FDA Orange Book
Is there a generic for Ryaltris?
Ryaltris contains olopatadine and mometasone furoate. 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 Ryaltris (olopatadine and mometasone furoate). The Orange Book shows its last listed patent expires November 21, 2044 and its last listed exclusivity ends July 7, 2029.
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Ryaltris products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| spray, metered, nasal | 0.025MG/SPRAY;0.665MG/SPRAY | Marketed (Rx) | None | 0 | None |
NDA 211746, held by GLENMARK SPECIALTY SA. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Ryaltris patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10765686 | September 4, 2034 | Method of use | U-3295 | 211746 |
| 10758550 | September 4, 2034 | Method of use | U-3296 | 211746 |
| 10646500 | September 4, 2034 | Method of use | U-3297 | 211746 |
| 10548907 | September 4, 2034 | Method of use | U-3297 | 211746 |
| 11400101 | September 4, 2034 | Method of use | U-3297 | 211746 |
| 12064442 | September 4, 2034 | Method of use | U-3297 | 211746 |
| 10016443 | September 4, 2034 | Method of use | U-3297 | 211746 |
| 10517880 | September 4, 2034 | Drug product | U-3297 | 211746 |
| 9750754 | September 4, 2034 | Drug product | U-3297 | 211746 |
| 9078923 | September 4, 2034 | Drug product | U-3297 | 211746 |
| 10561672 | September 4, 2034 | Drug product | None | 211746 |
| 9370483 | September 4, 2034 | Drug product | None | 211746 |
| 10376526 | September 4, 2034 | Drug product | None | 211746 |
| 9937189 | September 4, 2034 | Drug product | None | 211746 |
| 11679210 | September 3, 2038 | Drug product | None | 211746 |
| 12303635 | April 8, 2039 | Drug substance, Drug product | None | 211746 |
| 12653833 | November 21, 2044 | Drug product | U-4564 | 211746 |
Ryaltris exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NPP | New patient population | July 7, 2029 | 211746 |
Ryaltris NDC codes
Questions
Is there a generic for Ryaltris?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Ryaltris (olopatadine and mometasone furoate). The Orange Book shows its last listed patent expires November 21, 2044 and its last listed exclusivity ends July 7, 2029.
What is the generic name for Ryaltris?
The active ingredient in Ryaltris is olopatadine and mometasone furoate, per the FDA Orange Book.
When does the Ryaltris patent expire?
The last patent listed for Ryaltris in the Orange Book expires November 21, 2044. 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 Ryaltris and Olopatadine and Mometasone Furoate
- What is Ryaltris used for?FDA label uses
- Is Ryaltris a controlled substance?Federal schedule
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- Histamine-1 Receptor Inhibitors listFDA drug class
- Mast Cell Stabilizers listFDA drug class
- NDC 59467-700Ryaltris NDC record
- NDC 68462-659Ryaltris NDC record