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Azelaic acid - Generic Drug Details
What are the generic sources for azelaic acid and what is the scope of azelaic acid patent protection?
Azelaic acid
is the generic ingredient in two branded drugs marketed by Leo Pharma As and Aqua Pharms Llc, and is included in three NDAs. There are eight patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Azelaic acid has one hundred and ninety-five patent family members in thirty-one countries.
There are eight drug master file entries for azelaic acid. Six suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for azelaic acid
| International Patents: | 195 |
| US Patents: | 8 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 3 |
| Drug Master File Entries: | 8 |
| Suppliers / Packagers: | 6 |
| Bulk Api Vendors: | 95 |
| Clinical Trials: | 28 |
| Patent Applications: | 5,758 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for azelaic acid |
| DailyMed Link: | azelaic acid at DailyMed |
Pharmacology for azelaic acid
| Physiological Effect | Decreased Protein Synthesis Decreased Sebaceous Gland Activity |
Synonyms for azelaic acid
| 0C50D8EC-0DB0-4F24-8EFC-2919E1F0D9BF |
| 1,7-Dicarboxyheptane |
| 1,7-Heptanedicarboxylate |
| 1,7-Heptanedicarboxylic acid |
| 1,9-Nonanedioate |
| 1,9-Nonanedioic acid |
| 123-99-9 |
| 123-99-9 (Parent) |
| 17265-13-3 (di-hydrochloride salt) |
| 17356-30-8 (mono-hydrochloride salt) |
| 19619-43-3 (unspecified potassium salt) |
| 1tuf |
| 21175-EP2269988A2 |
| 21175-EP2270008A1 |
| 21175-EP2275413A1 |
| 21175-EP2287156A1 |
| 21175-EP2292617A1 |
| 21175-EP2301940A1 |
| 21175-EP2314295A1 |
| 21175-EP2374895A1 |
| 21175-EP2380874A2 |
| 26776-28-3 |
| 27825-99-6 |
| 27825-99-6 (unspecified hydrochloride salt) |
| 32733-99-6 |
| 38900-29-7 (di-lithium salt) |
| 4-02-00-02055 (Beilstein Handbook Reference) |
| 52457-54-2 (di-potassium salt) |
| A-9800 |
| A0561 |
| AB00052140_12 |
| AC1L1DAO |
| AC1Q75FC |
| acide azelaique |
| Acide azelaique [French] |
| Acido azelaico |
| Acido azelaico [Spanish] |
| Acidum acelaicum |
| acidum azelaicum |
| Acidum azelaicum [Latin] |
| ACMC-1BTAP |
| AGN-191861 |
| AI3-06299 |
| AK174117 |
| AKOS000120052 |
| AN-22935 |
| Anchoate |
| Anchoic acid |
| ANW-18182 |
| ARONIS24596 |
| AZ1 |
| Azalaic Acid |
| Azelaic |
| Azelaic acid (USAN/INN) |
| Azelaic acid [USAN:INN] |
| Azelaic acid 99% |
| azelaic acid dipotassium salt |
| Azelaic acid polyanhydride |
| AZELAIC ACID, 95% |
| Azelaic acid, 98% |
| Azelaic acid, 98% 25g |
| Azelaic acid, analytical standard |
| Azelaic acid, technical grade |
| Azelaic acid, technical grade, 80% |
| Azelaic acid, technical, ~85% (GC) |
| Azelaic acid, Vetec(TM) reagent grade |
| Azelaic acid,technical grade |
| Azelaic polyanhydride |
| azelaicacid |
| Azelaicacidtech |
| Azelainic acid |
| Azelainsaeure |
| Azelainsaure |
| azelate |
| Azelex |
| Azelex (TN) |
| Azleaic Acid |
| BDJRBEYXGGNYIS-UHFFFAOYSA-N |
| BIDD:GT0315 |
| BRN 1101094 |
| BSPBio_001756 |
| C08261 |
| CAS-123-99-9 |
| CCG-40081 |
| CHEBI:48131 |
| CHEMBL1238 |
| CTK0H8917 |
| D03034 |
| D0E4WR |
| DB00548 |
| Dicarboxylic acid C9 |
| Dicarboxylic acid C9; Nonanedioic acid; AZA |
| DivK1c_000532 |
| DSSTox_CID_1640 |
| DSSTox_GSID_21640 |
| DSSTox_RID_76254 |
| DTXSID8021640 |
| EINECS 204-669-1 |
| Emerox 1110 |
| Emerox 1144 |
| Emery's L-110 |
| Epitope ID:187039 |
| EU-0100051 |
| F2VW3D43YT |
| F8889-5093 |
| Finacea |
| Finacea (TN) |
| Finevin |
| Finevin (TN) |
| FT-0626920 |
| GTPL7484 |
| heptane-1,7-dicarboxylic acid |
| Heptanedicarboxylic acid |
| HMS1921O11 |
| HMS2092E22 |
| HMS2234D10 |
| HMS3260K03 |
| HMS3372J07 |
| HMS501K14 |
| HSDB 7659 |
| HY-B0704 |
| I04-0585 |
| IDI1_000532 |
| InChI=1/C9H16O4/c10-8(11)6-4-2-1-3-5-7-9(12)13/h1-7H2,(H,10,11)(H,12,13 |
| KB-74817 |
