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Otezla patents expiration

OTEZLA's oppositions filed in EPO
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US6020358 AMGEN INC Substituted phenethylsulfones and method of reducing TNFα levels
Oct, 2018

(5 years ago)

US7893101 AMGEN INC Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, compositions thereof, and uses thereof
Dec, 2023

(4 months ago)

US7427638 AMGEN INC (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione:, and methods of synthesis and compositions thereof
Feb, 2028

(3 years from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7208516 AMGEN INC Methods of the treatment of psoriatic arthritis using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione
Mar, 2023

(1 year, 1 month ago)

US8802717 AMGEN INC Methods of treating arthritic conditions using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline 1,3-dione
Mar, 2023

(1 year, 1 month ago)

US7659302 AMGEN INC Methods of using (+)-2-[1-(3-ethoxy-4 methoxyphenyl)-2-methylsulfonylethyl]-4 acetylaminoisoindoline 1,3-dione
Mar, 2023

(1 year, 1 month ago)

US8455536 AMGEN INC Methods of using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline 1,3-dione
Mar, 2023

(1 year, 1 month ago)

US6962940 AMGEN INC (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione: methods of using and compositions thereof
Mar, 2023

(1 year, 1 month ago)

US9724330 AMGEN INC Methods of using (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione
Mar, 2023

(1 year, 1 month ago)

US9018243 AMGEN INC Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, compositions thereof, and uses thereof
Mar, 2023

(1 year, 1 month ago)

US10092541 AMGEN INC Methods for the treatment of diseases ameliorated by PDE4 inhibition using dosage titration of apremilast
May, 2034

(10 years from now)

US9872854 AMGEN INC Methods for the treatment of psoriatic arthritis using apremilast
May, 2034

(10 years from now)

Otezla is owned by Amgen Inc.

Otezla contains Apremilast.

Otezla has a total of 12 drug patents out of which 9 drug patents have expired.

Expired drug patents of Otezla are:

  • US7208516
  • US8802717
  • US7659302
  • US8455536
  • US6962940
  • US9724330
  • US9018243
  • US6020358
  • US7893101

Otezla was authorised for market use on 21 March, 2014.

Otezla is available in tablet;oral dosage forms.

Otezla can be used as use of otezla (apremilast) for inhibiting pde4, treatment of adult patients with oral ulcers associated with behcet's disease using a dosage titration schedule, treatment of psoriatic arthritis with apremilast using a dosage titration schedule and a second active agent, treatment of patients with plaque psoriasis who are candidates for phototherapy or systemic therapy, use of otezla (apremilast) for the treatment of psoriatic arthritis.

Drug patent challenges can be filed against Otezla from 21 March, 2018.

The generics of Otezla are possible to be released after 29 May, 2034.

Drug Exclusivity Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-248) Jul 19, 2026
New Indication(I-884) Dec 20, 2024
M(M-299) Jul 20, 2026
New Chemical Entity Exclusivity(NCE) Mar 21, 2019
New Indication(I-694) Sep 23, 2017
New Indication(I-803) Jul 19, 2022
M(M-257) Apr 10, 2023

Drugs and Companies using APREMILAST ingredient

NCE-1 date: 21 March, 2018

Market Authorisation Date: 21 March, 2014

Treatment: Use of otezla (apremilast) for the treatment of psoriatic arthritis; Treatment of patients with plaque psoriasis who are candidates for phototherapy or systemic therapy; Use of otezla (apremilast) for...

Dosage: TABLET;ORAL

How can I launch a generic of OTEZLA before it's drug patent expiration?
More Information on Dosage

OTEZLA family patents

Family Patents