ORACEA Drug Patent Profile

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Which patents cover Oracea, and what generic alternatives are available?

Oracea is a drug marketed by Galderma Labs Lp and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has eighteen patent family members in eight countries.

The generic ingredient in ORACEA is doxycycline. There are twenty-eight drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the doxycycline profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Oracea

A generic version of ORACEA was approved as doxycycline by SUN PHARM INDS LTD on November 22^nd, 2000.

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Summary for ORACEA

International Patents:	18
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	13
Patent Applications:	2,585
Drug Prices:	Drug price information for ORACEA
Drug Sales Revenues:	Drug sales revenues for ORACEA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ORACEA
What excipients (inactive ingredients) are in ORACEA?	ORACEA excipients list
DailyMed Link:	ORACEA at DailyMed

Drug patent expirations by year for ORACEA

Recent Clinical Trials for ORACEA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Wake Forest University Health Sciences	Phase 4
The Skin of Color Society	Phase 4
Derm Research, PLLC	Phase 4

See all ORACEA clinical trials

Pharmacology for ORACEA

Drug Class	Tetracycline-class Drug

Paragraph IV (Patent) Challenges for ORACEA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ORACEA	Delayed-release Capsules	doxycycline	40 mg	050805	1	2008-12-12

US Patents and Regulatory Information for ORACEA

ORACEA is protected by six US patents.

Patents protecting ORACEA

Once daily formulations of tetracyclines
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTULES) OF ROSACEA

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for ORACEA

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006	⤷ Sign Up	⤷ Sign Up
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006	⤷ Sign Up	⤷ Sign Up
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006	⤷ Sign Up	⤷ Sign Up
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006	⤷ Sign Up	⤷ Sign Up
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for ORACEA

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Limited	Doxirobe	Doxycycline	EMEA/V/C/000044 Treatment of periodontal disease in dogs.Periodontal pocket probing depths >=4 mm are evidence of disease that may be responsive to treatment with the Doxirobe Gel. Use of this product as directed should result in attachment level gains, periodontal pocket depth reductions, local antimicrobial effect and improved gingival health. Noticeable improvements in these parameters should be evident within 2-4 weeks following treatment. The response in individual dogs is dependent on the severity of the condition and rigor of adjunctive therapy.	Withdrawn	no	no	no	1999-09-16
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for ORACEA

See the table below for patents covering ORACEA around the world.

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Country	Patent Number	Title	Estimated Expiration
Japan	2011168613	METHOD OF TREATING ACNE	⤷ Sign Up
Canada	2521885	FORMULATIONS DE TETRACYCLINES EN DOSE QUOTIDIENNE UNIQUE (ONCE DAILY FORMULATIONS OF TETRACYCLINES)	⤷ Sign Up
Portugal	1615622		⤷ Sign Up
Portugal	2204168		⤷ Sign Up
European Patent Office	1615622	FORMULATIONS DE DOXYCYCLINES EN DOSE QUOTIDIENNE UNIQUE (ONCE DAILY FORMULATIONS OF DOXYCYCLINES)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration