Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Dow
Moodys
Baxter
McKesson
Medtronic
Harvard Business School

Last Updated: December 2, 2022

Bosentan - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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 Pharms Ltd, Alvogen Pine Brook, Amneal Pharms Co, Chartwell Molecular, Hikma, Mylan, Natco Pharma Ltd, Par Pharm Inc, 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. Nine suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for bosentan

See drug prices for bosentan

Recent Clinical Trials for bosentan

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

SponsorPhase
Jean-Pierre RoutyN/A
Johns Hopkins UniversityPhase 3
University of OttawaPhase 3

See all bosentan clinical trials

Generic filers with tentative approvals for BOSENTAN
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing32MGTABLET, 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.

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
Hikma BOSENTAN bosentan TABLET;ORAL 208695-001 Apr 26, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan BOSENTAN bosentan TABLET;ORAL 205173-002 Jan 15, 2020 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan BOSENTAN bosentan TABLET;ORAL 205173-001 Jan 15, 2020 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for bosentan

Country Patent Number Title Estimated Expiration
Germany 602006011150 See Plans and Pricing
European Patent Office 1883397 COMPRIME DISPERSIBLE (DISPERSIBLE BOSERTAN TABLET) See Plans and Pricing
Brazil PI0610187 tablete dispersável ou um solvato ou sal farmaceuticamente aceitável do mesmo, e excipientes farmaceuticamente aceitáveis, processo para a preparação dos mesmos, e, uso de composto ou de um sal ou solvato farmaceuticamente aceitável do mesmo See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for bosentan

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0526708 02C0042 France See Plans and Pricing PRODUCT NAME: BOSENTAN MONOHYDRATE; NAT. REGISTRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: LI - 55841 20020228
0526708 0290017-3 Sweden See Plans and Pricing PRODUCT NAME: BOSENTAN ELLER ETT SALT DAERAV; NAT. REGISTZRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: CH 55841 01 20020228
0526708 C300097 Netherlands See Plans and Pricing 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
>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:

Boehringer Ingelheim
McKesson
Express Scripts
Baxter
Merck
McKinsey

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 verification 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.