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Last Updated: November 2, 2024

APREMILAST Drug Patent Profile


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

Apremilast is a drug marketed by Alkem Labs Ltd, Amneal, Annora, Aurobindo Pharma Ltd, Dr Reddys, Glenmark Pharms Ltd, Mankind Pharma, Shilpa, Teva Pharms Usa Inc, and Unichem. and is included in ten NDAs.

The generic ingredient in APREMILAST 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 Apremilast

A generic version of APREMILAST was approved as apremilast by ALKEM LABS LTD on September 21st, 2021.

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Drug patent expirations by year for APREMILAST
Recent Clinical Trials for APREMILAST

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

SponsorPhase
TakedaPhase 3
Assiut UniversityPhase 1
Humanis Saglık Anonim SirketiPhase 3

See all APREMILAST clinical trials

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
Unichem APREMILAST apremilast TABLET;ORAL 211819-001 Feb 17, 2021 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Unichem APREMILAST apremilast TABLET;ORAL 211819-002 Feb 17, 2021 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alkem Labs Ltd APREMILAST apremilast TABLET;ORAL 211761-001 Sep 21, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Glenmark Pharms Ltd APREMILAST apremilast TABLET;ORAL 211674-003 Oct 16, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

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