FDA Orange Book
Generic for Alphagan P
Alphagan P contains brimonidine. 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 Alphagan P is brimonidine. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AT.
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Alphagan P products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, ophthalmic | 0.1% | Marketed (Rx) | AB | 9 | AB |
| solution/drops, ophthalmic | 0.15% | Marketed (Rx) | AT | 3 | AT |
NDA 021770, 021262, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic brimonidine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| APOTEX INC | 078479 | AT (A-rated, therapeutically equivalent) | January 31, 2022 | 0.15% |
| APOTEX INC | 078480 | AB (A-rated, therapeutically equivalent) | December 21, 2022 | 0.1% |
| ALEMBIC PHARMACEUTICALS LTD | 215225 | AT (A-rated, therapeutically equivalent) | March 29, 2023 | 0.15% |
| ALEMBIC PHARMACEUTICALS LTD | 216909 | AB (A-rated, therapeutically equivalent) | August 1, 2023 | 0.1% |
| SANDOZ INC | 203172 | AB (A-rated, therapeutically equivalent) | March 4, 2024 | 0.1% |
| UPSHER SMITH LABORATORIES LLC | 216772 | AT (A-rated, therapeutically equivalent) | June 12, 2024 | 0.15% |
| SOMERSET THERAPEUTICS LLC | 216906 | AB (A-rated, therapeutically equivalent) | August 9, 2024 | 0.1% |
| LUPIN LTD | 213215 | AB (A-rated, therapeutically equivalent) | August 26, 2024 | 0.1% |
| UPSHER SMITH LABORATORIES LLC | 217599 | AB (A-rated, therapeutically equivalent) | July 30, 2025 | 0.1% |
| GLAND PHARMA LTD | 219219 | AB (A-rated, therapeutically equivalent) | March 11, 2026 | 0.1% |
| MANKIND PHARMA LTD | 220398 | AB (A-rated, therapeutically equivalent) | April 16, 2026 | 0.1% |
| MICRO LABS LTD | 218558 | AB (A-rated, therapeutically equivalent) | May 7, 2026 | 0.1% |
Alphagan P NDC codes
Questions
Is there a generic for Alphagan P?
Yes. The generic name for Alphagan P is brimonidine. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AT.
What is the generic name for Alphagan P?
The active ingredient in Alphagan P is brimonidine, per the FDA Orange Book.
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 Alphagan P and Brimonidine
- What is Alphagan P used for?FDA label uses
- Is Alphagan P a controlled substance?Federal schedule
- What is Brimonidine used for?FDA label uses
- Is Brimonidine a controlled substance?Federal schedule
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- Generic for AlphaganFDA Orange Book
- Generic for QolianaFDA Orange Book
- Alpha-Adrenergic Agonists listFDA drug class
- NDC 0023-9177Alphagan P NDC record
- NDC 0023-9321Alphagan P NDC record