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Ambrisentan - Generic Drug Details
What are the generic sources for ambrisentan and what is the scope of ambrisentan freedom to operate?
Ambrisentan
is the generic ingredient in one branded drug marketed by Gilead and is included in one NDA. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.There are nine drug master file entries for ambrisentan. One supplier is listed for this compound.
Summary for ambrisentan
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 9 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 66 |
| Clinical Trials: | 51 |
| Patent Applications: | 1,681 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ambrisentan |
| DailyMed Link: | ambrisentan at DailyMed |
Pharmacology for ambrisentan
| Drug Class | Endothelin Receptor Antagonist |
| Mechanism of Action | Endothelin Receptor Antagonists |
Synonyms for ambrisentan
| (+-)-(2S)-2-((4,6-Dimethylpyrimidin-2-yl)oxy)-3-methoxy-3,3-diphenylpropanoic acid |
| (2S)-2-(4,6-dimethylpyrimidin-2-yl)oxy-3-methoxy-3,3-di(phenyl)propanoic acid |
| (2S)-2-(4,6-dimethylpyrimidin-2-yl)oxy-3-methoxy-3,3-diphenyl-propanoic acid |
| (2S)-2-(4,6-dimethylpyrimidin-2-yl)oxy-3-methoxy-3,3-diphenylpropanoic acid |
| (2S)-2-[(4,6-dimethyl-2-pyrimidinyl)oxy]-3-methoxy-3,3-diphenylpropanoic acid |
| (2S)-2-[(4,6-dimethylpyrimidin-2-yl)oxy]-3-methoxy- 3,3-diphenylpropanoic acid |
| (S)-2-((4,6-Dimethylpyrimidin-2-yl)oxy)-3-methoxy-3,3-diphenylpropanoic acid |
| (S)-2-(4,6-Dimethyl-pyrimidin-2-yloxy)-3-methoxy-3,3-diphenyl-propionic acid |
| (S)-2-(4,6-Dimethylpyrimidin-2-yloxy)-3-methoxy-3,3-diphenylpropanoic acid |
| (s)-2-[(4,6-dimethylpyrimidin-2-yl)oxy]-3-methoxy-3,3-diphenylpropionic acid |
| 177036-94-1 |
| 2-(4,6-dimethylpyrimidin-2-yl)oxy-3-methoxy-3,3-diphenyl-propanoic acid |
| 2-(4,6-dimethylpyrimidin-2-yl)oxy-3-methoxy-3,3-diphenylpropanoic acid |
| 2-[(4,6-dimethylpyrimidin-2-yl)oxy]-3-methoxy-3,3-diphenylpropanoic acid |
| A812234 |
| AB0009811 |
| AB01566890_01 |
| AB2000501 |
| AC-9015 |
| AC1OCFHZ |
| AJ-23403 |
| AK-38379 |
| AKOS015994540 |
| Ambrisentan (JAN/INN) |
| Ambrisentan [INN:BAN:JAN] |
| Ambrisentan [INN] |
| ANW-59416 |
| AX8118907 |
| BC224510 |
| BDBM50146710 |
| Benzenepropanoic acid, .alpha.-[(4,6-dimethyl-2-pyrimidinyl)oxy]-.beta.-methoxy-.beta.-phe |
| BSF 208075 |
| BSF 208075;AMBRISENTAN |
| BSF-208075 |
| BSF208075 |
| CA0131 |
| CAS-177036-94-1 |
| CHEBI:135949 |
| CHEMBL1111 |
| CS-0447 |
| CTK8B8152 |
| D07077 |
| D0X5ZI |
| DB06403 |
| DE-0223 |
| DSSTox_CID_26282 |
| DSSTox_GSID_46282 |
| DSSTox_RID_81508 |
| DTXSID4046282 |
| FD7219 |
| FT-0650339 |
| Gilead brand of ambrisentan |
| GTPL3951 |
| HE167810 |
| HW6NV07QEC |
| HY-13209 |
| J-519579 |
| K-5435 |
| KS-00000FU3 |
| Letairis |
| Letairis (TN) |
| LU 208075 |
| LU-208075 |
| LU208075 |
| MFCD08672619 |
| MLS006010218 |
| MolPort-005-942-453 |
| NCGC00160662-01 |
| NCGC00160662-02 |
| NCGC00346730-01 |
| OUJTZYPIHDYQMC-LJQANCHMSA-N |
| PubChem18318 |
| s2097 |
| SCHEMBL3679 |
| SMR004701307 |
| TC-148161 |
| Tox21_111967 |
| Tox21_111967_1 |
| UNII-7B43003091 component OUJTZYPIHDYQMC-LJQANCHMSA-N |
| UNII-HW6NV07QEC |
| Volibris |
| Volibris (TN) |
| ZINC538627 |
US Patents and Regulatory Information for ambrisentan
| 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 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Gilead | LETAIRIS | ambrisentan | TABLET;ORAL | 022081-001 | Jun 15, 2007 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Gilead | LETAIRIS | ambrisentan | TABLET;ORAL | 022081-002 | Jun 15, 2007 | 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 ambrisentan
| 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 | 022081-001 | Jun 15, 2007 | ➤ Sign Up | ➤ Sign Up |
| Gilead | LETAIRIS | ambrisentan | TABLET;ORAL | 022081-002 | Jun 15, 2007 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for ambrisentan
Supplementary Protection Certificates for ambrisentan
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 0361 | Netherlands | ➤ Sign Up | 300361, 20151007, EXPIRES: 20201006 |
| 487 | Luxembourg | ➤ Sign Up | 91487, EXPIRES: 20201007 |
| C/GB08/047 | United Kingdom | ➤ Sign Up | PRODUCT NAME: AMBRISENTAN; REGISTERED: UK EU/1/08/451/001 20080421; UK EU/1/08/451/002 20080421; UK EU/1/08/451/003 20080421; UK EU/1/08/451/004 20080421 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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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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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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