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ORACEA Drug Profile
» See Plans and Pricing
When do Oracea patents expire, and when can generic versions of Oracea launch?
Oracea is a drug marketed by Galderma Labs Lp and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.
This drug has thirty-seven patent family members in thirteen countries.
The generic ingredient in ORACEA is doxycycline. There are twenty-eight drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the doxycycline profile page.
US ANDA Litigation and Generic Entry Outlook for Oracea
A generic version of ORACEA was approved as doxycycline by WEST-WARD PHARMS INT on March 9th, 1988.
Summary for ORACEA
| International Patents: | 37 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 45 |
| Clinical Trials: | 8 |
| Patent Applications: | 746 |
| Formulation / Manufacturing: | see details |
| 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 |
| DailyMed Link: | ORACEA at DailyMed |
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 |
Pharmacology for ORACEA
| Drug Class | Tetracycline-class Drug |
Paragraph IV (Patent) Challenges for ORACEA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ORACEA | CAPSULE;ORAL | doxycycline | 050805 | 2008-12-12 |
| ORACEA | CAPSULE;ORAL | doxycycline | 050805 | 2008-12-11 |
US Patents and Regulatory Information for ORACEA
| 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 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | Start Trial | Start Trial |
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ORACEA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2011168613 | Start Trial |
| Japan | 2004536046 | Start Trial |
| Japan | 5622773 | Start Trial |
| Denmark | 2204168 | Start Trial |
| Canada | 2440472 | Start Trial |
| European Patent Office | 1383508 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
