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Isotretinoin - Generic Drug Details
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What are the generic sources for isotretinoin and what is the scope of isotretinoin patent protection?
Isotretinoin has eleven patent family members in eight countries.
There are twelve drug master file entries for isotretinoin. Seven suppliers are listed for this compound.
Summary for isotretinoin
| International Patents: | 11 |
| US Patents: | 5 |
| Tradenames: | 8 |
| Applicants: | 8 |
| NDAs: | 10 |
| Drug Master File Entries: | 12 |
| Suppliers / Packagers: | 7 |
| Bulk Api Vendors: | 52 |
| Clinical Trials: | 106 |
| Patent Applications: | 7,601 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for isotretinoin |
| DailyMed Link: | isotretinoin at DailyMed |
Pharmacology for isotretinoin
| Ingredient-type | Retinoids |
| Drug Class | Retinoid |
Medical Subject Heading (MeSH) Categories for isotretinoin
Synonyms for isotretinoin
| (13-cis)-Retinoate |
| (13-cis)-Retinoic acid |
| (13cis)-retinoic acid |
| (2Z,4E,6E,8E)-3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic Acid |
| (2Z,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexenyl)nona-2,4,6,8-tetraenoic acid |
| (2Z,4E,6E,8E)-3,7-Dimethyl-9-(2,6,6-trimethyl-cyclohex-1-enyl)-nona-2,4,6,8-tetraenoic acid |
| (2Z,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohex-1-en-1-yl)nona-2,4,6,8-tetraenoic acid |
| (2Z,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid |
| (2Z,4E)-3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclohexenyl)-2,4,6,8-nonatetraenoic acid |
| (2Z,4E6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohex-1-en-1-yl)nona-2,4,6,8-tetraenoic acid |
| (7E,9E,11E,13Z)-retinoic acid |
| 13 cis retinoic acid |
| 13 Cis-Retinoic Acid |
| 13-cis RA |
| 13-cis retinoic acid |
| 13-cis-Retinoic acid |
| 13-cis-Retinoic acid, >=98% (HPLC) |
| 13-cis-retinoic acid,Isotretinoin |
| 13-cis-Retinoic acid|||Retinoid analogues |
| 13-cis-Vitamin A acid |
| 13-RA |
| 13cRA |
| 24210-EP2311808A1 |
| 24210-EP2311829A1 |
| 24210-EP2314590A1 |
| 3,7-DIMETHYL-9-(2,6,6-TRIMETHYL-1-CYCLOHEXEN-1-YL)-2-CIS-4-TRANS-6-TRANS-8-TRANS-NONATETRAENOIC ACID |
| 3,7-DIMETHYL-9-(2,6,6-TRIMETHYL-1-CYCLOHEXEN-1-YL)-2Z,4E,6E,8E-NONATETRANENOIC ACID |
| 3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)2-cis-4-trans-6-trans-8-trans-nonatetraenoic acid |
| 4-09-00-02388 (Beilstein Handbook Reference) |
| 4759-48-2 |
| 5952-EP0930075A1 |
| 5952-EP2295426A1 |
| 5952-EP2311840A1 |
| 59I482 |
| AB03039 |
| Absorica |
| Absorica (TN) |
| AC1NQZZ4 |
| accure |
| Accutane |
| Accutane (TN) |
| AKOS015841158 |
| Ambap302-79-4 |
| Amnesteem |
| Amnesteem (TN) |
| AN-15746 |
| BDBM50031459 |
| BML2-E07 |
| BPBio1_000080 |
| BRD-K76723084-001-05-9 |
| BRN 1885770 |
| BSPBio_000072 |
| BSPBio_001331 |
| BSPBio_003345 |
| C07058 |
| CAS-4759-48-2 |
| CC-29726 |
| CCG-205158 |
| CCRIS 4286 |
| CHEBI:6067 |
| CHEMBL547 |
| CIP-Isotretinoin |
| cis retinoic acid |
| cis-RA |
| cis-Retinoate |
| cis-Retinoic acid |
| Claravi (TN) |
| Claravis |
| Clarus (TN) |
| CPD000471891 |
| CS-1864 |
| D00348 |
| D00DKK |
| DB00982 |
| Decutan (TN) |
| DR001197 |
| DSSTox_CID_3177 |
| DSSTox_GSID_23177 |
| DSSTox_RID_76906 |
| DTXSID4023177 |
| EH28UP18IF |
| EINECS 225-296-0 |
| EU-0101081 |
| GTPL7600 |
| HMS1361C13 |
| HMS1568D14 |
| HMS1791C13 |
| HMS1921D08 |
| HMS1989C13 |
| HMS2092N07 |
| HMS2095D14 |
| HMS2233A07 |
| HMS3259J09 |
| HMS3263I04 |
| HMS3402C13 |
| HSDB 3929 |
| HY-15127 |
| I14-16776 |
| IDI1_033801 |
| ISORETINOIN |
