FDA Orange Book

Generic for Lo Loestrin Fe

Lo Loestrin Fe contains norethindrone acetate and ethinyl estradiol. 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 Lo Loestrin Fe is norethindrone acetate and ethinyl estradiol. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Lo Loestrin Fe products in the Orange Book

Lo Loestrin Fe products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, oral0.01MG,0.01MG;1MG,N/AMarketed (Rx)AB1AB

NDA 022501, held by ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic norethindrone acetate and ethinyl estradiol

Approved generic versions of Lo Loestrin Fe
CompanyANDATE codeApprovedStrengths
TEVA PHARMACEUTICALS INC219324AB (A-rated, therapeutically equivalent)June 22, 20260.01MG,0.01MG;1MG,N/A

Lo Loestrin Fe patents

Patents listed for Lo Loestrin Fe
PatentExpiresCoversUse codeNDA
7704984February 2, 2029Method of useU-1090022501

Questions

Is there a generic for Lo Loestrin Fe?

Yes. The generic name for Lo Loestrin Fe is norethindrone acetate and ethinyl estradiol. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Lo Loestrin Fe?

The active ingredient in Lo Loestrin Fe is norethindrone acetate and ethinyl estradiol, per the FDA Orange Book.

When does the Lo Loestrin Fe patent expire?

The last patent listed for Lo Loestrin Fe in the Orange Book expires February 2, 2029. 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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