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TWINJECT 0.3 Drug Profile
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» See Plans and PricingWhich patents cover Twinject 0.3, and when can generic versions of Twinject 0.3 launch?
Twinject 0.3 is a drug marketed by Impax and is included in one NDA. There are two patents protecting this drug.
This drug has forty-three patent family members in fifteen countries.
The generic ingredient in TWINJECT 0.3 is epinephrine. There are twenty-one drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the epinephrine profile page.
US ANDA Litigation and Generic Entry Outlook for Twinject 0.3
A generic version of TWINJECT 0.3 was approved as epinephrine by BELCHER on July 29th, 2014.
Summary for TWINJECT 0.3
| International Patents: | 43 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 6 |
| Bulk Api Vendors: | 71 |
| Clinical Trials: | 1 |
| Patent Applications: | 4,425 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | TWINJECT 0.3 at DailyMed |
Recent Clinical Trials for TWINJECT 0.3
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Arthroplasty Foundation, Inc. | Phase 4 |
| University of Louisville | Phase 4 |
Synonyms for TWINJECT 0.3
| (-)-(R)-Epinephrine |
| (-)-3,4-dihydroxy-a-[(methylamino)methyl]-Benzyl alcohol |
| (-)-3,4-Dihydroxy-a-[2-(methylamino)ethyl]benzyl alcohol |
| (-)-3,4-Dihydroxy-alpha-((methylamino)methyl)benzyl alcohol |
| (-)-3,4-dihydroxy-alpha-[(methylamino)methyl]-Benzyl alcohol |
| (-)-3,4-Dihydroxy-alpha-[2-(methylamino)ethyl]benzyl alcohol |
| (-)-Adrenalin |
| (-)-Adrenaline |
| (-)-Epinephrine |
| (-)-Epinephrine, >=97.0% (NT) |
| (-)-R-Epinephrine |
| (+/-)-3,4-Dihydroxy-alpha-(methylaminomethyl)benzyl alcohol |
| (+/-)-Adrenalin |
| (+/-)-Epinephrine |
| (R)-(-)-3,4-Dihydroxy-alpha-(methylaminomethyl)benzyl alcohol |
| (R)-(-)-Adnephrine |
| (R)-(-)-Adrenaline |
| (R)-(-)-Epinephrine |
| (R)-(-)-Epirenamine |
| (r)-4-(1-hydroxy-2-(methylamino)ethyl)benzene-1,2-diol |
| (R)-4-[1-Hydroxy-2-(methylamino)ethyl]-1,2-benzenediol |
| (R)-Adrenaline |
| (R)-Epinephrine |
| 1-1-(3,4-Dihydroxyphenyl)-2-methylaminoethanol |
| 1-Adrenalin |
| 1-Epinephrine |
| 1,2-Benzenediol, 4-((1R)-1-hydroxy-2-(methylamino)ethyl)- |
| 1,2-Benzenediol, 4-(1-hydroxy-2-(methylamino)ethyl)-, (R)- |
| 1,2-Benzenediol, 4-(1-hydroxy-2-(methylamino)ethyl)-, (theta)- |
| 1,2-Benzenediol, 4-[(1R)-1-hydroxy-2-(methylamino)ethyl]- |
| 1,2-Benzenediol, 4-[1-hydroxy-2-(methylamino)ethyl]-, (R)- |
| 1401-EP2270011A1 |
| 1401-EP2298735A1 |
| 1401-EP2301934A1 |
| 1401-EP2305677A1 |
| 1401-EP2308562A2 |
| 1401-EP2308861A1 |
| 1401-EP2311464A1 |
| 1401-EP2311823A1 |
| 1401-EP2314571A2 |
| 2,3-bis(oxidanyl)butanedioic acid;4-[(1R)-2-(methylamino)-1-oxidanyl-ethyl]benzene-1,2-diol |
| 2,3-dihydroxybutanedioic acid;4-[(1R)-1-hydroxy-2-(methylamino)ethyl]benzene-1,2-diol |
| 204017-EP2277867A2 |
| 204017-EP2280003A2 |
| 3,4-Dihydroxy-.alpha.-((methylamino)methyl)benzyl alcohol |
| 3,4-Dihydroxy-alpha-(methylaminomethyl)benzyl alcohol |
| 4-(1-Hydroxy-2-(methylamino)ethyl)-1,2-benzenediol |
| 4-(1-hydroxy-2-methylamino-ethyl)benzene-1,2-diol |
| 4-[(1R)-1-Hydroxy-2-(methylamino)ethyl]-1,2-benzenediol |
| 4-[(1R)-1-hydroxy-2-(methylamino)ethyl]benzene-1,2-diol |
| 4-[(1R)-1-hydroxy-2-(methylamino)ethyl]pyrocatechol;tartaric acid |
