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.
Summary for APREMILAST
| US Patents: | 0 |
| Applicants: | 10 |
| NDAs: | 10 |
| Raw Ingredient (Bulk) Api Vendors: | 86 |
| Clinical Trials: | 110 |
| Patent Applications: | 925 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for APREMILAST |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for APREMILAST
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
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Unichem | APREMILAST | apremilast | TABLET;ORAL | 211819-002 | Feb 17, 2021 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Alkem Labs Ltd | APREMILAST | apremilast | TABLET;ORAL | 211761-001 | Sep 21, 2021 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Glenmark Pharms Ltd | APREMILAST | apremilast | TABLET;ORAL | 211674-003 | Oct 16, 2023 | AB | RX | 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 | |||
| Annora | APREMILAST | apremilast | TABLET;ORAL | 211878-001 | Jul 26, 2023 | AB | RX | 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 | ||||
| >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 |
