FDA Orange Book
Generic for Ortho Tri-cyclen
Ortho Tri-cyclen contains ethinyl estradiol and norgestimate. 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 Ortho Tri-cyclen is ethinyl estradiol and norgestimate. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Ortho Tri-cyclen products the Orange Book lists.
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Ortho Tri-cyclen products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral-21 | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG | Discontinued | None | 0 | None |
| tablet, oral-28 | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG | Discontinued | None | 8 | AB |
NDA 019697, held by JANSSEN PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ethinyl estradiol and norgestimate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BARR LABORATORIES INC | 075808 | AB (A-rated, therapeutically equivalent) | December 29, 2003 | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG |
| GLENMARK PHARMACEUTICALS LTD | 200494 | AB (A-rated, therapeutically equivalent) | June 17, 2011 | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG |
| NOVAST LABORATORIES LTD | 090524 | AB (A-rated, therapeutically equivalent) | May 30, 2012 | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG |
| XIROMED PHARMA ESPANA SL | 090793 | AB (A-rated, therapeutically equivalent) | January 30, 2013 | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG |
| NAARI PTE LTD | 200383 | AB (A-rated, therapeutically equivalent) | April 7, 2015 | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG |
| LUPIN LTD | 205588 | AB (A-rated, therapeutically equivalent) | April 26, 2016 | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG |
| AUROBINDO PHARMA LTD | 205441 | AB (A-rated, therapeutically equivalent) | July 6, 2016 | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG |
| ANNORA PHARMA PRIVATE LTD | 220876 | AB (A-rated, therapeutically equivalent) | September 23, 2026 | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG |
Questions
Is there a generic for Ortho Tri-cyclen?
Yes. The generic name for Ortho Tri-cyclen is ethinyl estradiol and norgestimate. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Ortho Tri-cyclen products the Orange Book lists.
What is the generic name for Ortho Tri-cyclen?
The active ingredient in Ortho Tri-cyclen is ethinyl estradiol and norgestimate, 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.