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Tranexamic acid - Generic Drug Details
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What are the generic drug sources for tranexamic acid and what is the scope of tranexamic acid patent protection?
Tranexamic acid
is the generic ingredient in three branded drugs marketed by Pharmacia And Upjohn, Acic Pharms, Akorn, Amneal Pharms Co, Aurobindo Pharma Ltd, Emcure Pharms Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Luitpold, Mylan Institutional, Virtus Pharms, Viva Hlthcare, X-gen Pharms Inc, Zydus Pharms Usa Inc, Ferring Pharms Inc, Actavis Labs Fl Inc, Amerigen Pharms Ltd, Apotex Inc, and Mylan, and is included in twenty-two NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.There are seven drug master file entries for tranexamic acid. Twenty-four suppliers are listed for this compound.
Summary for tranexamic acid
| US Patents: | 8 |
| Tradenames: | 3 |
| Applicants: | 19 |
| NDAs: | 22 |
| Drug Master File Entries: | 7 |
| Suppliers / Packagers: | 24 |
| Bulk Api Vendors: | 166 |
| Clinical Trials: | 268 |
| Patent Applications: | 4,905 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for tranexamic acid |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for tranexamic acid |
| DailyMed Link: | tranexamic acid at DailyMed |
Pharmacology for tranexamic acid
| Drug Class | Antifibrinolytic Agent |
| Physiological Effect | Decreased Fibrinolysis |
Medical Subject Heading (MeSH) Categories for tranexamic acid
Synonyms for tranexamic acid
| (1r,4r)-4-(aminomethyl)cyclohexane-1-carboxylic acid |
| (trans)-4-(aminomethyl)cyclohexanecarboxylic acid |
| 1197-17-7 |
| 1197-18-8 |
| 1510-00-5 |
| 197T188 |
| 1ceb |
| 204139-EP2277867A2 |
| 204139-EP2280003A2 |
| 21573-60-4 |
| 3-14-00-00868 (Beilstein Handbook Reference) |
| 37YD696II6 |
| 4-(Aminomethyl)-Cyclohexanecarboxylic Acid |
| 4-(aminomethyl)cyclohexane-1-carboxylic acid |
| 4-(Aminomethyl)cyclohexanecarboxylic acid |
| 4-(Aminomethyl)cyclohexanecarboxylic Acid (cis- and trans- mixture) |
| 4-Aminomethyl-cyclohexanecarboxylic acid |
| 4-aminomethylcyclohexanecarboxylic acid |
| 4-trans-(Aminomethyl)cyclohexanecarboxylic acid # |
| 4alpha-Aminomethyl-1alpha-cyclohexanecarboxylic acid |
| 6T84R30KC1 |
| 701-54-2 |
| 701-54-2 (cis+trans) |
| 701-54-2 tranexamic acid |
| A0236 |
| AB00052260 |
| AB00052260_05 |
| AB00052260_06 |
| AB00052260-04 |
| AB0013391 |
| AB1003647 |
| AC-4687 |
| AC1L1KJH |
| AC1Q50F3 |
| AC1Q546D |
| AC1Q5U04 |
| Acide tranexamique |
| Acide tranexamique [INN-French] |
| Acido tranexamico |
| Acido tranexamico [INN-Spanish] |
| Acidum tranexamicum |
| Acidum tranexamicum [INN-Latin] |
| ACMC-209a3u |
| ACMC-20h19o |
| AJ-26859 |
| AK134863 |
| AK516712 |
| AKOS005171632 |
| AKOS015854573 |
| AKOS024257901 |
| ALBB-006013 |
| AM84352 |
| AMCA |
| AMCA|||AMCHA|||HAKU|||TAMCHA |
| AMCHA |
| Amchafibrin |
| AMH |
| Amikapron |
| Amstat |
| AN-47328 |
| AN-646 |
| Anvitoff |
| ANW-17368 |
| BAY 3517 |
| BB 0260034 |
| BBL004469 |
| BC215624 |
| BDBM50428067 |
| BP-12345 |
| BPBio1_000069 |
| BRD-K15014948-001-01-2 |
| BRN 2207452 |
| BS-3867 |
| BSPBio_000061 |
| BSPBio_002837 |
| C-5054 |
| C12535 |
| Carxamin |
| CAS-1197-18-8 |
| CCG-39692 |
| CHEBI:48669 |
| CHEBI:94518 |
| CHEMBL292500 |
| CHEMBL877 |
| cis-4-(Aminomethyl)-1-cyclohexanecarboxylic Acid |
| cis-4-(Aminomethyl)cyclohexanecarboxylic acid |
| cis-4-aminomethyl-1-cyclohexanecarboxylic acid |
| cis-4-Aminomethylcyclohexane-1-carboxylic acid |
| cis-AMCHA |
| cis-Tranexamic Acid |
| CL 65336 |
| CL-65336 |
| CS-1965 |
| CTK0H8184 |
