LETAIRIS Drug Patent Profile
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When do Letairis patents expire, and when can generic versions of Letairis launch?
Letairis is a drug marketed by Gilead and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.
This drug has fifty-one patent family members in twenty-six countries.
The generic ingredient in LETAIRIS is ambrisentan. There are nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the ambrisentan profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Letairis
A generic version of LETAIRIS was approved as ambrisentan by MYLAN on March 28th, 2019.
Summary for LETAIRIS
International Patents: | 51 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 88 |
Clinical Trials: | 23 |
Patent Applications: | 2,556 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for LETAIRIS |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LETAIRIS |
What excipients (inactive ingredients) are in LETAIRIS? | LETAIRIS excipients list |
DailyMed Link: | LETAIRIS at DailyMed |
Recent Clinical Trials for LETAIRIS
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Ochsner Health System | Phase 4 |
Medical University of South Carolina | Phase 4 |
Gilead Sciences | Phase 1 |
Pharmacology for LETAIRIS
Drug Class | Endothelin Receptor Antagonist |
Mechanism of Action | Endothelin Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for LETAIRIS
Paragraph IV (Patent) Challenges for LETAIRIS
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
LETAIRIS | Tablets | ambrisentan | 5 mg and 10 mg | 022081 | 1 | 2015-02-09 |
US Patents and Regulatory Information for LETAIRIS
LETAIRIS is protected by three US patents.
Patents protecting LETAIRIS
Method for treating a pulmonary hypertension condition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: FOR THE TREATMENT OF PULMONARY HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL
Method for treating a pulmonary hypertension condition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: FOR THE TREATMENT OF PULMONARY HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL
Compositions and methods of treating pulmonary hypertension
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL, WHEREIN THE WEIGHT RATIO OF AMBRISENTAN TO TADALAFIL IS ABOUT 1:2 TO ABOUT 1:3
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Gilead | LETAIRIS | ambrisentan | TABLET;ORAL | 022081-001 | Jun 15, 2007 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Gilead | LETAIRIS | ambrisentan | TABLET;ORAL | 022081-002 | Jun 15, 2007 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Gilead | LETAIRIS | ambrisentan | TABLET;ORAL | 022081-001 | Jun 15, 2007 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Gilead | LETAIRIS | ambrisentan | TABLET;ORAL | 022081-001 | Jun 15, 2007 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Gilead | LETAIRIS | ambrisentan | TABLET;ORAL | 022081-002 | Jun 15, 2007 | AB | RX | Yes | Yes | ⤷ 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 |
Expired US Patents for LETAIRIS
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Gilead | LETAIRIS | ambrisentan | TABLET;ORAL | 022081-001 | Jun 15, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Gilead | LETAIRIS | ambrisentan | TABLET;ORAL | 022081-002 | Jun 15, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Gilead | LETAIRIS | ambrisentan | TABLET;ORAL | 022081-002 | Jun 15, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Gilead | LETAIRIS | ambrisentan | TABLET;ORAL | 022081-001 | Jun 15, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Gilead | LETAIRIS | ambrisentan | TABLET;ORAL | 022081-001 | Jun 15, 2007 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for LETAIRIS
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
GlaxoSmithKline (Ireland) Limited | Volibris | ambrisentan | EMEA/H/C/000839 Volibris is indicated for treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment (see section 5.1). Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.Volibris is indicated for treatment of PAH in adolescents and children (aged 8 to less than 18 years) of WHO Functional Class (FC) II to III including use in combination treatment. Efficacy has been shown in IPAH, familial, corrected congenital and in PAH associated with connective tissue disease (see section 5.1). |
Authorised | no | no | no | 2008-04-20 | |
Mylan S.A.S | Ambrisentan Mylan | ambrisentan | EMEA/H/C/004985 Ambrisentan Mylan is indicated for the treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.Ambrisentan Mylan is indicated for the treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease. |
Authorised | yes | no | no | 2019-06-20 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for LETAIRIS
When does loss-of-exclusivity occur for LETAIRIS?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 07333115
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 69536
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 16597
Estimated Expiration: ⤷ Sign Up
Patent: 16017
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 01777
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 01777
Estimated Expiration: ⤷ Sign Up
Patent: 52193
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 18393
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 25355
Estimated Expiration: ⤷ Sign Up
Patent: 600027
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 10512414
Estimated Expiration: ⤷ Sign Up
Luxembourg
Patent: 081
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 01777
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 01777
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 01777
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 44724
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 LETAIRIS around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 9526716 | ⤷ Sign Up | |
South Africa | 9502614 | ⤷ Sign Up | |
Japan | 2007169295 | PHARMACEUTICAL COMPOSITION | ⤷ Sign Up |
Serbia | 56135 | KOMPOZICIJE I METODE ZA LEČENJE PLUĆNE HIPERTENZIJE (COMPOSITIONS AND METHODS OF TREATING PULMONARY HYPERTENSION) | ⤷ Sign Up |
Portugal | 752854 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LETAIRIS
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2101777 | 2016C/032 | Belgium | ⤷ Sign Up | PRODUCT NAME: AMBRISENTAN EN COMBINAISON AVEC LE TADALAFIL; AUTHORISATION NUMBER AND DATE: EU/1/08/451 20151125 |
0785926 | SPC029/2008 | Ireland | ⤷ Sign Up | SPC029/2008: 20091119, EXPIRES: 20201006 |
2101777 | 93081 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125 |
2101777 | C20160017 00199 | Estonia | ⤷ Sign Up | PRODUCT NAME: AMBRISENTAAN;REG NO/DATE: EU/1/08/451 25.11.2015 |
0785926 | C00785926/01 | Switzerland | ⤷ Sign Up | FORMER OWNER: ABBVIE DEUTSCHLAND GMBH AND CO. KG, DE |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |