Assyro AI

Orange Book product · Brand (NDA)

YUPELRI

REVEFENACIN

Brand (NDA)NDA 210598RX MYLAN IRELAND LTD

At a glance

Nov 09, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

10

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 09, 2018

    7 yr 9 mo ago

  2. Today

  3. Patent 7288657 expires

    Listed drug substance patent expiration.

    Oct 31, 2028

    in 2 yr 5 mo

  4. Patent 10550081 expires

    Listed drug substance patent expiration.

    Jul 14, 2030

    in 4 yr 2 mo

  5. Patent 11008289 expires

    Listed method-of-use patent (U-2440) expiration.

    Jul 14, 2030

    in 4 yr 2 mo

  6. Patent 11691948 expires

    Listed drug product patent expiration.

    Jul 14, 2030

    in 4 yr 2 mo

  7. Patent 11858898 expires

    Listed drug substance patent expiration.

    Jul 14, 2030

    in 4 yr 2 mo

  8. Patent 9765028 expires

    Listed drug substance patent expiration.

    Jul 14, 2030

    in 4 yr 2 mo

  9. Patent 8541451 expires

    Listed drug substance patent expiration.

    Aug 25, 2031

    in 5 yr 3 mo

  10. Patent 12048692 expires

    Listed method-of-use patent (U-2440) expiration.

    Aug 29, 2039

    in 13 yr 5 mo

  11. Patent 12285417 expires

    Listed method-of-use patent (U-2440) expiration.

    Aug 29, 2039

    in 13 yr 5 mo

  12. Patent 11484531 expires

    Listed method-of-use patent (U-2440) expiration.

    Oct 23, 2039

    in 13 yr 6 mo

Pharmaceutical detail

Active ingredient

REVEFENACIN

Strength

175MCG/3ML

Dosage form

SOLUTION

Route

INHALATION

TE code

Not listed

Application

NDA 210598

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 (10)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7288657Oct 31, 2028in 2 yr 5 mo
Substance
10550081Jul 14, 2030in 4 yr 2 mo
Substance
11008289Jul 14, 2030in 4 yr 2 mo
U-2440
11691948Jul 14, 2030in 4 yr 2 mo
Product
11858898Jul 14, 2030in 4 yr 2 mo
SubstanceProductU-2440
9765028Jul 14, 2030in 4 yr 2 mo
Substance
8541451Aug 25, 2031in 5 yr 3 mo
Substance
12048692Aug 29, 2039in 13 yr 5 mo
U-2440
12285417Aug 29, 2039in 13 yr 5 mo
U-2440
11484531Oct 23, 2039in 13 yr 6 mo
U-2440
Agent CTA Background

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