Assyro AI

Orange Book product · Brand (NDA)

NUMBRINO

COCAINE HYDROCHLORIDE

Brand (NDA)NDA 209575RX OMNIVIUM PHARMS
View COCAINE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Jan 10, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

18

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 10, 2020

    6 yr 6 mo ago

  2. Today

  3. Patent 10016407 expires

    Listed method-of-use patent (U-2225) expiration.

    Feb 07, 2037

    in 10 yr 10 mo

  4. Patent 10016407 expires

    Listed method-of-use patent (U-2226) expiration.

    Feb 07, 2037

    in 10 yr 10 mo

  5. Patent 10016407 expires

    Listed method-of-use patent (U-2329) expiration.

    Feb 07, 2037

    in 10 yr 10 mo

  6. Patent 10149843 expires

    Listed method-of-use patent (U-2478) expiration.

    Feb 07, 2037

    in 10 yr 10 mo

  7. Patent 10149843 expires

    Listed method-of-use patent (U-2479) expiration.

    Feb 07, 2037

    in 10 yr 10 mo

  8. Patent 10231961 expires

    Listed drug product patent expiration.

    Feb 07, 2037

    in 10 yr 10 mo

  9. Patent 10413505 expires

    Listed method-of-use patent (U-3014) expiration.

    Feb 07, 2037

    in 10 yr 10 mo

  10. Patent 10420760 expires

    Listed method-of-use patent (U-2478) expiration.

    Feb 07, 2037

    in 10 yr 10 mo

  11. Patent 10857095 expires

    Listed method-of-use patent (U-3014) expiration.

    Feb 07, 2037

    in 10 yr 10 mo

  12. Patent 10894012 expires

    Listed method-of-use patent (U-3014) expiration.

    Feb 07, 2037

    in 10 yr 10 mo

  13. Patent 10933060 expires

    Listed method-of-use patent (U-2478) expiration.

    Feb 07, 2037

    in 10 yr 10 mo

  14. Patent 10933060 expires

    Listed method-of-use patent (U-3014) expiration.

    Feb 07, 2037

    in 10 yr 10 mo

  15. Patent 10973811 expires

    Listed method-of-use patent (U-3680) expiration.

    Feb 07, 2037

    in 10 yr 10 mo

  16. Patent 11040032 expires

    Listed drug product patent expiration.

    Feb 07, 2037

    in 10 yr 10 mo

  17. Patent 9867815 expires

    Listed method-of-use patent (U-2225) expiration.

    Feb 07, 2037

    in 10 yr 10 mo

  18. Patent 9867815 expires

    Listed method-of-use patent (U-2329) expiration.

    Feb 07, 2037

    in 10 yr 10 mo

  19. Patent 9867815 expires

    Listed method-of-use patent (U-2227) expiration.

    Feb 07, 2037

    in 10 yr 10 mo

  20. Patent 9867815 expires

    Listed method-of-use patent (U-2226) expiration.

    Feb 07, 2037

    in 10 yr 10 mo

Pharmaceutical detail

Active ingredient

COCAINE HYDROCHLORIDE

Strength

4%

Dosage form

SOLUTION

Route

NASAL

TE code

Not listed

Application

NDA 209575

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 (18)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10016407Feb 07, 2037in 10 yr 10 mo
U-2225
10016407Feb 07, 2037in 10 yr 10 mo
U-2226
10016407Feb 07, 2037in 10 yr 10 mo
U-2329
10149843Feb 07, 2037in 10 yr 10 mo
U-2478
10149843Feb 07, 2037in 10 yr 10 mo
U-2479
10231961Feb 07, 2037in 10 yr 10 mo
Product
10413505Feb 07, 2037in 10 yr 10 mo
U-3014
10420760Feb 07, 2037in 10 yr 10 mo
U-2478
10857095Feb 07, 2037in 10 yr 10 mo
U-3014
10894012Feb 07, 2037in 10 yr 10 mo
U-3014
10933060Feb 07, 2037in 10 yr 10 mo
U-2478
10933060Feb 07, 2037in 10 yr 10 mo
U-3014
10973811Feb 07, 2037in 10 yr 10 mo
U-3680
11040032Feb 07, 2037in 10 yr 10 mo
Product
9867815Feb 07, 2037in 10 yr 10 mo
U-2225
9867815Feb 07, 2037in 10 yr 10 mo
U-2329
9867815Feb 07, 2037in 10 yr 10 mo
U-2227
9867815Feb 07, 2037in 10 yr 10 mo
U-2226
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