FDA Orange Book
Generic for Tradjenta
Tradjenta contains linagliptin. 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 Tradjenta is linagliptin. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Tradjenta 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.
Tradjenta products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 5MG | Marketed (Rx) | AB | 8 | AB |
NDA 201280, held by BOEHRINGER INGELHEIM PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic linagliptin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUNSHINE LAKE PHARMA CO LTD | 208335 | AB (A-rated, therapeutically equivalent) | August 31, 2021 | 5MG |
| ZYDUS PHARMACEUTICALS USA INC | 208448 | AB (A-rated, therapeutically equivalent) | March 30, 2023 | 5MG |
| INVAGEN PHARMACEUTICALS INC | 208423 | AB (A-rated, therapeutically equivalent) | September 3, 2024 | 5MG |
| AUROBINDO PHARMA LTD | 208415 | AB (A-rated, therapeutically equivalent) | November 3, 2025 | 5MG |
| DR REDDYS LABORATORIES LTD | 208428 | AB (A-rated, therapeutically equivalent) | November 3, 2025 | 5MG |
| MSN LABORATORIES PRIVATE LTD | 208457 | AB (A-rated, therapeutically equivalent) | November 3, 2025 | 5MG |
| MYLAN PHARMACEUTICALS INC | 208431 | AB (A-rated, therapeutically equivalent) | November 3, 2025 | 5MG |
| TEVA PHARMACEUTICALS USA INC | 208433 | AB (A-rated, therapeutically equivalent) | May 27, 2026 | 5MG |
Tradjenta patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8883805 | November 26, 2025 | Drug product | None | 201280 |
| 8883805*PED | May 26, 2026 | Method of use | None | 201280 |
| 8673927 | May 4, 2027 | Method of use | U-1503 | 201280 |
| 12178819 | May 4, 2027 | Drug product | None | 201280 |
| 11033552 | May 4, 2027 | Drug product | None | 201280 |
| 8673927*PED | November 4, 2027 | Method of use | None | 201280 |
| 11033552*PED | November 4, 2027 | Method of use | None | 201280 |
| 9486526 | August 5, 2029 | Method of use | U-1915 | 201280 |
| 10034877 | August 5, 2029 | Method of use | U-2347 | 201280 |
| 10034877*PED | February 5, 2030 | Method of use | None | 201280 |
| 9486526*PED | February 5, 2030 | Method of use | None | 201280 |
| 11911388 | April 10, 2030 | Method of use | U-3854 | 201280 |
| 8846695 | June 4, 2030 | Method of use | U-1503 | 201280 |
| 8846695*PED | December 4, 2030 | Method of use | None | 201280 |
| 8853156 | March 5, 2031 | Drug product | U-1642 | 201280 |
| 8853156*PED | September 5, 2031 | Method of use | None | 201280 |
| 12364700 | June 8, 2037 | Method of use | U-4224 | 201280 |
| 12364700*PED | December 8, 2037 | Method of use | None | 201280 |
Tradjenta exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-295 | Miscellaneous | June 20, 2026 | 201280 |
| PED | Pediatric exclusivity | December 20, 2026 | 201280 |
Tradjenta NDC codes
Questions
Is there a generic for Tradjenta?
Yes. The generic name for Tradjenta is linagliptin. 8 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 Tradjenta?
The active ingredient in Tradjenta is linagliptin, per the FDA Orange Book.
When does the Tradjenta patent expire?
The last patent listed for Tradjenta in the Orange Book expires December 8, 2037. 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.