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Last Updated: April 29, 2024

Apremilast - Generic Drug Details

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What are the generic sources for apremilast and what is the scope of patent protection?

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:	110
Patent Applications:	2,028
Formulation / Manufacturing:	see details
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
Wake Forest University Health Sciences	Early Phase 1
Amgen	Early Phase 1
Robert Micheletti	Phase 2

See all apremilast clinical trials

Generic filers with tentative approvals for APREMILAST

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	30MG	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	20MG	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	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	10	2018-03-22

US Patents and Regulatory Information for apremilast

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Shilpa	APREMILAST	apremilast	TABLET;ORAL	211774-002	Apr 7, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Shilpa	APREMILAST	apremilast	TABLET;ORAL	211774-001	Apr 7, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Annora	APREMILAST	apremilast	TABLET;ORAL	211878-002	Jul 26, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Amneal	APREMILAST	apremilast	TABLET;ORAL	211782-003	Jun 30, 2021		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Amneal	APREMILAST	apremilast	TABLET;ORAL	211782-001	Jun 30, 2021		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Shilpa	APREMILAST	apremilast	TABLET;ORAL	211774-003	Apr 7, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for apremilast

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-001	Mar 21, 2014	⤷ Try a Trial	⤷ Try a Trial
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-002	Mar 21, 2014	⤷ Try a Trial	⤷ Try a Trial
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-001	Mar 21, 2014	⤷ Try a Trial	⤷ Try a Trial
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-002	Mar 21, 2014	⤷ Try a Trial	⤷ Try a Trial
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-001	Mar 21, 2014	⤷ Try a Trial	⤷ Try a Trial
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-003	Mar 21, 2014	⤷ Try a Trial	⤷ Try a Trial
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-002	Mar 21, 2014	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for apremilast

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for apremilast

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Country	Patent Number	Title	Estimated Expiration
Hong Kong	1073426	(+)-2-[1-(3-ETHOXY-4-METHOXYPHENYL)-2-METHYLSULFONYLETHYL]-4-ACETYLAMINOIS OINDOLINE-1, 3-DIONE FOR USE IN TREATING PSORIASIS BY ORAL ADMINISTRATION	⤷ Try a Trial
Hungary	E045489		⤷ Try a Trial
South Korea	101104991		⤷ Try a Trial
Portugal	2223687		⤷ Try a Trial
Denmark	2420490		⤷ Try a Trial
Denmark	2295055		⤷ Try a Trial
Canada	2756798	(+)-2-[1-(3-ETHOXY-4-METHOXYPHENYL)-2-METHYLSULFONYLETHYL]-4-ACETYLAMINOISOINDOLINE-1,3-DIONE: LEURS PROCEDES D'UTILISATION ET LEURS COMPOSITIONS ((+)-2-[1-(3-ETHOXY-4-METHOXYPHENYL)-2-METHYLSULFONYLETHYL]-4-ACETYLAMINOISOINDOLINE-1,3-DIONE: METHODS OF USING AND COMPOSITIONS THEREOF)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for apremilast

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2962690	1990037-2	Sweden	⤷ Try a Trial	PRODUCT NAME: APREMILAST OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/14/981 20150116
2962690	37/2019	Austria	⤷ Try a Trial	PRODUCT NAME: APREMILAST ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/981 (MITTEILUNG) 20150116
2962690	CA 2019 00033	Denmark	⤷ Try a Trial	PRODUCT NAME: APREMILAST ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/981 20150116
2962690	C02962690/01	Switzerland	⤷ Try a Trial	VERTRETERLOESCHUNG
2962690	2019/037	Ireland	⤷ Try a Trial	PRODUCT NAME: APREMILAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/14/981 20150115
2962690	2019C/008	Belgium	⤷ Try a Trial	DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION
2962690	SPC/GB19/045	United Kingdom	⤷ Try a Trial	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.