DrugPatentWatch Database Preview
ORACEA Drug Profile
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Which patents cover Oracea, and when can generic versions of Oracea launch?
This drug has thirty-five patent family members in twelve countries.
The generic ingredient in ORACEA is doxycycline. There are twenty-seven drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the doxycycline profile page.
Summary for ORACEA
| International Patents: | 35 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 4 |
| Bulk Api Vendors: | 45 |
| Clinical Trials: | 6 |
| Patent Applications: | 1,487 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ORACEA |
| DailyMed Link: | ORACEA at DailyMed |
Pharmacology for ORACEA
| Ingredient-type | Tetracyclines |
| Drug Class | Tetracycline-class Drug |
Medical Subject Heading (MeSH) Categories for ORACEA
Synonyms for ORACEA
| (2E,4S,4aR,5S,5aR,6R,12aS)-2-[amino(hydroxy)methylidene]-4-(dimethylamino)-5,10,11,12a-tetrahydroxy-6-methyl-4a,5,5a,6-tetrahydro-4H-tetracene-1,3,12-trione |
| (2Z,4S,4AR,5S,5AR,6R,12AS)-2-[AMINO(HYDROXY)METHYLIDENE]-4-(DIMETHYLAMINO)-5,10,11,12A-TETRAHYDROXY-6-METHYL-1,2,3,4,4A,5,5A,6,12,12A-DECAHYDROTETRACENE-1,3,12-TRIONE |
| (2Z,4S,4aR,5S,5aR,6R,12aS)-2-[amino(hydroxy)methylidene]-4-(dimethylamino)-5,10,11,12a-tetrahydroxy-6-methyl-4a,5,5a,6-tetrahydro-4H-tetracene-1,3,12-trione |
| (2Z,4S,4aR,5S,5aR,6R)-2-[amino(hydroxy)methylidene]-4-(dimethylamino)-5,10,11,12a-tetrahydroxy-6-methyl-4a,5,5a,6-tetrahydro-4H-tetracene-1,3,12-trione |
| (2Z)-2-[amino(hydroxy)methylidene]-4-(dimethylamino)-5,10,11,12a-tetrahydroxy-6-methyl-4a,5,5a,6-tetrahydro-4H-tetracene-1,3,12-trione |
| (4S,4aR,5S,5aR,6R,12aR)-4-(dimethylamino)-1,5,10,11,12a-pentahydroxy-6-methyl-3,12-dioxo-4a,5,5a,6-tetrahydro-4H-tetracene-2-carboxamide |
| (4S,4aR,5S,5aR,6R,12aS)-2-[amino(hydroxy)methylidene]-4-(dimethylamino)-5,10,11,12a-tetrahydroxy-6-methyl-4a,5,5a,6-tetrahydro-4H-tetracene-1,3,12-trione |
| (4s,4ar,5s,5ar,6r,12as)-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide |
| (4S,4aR,5S,5aR,6R,12aS)-4-(dimethylamino)-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide |
| (4S,4aR,5S,5aR,6R,12aS)-4-(dimethylamino)-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-4a,5,5a,6-tetrahydro-4H-tetracene-2-carboxamide |
| 10597-92-9 |
| 1368-EP2269978A2 |
| 1368-EP2269985A2 |
| 1368-EP2269991A2 |
| 1368-EP2284150A2 |
| 1368-EP2284151A2 |
| 1368-EP2284152A2 |
| 1368-EP2284153A2 |
| 1368-EP2284155A2 |
| 1368-EP2284156A2 |
| 1368-EP2284164A2 |
| 1368-EP2287140A2 |
| 1368-EP2287148A2 |
| 1368-EP2287150A2 |
| 1368-EP2289871A1 |
| 1368-EP2295402A2 |
| 1368-EP2295419A2 |
| 1368-EP2298732A1 |
| 1368-EP2301534A1 |
| 1368-EP2301912A2 |
| 1368-EP2301913A1 |
| 1368-EP2301914A1 |
| 1368-EP2301916A2 |
| 1368-EP2305637A2 |
| 1368-EP2305640A2 |
| 1368-EP2308863A1 |
| 1368-EP2311451A1 |
| 1368-EP2311796A1 |
| 1368-EP2311797A1 |
| 1368-EP2311798A1 |
| 1368-EP2311799A1 |
| 1368-EP2316450A1 |
| 17086-28-1 (mono-hydrate) |
| 2-Naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, (4S-(4alpha,4aalpha,5alpha,5aalpha,6alpha,12aalpha))- |
| 2-Naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, (4S,4aR,5S,5aR,6R,12aS) |
| 2-Naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, (4S,4aR,5S,5aR,6R,12aS)- |
| 2-Naphthacenecarboxamide, 4-alpha-S-(dimethylamino)-1,4,4a-alpha-5,5a-alpha,6,11,12a-octahydro-3,5-alpha,10,12,12a-alpha-pentahydroxy-6-alpha-methyl-1,11-dioxo- |
| 334895S862 |
| 4-Epioxytetracycline, 6-deoxy- |
| 41411-66-9 (6-epimer, mono-hydrochloride) |
| 5-Hydroxy-alpha-6-deoxytetracycline |
| 5-Hydroxy-alpha-6-deoxytetracycline monohydrate |
| 564-25-0 |
| 564D250 |
| 6-alpha-Deoxy-5-oxytetracycline |
| 6-Deoxyoxytetracycline |
| 6-Deoxytetracycline |
| 69935-17-7 (mono-hydrochloride, di-hydrate) |
| 6alpha-Deoxy-5-oxytetracycline |
| 7164-70-7 |
| 7264-10-0 |
| 94088-85-4 (calcium salt (1:2)) |
