Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Baxter
McKinsey
Medtronic
Dow
Express Scripts
Johnson and Johnson

Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Ambrisentan - Generic Drug Details

See Plans and Pricing

« Back to Dashboard

What are the generic drug sources for ambrisentan and what is the scope of patent protection?

Ambrisentan is the generic ingredient in two branded drugs marketed by Cipla, Mylan, Par Pharm Inc, Sigmapharm Labs Llc, Sun Pharm, Watson Labs Inc, Zydus Pharms, and Gilead, and is included in eight NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ambrisentan has forty-nine patent family members in twenty-six countries.

There are nine drug master file entries for ambrisentan. Nine suppliers are listed for this compound.

Recent Clinical Trials for ambrisentan

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

SponsorPhase
Noorik Biopharmaceuticals AGPhase 2
United TherapeuticsPhase 3
Ochsner Health SystemPhase 4

See all ambrisentan clinical trials

Recent Litigation for ambrisentan

Identify potential future generic entrants

District Court Litigation
Case NameDate
GILEAD SCIENCES, INC. v. SIGMAPHARM LABORATORIES, LLC2015-06-30
GILEAD SCIENCES, INC. v. SIGMAPHARM LABORATORIES, LLC.

See all ambrisentan litigation

Pharmacology for ambrisentan
Synonyms for ambrisentan
(?S)-?-[(4,6-Dimethyl-2-pyrimidinyl)oxy]-?-methoxy-?-phenylbenzenepropanoic acid
(+-)-(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
A812234
AB0009811
AB01566890_01
AB2000501
AC-9015
AC1OCFHZ
AJ-23403
AK-38379
AKOS015994540
Ambrisentan (JAN/INN)
Ambrisentan [INN:BAN:JAN]
ANW-59416
AX8118907
BC224510
BDBM50146710
Benzenepropanoic acid, alpha-[(4,6-dimethyl-2-pyrimidinyl)oxy]-beta-methoxy-beta-phenyl-, (alphaS)-
BSF 208075
BSF 208075; Letairis; Volibris
BSF 208075;AMBRISENTAN
BSF-208075
CA0131
CAS-177036-94-1
CHEBI:135949
CHEMBL1111
CS-0447
CTK8B8152
D07077
DB06403
DE-0223
DSSTox_CID_26282
DSSTox_GSID_46282
DSSTox_RID_81508
DTXSID4046282
FD7219
FT-0650339
GTPL3951
HW6NV07QEC
HY-13209
J-519579
K-5435
KS-00000FU3
Letairis
Letairis (TN)
LU 208075
LU-208075
LU208075
MLS006010218
MolPort-005-942-453
NCGC00160662-01
NCGC00160662-02
NCGC00346730-01
OUJTZYPIHDYQMC-LJQANCHMSA-N
PubChem18318
s2097
SB17358
SCHEMBL3679
SMR004701307
SW219060-1
TC-148161
Tox21_111967
Tox21_111967_1
UNII-7B43003091 component OUJTZYPIHDYQMC-LJQANCHMSA-N
UNII-HW6NV07QEC
Volibris
Volibris (TN)
ZINC538627
Paragraph IV (Patent) Challenges for AMBRISENTAN
Tradename Dosage Ingredient NDA Submissiondate
LETAIRIS TABLET;ORAL ambrisentan 022081 2015-02-09

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 022081-002 Jun 15, 2007 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-001 Jun 15, 2007 AB RX Yes No   Start Trial   Start Trial   Start Trial
Cipla AMBRISENTAN ambrisentan TABLET;ORAL 210715-002 Apr 26, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Par Pharm Inc AMBRISENTAN ambrisentan TABLET;ORAL 209509-002 Apr 10, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan AMBRISENTAN ambrisentan TABLET;ORAL 208441-001 Mar 28, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
>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   Start Trial   Start Trial
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-002 Jun 15, 2007   Start Trial   Start Trial
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-001 Jun 15, 2007   Start Trial   Start Trial
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-001 Jun 15, 2007   Start Trial   Start Trial
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-002 Jun 15, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ambrisentan

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0785926 SPC/GB08/047 United Kingdom   Start Trial 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
2101777 CA 2016 00024 Denmark   Start Trial PRODUCT NAME: AMBRISENTAN USED IN COMBINATION TREATMENT WITH TADALAFIL; REG. NO/DATE: EU/1/08/451 (001-004) 20151125
2101777 300813 Netherlands   Start Trial PRODUCT NAME: AMBRISENTAN TOEGEPAST IN COMBINATIEBEHANDELING MET TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 (C(2008) 1637) 20151125
2101777 C20160017 00199 Estonia   Start Trial PRODUCT NAME: AMBRISENTAAN;REG NO/DATE: EU/1/08/451 25.11.2015
2101777 2016C/032 Belgium   Start Trial PRODUCT NAME: AMBRISENTAN EN COMBINAISON AVEC LE TADALAFIL; AUTHORISATION NUMBER AND DATE: EU/1/08/451 20151125
>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:

Mallinckrodt
Express Scripts
McKinsey
Harvard Business School
Boehringer Ingelheim
Baxter

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.