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Orange Book product · Brand (NDA)

RAVICTI

GLYCEROL PHENYLBUTYRATE

Brand (NDA)NDA 203284TE AARX HORIZON THERAP US
View GLYCEROL PHENYLBUTYRATE familyOpen on FDA Orange Book

At a glance

Feb 01, 2013

Approved

Brand (NDA)

Application

AA

TE code

15

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 01, 2013

    13 yr 7 mo ago

  2. Today

  3. Patent 10045958 expires

    Listed method-of-use patent (U-1816) expiration.

    Sep 22, 2030

    in 4 yr 4 mo

  4. Patent 10045959 expires

    Listed method-of-use patent (U-1816) expiration.

    Sep 22, 2030

    in 4 yr 4 mo

  5. Patent 10183002 expires

    Listed method-of-use patent (U-1816) expiration.

    Sep 22, 2030

    in 4 yr 4 mo

  6. Patent 10183003 expires

    Listed method-of-use patent (U-1816) expiration.

    Sep 22, 2030

    in 4 yr 4 mo

  7. Patent 10183004 expires

    Listed method-of-use patent (U-1816) expiration.

    Sep 22, 2030

    in 4 yr 4 mo

  8. Patent 10183005 expires

    Listed method-of-use patent (U-1816) expiration.

    Sep 22, 2030

    in 4 yr 4 mo

  9. Patent 10183006 expires

    Listed method-of-use patent (U-1816) expiration.

    Sep 22, 2030

    in 4 yr 4 mo

  10. Patent 10668040 expires

    Listed method-of-use patent (U-1816) expiration.

    Sep 22, 2030

    in 4 yr 4 mo

  11. Patent 8642012 expires

    Listed method-of-use patent (U-1383) expiration.

    Sep 22, 2030

    in 4 yr 4 mo

  12. Patent 9254278 expires

    Listed method-of-use patent (U-1816) expiration.

    Sep 22, 2030

    in 4 yr 4 mo

  13. Patent 9326966 expires

    Listed method-of-use patent (U-1816) expiration.

    Sep 22, 2030

    in 4 yr 4 mo

  14. Patent 9561197 expires

    Listed method-of-use patent (U-1383) expiration.

    Sep 22, 2030

    in 4 yr 4 mo

  15. Patent 9962359 expires

    Listed method-of-use patent (U-1816) expiration.

    Sep 22, 2030

    in 4 yr 4 mo

  16. Patent 9999608 expires

    Listed method-of-use patent (U-1816) expiration.

    Sep 22, 2030

    in 4 yr 4 mo

  17. Patent 8404215 expires

    Listed method-of-use patent (U-1383) expiration.

    Mar 09, 2032

    in 5 yr 10 mo

Pharmaceutical detail

Active ingredient

GLYCEROL PHENYLBUTYRATE

Strength

1.1GM/ML

Dosage form

LIQUID

Route

ORAL

TE code

AA

Application

NDA 203284

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 (15)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10045958Sep 22, 2030in 4 yr 4 mo
U-1816
10045959Sep 22, 2030in 4 yr 4 mo
U-1816
10183002Sep 22, 2030in 4 yr 4 mo
U-1816
10183003Sep 22, 2030in 4 yr 4 mo
U-1816
10183004Sep 22, 2030in 4 yr 4 mo
U-1816
10183005Sep 22, 2030in 4 yr 4 mo
U-1816
10183006Sep 22, 2030in 4 yr 4 mo
U-1816
10668040Sep 22, 2030in 4 yr 4 mo
U-1816
8642012Sep 22, 2030in 4 yr 4 mo
U-1383
9254278Sep 22, 2030in 4 yr 4 mo
U-1816
9326966Sep 22, 2030in 4 yr 4 mo
U-1816
9561197Sep 22, 2030in 4 yr 4 mo
U-1383
9962359Sep 22, 2030in 4 yr 4 mo
U-1816
9999608Sep 22, 2030in 4 yr 4 mo
U-1816
8404215Mar 09, 2032in 5 yr 10 mo
U-1383Delisted
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