| KBio1_000532 |
| KBio2_000437 |
| KBio2_003005 |
| KBio2_005573 |
| KBio3_001256 |
| KBioGR_000662 |
| KBioSS_000437 |
| KS-00000WLV |
| KS-000046KE |
| KS-5293 |
| KSC178S1P |
| Lepargylate |
| Lepargylic acid |
| LMFA01170054 |
| Lopac-246379 |
| Lopac0_000051 |
| LP00051 |
| LP083134 |
| LS-22779 |
| LS41867 |
| M112324 |
| MCULE-4093240509 |
| MFCD00004432 |
| MLS-0066619 |
| MLS-0066619.P021 |
| MLS000069659 |
| MLS001148615 |
| MolPort-001-779-873 |
| n-Nonanedioate |
| n-Nonanedioic acid |
| NCGC00014993-01 |
| NCGC00014993-02 |
| NCGC00014993-03 |
| NCGC00014993-04 |
| NCGC00014993-05 |
| NCGC00014993-06 |
| NCGC00014993-07 |
| NCGC00014993-08 |
| NCGC00014993-09 |
| NCGC00014993-10 |
| NCGC00014993-12 |
| NCGC00093565-01 |
| NCGC00093565-02 |
| NCGC00093565-03 |
| NCGC00093565-04 |
| NCGC00093565-05 |
| NCGC00093565-06 |
| NCGC00093565-07 |
| NCGC00256508-01 |
| NCGC00259538-01 |
| NCGC00260736-01 |
| NE10317 |
| NINDS_000532 |
| Nonandisaeure |
| Nonandisaure |
| NONANEDIOIC ACID |
| Nonanedioic acid Azelaic acid |
| Nonanedioic acid homopolymer |
| Nonanedioic acid, homopolymer |
| Nonanedioic acid, sodium salt |
| NSC 19493 |
| NSC-19493 |
| NSC-757406 |
| NSC19493 |
| NSC757406 |
| Opera_ID_740 |
| Pharmakon1600-01500648 |
| Poly(azelaic anhydride) |
| Polyazelaic anhydride |
| Polyazelaic Polyanhydride |
| RP17465 |
| RTR-003741 |
| s4550 |
| SBB060279 |
| SBI-0050040.P003 |
| SC-16119 |
| SCHEMBL3887 |
| SDCCGMLS-0066619.P001 |
| SH-441 |
| Skinorem |
| Skinoren |
| Skinoren (TN) |
| SMR000059164 |
| SPBio_001089 |
| Spectrum_000057 |
| SPECTRUM1500648 |
| Spectrum2_000995 |
| Spectrum3_000278 |
| Spectrum4_000401 |
| Spectrum5_001304 |
| SR-01000075671 |
| SR-01000075671-1 |
| ST45053319 |
| STL059432 |
| Tox21_110063 |
| Tox21_110063_1 |
| Tox21_201989 |
| Tox21_303011 |
| Tox21_500051 |
| TR-003741 |
| TRA0060478 |
| UNII-F2VW3D43YT |
| Z57127532 |
| ZINC1531036 |
| ZK 62498 |
| ZK-62498 |
Tentative approvals for AZELAIC ACID
| Applicant | Application No. | Strength | Dosage Form |
| ➤ Try a Free Trial | ➤ Try a Free Trial | 15% | GEL;TOPICAL |
US Patents and Regulatory Information for azelaic acid
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Leo Pharma As | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071-001 | Jul 29, 2015 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Leo Pharma As | FINACEA | azelaic acid | GEL;TOPICAL | 021470-001 | Dec 24, 2002 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Leo Pharma As | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071-001 | Jul 29, 2015 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Leo Pharma As | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071-001 | Jul 29, 2015 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Leo Pharma As | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071-001 | Jul 29, 2015 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free 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 azelaic acid
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Aqua Pharms Llc | AZELEX | azelaic acid | CREAM;TOPICAL | 020428-001 | Sep 13, 1995 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Leo Pharma As | FINACEA | azelaic acid | GEL;TOPICAL | 021470-001 | Dec 24, 2002 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Leo Pharma As | FINACEA | azelaic acid | GEL;TOPICAL | 021470-001 | Dec 24, 2002 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for azelaic acid
| Country | Document Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2007054818 | ➤ Try a Free Trial |
| Israel | 136101 | ➤ Try a Free Trial |
| Hong Kong | 1175403 | ➤ Try a Free Trial |
| Spain | 2532906 | ➤ Try a Free Trial |
| Canada | 2611577 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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