OTEZLA Drug Patent Profile

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

Otezla is a drug marketed by Amgen Inc and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has ninety patent family members in twenty-four countries.

The generic ingredient in OTEZLA is apremilast. There are twenty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the apremilast profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Otezla

A generic version of OTEZLA was approved as apremilast by ALKEM LABS LTD on September 21^st, 2021.

Summary for OTEZLA

International Patents:	90
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	50
Patent Applications:	755
Drug Prices:	Drug price information for OTEZLA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OTEZLA
What excipients (inactive ingredients) are in OTEZLA?	OTEZLA excipients list
DailyMed Link:	OTEZLA at DailyMed

See drug prices for OTEZLA

Recent Clinical Trials for OTEZLA

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

Sponsor	Phase
Wake Forest University Health Sciences	Early Phase 1
Amgen	Early Phase 1
Robert Micheletti	Phase 2

See all OTEZLA clinical trials

Pharmacology for OTEZLA

Drug Class	Phosphodiesterase 4 Inhibitor
Mechanism of Action	Phosphodiesterase 4 Inhibitors

Paragraph IV (Patent) Challenges for OTEZLA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OTEZLA	Tablets	apremilast	10 mg, 20 mg and 30 mg	205437	11	2018-03-22

US Patents and Regulatory Information for OTEZLA

OTEZLA is protected by three US patents and seven FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-003	Mar 21, 2014	AB	RX	Yes	Yes
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-003	Mar 21, 2014	AB	RX	Yes	Yes
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-001	Mar 21, 2014	AB	RX	Yes	No					Y
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-002	Mar 21, 2014	AB	RX	Yes	No
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-003	Mar 21, 2014	AB	RX	Yes	Yes
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-001	Mar 21, 2014	AB	RX	Yes	No
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-001	Mar 21, 2014	AB	RX	Yes	No

Expired US Patents for OTEZLA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-003	Mar 21, 2014
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-002	Mar 21, 2014
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-002	Mar 21, 2014
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-002	Mar 21, 2014
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-003	Mar 21, 2014
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-003	Mar 21, 2014
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-002	Mar 21, 2014

EU/EMA Drug Approvals for OTEZLA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Amgen Europe BV	Otezla	apremilast	EMEA/H/C/003746 Psoriatic arthritisOtezla, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy.PsoriasisOtezla is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA).	Authorised	no	no	no	2015-01-15

International Patents for OTEZLA

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

Country	Patent Number	Title	Estimated Expiration
Brazil	9915201
Hungary	E029682
Cyprus	1119204
Norway	319790
China	105050624	Treatment of psoriatic arthritis using apremilast
Denmark	2295055
Australia	2003224729	(+)-2-(1-(3-ETHOXY-4-METHOXYPHENYL)-2-METHYLSULFONYLETHYL)-4-ACETYLAMINOISOINDOLINE-1,3-DIONE: METHODS OF USING AND COMPOSITIONS THEREOF

Supplementary Protection Certificates for OTEZLA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2962690	1990037-2	Sweden		PRODUCT NAME: APREMILAST OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/14/981 20150116
2962690	C02962690/01	Switzerland		VERTRETERLOESCHUNG
2962690	365 14-2019	Slovakia		PRODUCT NAME: APREMILAST VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/981 20150116
2962690	122019000070	Germany		PRODUCT NAME: APREMILAST ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/981 20150115
2962690	C201930044	Spain		PRODUCT NAME: APREMILAST O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/14/981; DATE OF AUTHORISATION: 20150115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/981; DATE OF FIRST AUTHORISATION IN EEA: 20150115
2962690	2019/037	Ireland		PRODUCT NAME: APREMILAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/14/981 20150115
2962690	CA 2019 00033	Denmark		PRODUCT NAME: APREMILAST ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/981 20150116

OTEZLA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: OTEZLA

Introduction

OTEZLA, known generically as apremilast, is a significant player in the pharmaceutical market, particularly in the treatment of psoriasis, psoriatic arthritis, and Behçet's Disease. This article delves into the market dynamics and financial trajectory of OTEZLA, highlighting its sales performance, market position, and the impact of various factors on its financial health.

Market Position and Indications

OTEZLA is the only oral, non-biologic treatment approved for moderate-to-severe plaque psoriasis, active psoriatic arthritis, and oral ulcers associated with Behçet's Disease. It is approved in over 50 markets worldwide, including the U.S., the European Union, and Japan[4].

Sales Performance

Historical Sales

As of 2023, the global sales of OTEZLA stood at USD 2,188 million. Despite this, the drug experienced a historical decline with a compound annual growth rate (CAGR) of -0.11% between 2020 and 2023[1].

