Assyro AI

Orange Book product · Brand (NDA)

KYNMOBI

APOMORPHINE HYDROCHLORIDE

Brand (NDA)NDA 210875DISCN SUMITOMO PHARMA AM

At a glance

May 21, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

12

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 21, 2020

    6 yr 2 mo ago

  2. Today

  3. Patent 10821074 expires

    Listed drug product patent expiration.

    Aug 07, 2029

    in 3 yr 2 mo

  4. Patent 10420763 expires

    Listed drug product patent expiration.

    Jun 11, 2030

    in 4 yr

  5. Patent 9044475 expires

    Listed drug product patent expiration.

    Jun 11, 2030

    in 4 yr

  6. Patent 9283219 expires

    Listed drug product patent expiration.

    Jun 11, 2030

    in 4 yr

  7. Patent 9326981 expires

    Listed method-of-use patent (U-2825) expiration.

    Jun 11, 2030

    in 4 yr

  8. Patent 9669019 expires

    Listed drug product patent expiration.

    Jun 11, 2030

    in 4 yr

  9. Patent 9669021 expires

    Listed method-of-use patent (U-2825) expiration.

    Jun 11, 2030

    in 4 yr

  10. Patent 11419769 expires

    Listed drug product patent expiration.

    Dec 16, 2031

    in 5 yr 7 mo

  11. Patent 8414922 expires

    Listed drug product patent expiration.

    Dec 16, 2031

    in 5 yr 7 mo

  12. Patent 8846074 expires

    Listed drug product patent expiration.

    Dec 16, 2031

    in 5 yr 7 mo

  13. Patent 10449146 expires

    Listed method-of-use patent (U-2825) expiration.

    Apr 19, 2036

    in 10 yr

  14. Patent 10959943 expires

    Listed method-of-use patent (U-2825) expiration.

    Apr 19, 2036

    in 10 yr

Pharmaceutical detail

Active ingredient

APOMORPHINE HYDROCHLORIDE

Strength

15MG

Dosage form

FILM

Route

SUBLINGUAL

TE code

Not listed

Application

NDA 210875

Product number

002

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

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 (12)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10821074Aug 07, 2029in 3 yr 2 mo
Product
10420763Jun 11, 2030in 4 yr
ProductU-2825
9044475Jun 11, 2030in 4 yr
Product
9283219Jun 11, 2030in 4 yr
ProductU-2825
9326981Jun 11, 2030in 4 yr
U-2825
9669019Jun 11, 2030in 4 yr
ProductU-2825
9669021Jun 11, 2030in 4 yr
U-2825
11419769Dec 16, 2031in 5 yr 7 mo
ProductU-2825
8414922Dec 16, 2031in 5 yr 7 mo
ProductU-2825
8846074Dec 16, 2031in 5 yr 7 mo
ProductU-2825
10449146Apr 19, 2036in 10 yr
U-2825
10959943Apr 19, 2036in 10 yr
U-2825
Agent CTA Background

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