OTEZLA Drug Patent Profile

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

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
Amgen	Early Phase 1
Wake Forest University Health Sciences	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.

Patents protecting OTEZLA

FDA Regulatory Exclusivity protecting OTEZLA

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	205437-003	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
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-001	Mar 21, 2014
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-003	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
China	101683334	(+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione: methods of using and compositions thereof
Hungary	S1900032
Australia	2014235273	Treatment of psoriatic arthritis using apremilast
Spain	2742729
European Patent Office	1126839
Japan	5936521
Portugal	2295055

Supplementary Protection Certificates for OTEZLA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2962690	C 2019 032	Romania		PRODUCT NAME: APREMILAST SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/14/981; DATE OF NATIONAL AUTHORISATION: 20150115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/981; DATE OF FIRST AUTHORISATION IN EEA: 20150115
2962690	CA 2019 00033	Denmark		PRODUCT NAME: APREMILAST ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/981 20150116
2962690	SPC/GB19/045	United Kingdom		PRODUCT NAME: APREMILAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/14/981/001(NI) 20150116; UK EU/1/14/981/002(NI) 20150116; UK EU/1/14/981/003(NI) 20150116; UK PLGB 50412/0006 20150116; UK PLGB 50412/0007 20150116
2962690	LUC00125	Luxembourg		PRODUCT NAME: APREMILAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/14/981 20150116
2962690	37/2019	Austria		PRODUCT NAME: APREMILAST ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/981 (MITTEILUNG) 20150116
2962690	2019/037	Ireland		PRODUCT NAME: APREMILAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; 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