FDA Orange Book
Is there a generic for Gocovri?
Gocovri contains amantadine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Gocovri (amantadine). The Orange Book shows its last listed patent expires August 23, 2038.
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Gocovri products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, extended release, oral | EQ 137MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, extended release, oral | EQ 68.5MG BASE | Marketed (Rx) | None | 0 | None |
NDA 208944, held by SUPERNUS PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Gocovri patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8389578 | January 22, 2028 | Method of use | U-2105 | 208944 |
| 9867792 | December 2, 2030 | Method of use | U-2106 | 208944 |
| 9867791 | December 2, 2030 | Method of use | U-2106 | 208944 |
| 9877933 | December 2, 2030 | Method of use | U-2224 | 208944 |
| 8741343 | December 2, 2030 | Method of use | U-2106 | 208944 |
| 9867793 | December 2, 2030 | Method of use | U-2106 | 208944 |
| 11197835 | December 2, 2030 | Method of use | U-2106 | 208944 |
| 10646456 | June 17, 2034 | Method of use | U-2808 | 208944 |
| 11903908 | June 17, 2034 | Method of use | U-3822 | 208944 |
| 10154971 | December 4, 2034 | Method of use | U-2459 | 208944 |
| 12233033 | August 23, 2038 | Method of use | U-2106 | 208944 |
| 12233033 | August 23, 2038 | Method of use | U-3180 | 208944 |
| 12233033 | August 23, 2038 | Method of use | U-2224 | 208944 |
| 11077073 | August 23, 2038 | Method of use | U-2106 | 208944 |
| 11077073 | August 23, 2038 | Method of use | U-2224 | 208944 |
| 11077073 | August 23, 2038 | Method of use | U-3180 | 208944 |
| 11065213 | August 23, 2038 | Drug product | None | 208944 |
Gocovri NDC codes
Questions
Is there a generic for Gocovri?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Gocovri (amantadine). The Orange Book shows its last listed patent expires August 23, 2038.
What is the generic name for Gocovri?
The active ingredient in Gocovri is amantadine, per the FDA Orange Book.
When does the Gocovri patent expire?
The last patent listed for Gocovri in the Orange Book expires August 23, 2038. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.
More on Gocovri and Amantadine
- What is Gocovri used for?FDA label uses
- Is Gocovri a controlled substance?Federal schedule
- What is Amantadine used for?FDA label uses
- Is Amantadine a controlled substance?Federal schedule
- Generic for SymmetrelFDA Orange Book
- Influenza A M2 Protein Inhibitors listFDA drug class
- NDC 17772-085Gocovri NDC record
- NDC 17772-170Gocovri NDC record
- NDC 70482-085Gocovri NDC record