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Opsumit patents expiration

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.
US7094781 ACTELION Sulfamides and their use as endothelin receptor antagonists
Dec, 2025

(1 year, 5 months from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10946015 ACTELION Stable pharmaceutical compositions comprising a pyrimidine-sulfamide
Sep, 2026

(2 years from now)

US9265762 ACTELION Stable pharmaceutical compositions comprising a pyrimidine-sulfamide
May, 2027

(2 years from now)

US8367685 ACTELION Stable pharmaceutical compositions comprising a pyrimidine-sulfamide
Oct, 2028

(4 years from now)

US8268847 ACTELION Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor
Apr, 2029

(4 years from now)

Opsumit is owned by Actelion.

Opsumit contains Macitentan.

Opsumit has a total of 5 drug patents out of which 0 drug patents have expired.

Opsumit was authorised for market use on 18 October, 2013.

Opsumit is available in tablet;oral dosage forms.

Opsumit can be used as method of treating pulmonary hypertension comprising administering macitentan in combination with a compound having phosphodiesterase-5 inhibitory properties, method of treating pulmonary arterial hypertension by administering a pharmaceutical composition comprising macitentan and a polysorbate, wherein the polysorbate represents 0.1 to 3% of the weight of said pharmaceutical composition, method of treating pulmonary arterial hypertension by administering a pharmaceutical composition comprising macitentan and a polysorbate, wherein the polysorbate represents 0.1 to 1% of the weight of said pharmaceutical composition.

Drug patent challenges can be filed against Opsumit from 18 October, 2017.

The generics of Opsumit are possible to be released after 18 April, 2029.

Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Oct 18, 2018
Orphan Drug Exclusivity(ODE) Oct 18, 2020
Orphan Drug Exclusivity(ODE-54) Oct 18, 2020

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Drugs and Companies using MACITENTAN ingredient

NCE-1 date: 18 October, 2017

Market Authorisation Date: 18 October, 2013

Treatment: Method of treating pulmonary arterial hypertension by administering a pharmaceutical composition comprising macitentan and a polysorbate, wherein the polysorbate represents 0.1 to 1% of the weight of ...

Dosage: TABLET;ORAL

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

OPSUMIT family patents

Family Patents