| CTK3I9745 |
| Cyclo-F |
| Cyclocapron |
| Cyclohexanecarboxylic acid, 4-(aminomethyl)- |
| Cyclohexanecarboxylic acid, 4-(aminomethyl)-, cis- |
| Cyclohexanecarboxylic acid, 4-(aminomethyl)-, trans- |
| Cyclohexanecarboxylicacid, 4-(aminomethyl)-, cis- |
| Cyklokapron |
| Cyklokapron (TN) |
| D01136 |
| D05HXX |
| DB-074265 |
| DB00302 |
| DivK1c_000655 |
| DSSTox_CID_25350 |
| DSSTox_GSID_45350 |
| DSSTox_RID_80817 |
| DTXSID3045350 |
| DV 79 |
| DV-79 |
| DV79 |
| EINECS 214-818-2 |
| Emorhalt |
| EN300-91506 |
| Exacyl |
| F8886-7867 |
| Femstrual |
| FMOC-(R)-2-aminobutyric acid |
| Frenolyse |
| FT-0654339 |
| FT-0675360 |
| FT-0700806 |
| GTPL6573 |
| GYDJEQRTZSCIOI-KNVOCYPGSA-N |
| GYDJEQRTZSCIOI-LJGSYFOKSA-N |
| GYDJEQRTZSCIOI-UHFFFAOYSA-N |
| H967 |
| HAKU |
| Hexapromin |
| Hexatron |
| HMS1568D03 |
| HMS1921F08 |
| HMS2092P03 |
| HMS2095D03 |
| HMS502A17 |
| HTS001347 |
| HY-B0149 |
| I04-0993 |
| I14-15270 |
| IDI1_000655 |
| KABI 2161 |
| KB-271963 |
| KBio1_000655 |
| KBio2_001871 |
| KBio2_004439 |
| KBio2_007007 |
| KBio3_002337 |
| KBioGR_000511 |
| KBioSS_001871 |
| KS-00000IPI |
| KS-00000NS2 |
| KSC489O4L |
| LS-56611 |
| LS-56612 |
| LT00159441 |
| Lysteda |
| Mastop |
| MCULE-6087008336 |
| MFCD00001466 |
| MFCD00064951 |
| MolPort-001-792-390 |
| MolPort-002-512-008 |
| NCGC00016569-01 |
| NCGC00016569-02 |
| NCGC00016569-03 |
| NCGC00016569-04 |
| NCGC00016569-05 |
| NCGC00016569-06 |
| NCGC00016569-08 |
| NCGC00016569-09 |
| NCGC00094944-01 |
| NCGC00094944-02 |
| NINDS_000655 |
| NSC 291305 |
| NSC-291305 |
| NSC-758176 |
| NSC291305 |
| NSC758176 |
| Oprea1_786414 |
| OR041375 |
| OR176508 |
| OR208045 |
| OR208047 |
| p-(Aminomethyl)cyclohexanecarboxylic acid |
| Pharmakon1600-01502026 |
| Prestwick_476 |
| Prestwick0_000171 |
| Prestwick1_000171 |
| Prestwick2_000171 |
| Prestwick3_000171 |
| PubChem19810 |
| Q-201848 |
| Q-9390 |
| rel-(1R,4R)-4-(aminomethyl)cyclohexane-1-carboxylic acid |
| rel-(1r,4r)-4-(Aminomethyl)cyclohexanecarboxylic acid |
| Retavase |
| Rikavarin |
| Rikavarin (TN) |
| Rikavarin-S |
| RP 18,429 |
| RP22118 |
| RTX-010404 |
| s1875 |
| SBB006715 |
| SBI-0051705.P002 |
| SC-19036 |
| SC-90830 |
| SCHEMBL16974 |
| SCHEMBL186034 |
| SCHEMBL349408 |
| SCHEMBL6885575 |
| SCHEMBL9885628 |
| SPBio_000689 |
| SPBio_001982 |
| Spectrum_001391 |
| SPECTRUM1502026 |
| Spectrum2_000655 |
| Spectrum3_001189 |
| Spectrum4_000046 |
| Spectrum5_001258 |
| Spiramin |
| SR-05000001794 |
| SR-05000001794-3 |
| ST50307111 |
| STK503668 |
| STOCK1N-16183 |
| t-AMCHA |
| Tamcha |
| Tox21_110500 |
| TR-023271 |
| TRA0027406 |
| Tranesamic acid |
| Tranex |
| tranexamate |
| Tranexamic acid (JP15/USAN/INN) |
| Tranexamic acid (JP17/USAN/INN) |
| Tranexamic acid (Transamin) |
| Tranexamic acid [USAN:INN:BAN:JAN] |
| Tranexamic acid [USAN:USP:INN:BAN:JAN] |
| Tranexamic acid cis-form |
| Tranexamic acid, European Pharmacopoeia (EP) Reference Standard |
| Tranexamic acid, Pharmaceutical Secondary Standard; Certified Reference Material |
| Tranexamic acid, United States Pharmacopeia (USP) Reference Standard |
| Tranexamicacid |
| Tranexamsaeure |
| Tranexan |
| tranexmic acid |
| Tranhexamic acid |
| tranol |
| trans 4-aminomethylcyclohexanecarboxylic acid |
| trans 4aminomethylcyclohexanecarboxylic acid |
| Trans AMCHA |
| trans-?4-?(Aminomethyl)?cyclohexanecarboxylic acid |
| trans-1-(Aminomethyl)cyclohexane-4-carboxylic acid |
| trans-1-Aminomethylcyclohexane-4-carboxylic acid |
| trans-4 -(aminomethyl)cyclohexanecarboxylic acid |
| trans-4- (aminomethyl) cyclohexanecarboxylic acid |
| trans-4-(aminomethyl)- cyclohexane carboxylic acid |
