Assyro AI

Orange Book product · Brand (NDA)

UPTRAVI

SELEXIPAG

Brand (NDA)NDA 214275RX ACTELION

At a glance

Jul 29, 2021

Approved

Brand (NDA)

Application

Not listed

TE code

8

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 29, 2021

    5 yr ago

  2. Today

  3. Patent 7205302 expires

    Listed drug substance patent expiration.

    Oct 31, 2026

    in 4 mo

  4. Patent 7205302*PED expires

    Listed listed patent expiration.

    Apr 30, 2027

    in 11 mo

  5. Patent 9173881 expires

    Listed method-of-use patent (U-1798) expiration.

    Aug 12, 2029

    in 3 yr 2 mo

  6. Patent 9173881*PED expires

    Listed listed patent expiration.

    Feb 12, 2030

    in 3 yr 8 mo

  7. Patent 9284280 expires

    Listed method-of-use patent (U-1831) expiration.

    Jun 25, 2030

    in 4 yr 1 mo

  8. Patent 8791122 expires

    Listed drug substance patent expiration.

    Aug 01, 2030

    in 4 yr 2 mo

  9. Patent 9284280*PED expires

    Listed listed patent expiration.

    Dec 25, 2030

    in 4 yr 7 mo

  10. Patent 8791122*PED expires

    Listed listed patent expiration.

    Feb 01, 2031

    in 4 yr 8 mo

Pharmaceutical detail

Active ingredient

SELEXIPAG

Strength

1.8MG/VIAL

Dosage form

POWDER

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 214275

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents (8)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7205302Oct 31, 2026in 4 mo
SubstanceProductU-1797
7205302*PEDApr 30, 2027in 11 mo
9173881Aug 12, 2029in 3 yr 2 mo
U-1798
9173881*PEDFeb 12, 2030in 3 yr 8 mo
9284280Jun 25, 2030in 4 yr 1 mo
U-1831
8791122Aug 01, 2030in 4 yr 2 mo
SubstanceProduct
9284280*PEDDec 25, 2030in 4 yr 7 mo
8791122*PEDFeb 01, 2031in 4 yr 8 mo
Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.