Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Merck
AstraZeneca
Moodys
Mallinckrodt
Dow
Johnson and Johnson

Last Updated: August 19, 2022

OPSUMIT Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


Which patents cover Opsumit, and when can generic versions of Opsumit launch?

Opsumit is a drug marketed by Actelion and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-four patent family members in thirty-two countries.

The generic ingredient in OPSUMIT is macitentan. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the macitentan profile page.

DrugPatentWatch® Generic Entry Outlook for Opsumit

Opsumit was eligible for patent challenges on October 18, 2017.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are two tentative approvals for the generic drug (macitentan), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

< Available with Subscription >

  Try it Free

Drug patent expirations by year for OPSUMIT
Drug Prices for OPSUMIT

See drug prices for OPSUMIT

Recent Clinical Trials for OPSUMIT

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

SponsorPhase
Janssen, LPPhase 4
American Heart AssociationPhase 4
Janssen Pharmaceutical K.K.Phase 3

See all OPSUMIT clinical trials

Pharmacology for OPSUMIT
Paragraph IV (Patent) Challenges for OPSUMIT
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
OPSUMIT Tablets macitentan 10 mg 204410 11 2017-10-18

US Patents and Regulatory Information for OPSUMIT

OPSUMIT is protected by five US patents.

Patents protecting OPSUMIT

Stable pharmaceutical compositions comprising a pyrimidine-sulfamide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING MACITENTAN AND A POLYSORBATE, WHERIN THE POLYSORBATE REPRESENTS 0.1 TO 1% OF THE WEIGHT OF SAID PHARMACEUTICAL COMPOSITION

Sulfamides and their use as endothelin receptor antagonists
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING ADMINISTERING MACITENTAN IN COMBINATION WITH A COMPOUND HAVING PHOSPHODIESTERASE-5 INHIBITORY PROPERTIES

Stable pharmaceutical compositions comprising a pyrimidine-sulfamide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING MACITENTAN AND A POLYSORBATE, WHERIN THE POLYSORBATE REPRESENTS 0.1 TO 1% OF THE WEIGHT OF SAID PHARMACEUTICAL COMPOSITION

Stable pharmaceutical compositions comprising a pyrimidine-sulfamide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: 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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actelion OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Actelion OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Actelion OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Actelion OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Actelion OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 OPSUMIT

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Janssen-Cilag International N.V.   Opsumit macitentan EMEA/H/C/002697
Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III.Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.
Authorised no no yes 2013-12-20
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for OPSUMIT

When does loss-of-exclusivity occur for OPSUMIT?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 2501
Estimated Expiration: See Plans and Pricing

Australia

Patent: 07290099
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0715698
Estimated Expiration: See Plans and Pricing

Canada

Patent: 59770
Estimated Expiration: See Plans and Pricing

Chile

Patent: 07002494
Estimated Expiration: See Plans and Pricing

China

Patent: 1511365
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0131233
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 14735
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 59246
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 59246
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 33597
Estimated Expiration: See Plans and Pricing

Israel

Patent: 7235
Estimated Expiration: See Plans and Pricing

Japan

Patent: 08113
Estimated Expiration: See Plans and Pricing

Patent: 10502588
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 4591
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 09002057
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 704
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 5702
Estimated Expiration: See Plans and Pricing

Norway

Patent: 2554
Estimated Expiration: See Plans and Pricing

Patent: 091254
Estimated Expiration: See Plans and Pricing

Poland

Patent: 59246
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 59246
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 62249
Estimated Expiration: See Plans and Pricing

Patent: 09111378
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 59246
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0902164
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1473022
Estimated Expiration: See Plans and Pricing

Patent: 090057009
Estimated Expiration: See Plans and Pricing

Spain

Patent: 38792
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 88556
Estimated Expiration: See Plans and Pricing

Patent: 0823198
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering OPSUMIT around the world.

Country Patent Number Title Estimated Expiration
Germany 60118782 See Plans and Pricing
Malaysia 129150 NOVEL SULFAMIDES See Plans and Pricing
Norway 324952 See Plans and Pricing
European Patent Office 1345920 NOUVEAUX SULFAMIDES ET LEUR UTILISATION COMME ANTAGONISTES DU RECEPTEUR DE L'ENDOTHELINE (NOVEL SULFAMIDES AND THEIR USE AS ENDOTHELIN RECEPTOR ANTAGONISTS) See Plans and Pricing
Australia 2002227984 See Plans and Pricing
Malaysia 154591 THERAPEUTIC COMPOSITIONS COMPRISING A SPECIFIC ENDOTHELIN RECEPTOR ANTAGONIST AND A PDE5 INHIBITOR See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for OPSUMIT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1345920 CR 2014 00012 Denmark See Plans and Pricing PRODUCT NAME: MACITENTAN OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/13/893 20131227
1345920 132014902244514 Italy See Plans and Pricing PRODUCT NAME: MACITENTAN(OPSUMIT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/893/001-002, 20131220
1345920 300672 Netherlands See Plans and Pricing PRODUCT NAME: MACITENTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220
1345920 92381 Luxembourg See Plans and Pricing PRODUCT NAME: MACITENTAN ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES(OPSUMIT)
1345920 2014C/019 Belgium See Plans and Pricing PRODUCT NAME: MACITENTAN ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/13/893 20131227
1345920 C300672 Netherlands See Plans and Pricing PRODUCT NAME: MACITENTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Express Scripts
Boehringer Ingelheim
McKesson
Colorcon
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.