FDA Orange Book
Generic for Lyrica CR
Lyrica CR contains pregabalin. 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
Yes. The generic name for Lyrica CR is pregabalin. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Lyrica CR and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Lyrica CR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 165MG | Marketed (Rx) | AB | 4 | AB |
| tablet, extended release, oral | 330MG | Marketed (Rx) | AB | 4 | AB |
| tablet, extended release, oral | 82.5MG | Marketed (Rx) | AB | 3 | AB |
NDA 209501, held by UPJOHN US 2 LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic pregabalin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MSN LABORATORIES PRIVATE LTD | 213226 | AB (A-rated, therapeutically equivalent) | April 13, 2021 | 165MG, 330MG, 82.5MG |
| RUBICON RESEARCH LTD | 215249 | AB (A-rated, therapeutically equivalent) | March 22, 2022 | 165MG, 330MG, 82.5MG |
| EPIC PHARMA LLC | 214496 | AB (A-rated, therapeutically equivalent) | June 1, 2023 | 165MG, 330MG, 82.5MG |
| AIPING PHARMACEUTICAL INC | 217857 | AB (A-rated, therapeutically equivalent) | June 24, 2026 | 165MG, 330MG |
Lyrica CR patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10022447 | November 2, 2026 | Method of use | U-2137 | 209501 |
| 8945620 | November 2, 2026 | Drug product | U-2136 | 209501 |
| 10022447 | November 2, 2026 | Method of use | U-2136 | 209501 |
| 8945620 | November 2, 2026 | Drug product | U-2137 | 209501 |
| 9144559 | November 2, 2026 | Drug product | None | 209501 |
| 9144559*PED | May 2, 2027 | Method of use | None | 209501 |
| 10022447*PED | May 2, 2027 | Method of use | None | 209501 |
| 8945620*PED | May 2, 2027 | Method of use | None | 209501 |
Lyrica CR NDC codes
Questions
Is there a generic for Lyrica CR?
Yes. The generic name for Lyrica CR is pregabalin. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Lyrica CR?
The active ingredient in Lyrica CR is pregabalin, per the FDA Orange Book.
When does the Lyrica CR patent expire?
The last patent listed for Lyrica CR in the Orange Book expires May 2, 2027. 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 Lyrica CR and Pregabalin
- What is Lyrica CR used for?FDA label uses
- Is Lyrica CR a controlled substance?Schedule V
- What is Pregabalin used for?FDA label uses
- Is Pregabalin a controlled substance?Schedule V
- Generic for LyricaFDA Orange Book
- Lyrica CR Medicare Part D coverageBy plan and state
- NDC 58151-245Lyrica CR NDC record
- NDC 58151-246Lyrica CR NDC record
- NDC 58151-247Lyrica CR NDC record
- Schedule V drugs listDEA schedule