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Orange Book product · Brand (NDA)

GOCOVRI

AMANTADINE HYDROCHLORIDE

Brand (NDA)NDA 208944RX SUPERNUS PHARMS
View AMANTADINE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Aug 24, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

17

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 24, 2017

    8 yr 11 mo ago

  2. Today

  3. Patent 8389578 expires

    Listed method-of-use patent (U-2105) expiration.

    Jan 22, 2028

    in 1 yr 7 mo

  4. Patent 11197835 expires

    Listed method-of-use patent (U-2106) expiration.

    Dec 02, 2030

    in 4 yr 6 mo

  5. Patent 8741343 expires

    Listed method-of-use patent (U-2106) expiration.

    Dec 02, 2030

    in 4 yr 6 mo

  6. Patent 9867791 expires

    Listed method-of-use patent (U-2106) expiration.

    Dec 02, 2030

    in 4 yr 6 mo

  7. Patent 9867792 expires

    Listed method-of-use patent (U-2106) expiration.

    Dec 02, 2030

    in 4 yr 6 mo

  8. Patent 9867793 expires

    Listed method-of-use patent (U-2106) expiration.

    Dec 02, 2030

    in 4 yr 6 mo

  9. Patent 9877933 expires

    Listed method-of-use patent (U-2224) expiration.

    Dec 02, 2030

    in 4 yr 6 mo

  10. Patent 10646456 expires

    Listed method-of-use patent (U-2808) expiration.

    Jun 17, 2034

    in 8 yr 1 mo

  11. Patent 11903908 expires

    Listed method-of-use patent (U-3822) expiration.

    Jun 17, 2034

    in 8 yr 1 mo

  12. Patent 10154971 expires

    Listed method-of-use patent (U-2459) expiration.

    Dec 04, 2034

    in 8 yr 7 mo

  13. Patent 11065213 expires

    Listed drug product patent expiration.

    Aug 23, 2038

    in 12 yr 4 mo

  14. Patent 11077073 expires

    Listed method-of-use patent (U-2106) expiration.

    Aug 23, 2038

    in 12 yr 4 mo

  15. Patent 11077073 expires

    Listed method-of-use patent (U-2224) expiration.

    Aug 23, 2038

    in 12 yr 4 mo

  16. Patent 11077073 expires

    Listed method-of-use patent (U-3180) expiration.

    Aug 23, 2038

    in 12 yr 4 mo

  17. Patent 12233033 expires

    Listed method-of-use patent (U-2106) expiration.

    Aug 23, 2038

    in 12 yr 4 mo

  18. Patent 12233033 expires

    Listed method-of-use patent (U-3180) expiration.

    Aug 23, 2038

    in 12 yr 4 mo

  19. Patent 12233033 expires

    Listed method-of-use patent (U-2224) expiration.

    Aug 23, 2038

    in 12 yr 4 mo

Pharmaceutical detail

Active ingredient

AMANTADINE HYDROCHLORIDE

Strength

EQ 68.5MG BASE

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 208944

Product number

001

Marketing status

RX

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 (17)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8389578Jan 22, 2028in 1 yr 7 mo
U-2105
11197835Dec 02, 2030in 4 yr 6 mo
U-2106
8741343Dec 02, 2030in 4 yr 6 mo
U-2106
9867791Dec 02, 2030in 4 yr 6 mo
U-2106
9867792Dec 02, 2030in 4 yr 6 mo
U-2106
9867793Dec 02, 2030in 4 yr 6 mo
U-2106
9877933Dec 02, 2030in 4 yr 6 mo
U-2224
10646456Jun 17, 2034in 8 yr 1 mo
U-2808
11903908Jun 17, 2034in 8 yr 1 mo
U-3822
10154971Dec 04, 2034in 8 yr 7 mo
U-2459
11065213Aug 23, 2038in 12 yr 4 mo
Product
11077073Aug 23, 2038in 12 yr 4 mo
U-2106
11077073Aug 23, 2038in 12 yr 4 mo
U-2224
11077073Aug 23, 2038in 12 yr 4 mo
U-3180
12233033Aug 23, 2038in 12 yr 4 mo
U-2106
12233033Aug 23, 2038in 12 yr 4 mo
U-3180
12233033Aug 23, 2038in 12 yr 4 mo
U-2224
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