APREMILAST - Generic Drug Details

What are the generic sources for apremilast and what is the scope of freedom to operate?

Apremilast is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Amneal, Annora, Aurobindo Pharma Ltd, Dr Reddys, Glenmark Pharms Ltd, Mankind Pharma, Shilpa, Teva Pharms Usa Inc, Unichem, and Amgen Inc, and is included in eleven NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Apremilast has ninety patent family members in twenty-four countries.

There are twenty-eight drug master file entries for apremilast. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for APREMILAST

International Patents:	90
US Patents:	3
Tradenames:	2
Applicants:	11
NDAs:	11
Drug Master File Entries:	28
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	116
Patent Applications:	1,657
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for APREMILAST
What excipients (inactive ingredients) are in APREMILAST?	APREMILAST excipients list
DailyMed Link:	APREMILAST at DailyMed

Recent Clinical Trials for APREMILAST

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

Sponsor	Phase
Takeda	Phase 3
Assiut University	Phase 1
Humanis Saglık Anonim Sirketi	Phase 3

See all APREMILAST clinical trials

Generic filers with tentative approvals for APREMILAST

Applicant	Application No.	Strength	Dosage Form
		30MG	TABLET;ORAL
		20MG	TABLET;ORAL
		10MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for APREMILAST

Drug Class	Phosphodiesterase 4 Inhibitor
Mechanism of Action	Phosphodiesterase 4 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for APREMILAST

L04AA	Selective immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for APREMILAST

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 APREMILAST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Ltd	APREMILAST	apremilast	TABLET;ORAL	211716-002	Jul 19, 2023		DISCN	No	No
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-002	Mar 21, 2014	AB	RX	Yes	No
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-001	Mar 21, 2014	AB	RX	Yes	No
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-002	Mar 21, 2014	AB	RX	Yes	No
Unichem	APREMILAST	apremilast	TABLET;ORAL	211819-002	Feb 17, 2021		DISCN	No	No
Unichem	APREMILAST	apremilast	TABLET;ORAL	211819-001	Feb 17, 2021		DISCN	No	No

Expired US Patents for APREMILAST

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

EU/EMA Drug Approvals for APREMILAST

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 APREMILAST

Country	Patent Number	Title	Estimated Expiration
Portugal	1485087
Portugal	2420490
Luxembourg	C00125
New Zealand	628320	Treatment of psoriatic arthritis using apremilast
China	1652772	(+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1, 3-dione: methods of using and compositions thereof
Spain	2635361

Supplementary Protection Certificates for APREMILAST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2962690	C20190029 00295	Estonia		PRODUCT NAME: APREMILAST;REG NO/DATE: EU/1/14/981 16.01.2015
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	365 14-2019	Slovakia		PRODUCT NAME: APREMILAST VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/981 20150116
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	CR 2019 00033	Denmark		PRODUCT NAME: APREMILAST ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/981 20150116