FDA Orange Book
Is there a generic for Delstrigo?
Delstrigo contains doravirine, lamivudine and tenofovir disoproxil. 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 Delstrigo (doravirine, lamivudine and tenofovir disoproxil). The Orange Book shows its last listed patent expires November 29, 2036.
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Delstrigo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG;300MG;300MG | Marketed (Rx) | None | 0 | None |
NDA 210807, held by MERCK SHARP AND DOHME CORP A SUB OF MERCK AND CO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Delstrigo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8486975 | August 30, 2032 | Drug substance, Drug product | U-2629 | 210807 |
| 8486975 | August 30, 2032 | Drug substance, Drug product | U-2395 | 210807 |
| 8486975 | August 30, 2032 | Drug substance, Drug product | U-3307 | 210807 |
| 10603282 | November 29, 2036 | Drug product | None | 210807 |
| 10842751 | November 29, 2036 | Drug product | None | 210807 |
Delstrigo NDC codes
Questions
Is there a generic for Delstrigo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Delstrigo (doravirine, lamivudine and tenofovir disoproxil). The Orange Book shows its last listed patent expires November 29, 2036.
What is the generic name for Delstrigo?
The active ingredient in Delstrigo is doravirine, lamivudine and tenofovir disoproxil, per the FDA Orange Book.
When does the Delstrigo patent expire?
The last patent listed for Delstrigo in the Orange Book expires November 29, 2036. 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.
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