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Orange Book product · Brand (NDA)

GOPRELTO

COCAINE HYDROCHLORIDE

Brand (NDA)NDA 209963RX LXO IRELAND
View COCAINE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Dec 14, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

15

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 14, 2017

    8 yr 8 mo ago

  2. Today

  3. Patent 10016407 expires

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

    Feb 07, 2037

    in 10 yr 10 mo

  4. Patent 10149843 expires

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

    Feb 07, 2037

    in 10 yr 10 mo

  5. Patent 10149843 expires

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

    Feb 07, 2037

    in 10 yr 10 mo

  6. Patent 10231961 expires

    Listed drug product patent expiration.

    Feb 07, 2037

    in 10 yr 10 mo

  7. Patent 10413505 expires

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

    Feb 07, 2037

    in 10 yr 10 mo

  8. Patent 10420760 expires

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

    Feb 07, 2037

    in 10 yr 10 mo

  9. Patent 10857095 expires

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

    Feb 07, 2037

    in 10 yr 10 mo

  10. Patent 10894012 expires

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

    Feb 07, 2037

    in 10 yr 10 mo

  11. Patent 10933060 expires

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

    Feb 07, 2037

    in 10 yr 10 mo

  12. Patent 10973811 expires

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

    Feb 07, 2037

    in 10 yr 10 mo

  13. Patent 10987347 expires

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

    Feb 07, 2037

    in 10 yr 10 mo

  14. Patent 11040032 expires

    Listed drug product patent expiration.

    Feb 07, 2037

    in 10 yr 10 mo

  15. Patent 9867815 expires

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

    Feb 07, 2037

    in 10 yr 10 mo

  16. Patent 9867815 expires

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

    Feb 07, 2037

    in 10 yr 10 mo

  17. Patent 9867815 expires

    Listed method-of-use patent (U-2227) 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 209963

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
10016407Feb 07, 2037in 10 yr 10 mo
U-2329
10149843Feb 07, 2037in 10 yr 10 mo
U-2479
10149843Feb 07, 2037in 10 yr 10 mo
U-2478
10231961Feb 07, 2037in 10 yr 10 mo
Product
10413505Feb 07, 2037in 10 yr 10 mo
U-2479
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-3014
10973811Feb 07, 2037in 10 yr 10 mo
U-2226
10987347Feb 07, 2037in 10 yr 10 mo
U-2225
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-2226
9867815Feb 07, 2037in 10 yr 10 mo
U-2227
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