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Last Updated: August 5, 2020

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AMBRISENTAN - Generic Drug Details

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What are the generic sources for ambrisentan and what is the scope of freedom to operate?

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 fifty patent family members in twenty-six countries.

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

Drug Prices for AMBRISENTAN

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Recent Clinical Trials for AMBRISENTAN

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

SponsorPhase
Cambridge University Hospitals NHS Foundation TrustPhase 2/Phase 3
Noorik Biopharmaceuticals AGPhase 2
United TherapeuticsPhase 3

See all AMBRISENTAN clinical trials

Pharmacology for AMBRISENTAN
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 022081-001 Jun 15, 2007 AB RX Yes No   Start Trial   Start Trial   Start Trial
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-002 Jun 15, 2007 AB RX Yes Yes   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
>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 022081-002 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
0785926 08C0041 France   Start Trial PRODUCT NAME: AMBRISENTAN; REGISTRATION NO/DATE: EU/1/08/451/001-004 20080421
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Harvard Business School

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