| trans-4-(Aminomethyl)-1-cyclohexanecarboxylic acid |
| Trans-4-(aminomethyl)-cyclohexane carboxylic acid |
| trans-4-(aminomethyl)-cyclohexanecarboxylic acid |
| trans-4-(Aminomethyl)cyclohexane carboxylic acid |
| trans-4-(Aminomethyl)cyclohexane-1-carboxylic acid |
| trans-4-(Aminomethyl)cyclohexane-carboxylic acid |
| trans-4-(Aminomethyl)cyclohexanecarboxylic acid |
| trans-4-(Aminomethyl)cyclohexanecarboxylic acid (Tranexamic acid) |
| trans-4-(Aminomethyl)cyclohexanecarboxylic acid ester |
| trans-4-(Aminomethyl)cyclohexanecarboxylic acid, 97% |
| trans-4-(aminomethyl)cyclohexylcarboxylic acid |
| Trans-4-Aminomethyl cyclohexane carboxylic acid |
| trans-4-aminomethyl cyclohexanecarboxylic acid |
| trans-4-aminomethyl-1-cyclohexane carboxylic acid |
| trans-4-aminomethyl-1-cyclohexanecarboxylic acid |
| trans-4-aminomethyl-cyclohexanecarboxylic acid |
| trans-4-aminomethylcyclohexane carboxylic acid |
| trans-4-Aminomethylcyclohexane-1-carboxylic acid |
| trans-4-aminomethylcyclohexanecarboxylic acid |
| Trans-4-aminomethylcyclohexylcarboxylic acid |
| trans-4(aminomethyl)cyclohexanecarboxylic acid |
| trans-Amcha |
| Trans-p-(Aminomethyl)cyclohexanecarboxylic |
| trans-p-(Aminomethyl)cyclohexanecarboxylic acid |
| trans-p-Aminomethylcyclohexanecarboxylic acid |
| trans-Tranexamic acid |
| trans4-aminomethylcyclohexane-1-carboxylic acid |
| Transamin |
| Transamin (TN) |
| Transamlon |
| Trasamlon |
| TS-02090 |
| Ugurol |
| UNII-37YD696II6 |
| UNII-6T84R30KC1 |
| WLN: L6TJ AVQ D1Z -T |
| WT319 |
| Z1741970429 |
| zataranax |
| ZINC100007011 |
| ZINC100071256 |
| ZINC1542907 |
US Patents and Regulatory Information for tranexamic acid
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Luitpold | TRANEXAMIC ACID | tranexamic acid | INJECTABLE;INJECTION | 201885-001 | Aug 10, 2011 | AP | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Ferring Pharms Inc | LYSTEDA | tranexamic acid | TABLET;ORAL | 022430-001 | Nov 13, 2009 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Acic Pharms | TRANEXAMIC ACID | tranexamic acid | INJECTABLE;INJECTION | 202436-001 | Feb 11, 2014 | AP | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Ferring Pharms Inc | LYSTEDA | tranexamic acid | TABLET;ORAL | 022430-001 | Nov 13, 2009 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Zydus Pharms Usa Inc | TRANEXAMIC ACID | tranexamic acid | INJECTABLE;INJECTION | 205228-001 | Jul 17, 2017 | AP | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Mylan | TRANEXAMIC ACID | tranexamic acid | TABLET;ORAL | 205133-001 | Sep 21, 2015 | AB | RX | No | No | ➤ 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 tranexamic acid
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pharmacia And Upjohn | CYKLOKAPRON | tranexamic acid | INJECTABLE;INJECTION | 019281-001 | Dec 30, 1986 | ➤ Sign Up | ➤ Sign Up |
| Pharmacia And Upjohn | CYKLOKAPRON | tranexamic acid | TABLET;ORAL | 019280-001 | Dec 30, 1986 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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International Patents for tranexamic acid
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Japan | 2008508276 | ➤ Sign Up |
| Japan | 5205053 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 2006023000 | ➤ Sign Up |
| Japan | 2008508275 | ➤ Sign Up |
| Japan | 2014193878 | ➤ Sign Up |
| Japan | 2011168596 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
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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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