FDA Orange Book

Generic for Oracea

Oracea contains doxycycline. 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 Oracea is doxycycline. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Oracea products in the Orange Book

Oracea products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
capsule, oral	40MG	Marketed (Rx)	AB	7	AB

NDA 050805, held by GALDERMA LABORATORIES LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic doxycycline

Approved generic versions of Oracea
Company	ANDA	TE code	Approved	Strengths
DR REDDYS LABORATORIES LTD	218034	AB (A-rated, therapeutically equivalent)	April 8, 2024	40MG
LUPIN INC	216631	AB (A-rated, therapeutically equivalent)	April 8, 2024	40MG
ALEMBIC PHARMACEUTICALS LTD	217674	AB (A-rated, therapeutically equivalent)	June 27, 2024	40MG
APOTEX INC	217170	AB (A-rated, therapeutically equivalent)	July 11, 2024	40MG
PRINSTON PHARMACEUTICAL INC	217098	AB (A-rated, therapeutically equivalent)	January 27, 2025	40MG
MACLEODS PHARMACEUTICALS LTD	210381	AB (A-rated, therapeutically equivalent)	March 27, 2025	40MG
AIPING PHARMACEUTICAL INC	219978	AB (A-rated, therapeutically equivalent)	October 1, 2025	40MG

Oracea patents

Patents listed for Oracea
Patent	Expires	Covers	Use code	NDA
7749532	December 19, 2027	Drug product	U-1063	050805

Oracea NDC codes

Questions

Is there a generic for Oracea?

Yes. The generic name for Oracea is doxycycline. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Oracea?

The active ingredient in Oracea is doxycycline, per the FDA Orange Book.

When does the Oracea patent expire?

The last patent listed for Oracea in the Orange Book expires December 19, 2027. 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.