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Generated: July 22, 2017
What are the generic drug sources for ambrisentan and what is the scope of ambrisentan patent protection?
Ambrisentan is the generic ingredient in one branded drug marketed by Gilead and is included in one NDA. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 1 |
| Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: see list | 8 |
| Suppliers / Packagers: see list | 1 |
| Bulk Api Vendors: see list | 53 |
| Clinical Trials: see list | 50 |
| Patent Applications: see list | 1,390 |
| Therapeutic Class: | Respiratory Tract Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | ambrisentan at DailyMed |
| Drug Class | Endothelin Receptor Antagonist |
| Mechanism of Action | Endothelin Receptor Antagonists |
| 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 | 022081-002 | Jun 15, 2007 | RX | Yes | Yes | 9,549,926 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Gilead | LETAIRIS | ambrisentan | TABLET;ORAL | 022081-001 | Jun 15, 2007 | RX | Yes | No | 9,549,926 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Gilead | LETAIRIS | ambrisentan | TABLET;ORAL | 022081-001 | Jun 15, 2007 | RX | Yes | No | 9,474,752 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Gilead | LETAIRIS | ambrisentan | TABLET;ORAL | 022081-002 | Jun 15, 2007 | RX | Yes | Yes | ► Subscribe | ► Subscribe | |||||||||||||||||||
Gilead | LETAIRIS | ambrisentan | TABLET;ORAL | 022081-001 | Jun 15, 2007 | RX | Yes | No | 8,377,933 | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Gilead | LETAIRIS | ambrisentan | TABLET;ORAL | 022081-002 | Jun 15, 2007 | 8,349,843 | ► Subscribe | ||||||||||||||||||||||
Gilead | LETAIRIS | ambrisentan | TABLET;ORAL | 022081-001 | Jun 15, 2007 | 7,601,730 | ► Subscribe | ||||||||||||||||||||||
Gilead | LETAIRIS | ambrisentan | TABLET;ORAL | 022081-001 | Jun 15, 2007 | 8,349,843 | ► Subscribe | ||||||||||||||||||||||
Gilead | LETAIRIS | ambrisentan | TABLET;ORAL | 022081-002 | Jun 15, 2007 | 7,601,730 | ► Subscribe | ||||||||||||||||||||||
Gilead | LETAIRIS | ambrisentan | TABLET;ORAL | 022081-001 | Jun 15, 2007 | 5,703,017 | ► Subscribe | ||||||||||||||||||||||
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| RE42477 | Carboxylic acid derivatives, their preparation and use | ► Subscribe | |||||||||||||||||||||||||||
| 6,600,043 | Carboxylic acid derivatives, their preparation and use | ► Subscribe | |||||||||||||||||||||||||||
| 7,109,205 | Carboxylic acid derivatives, their preparation and use | ► Subscribe | |||||||||||||||||||||||||||
| 5,772,589 | Measurement process for blood gas analysis sensors | ► Subscribe | |||||||||||||||||||||||||||
| 7,119,097 | Carboxylic acid derivatives, their preparation and their use | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hungary | T77443 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 4512106 | ► Subscribe | |||||||||||||||||||||||||||
| Eurasian Patent Organization | 201390428 | ► Subscribe | |||||||||||||||||||||||||||
| Germany | 19512478 | ► Subscribe | |||||||||||||||||||||||||||
| New Zealand | 707213 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0813 | Netherlands | ► Subscribe | PRODUCT NAME: AMBRISENTAN TOEGEPAST IN COMBINATIEBEHANDELING MET TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 (C(2008) 1637) 20151125 | ||||||||||||||||||||||||||
| 2016000039 | Germany | ► Subscribe | PRODUCT NAME: AMBRISENTAN IN VERWENDUNG IN DER KOMBINATIONSTHERAPIE MIT TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 20151120 | ||||||||||||||||||||||||||
| 0361 | Netherlands | ► Subscribe | 300361, 20151007, EXPIRES: 20201006 | ||||||||||||||||||||||||||
| 487 | Luxembourg | ► Subscribe | 91487, EXPIRES: 20201007 | ||||||||||||||||||||||||||
| 081 | Luxembourg | ► Subscribe | PRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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.
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