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ACTICLATE Drug Profile
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When do Acticlate patents expire, and what generic alternatives are available?
Acticlate is a drug marketed by Almirall and is included in two NDAs.
The generic ingredient in ACTICLATE is doxycycline hyclate. There are twenty-eight drug master file entries for this compound. Seventy-seven suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
US ANDA Litigation and Generic Entry Outlook for Acticlate
A generic version of ACTICLATE was launched as doxycycline hyclate by CARIBE HOLDINGS on December 11th, 2019.
Summary for ACTICLATE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 33 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ACTICLATE |
| Drug Sales Revenues: | Drug sales revenues for ACTICLATE |
| DailyMed Link: | ACTICLATE at DailyMed |
Pharmacology for ACTICLATE
| Drug Class | Tetracycline-class Drug |
Synonyms for ACTICLATE
| (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; ethanol; hydrate; dihydrochloride |
| (2Z,4S,4aR,5S,5aR,6R,12aS)-2-[amino(hydroxy)methylene]-4-(dimethylamino)-5,10,11,12a-tetrahydroxy-6-methyl-4a,5,5a,6-tetrahydro-4H-tetracene-1,3,12-trione; ethanol; hydrate; dihydrochloride |
| (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; ethanol; hydrate; dihydrochloride |
| (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 - ethanol (2:1) dihydrochloride hydrate |
| (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 compound with ethanol (2:1) dihydrochloride hydrate |
| (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;ethanol;hydrate;dihydrochloride |
| 10592-13-9 |
| 10592-13-9 (. HCl) |
| 19XTS3T51U |
| 2-Naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, hydrochloride, (4S,4aR,5S,5aR,6R,12aS)-, compd. with ethanol, hydrate (2:2:1:1) |
| 2-Naphthacenecarboxamide, 4beta-(dimeethylamino)-1,4,4abeta,5,5abeta,6,11,12a-octahydro-3,5beta,10,12,12abeta-pentahydroxy-6beta-methyl-1,11-dioxo-, monohydrochloride, compd. with ethyl alcohol (2:1), monohydrate |
| 2387AH |
| 24390-14-5 |
| 2C22H24N2O8.C2H6O.2ClH.H2O |
| 2C22H24N2O8.C2H6O.H2O |
| 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate |
| 6-Deoxy-5-hydroxytetracycline hydrochloride hemihydrate |
| 62149-53-5 |
| AC-6017 |
| AC1NQZPV |
| AC1NUYS5 |
| Acticlate CAP |
| AK175707 |
| AKOS025402170 |
| AN-18097 |
| Atridox |
| bis((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) ethanol hydrate dihydrochloride |
| CHEMBL3989740 |
| D02129 |
| Dentista |
| Doryx |
| Doryx (TN) |
| Doryx Mpc |
| Doxteric |
| DOXY |
| Doxy 100 |
| DOXY 200 |
| Doxy-Lemmon |
| Doxychel Hyclate |
| Doxycycline hyclate |
| Doxycycline Hyclate (100 mg) |
| Doxycycline hyclate (internal use) |
| Doxycycline hyclate (USP) |
| Doxycycline hyclate [USAN:USP] |
| doxycycline hyclate 20 mg twice daily |
| Doxycycline hydrochloride hemiethanolate hemihydrate |
| Doxycycline hydrochloride hydrate (JP17) |
| DOXYCYCLINE HYLATE |
| Doxyprex |
| DS-9077 |
| DTXSID4041020 |
| Ethanol, compd. with (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 monohydrochloride (1:2), monohydrate |
| Hydramycin |
| LS-174052 |
| MFCD07357237 |
| MolPort-005-932-536 |
| Monodoks |
| Periostat |
| Periostat (TN) |
| Roximycin |
| SW219440-1 |
| SW219440-2 |
| Tetraclean |
| UNII-19XTS3T51U |
| Vibra-tabs (TN) |
| Vibramycin hyclate |
| Vivox |
| WC 2031 |
| Z2791720087 |
US Patents and Regulatory Information for ACTICLATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Almirall | ACTICLATE | doxycycline hyclate | TABLET;ORAL | 205931-001 | Jul 25, 2014 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Almirall | ACTICLATE | doxycycline hyclate | TABLET;ORAL | 205931-002 | Jul 25, 2014 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Almirall | ACTICLATE CAP | doxycycline hyclate | CAPSULE;ORAL | 208253-001 | Apr 26, 2016 | DISCN | Yes | No | 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 |
