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Last Updated: March 19, 2024

Selexipag - Generic Drug Details


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

Selexipag is the generic ingredient in two branded drugs marketed by Actelion, Alembic, and Zydus, and is included in four NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Selexipag has one hundred and forty-eight patent family members in thirty-eight countries.

There are two drug master file entries for selexipag. One supplier is listed for this compound. There are two tentative approvals for this compound.

Summary for selexipag
Recent Clinical Trials for selexipag

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

SponsorPhase
University of Newcastle Upon-TynePhase 4
Sheffield Teaching Hospitals NHS Foundation TrustPhase 4
University of GlasgowPhase 4

See all selexipag clinical trials

Generic filers with tentative approvals for SELEXIPAG
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial1600MCGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial1400MCGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial1200MCGTABLET;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 selexipag
Paragraph IV (Patent) Challenges for SELEXIPAG
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
UPTRAVI For Injection selexipag 1.8 mg/vial 214275 1 2022-07-29
UPTRAVI Tablets selexipag 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg and 1.6 mg 207947 4 2019-12-23

US Patents and Regulatory Information for selexipag

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actelion UPTRAVI selexipag TABLET;ORAL 207947-008 Dec 21, 2015 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Actelion UPTRAVI selexipag TABLET;ORAL 207947-004 Dec 21, 2015 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Actelion UPTRAVI selexipag TABLET;ORAL 207947-002 Dec 21, 2015 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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 selexipag

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Janssen Cilag International NV Uptravi selexipag EMEA/H/C/003774
Uptravi is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO functional class (FC) II–III, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies., , Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.,
Authorised no no no 2016-05-12
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for selexipag

Country Patent Number Title Estimated Expiration
China 1516690 ⤷  Try a Trial
China 104326991 CRYSTALs ⤷  Try a Trial
Israel 216928 צורה גבישית של 2-{4-[n-(5,6-דיפנילפיראזינ-2-איל)-n- איזופרופילאמינו] בוטוקסי}-n-(מתילסולפוניל) אצטאמיד, הרכב פרמצבטי המכיל אותה והשימוש בו להכנת תרופה (Crystal form of 2-{4-[n-(5,6-diphenylpyrazin-2-yl)-n-isopropylamino] butyloxy}-n-(methylsulfonyl) acetamide, pharmaceutical composition comprising it and its use in the manufacture of a medicament) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for selexipag

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1400518 CR 2016 00048 Denmark ⤷  Try a Trial PRODUCT NAME: SELEXIPAG ELLER ET SALT DERAF; REG. NO/DATE: EU/1/15/1083 20160519
1400518 532 Finland ⤷  Try a Trial
1400518 2016/047 Ireland ⤷  Try a Trial PRODUCT NAME: SELEXIPAG OR SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1083 20160512
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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