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Azelaic acid - Generic Drug Details
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What are the generic sources for azelaic acid and what is the scope of freedom to operate?
Azelaic acid
is the generic ingredient in three branded drugs marketed by Leo Pharma As, Almirall, Actavis Labs Ut Inc, Glenmark Pharms, Taro, and Tolmar, and is included in seven NDAs. There are nine 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 sixty-three patent family members in twenty-two countries.
There are eight drug master file entries for azelaic acid. Ten suppliers are listed for this compound.
Summary for azelaic acid
| International Patents: | 163 |
| US Patents: | 9 |
| Tradenames: | 3 |
| Applicants: | 6 |
| NDAs: | 7 |
| Drug Master File Entries: | 8 |
| Suppliers / Packagers: | 10 |
| Bulk Api Vendors: | 103 |
| Clinical Trials: | 29 |
| Patent Applications: | 7,666 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for azelaic acid |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for azelaic acid |
| DailyMed Link: | azelaic acid at DailyMed |
Recent Clinical Trials for azelaic acid
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Clinical Research Center of the Carolinas | Phase 4 |
| Assiut University | Phase 4 |
| Taro Pharmaceuticals USA | Phase 1 |
Recent Litigation for azelaic acid
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Bayer HealthCare Pharmaceuticals Inc. v. Perrigo UK FINCO Limited Partnership | 2018-02-15 |
| LEO Pharma A/S v. Teva Pharmaceuticals USA, Inc. | 2018-01-03 |
| Delcor Asset Corporation v. Taro Pharmaceutical Industries, Ltd. | 2016-03-01 |
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 |
| 1219811-33-2 |
| 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 |
| AKOS000120052 |
| AN-22935 |
| Anchoate |
| Anchoic acid |
| ANW-18182 |
| ARONIS24596 |
| AZ1 |
| Azalaic Acid |
| azelaate |
| Azelaic |
| Azelaic acid (USAN/INN) |
| Azelaic acid [USAN:INN] |
| Azelaic acid 99% |
| Azelaic acid polyanhydride |
| AZELAIC ACID, 95% |
| Azelaic acid, 98% |
| 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 polyanhydride |
| azelaicacid |
| Azelaicacidtech |
| Azelainic acid |
| Azelainsaeure |
| Azelainsaure |
| azelate |
| Azelex |
| Azelex (TN) |
| Azleaic Acid |
| BCP18690 |
| BDJRBEYXGGNYIS-UHFFFAOYSA-N |
| BIDD:GT0315 |
| BRN 1101094 |
| BSPBio_001756 |
| C08261 |
| CAS-123-99-9 |
| CCG-40081 |
| CHEBI:48131 |
| CHEMBL1238 |
| CTK0H8917 |
| D03034 |
| DB00548 |
| Dicarboxylic acid C9; Nonanedioic acid; AZA |
| DivK1c_000532 |
| DSSTox_CID_1640 |
| DSSTox_GSID_21640 |
| DSSTox_RID_76254 |
| DTXSID8021640 |
| EC 204-669-1 |
| EINECS 204-669-1 |
| Emerox 1110 |
| Emerox 1144 |
| Emery's L-110 |
| Epitope ID:187039 |
| EU-0100051 |
| F2VW3D43YT |
| F8889-5093 |
| Finacea |
| Finacea (TN) |
| Finevin |
| 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 |
| 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 |
| nonanedionic acid |
| 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 |
| SMR000059164 |
| SPBio_001089 |
| Spectrum_000057 |
| SPECTRUM1500648 |
| Spectrum2_000995 |
| Spectrum3_000278 |
| Spectrum4_000401 |
| Spectrum5_001304 |
| SR-01000075671 |
| SR-01000075671-1 |
| SR-01000075671-4 |
| SR-01000075671-6 |
| ST45053319 |
| STL059432 |
| Tox21_110063 |
| Tox21_110063_1 |
| Tox21_201989 |
| Tox21_303011 |
| Tox21_500051 |
| TR-003741 |
| TRA0060478 |
| UNII-F2VW3D43YT |
| Z57127532 |
| ZINC1531036 |
| ZK 62498 |
| ZK-62498 |
Paragraph IV (Patent) Challenges for AZELAIC ACID
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| FINACEA | AEROSOL, FOAM;TOPICAL | azelaic acid | 207071 | 2017-09-14 |
| FINACEA | GEL;TOPICAL | azelaic acid | 021470 | 2012-07-27 |
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 | GEL;TOPICAL | 021470-001 | Dec 24, 2002 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Almirall | AZELEX | azelaic acid | CREAM;TOPICAL | 020428-001 | Sep 13, 1995 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Leo Pharma As | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071-001 | Jul 29, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Leo Pharma As | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071-001 | Jul 29, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | 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 azelaic acid
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Leo Pharma As | FINACEA | azelaic acid | GEL;TOPICAL | 021470-001 | Dec 24, 2002 | Start Trial | Start Trial |
| Almirall | AZELEX | azelaic acid | CREAM;TOPICAL | 020428-001 | Sep 13, 1995 | Start Trial | Start Trial |
| Leo Pharma As | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071-001 | Jul 29, 2015 | Start Trial | Start Trial |
| Leo Pharma As | FINACEA | azelaic acid | GEL;TOPICAL | 021470-001 | Dec 24, 2002 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for azelaic acid
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Spain | 2407407 | Start Trial |
| Australia | 760153 | Start Trial |
| Mexico | PA06001381 | Start Trial |
| European Patent Office | 1670435 | Start Trial |
| >Country | >Patent 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, 2020, www.DrugPatentWatch.com.