OPSYNVI Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Opsynvi, and what generic alternatives are available?
Opsynvi is a drug marketed by Actelion and is included in one NDA. There are three patents protecting this drug.
This drug has ninety-four patent family members in thirty-two countries.
The generic ingredient in OPSYNVI is macitentan; tadalafil. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the macitentan; tadalafil profile page.
DrugPatentWatch® Generic Entry Outlook for Opsynvi
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be March 22, 2031. This may change due to patent challenges or generic licensing.
There have been five 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.
Indicators of Generic Entry
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for OPSYNVI?
- What are the global sales for OPSYNVI?
- What is Average Wholesale Price for OPSYNVI?
Summary for OPSYNVI
| International Patents: | 94 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Drug Prices: | Drug price information for OPSYNVI |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OPSYNVI |
| What excipients (inactive ingredients) are in OPSYNVI? | OPSYNVI excipients list |
| DailyMed Link: | OPSYNVI at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for OPSYNVI
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for OPSYNVI
| Drug Class | Endothelin Receptor Antagonist Phosphodiesterase 5 Inhibitor |
| Mechanism of Action | Endothelin Receptor Antagonists Phosphodiesterase 5 Inhibitors |
US Patents and Regulatory Information for OPSYNVI
OPSYNVI is protected by three US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of OPSYNVI is ⤷ Sign Up.
This potential generic entry date is based on CHRONIC TREATMENT OF ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH, WHO GROUP I AND WHO FUNCTIONAL CLASS (FC) II-III).
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting OPSYNVI
Stable pharmaceutical compositions comprising a pyrimidine-sulfamide
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF THE COMBINATION OF MACITENTAN AND TADALAFIL FOR THE CHRONIC TREATMENT OF ADULTS WITH PULMONARY ARTERIAL HYPERTENSION
Sulfamides and their use as endothelin receptor antagonists
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A COMBINATION OF MACITENTAN AND TADALAFIL
FDA Regulatory Exclusivity protecting OPSYNVI
NEW PRODUCT
Exclusivity Expiration: ⤷ Sign Up
CHRONIC TREATMENT OF ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH, WHO GROUP I AND WHO FUNCTIONAL CLASS (FC) II-III)
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Actelion | OPSYNVI | macitentan; tadalafil | TABLET;ORAL | 218490-001 | Mar 22, 2024 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Actelion | OPSYNVI | macitentan; tadalafil | TABLET;ORAL | 218490-002 | Mar 22, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Actelion | OPSYNVI | macitentan; tadalafil | TABLET;ORAL | 218490-001 | Mar 22, 2024 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for OPSYNVI
When does loss-of-exclusivity occur for OPSYNVI?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 2501
Patent: COMPOSICIONES TERAPEUTICAS
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 07290099
Patent: Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0715698
Patent: produto, composiÇço farmacÊutica que o contÉm e uso de composto
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 59770
Patent: COMPOSITIONS THERAPEUTIQUES (THERAPEUTIC COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 07002494
Patent: COMPOSICION FARMACEUTICA QUE COMPRENDE UNA PIRIMIDINA TRISUSTITUIDA EN COMBINACION CON UN COMPUESTO CON PROPIEDADES INHIBITORIAS DE PDE5; Y USO EN EL TRATAMIENTO DE UNA ENFERMEDAD QUE INVOLUCRE VASOCONSTRICCION.
Estimated Expiration: ⤷ Sign Up
China
Patent: 1511365
Patent: Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0131233
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 14735
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 59246
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 59246
Patent: Compositions thérapeutiques comprenant une antagoniste spécifique pour les récepteurs à l'endothéline et un inhibiteur de la PDE5 (Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 33597
Patent: THERAPEUTIC COMPOSITIONS COMPRISING A SPECIFIC ENDOTHELIN RECEPTOR ANTAGONIST AND A PDE5 INHIBITOR
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 7235
Patent: תכשירים רפואיים ומוצר המכילים מרכיבים בעלי תכונות מעכבי pde5, ושימוש בהם ביצור תרופות (Therapeutic compositions and products comprising compounds having pde5-inhibitory properties and their use in the manufacture of medicaments)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 08113
Estimated Expiration: ⤷ Sign Up
Patent: 10502588
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 4591
Patent: THERAPEUTIC COMPOSITIONS COMPRISING A SPECIFIC ENDOTHELIN RECEPTOR ANTAGONIST AND A PDE5 INHIBITOR
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 09002057
Patent: COMPOSICIONES TERAPEUTICAS QUE COMPRENDEN UN ANTAGONISTA DEL RECEPTOR DE ENDOTELINA ESPECIFICO Y UN INHIBIDOR PDE5. (THERAPEUTIC COMPOSITIONS.)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 704
Patent: COMPOSITIONS THERAPEUTIQUES
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 5702
Patent: THERAPEUTIC COMPOSITIONS COMPRISING A SPECIFIC ENDOTHELIN RECEPTOR ANTAGONIST AND A PDE5 INHIBITOR
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 2554
Estimated Expiration: ⤷ Sign Up
Patent: 091254
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 59246
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 59246
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 62249
Patent: ТЕРАПЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ СПЕЦИФИЧЕСКИЙ АНТАГОНИСТ РЕЦЕПТОРА ЭНДОТЕЛИНА И ИНГИБИТОР PDE5 (THERAPEUTIC COMPOSITIONS CONTAINING SPECIFIC ENDOTHELIN RECEPTOR ANTAGONIST AND PDE5 INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Patent: 09111378
Patent: ТЕРАПЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ СПЕЦИФИЧЕСКИЙ АНТАГОНИСТ РЕЦЕПТОРА ЭНДОТЕЛИНА И ИНГИБИТОРОВ PDE5
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 59246
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 0902164
Patent: Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1473022
Estimated Expiration: ⤷ Sign Up
Patent: 090057009
Patent: THERAPEUTIC COMPOSITIONS
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 38792
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 88556
Estimated Expiration: ⤷ Sign Up
Patent: 0823198
Patent: Therapeutic compositions
Estimated Expiration: ⤷ Sign Up
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 OPSYNVI around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 101511365 | Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 02053557 | ⤷ Sign Up | |
| Norway | 20091254 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OPSYNVI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1345920 | CR 2014 00012 | Denmark | ⤷ Sign Up | PRODUCT NAME: MACITENTAN OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/13/893 20131227 |
| 1345920 | 14C0017 | France | ⤷ Sign Up | PRODUCT NAME: MACITENTAN ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/893 20131220 |
| 1345920 | 132014902244514 | Italy | ⤷ Sign Up | PRODUCT NAME: MACITENTAN(OPSUMIT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/893/001-002, 20131220 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - Digital Marketing for Life Sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