| AB00053465_04 |
| AB00053465_05 |
| AB00053465-03 |
| AB08 (*Fosfatex) |
| AC1L1WYQ |
| AC1NQXW7 |
| AC1NUYS8 |
| Acticlate |
| AK322076 |
| AKOS015900372 |
| alpha-6-Deoxy-5-hydroxytetracycline |
| alpha-6-Deoxyoxytetracycline |
| alpha-6-Deoxyoxytetracycline monohydrate |
| alpha-6-Tetracycline monohydrate |
| alpha-Doxycycline |
| Alti-Doxycycline |
| Anhydrous doxycycline |
| API0002491 |
| Apo-Doxy |
| AS-13499 |
| Atridox |
| Azudoxat |
| BCBcMAP01_000024 |
| BMY 28689 |
| BMY-28689 |
| BMY28689 |
| BSPBio_001936 |
| BU 3839T |
| BU-3839T |
| C06973 |
| CCG-204498 |
| CHEBI:50845 |
| CHEMBL1433 |
| CHEMBL436921 |
| D07876 |
| D0S0LZ |
| DB00254 |
| Deoxymykoin |
| DivK1c_000345 |
| DMSC (*Fosfatex) |
| Doryx |
| Dossiciclina |
| Dossiciclina [DCIT] |
| DOXCYCLINE ANHYDROUS |
| Doxiciclina |
| Doxiciclina [INN-Spanish] |
| Doxiciclina [Italian] |
| Doxitard |
| Doxivetin |
| DOXY |
| Doxy-Caps |
| Doxy-Puren |
| Doxy-Tabs |
| Doxycen |
| Doxychel |
| Doxychel (TN) |
| Doxycin |
| Doxycyclin |
| doxycycline |
| Doxycycline (200mg/day) or Placebo |
| Doxycycline (anhydrous) |
| Doxycycline (INN) |
| Doxycycline (internal use) |
| Doxycycline (TN) |
| Doxycycline [USAN:INN:BAN] |
| Doxycycline anhydrous |
| DOXYCYCLINE CALCIUM |
| Doxycycline HCl |
| Doxycycline hyclate |
| Doxycycline hydrochloride |
| Doxycycline-Chinoin |
| Doxycycline, Antibiotic for Culture Media Use Only |
| Doxycyclinum |
| Doxycyclinum [INN-Latin] |
| Doxylin |
| Doxysol |
| Doxytec |
| Doxytetracycline |
| DTXSID0037653 |
| EINECS 209-271-1 |
| FT-0603476 |
| GS-3065 |
| GS-3065 (*monohydrate) |
| GTPL6464 |
| HMS2090E06 |
| HSDB 3071 |
| Hydramycin |
| I455 |
| IDI1_000345 |
| Investin |
| JBIWCJUYHHGXTC-AKNGSSGZSA-N |
| Jenacyclin |
| KBio1_000345 |
| KBio2_001287 |
| KBio2_003855 |
| KBio2_006423 |
| KBio3_001156 |
| KBioGR_001133 |
| KBioSS_001287 |
| Liviatin |
| LMPK07000001 |
| Lopac0_000405 |
| LS-187766 |
| LS-93868 |
| MCULE-4368118692 |
| MMV000011 |
| MolPort-002-507-423 |
| MolPort-039-338-208 |
| MolPort-042-652-606 |
| Monodox |
| Monodox (*monohydrate) |
| NCGC00161602-01 |
| NCGC00161602-03 |
| NCGC00161602-04 |
| NCGC00161602-05 |
| NCGC00188979-01 |
| NINDS_000345 |
| Novo-Doxylin |
| NSC633557 |
| Nu-Doxycycline |
| Oxytetracycline, 6-deoxy- |
| Periostat |
| Periostat (TN) |
| PL000396 |
| PL040705 |
| Ronaxan |
| RPRXAHFLWOCXQL-AKNGSSGZSA-N |
| SBI-0050391.P004 |
| SC-15766 |
| SCHEMBL17826665 |
| SCHEMBL19270298 |
| SCHEMBL40930 |
| SCHEMBL66828 |
| SGKRLCUYIXIAHR-AKNGSSGZSA-N |
| SMP1_000107 |
| Spanor |
| SPBio_000246 |
| Spectrum_000807 |
| Spectrum2_000143 |
| Spectrum3_000408 |
| Spectrum4_000527 |
| Spectrum5_000947 |
| SR-01000075844 |
| SR-01000075844-7 |
| STOCK1N-34341 |
| Supracyclin |
| UNII-334895S862 |
| UPCMLD-DP021 |
| UPCMLD-DP021:001 |
| Vibra-tabs |
| Vibramycin |
| Vibramycin (*monohydrate) |
| Vibramycin Novum |
| Vibramycine |
| Vibravenos |
| Vivox (*Hyclate) |
| W-105517 |
| Zenavod |
| ZINC100056779 |
| ZINC100302137 |
| ZINC100611210 |
| ZINC109562088 |
| ZINC16052277 |
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 | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | 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 |
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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 | ➤ 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 |
Paragraph IV (Patent) Challenges for ORACEA
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Delayed-release Capsules | 40 mg | ➤ Subscribe | 2008-12-11 |
Non-Orange Book US Patents for ORACEA
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 7,014,858 | Use methods of treating acne and telangiectasia | ➤ Sign Up |
| 8,658,189 | Methods of treating acne | ➤ Sign Up |
| 8,052,983 | Methods of treating acne | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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