| Isosuprea Lidose |
| Isotane |
| Isotane (TN) |
| Isotretinoin (USP) |
| Isotretinoin [USAN:BAN:INN] |
| Isotretinoin [USAN:INN:BAN] |
| Isotretinoin [USAN:USP:INN:BAN] |
| Isotretinoin for peak identification, European Pharmacopoeia (EP) Reference Standard |
| Isotretinoin Retinoic acid |
| Isotretinoin Zinc Salt, 13 cis Isomer |
| Isotretinoin Zinc Salt, 13-cis-Isomer |
| Isotretinoin, European Pharmacopoeia (EP) Reference Standard |
| Isotretinoin, pharmaceutical secondary standard; traceable to USP and PhEur |
| Isotretinoin, United States Pharmacopeia (USP) Reference Standard |
| isotretinoina |
| Isotretinoine |
| Isotretinoine [INN-French] |
| isotretinoino |
| Isotretinoino [INN-Spanish] |
| Isotretinoinum |
| Isotretinoinum [INN-Latin] |
| ISOTRETINON |
| Isotrex |
| ISOTREXGEL |
| Izotek (TN) |
| LMPR01090021 |
| Lopac0_001081 |
| LP01081 |
| LP124491 |
| LS-143465 |
| MFCD00079542 |
| MLS001074662 |
| MolPort-003-666-394 |
| Myorisan |
| NC00635 |
| NCGC00094358-01 |
| NCGC00094358-02 |
| NCGC00094358-03 |
| NCGC00094358-04 |
| NCGC00094358-05 |
| NCGC00094358-06 |
| NCGC00094358-07 |
| NCGC00094358-08 |
| NCGC00094358-09 |
| NCGC00094358-10 |
| NCGC00094358-11 |
| NCGC00094358-12 |
| NCGC00094358-13 |
| NCGC00094358-14 |
| NCGC00094358-15 |
| NCGC00257647-01 |
| NCGC00261766-01 |
| Neovitamin A acid |
| NSC-758156 |
| NSC758156 |
| Oratane (TN) |
| Pharmakon1600-01502013 |
| Prestwick_642 |
| Prestwick2_000256 |
| Prestwick3_000256 |
| R 3255 |
| R0088 |
| Retinoic acid, (13cis)- |
| RETINOIC ACID, 13-cis- |
| Ro 4 3780 |
| Ro 4-3780 |
| Ro 43780 |
| Ro-4-3780 |
| Ro-43780 |
| Roaccutan |
| Roaccutane |
| Roaccutane (TN) |
| Roacutan |
| RP17638 |
| SAM002548955 |
| SBI-0051051.P003 |
| SC-18589 |
| SCHEMBL38299 |
| SHGAZHPCJJPHSC-XFYACQKRSA-N |
| SMR000471891 |
| Sotret |
| Sotret (TN) |
| SPECTRUM1502013 |
| Spectrum5_001795 |
| Spectrum5_001937 |
| Teriosal |
| Tox21_200093 |
| Tox21_501081 |
| UNII-EH28UP18IF |
| Zenatane |
| ZINC3792789 |
US Patents and Regulatory Information for isotretinoin
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sun Pharm Inds Inc | ABSORICA | isotretinoin | CAPSULE;ORAL | 021951-003 | May 25, 2012 | BX | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Sun Pharm Inds Inc | ABSORICA | isotretinoin | CAPSULE;ORAL | 021951-004 | May 25, 2012 | BX | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Sun Pharm Inds Inc | ABSORICA | isotretinoin | CAPSULE;ORAL | 021951-003 | May 25, 2012 | BX | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Sun Pharm Inds Inc | ABSORICA | isotretinoin | CAPSULE;ORAL | 021951-002 | May 25, 2012 | BX | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ 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 isotretinoin
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-004 | Mar 28, 1983 | ➤ Sign Up | ➤ Sign Up |
| Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-004 | Mar 28, 1983 | ➤ Sign Up | ➤ Sign Up |
| Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-002 | May 7, 1982 | ➤ Sign Up | ➤ Sign Up |
| Hoffmann La Roche | ACCUTANE | isotretinoin | CAPSULE;ORAL | 018662-004 | Mar 28, 1983 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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International Patents for isotretinoin
| Country | Document Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2964195 | ➤ Sign Up |
| Canada | 2836228 | ➤ Sign Up |
| Spain | 2225600 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 0224172 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
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