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OTEZLA Drug Profile

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When do Otezla patents expire, and what generic alternatives are available?

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 eighty-nine patent family members in twenty-three 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.

US ANDA Litigation and Generic Entry Outlook for Otezla

Otezla was eligible for patent challenges on March 21, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 16, 2028. This may change due to patent challenges or generic licensing.

There have been eight patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are four tentative approvals for the generic drug (apremilast), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for OTEZLA

International Patents:	89
US Patents:	11
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	65
Clinical Trials:	33
Patent Applications:	90
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for OTEZLA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OTEZLA
DailyMed Link:	OTEZLA at DailyMed

See drug prices for OTEZLA

Generic Entry Opportunity Date for OTEZLA

NDA:

205437

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for OTEZLA

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

Sponsor	Phase
Dermatology Department University Hospital Frankfurt	Phase 2
Dr. Frank Behrens	Phase 2
Oslo University Hospital	Phase 2

See all OTEZLA clinical trials

Recent Litigation for OTEZLA

Identify potential future generic entrants

District Court Litigation

Case Name	Date
CELGENE CORPORATION v. DR. REDDY'S LABORATORIES, LTD.	2019-07-12
Celgene Corporation v. Amneal Pharmaceuticals LLC	2018-07-12
Celgene Corporation v. Aurobindo Pharma Limited	2018-07-06

See all OTEZLA litigation

Pharmacology for OTEZLA

Drug Class	Phosphodiesterase 4 Inhibitor
Mechanism of Action	Phosphodiesterase 4 Inhibitors

Synonyms for OTEZLA

(+)-N-(2-((1S)-1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl)-1,3-dioxo- 2,3-dihydro-1H-isoindol-4-yl)acetamide

(S)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione

(S)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione(Apremilast)

(S)-N-(2-(1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl)-1,3-dioxoisoindolin-4-yl)acetamide

(S)-N-{2-[1-(3-ethoxy-4-methoxy-phenyl)-2-methanesulfonyl-ethyl]-1,3-dioxo-2,3-dihydro-1H-isoindol-4-yl}-acetamide

4-[[5 pound not7-dihydroxy-2 pound not2-dimethyl-8-(2-methylpropanoyl)chromen-6-yl]methy l]-3 pound not5-dihydroxy-6 pound not6-dimethyl-2-(2-methylpropanoyl)cyclohexa-2 pound not4-dien- 1-one

608141-41-9

666854-78-0

AB0093139

AC-27650

Acetamide, N-(2-((1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl)- 2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl)-

AJ-84147

AKOS016339660

AOB87775

Apremilast

Apremilast (CC-10004)

Apremilast (JAN/USAN)

Apremilast [USAN:INN]

Apremilast/CC 10004/

apremilastum

BC600507

BCP03783

BCP0726000109

BCP25283

BCP9000311

BDBM50248919

C22H24N2O7S

cas:608141-41-9;Apremilast

CC 10004

CC-10004

CC10004

CHEBI:78540

CHEMBL514800

CS-0671

D08860

DB05676

EX-A336

FK-0727

FT-0700081

GTPL7372

HSDB 8221

HY-12085

IMOZEMNVLZVGJZ-QGZVFWFLSA-N

KB-74720

MolPort-023-219-158

N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-1,3-dioxoisoindol-4-yl]acetamide

N-{2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-1,3-dioxo-2,3-dihydro-1H-isoindol-4-yl}acetamide

N-{2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-methanesulfonylethyl]-1,3-dioxo-2,3-dihydro-1H-isoindol-4-yl}acetamide

Otezla (TN)

QCR-202

S-7765

s8034

SB16492

SC-95443

SCHEMBL302992

SW219856-1

UNII-N5UK68MGDZ component IMOZEMNVLZVGJZ-QGZVFWFLSA-N

UNII-UP7QBP99PN

UP7QBP99PN

Y0437

ZINC30691736

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		RX	Yes	Yes
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-002	Mar 21, 2014		RX	Yes	No
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-001	Mar 21, 2014		RX	Yes	No
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-002	Mar 21, 2014		RX	Yes	No
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-003	Mar 21, 2014		RX	Yes	Yes			Y	Y
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-001	Mar 21, 2014		RX	Yes	No
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-001	Mar 21, 2014		RX	Yes	No			Y	Y

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
South Korea	20100040938
China	1652772
Canada	2756798
New Zealand	535798
European Patent Office	1485087
Mexico	2015008685
Slovenia	2223687

Supplementary Protection Certificates for OTEZLA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2962690	37/2019	Austria		PRODUCT NAME: APREMILAST ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/981 (MITTEILUNG) 20150116
2962690	122019000070	Germany		PRODUCT NAME: APREMILAST ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; 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
2962690	LUC00125	Luxembourg		PRODUCT NAME: APREMILAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/14/981 20150116
2962690	132019000000096	Italy		PRODUCT NAME: APREMILAST(OTEZLA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/981, 20150116
2962690	2019C/008	Belgium		PRODUCT NAME: APREMILAST,OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/14/981 20150116
2962690	300994	Netherlands		PRODUCT NAME: APREMILAST OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/14/981 20150116