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OTEZLA Drug Profile

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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 eleven patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-one 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. Two suppliers are 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 UNICHEM on February 17^th, 2021.

Summary for OTEZLA

International Patents:	91
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	38
Patent Applications:	850
Formulation / Manufacturing:	see details
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
Boehringer Ingelheim	Phase 1
University of Erlangen-Nürnberg Medical School	Phase 3
University of California, San Francisco	Phase 2

See all OTEZLA clinical trials

Pharmacology for OTEZLA

Drug Class	Phosphodiesterase 4 Inhibitor
Mechanism of Action	Phosphodiesterase 4 Inhibitors

ATC Classes for OTEZLA

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

Paragraph IV (Patent) Challenges for OTEZLA

Tradename	Dosage	Ingredient	NDA	Submissiondate
OTEZLA	TABLET;ORAL	apremilast	205437	2018-03-22

US Patents and Regulatory Information for 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	205437-002	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	205437-003	Mar 21, 2014	AB	RX	Yes	Yes			Y	Y
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	205437-001	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

International Patents for OTEZLA

Country	Patent Number	Estimated Expiration
Australia	756308
Japan	5936521
Denmark	1752148
Cyprus	1110752
Cyprus	1119204

Supplementary Protection Certificates for OTEZLA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2962690	132019000000096	Italy		PRODUCT NAME: APREMILAST(OTEZLA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/981, 20150116
2962690	C20190029 00295	Estonia		PRODUCT NAME: APREMILAST;REG NO/DATE: EU/1/14/981 16.01.2015
2962690	365 14-2019	Slovakia		PRODUCT NAME: APREMILAST VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/981 20150116
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