Assyro AI

Orange Book product · Brand (NDA)

ONGENTYS

OPICAPONE

Brand (NDA)NDA 212489RX AMNEAL

At a glance

Apr 24, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

11

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 24, 2020

    6 yr 3 mo ago

  2. Today

  3. Patent 9550759 expires

    Listed method-of-use patent (U-3870) expiration.

    Jul 26, 2026

    in 1 mo

  4. Patent 9550759 expires

    Listed method-of-use patent (U-3871) expiration.

    Jul 26, 2026

    in 1 mo

  5. Patent 9550759 expires

    Listed method-of-use patent (U-3872) expiration.

    Jul 26, 2026

    in 1 mo

  6. Patent 8907099 expires

    Listed drug substance patent expiration.

    May 12, 2027

    in 11 mo

  7. Patent 9745290 expires

    Listed drug product patent expiration.

    Oct 10, 2027

    in 1 yr 4 mo

  8. Patent 8168793 expires

    Listed drug substance patent expiration.

    Apr 02, 2029

    in 2 yr 10 mo

  9. Patent 8524746 expires

    Listed method-of-use patent (U-3869) expiration.

    Jul 14, 2029

    in 3 yr 1 mo

  10. Patent 10071085 expires

    Listed drug product patent expiration.

    Mar 31, 2030

    in 3 yr 10 mo

  11. Patent 10583130 expires

    Listed method-of-use patent (U-3869) expiration.

    Mar 31, 2030

    in 3 yr 10 mo

  12. Patent 12129247 expires

    Listed method-of-use patent (U-4038) expiration.

    Jan 11, 2032

    in 5 yr 8 mo

  13. Patent 9630955 expires

    Listed drug substance patent expiration.

    Dec 12, 2032

    in 6 yr 7 mo

Pharmaceutical detail

Active ingredient

OPICAPONE

Strength

50MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 212489

Product number

002

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 (11)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9550759Jul 26, 2026in 1 mo
U-3870
9550759Jul 26, 2026in 1 mo
U-3871
9550759Jul 26, 2026in 1 mo
U-3872
8907099May 12, 2027in 11 mo
Substance
9745290Oct 10, 2027in 1 yr 4 mo
ProductU-3869
8168793Apr 02, 2029in 2 yr 10 mo
SubstanceProductU-3869
8524746Jul 14, 2029in 3 yr 1 mo
U-3869
10071085Mar 31, 2030in 3 yr 10 mo
Product
10583130Mar 31, 2030in 3 yr 10 mo
U-3869
12129247Jan 11, 2032in 5 yr 8 mo
U-4038
9630955Dec 12, 2032in 6 yr 7 mo
SubstanceProductU-3869
Agent CTA Background

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