Recent Trends

In contrast to the overall decline, OTEZLA saw a mid-double-digit year-on-year growth in 2021, indicating some periods of strong performance. However, the overall trend suggests a challenging market environment[1].

Acquisition and Ownership

Amgen's Acquisition

In 2019, Amgen acquired OTEZLA from Celgene Corporation for $13.4 billion in cash, a move that was expected to enhance Amgen's portfolio in the inflammatory diseases segment. This acquisition included the drug and related assets and liabilities[4].

Financial Performance

Product Sales

For Amgen, the fourth quarter of 2023 saw a 20% increase in total product sales, driven by a 23% volume growth, despite a 3% lower net selling price. For the full year 2023, product sales increased by 9%, driven by 15% volume growth, though offset by lower net selling prices and other factors[5].

Operating Expenses

Operating expenses for Amgen increased significantly in 2023. Research and development (R&D) expenses rose by 16% in the fourth quarter and by 8% for the full year, largely due to increased spending on later-stage clinical programs and support for marketed products. Selling, general, and administrative (SG&A) expenses also increased by 20% in the fourth quarter and by 5% for the full year, partly due to the integration of the Horizon acquisition[5].

Cost of Sales and Profit Margins

The cost of sales as a percentage of product sales remained flat in the fourth quarter but increased by 1.1 percentage points for the full year, influenced by higher profit share and royalties, as well as changes in product mix. The operating margin as a percentage of product sales decreased by 1.7 percentage points for the full year to 49.8%[5].

Market Dynamics

Competitive Landscape

OTEZLA operates in a competitive market with other treatments for psoriasis and psoriatic arthritis. The drug's unique position as an oral, non-biologic agent sets it apart, but it faces competition from biologic therapies and other oral treatments. The market is dynamic, with new launches and patent expirations affecting the landscape[3].

Regulatory and Patent Environment

OTEZLA enjoys patent exclusivity through various markets, which has been a significant factor in its market position. However, as patents expire, the drug may face increased competition from generics and biosimilars[4].

Financial Projections

Future Growth

Despite the current decline, GlobalData projects that OTEZLA sales will experience a positive CAGR in the future, though the exact figures are not specified. Amgen's overall strategy, including the strength of its portfolio and pipeline, is expected to drive growth in the coming years[1].

Impact of Acquisitions

The acquisition of OTEZLA and other assets from Horizon Therapeutics is expected to contribute to Amgen's growth. The integration of these assets and the expansion of Amgen's portfolio are key factors in the company's financial projections[5].

Challenges and Risks

Economic Factors

Economic factors such as interest rate and currency exchange rate fluctuations can impact the financial performance of OTEZLA and Amgen as a whole. These factors can affect the cost of sales, R&D expenses, and overall profitability[3].

Clinical and Regulatory Risks

OTEZLA, like other pharmaceuticals, faces risks related to clinical trials, regulatory approvals, and adverse reactions. The drug has been associated with side effects such as depression, weight loss, and gastrointestinal issues, which can impact its market acceptance and sales[4].

Key Takeaways

• Sales Performance: OTEZLA's global sales stood at USD 2,188 million in 2023, with a historical decline but a mid-double-digit growth in 2021.
• Ownership: Acquired by Amgen in 2019 for $13.4 billion.
• Financial Performance: Part of Amgen's product sales growth, despite challenges in operating expenses and profit margins.
• Market Dynamics: Competes in a dynamic market with biologic and other oral treatments; patent exclusivity is a significant factor.
• Future Growth: Projected to experience positive CAGR, driven by Amgen's portfolio and pipeline strength.

FAQs

What are the primary indications for OTEZLA?

OTEZLA is approved for the treatment of moderate-to-severe plaque psoriasis, active psoriatic arthritis, and oral ulcers associated with Behçet's Disease[4].

Who owns OTEZLA?

OTEZLA is owned by Amgen, which acquired it from Celgene Corporation in 2019[4].

What was the global sales figure for OTEZLA in 2023?

The global sales of OTEZLA stood at USD 2,188 million in 2023[1].

What factors have impacted the sales performance of OTEZLA?

Factors include a historical decline in sales, lower net selling prices, and changes in product mix and operating expenses[1][5].

What are the projected future growth prospects for OTEZLA?

GlobalData projects a positive CAGR for OTEZLA sales in the future, driven by Amgen's overall portfolio and pipeline strength[1].

Sources

1. GlobalData: The Global Drug sales of Otezla (2020 - 2026, USD Millions)
2. PR Newswire: AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2023 FINANCIAL RESULTS
3. Johnson & Johnson: Innovative Medicine Presentation
4. Amgen: Amgen To Acquire Otezla® For $13.4 Billion In Cash, Or Approximately $11.2 Billion Net Of Anticipated Future Cash Tax Benefits
5. Amgen: AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2023 FINANCIAL RESULTS