APREMILAST - Generic Drug Details
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What are the generic sources for apremilast and what is the scope of freedom to operate?
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: | 116 |
Patent Applications: | 1,657 |
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 |
---|---|
Takeda | Phase 3 |
Assiut University | Phase 1 |
Humanis Saglık Anonim Sirketi | Phase 3 |
Generic filers with tentative approvals for APREMILAST
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 30MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 20MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 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
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-001 | Mar 21, 2014 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Dr Reddys | APREMILAST | apremilast | TABLET;ORAL | 211756-001 | Jul 14, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Amneal | APREMILAST | apremilast | TABLET;ORAL | 211782-001 | Jun 30, 2021 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Aurobindo Pharma Ltd | APREMILAST | apremilast | TABLET;ORAL | 211716-003 | Jul 19, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
>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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-002 | Mar 21, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |
International Patents for APREMILAST
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20100040938 | (+)-2-[1-(3-ETHOXY-4-METHOXYPHENYL)-2-METHYLSULFONYLETHYL]-4-ACETYLAMINOISOINDOLINE-1,3-DIONE: METHODS OF USING AND COMPOSITIONS THEREOF | ⤷ Sign Up |
New Zealand | 535798 | (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione: methods of using and compositions thereof | ⤷ Sign Up |
South Korea | 20110022736 | (+)-2-[1-(3-ETHOXY-4-METHOXYPHENYL)-2-METHYLSULFONYLETHYL]-4-ACETYLAMINOISOINDOLINE-1,3-DIONE: METHODS OF USING AND COMPOSITIONS THEREOF | ⤷ Sign Up |
South Korea | 20050012722 | ⤷ Sign Up | |
Australia | 2003224729 | (+)-2-(1-(3-ETHOXY-4-METHOXYPHENYL)-2-METHYLSULFONYLETHYL)-4-ACETYLAMINOISOINDOLINE-1,3-DIONE: METHODS OF USING AND COMPOSITIONS THEREOF | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for APREMILAST
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2962690 | 365 14-2019 | Slovakia | ⤷ Sign Up | PRODUCT NAME: APREMILAST VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/981 20150116 |
2962690 | CA 2019 00033 | Denmark | ⤷ Sign Up | PRODUCT NAME: APREMILAST ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/981 20150116 |
2962690 | C 2019 032 | Romania | ⤷ Sign Up | PRODUCT NAME: APREMILAST SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/14/981; DATE OF NATIONAL AUTHORISATION: 20150115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/981; DATE OF FIRST AUTHORISATION IN EEA: 20150115 |
2962690 | 300994 | Netherlands | ⤷ Sign Up | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT |
2962690 | SPC/GB19/045 | United Kingdom | ⤷ Sign Up | 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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