, such as its oncology group, and the company remains optimistic about achieving above-market growth through new drug launches and label expansions[2].

Q: What are the key regions driving the demand for abiraterone acetate? A: The North American and Asia Pacific regions are driving the demand due to the high prevalence of prostate cancer and the availability of advanced healthcare infrastructure[4].

Q: What is the forecasted outlook for Zytiga sales? A: GlobalData projects that Zytiga sales will continue to decline at a significant CAGR due to ongoing generic competition and the evolving landscape of prostate cancer treatments[1].

Sources

1. GlobalData: "The Global Drug sales of Zytiga (2020 - 2026, USD Millions)"
2. FiercePharma: "J&J execs have plenty to brag about in pharma. Why downplay Zytiga and Xarelto?"
3. FDA: "Zytiga® (abiraterone acetate) Tablets 250 mg."
4. Acumen Research and Consulting: "Abiraterone Acetate Drugs - Global Market and Forecast Till 2028"