Bosentan - Generic Drug Details

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, Alembic, Alvogen Pine Brook, Amneal Pharms Co, Chartwell Molecular, Endo Operations, Hikma, Mylan, Natco Pharma Ltd, Sun Pharm, Watson Labs Inc, and Zydus Pharms, 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. Six suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for bosentan

International Patents:	28
US Patents:	2
Tradenames:	2
Applicants:	12
NDAs:	13
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	131
Patent Applications:	5,957
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
PPD	Phase 1
CTI BioPharma	Phase 1
Jean-Pierre Routy	N/A

See all bosentan clinical trials

Generic filers with tentative approvals for BOSENTAN

Applicant	Application No.	Strength	Dosage Form
		125MG	TABLET;ORAL
		62.5MG	TABLET;ORAL
		32MG	TABLET, FOR SUSPENSION;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for bosentan

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

Anatomical Therapeutic Chemical (ATC) Classes for bosentan

C02KX	Antihypertensives for pulmonary arterial hypertension
C02K	OTHER ANTIHYPERTENSIVES
C02	ANTIHYPERTENSIVES
C	Cardiovascular system

Paragraph IV (Patent) Challenges for BOSENTAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRACLEER	for Oral Suspension	bosentan	32 mg	209279	1	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
Chartwell Molecular	BOSENTAN	bosentan	TABLET;ORAL	210342-001	Jan 3, 2020		DISCN	No	No
Amneal Pharms Co	BOSENTAN	bosentan	TABLET;ORAL	209742-002	Apr 26, 2019		DISCN	No	No
Alvogen Pine Brook	BOSENTAN	bosentan	TABLET;ORAL	206002-001	Apr 26, 2019		DISCN	No	No
Amneal Pharms Co	BOSENTAN	bosentan	TABLET;ORAL	209742-001	Apr 26, 2019		DISCN	No	No
Actelion	TRACLEER	bosentan	TABLET, FOR SUSPENSION;ORAL	209279-001	Sep 5, 2017		RX	Yes	Yes			Y

Expired US Patents for bosentan

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

EU/EMA Drug Approvals for bosentan

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Janssen-Cilag International N.V.	Tracleer	bosentan	EMEA/H/C/000401 Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO functional class III.Efficacy has been shown in:, , , Primary (idiopathic and familial) PAH;, PAH secondary to scleroderma without significant interstitial pulmonary disease;, PAH associated with congenital systemic-to-pulmonary shunts and Eisenmenger's physiology., , , Some improvements have also been shown in patients with PAH WHO functional class II., , Tracleer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.,	Authorised	no	no	no	2002-05-14

International Patents for bosentan

Country	Patent Number	Title	Estimated Expiration
China	101175484	Dispersible bosertan tablet
Australia	2006248593	Dispersible bosertan tablet
Japan	2008540512
South Korea	20100093105	DISPERSIBLE TABLET
New Zealand	564167	Dispersible tablet comprising 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)-2-(pyrimidin-2-yl)-pyrimidin-4-yl]-benzenesulfonamide (bosutan)

Supplementary Protection Certificates for bosentan

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0526708	C300097	Netherlands		PRODUCT NAME: BOSENTAN, DESGEWENST IN DE VORM VAN EEN ZOUT OF EEN HYDRAAT OF IN DE VORM VAN EEN ESTER VAN DE HYDROXYLGROEP VAN DE 2-HYDROXYETHOXY REST MET EEN ZUUR MET DE FORMULE R5-OH, WAARIN R5 EEN C1-7-ALKANOYL, BENZOYL, OF HETEROCYCLYCARBONYL VOORSTELT; NATL. REGISTRATION NO/DATE: U/1/02/220/001 - 005 20020515; FIRST REGISTRATION: CH IKS 58841 01 - 02 20020228
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	02C0042	France		PRODUCT NAME: BOSENTAN MONOHYDRATE; NAT. REGISTRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: LI - 55841 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