Is there a generic for Doxycycline?

Yes. The FDA Orange Book lists 31 approved generic (ANDA) applications for Doxycycline, referencing the brand ORACEA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Doxycycline?

ORACEA (NDA 050805, GALDERMA LABS LP) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Doxycycline?

The Orange Book lists 1 patent against Doxycycline products, with the earliest listed expiry in 2027. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Doxycycline are approved?

Doxycycline is approved in the following dosage forms: capsule, for suspension, tablet.

FDA Orange Book · active-ingredient family

Doxycycline

Doxycycline is approved as 3 brand and 31 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ORACEA · NDA 050805

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule, for suspension, tablet

Product	Applicant	Application	TE	Approved
ORACEARLD	GALDERMA LABS LP	NDA 050805	AB	May 26, 2006
MONODOXRLD×4	CHARTWELL RX	NDA 050641	AB	Feb 10, 1992
VIBRAMYCINRLD	PFIZER	NDA 050006	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (31)

Product	Applicant	Application	TE	Approved
DOXYCYCLINE	AIPING PHARM INC	ANDA 219978	AB	Oct 01, 2025
DOXYCYCLINE	MACLEODS PHARMS LTD	ANDA 210381	AB	Mar 27, 2025
DOXYCYCLINE	PRINSTON INC	ANDA 217098	AB	Jan 27, 2025
DOXYCYCLINE	APOTEX	ANDA 217170	AB	Jul 11, 2024
DOXYCYCLINE	ALEMBIC	ANDA 217674	AB	Jun 27, 2024
DOXYCYCLINE	DR REDDYS	ANDA 218034	AB	Apr 08, 2024
DOXYCYCLINE	LUPIN	ANDA 216631	AB	Apr 08, 2024
DOXYCYCLINE×3	RISING	ANDA 208942	—	Jan 21, 2021
DOXYCYCLINE×3	DR REDDYS LABS SA	ANDA 209396	AB	Sep 29, 2017
DOXYCYCLINE×4	ZYDUS PHARMS	ANDA 209582	AB	Sep 28, 2017
DOXYCYCLINE×2	ALEMBIC	ANDA 209165	AB	Jul 28, 2017
DOXYCYCLINE×3	ZYDUS PHARMS	ANDA 205115	AB	Feb 18, 2016
DOXYCYCLINE×3	COSETTE	ANDA 204446	—	May 28, 2015
DOXYCYCLINE×3	LUPIN	ANDA 204234	AB	Mar 05, 2014
DOXYCYCLINE	LUPIN LTD	ANDA 201678	AB	Mar 18, 2013
DOXYCYCLINE	STRIDES PHARMA	ANDA 202778	—	Jun 08, 2012
DOXYCYCLINE×4	HERITAGE	ANDA 091605	AB	Dec 20, 2011
DOXYCYCLINE	IMPAX LABS INC	ANDA 200065	—	Feb 17, 2011
DOXYCYCLINE×3	SUN PHARM INDUSTRIES	ANDA 065471	—	Apr 17, 2009
DOXYCYCLINE	CHARTWELL	ANDA 065454	AB	Jul 16, 2008
DOXYCYCLINE	CHARTWELL RX	ANDA 065427	—	Jun 07, 2007
DOXYCYCLINE×3	SANDOZ INC	ANDA 065353	—	Nov 27, 2006
DOXYCYCLINE×3	CHARTWELL RX	ANDA 065377	—	Nov 07, 2006
DOXYCYCLINE×4	SUN PHARM INDS LTD	ANDA 065356	AB	May 31, 2006
DOXYCYCLINE×4	LANNETT CO INC	ANDA 065285	AB	Dec 08, 2005
DOXYCYCLINE×4	STRIDES PHARMA INTL	ANDA 065070	AB	Dec 15, 2000
DOXYCYCLINE×4	STRIDES PHARMA INTL	ANDA 065055	AB	Dec 01, 2000
DOXYCYCLINE×3	SUN PHARM INDS LTD	ANDA 065053	AB	Nov 22, 2000
DOXYCYCLINE×2	SANDOZ INC	ANDA 065032	—	Jun 30, 2000
DOXYCYCLINE×2	WATSON LABS	ANDA 065041	—	Apr 28, 2000
DOXYCHEL	RACHELLE	ANDA 061720	—	Approved Prior to Jan 1, 1982

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7749532	Dec 19, 2027	in 1 yr 6 mo	ProductU-1063

Doxycycline — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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