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Bosentan - Generic Drug Details

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

Bosentan is the generic ingredient in two branded drugs marketed by Actelion Pharms, Alembic Pharms Ltd, Alvogen Pine Brook, Amneal Pharms Co, Cipla, Hikma, Mylan, Natco Pharma Ltd, Par Pharm Inc, Sun Pharm, Watson Labs Inc, Zydus Pharms, and Actelion Pharms Ltd, and is included in thirteen NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Bosentan has twenty-eight patent family members in twenty-three countries.

There are nineteen drug master file entries for bosentan. Fourteen suppliers are listed for this compound.

Summary for bosentan

International Patents:	28
US Patents:	2
Tradenames:	2
Applicants:	13
NDAs:	13
Drug Master File Entries:	19
Suppliers / Packagers:	14
Bulk Api Vendors:	89
Clinical Trials:	122
Patent Applications:	6,562
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for bosentan
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for bosentan
What excipients (inactive ingredients) are in bosentan?	bosentan excipients list
DailyMed Link:	bosentan at DailyMed

See drug prices for bosentan

Recent Clinical Trials for bosentan

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

Sponsor	Phase
University Hospital, Rouen	Phase 2
Johns Hopkins University	Phase 3
National Cancer Institute (NCI)	Phase 1

See all bosentan clinical trials

Pharmacology for bosentan

Drug Class	Endothelin Receptor Antagonist
Mechanism of Action	Endothelin Receptor Antagonists Cytochrome P450 3A Inducers Cytochrome P450 2C9 Inducers

Paragraph IV (Patent) Challenges for BOSENTAN

Tradename	Dosage	Ingredient	NDA	Submissiondate
TRACLEER	TABLET, FOR SUSPENSION;ORAL	bosentan	209279	2019-02-08

US Patents and Regulatory Information for bosentan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	BOSENTAN	bosentan	TABLET;ORAL	209324-001	Apr 26, 2019	AB	RX	No	No
Par Pharm Inc	BOSENTAN	bosentan	TABLET;ORAL	205699-002	Apr 26, 2019	AB	RX	No	No
Natco Pharma Ltd	BOSENTAN	bosentan	TABLET;ORAL	206987-001	Apr 26, 2019	AB	RX	No	No

Expired US Patents for bosentan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Actelion Pharms Ltd	TRACLEER	bosentan	TABLET;ORAL	021290-001	Nov 20, 2001
Actelion Pharms Ltd	TRACLEER	bosentan	TABLET;ORAL	021290-002	Nov 20, 2001

International Patents for bosentan

Country	Patent Number	Estimated Expiration
South Korea	20080014002
Japan	4219399
South Africa	200710903

Supplementary Protection Certificates for bosentan

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0526708	0290017-3	Sweden		PRODUCT NAME: BOSENTAN ELLER ETT SALT DAERAV; NAT. REGISTZRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: CH 55841 01 20020228
0526708	SPC/GB02/030	United Kingdom		PRODUCT NAME: BOSENTAN 4-(1,1-DIMETHYLETHYL)-N-(6-(2-HYDROXYETHOXY)-5-(2-METHOXYPHENOXY)-2(PYRIMIDIN-2-YL)PYRIMIDIN-4-YL)BENZENESULFONAMIDE AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS
0526708	02C0042	France		PRODUCT NAME: BOSENTAN MONOHYDRATE; NAT. REGISTRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: LI - 55841 20020228