| 4-[(1R)-1-hydroxy-2-methylamino-ethyl]benzene-1,2-diol |
| 4-[(1R)-1-hydroxy-2-methylaminoethyl]benzene-1,2-diol |
| 4-[1-Hydroxy-2-(methylamino)ethyl]-1,2-benzenediol |
| 4-[1-Hydroxy-2-(methylamino)ethyl]-1,2-benzenediol # |
| 4,5-beta-trihydroxy-N-methylphenethylamine |
| 51-43-4 |
| 51-43-4 (FREE BASE) |
| 51028-73-0 |
| 6367-EP2272841A1 |
| 6367-EP2277861A1 |
| 6367-EP2301934A1 |
| 6367-EP2301936A1 |
| 6367-EP2314571A2 |
| 91382-EP2284149A1 |
| 91382-EP2305636A1 |
| A0173 |
| AB00573227_14 |
| AB00573227_15 |
| AB00573227-11 |
| AB00573227-12 |
| AB00573227-13 |
| AB2000623 |
| AC-13188 |
| Adnephrine |
| Adrenaclick |
| Adrenal |
| Adrenalin |
| Adrenalin (TN) |
| Adrenalin in Oil |
| Adrenalin-Medihaler |
| Adrenalina |
| Adrenalina [DCIT] |
| adrenaline |
| Adrenaline (JP15) |
| Adrenaline (JP17) |
| Adrenaline (L-Adrenaline) |
| Adrenaline with impurity F, European Pharmacopoeia (EP) Reference Standard |
| Adrenaline, European Pharmacopoeia (EP) Reference Standard |
| Adrenaline/Epinephrine |
| Adrenalinum |
| Adrenamine |
| Adrenan |
| Adrenapax |
| Adrenasol |
| Adrenatrate |
| Adrenine |
| Adrenodis |
| Adrenohorma |
| Adrenosan |
| Adrenutol |
| Adrin |
| Adrine |
| ADROP |
| AI3-19015 |
| AKOS024283500 |
| ALE |
| Ana-Guard |
| Ana-Kit |
| Antiasthmatique |
| AS-13813 |
| Asmatane Mist |
| Asthma meter mist |
| Asthma-nefrin |
| Asthmahaler Mist |
| Asthmanefrin |
| Astmahalin |
| Astminhal |
| Auvi-q |
| Auvi-q (TN) |
| Auvi-Q auto-injector |
| Balmadren |
| BCP09042 |
| BDBM44818 |
| BDBM50029050 |
| Benzyl alcohol, 3,4-dihydroxy-.alpha.-[(methylamino)methyl]-, (-)- |
| Benzyl alcohol, 3,4-dihydroxy-alpha-((methylamino)methyl)-, (-)- |
| Bernarenin |
| BIDD:GT0119 |
| Biorenine |
| bmse000316 |
| Bosmin |
| Brevirenin |
| Bronkaid |
| Bronkaid Mist |
| Bronkaid Suspension Mist |
| Bupivacaine Hcl and Epinephrine |
| C00788 |
| C9H13NO3 |
| CAS-51-43-4 |
| CCG-204593 |
| CCRIS 4812 |
| CHEBI:28918 |
| Chelafrin |
| CHEMBL679 |
| cid_6852374 |
| Citanest Forte |
| Citanest Forte (Salt/Mix) |
| component of E-Pilo (Salt/Mix) |
| Corisol |
| CS-2558 |
| CTK4J3509 |
| d-Adrenaline |
| D-Epifrin |
| D-Epinephrine |
| D00095 |
| D29A657 |
| DB00668 |
| Drenamist |
| DSSTox_CID_2986 |
| DSSTox_GSID_22986 |
| DSSTox_RID_76819 |
| DTXSID5022986 |
| Dylephrin |
| Dyspne-Inhal |
| E4250_SIGMA |
| EINECS 200-098-7 |
| EPI E Z PEN JR |
| Epi EZ Pen Jr |
| Epifrin |
| Epiglaufrin |
| Epinefrin |
| Epinefrin [Czech] |
| Epinefrina |
| Epinefrina [INN-Spanish] |
| Epinephran |
| Epinephrin |
| epinephrine |
| EPINEPHRINE (SEE ALSO: EPINEPHRINE HYDROCHLORIDE (CAS 55-31-2)) |
| Epinephrine (USP) |
| Epinephrine (USP/INN) |
| Epinephrine [USAN:INN:JAN] |
| Epinephrine [USP:INN:BAN:JAN] |
| Epinephrinum |
| Epinephrinum [INN-Latin] |
| Epipen |
| Epipen (TN) |
| Epipen Auto-Injector |
| EPIPEN E Z PEN |
| Epipen EZ Pen |
| EPIPEN JR |
| Epipen Jr. |
| Epipen Jr. Auto-Injector |
| Epirenamine |
| Epirenan |
| Epirenin |
| Epitrate (Salt/Mix) |
| Eppy |
| Esphygmogenina |
| Exadri |
| Exadrin |
| Glaucon |
| Glaucosan |
| Glauposine |
| Glycirenan |
| GTPL479 |
| Haemostasin |
| Haemostatin |
| Hektalin |
| Hemisine |
| Hemostasin |
| Hemostatin |
| HSCI1_000215 |
| HSDB 4289 |
| HY-B0447B |
| Hypernephrin |
| Hyporenin |
| Intranefrin |
| IOP |
| Isoptoepinal |
| J10365 |
| Kidoline |
| l-1-(3,4-Dihydroxyphenyl)-2-methylaminoethanol |
| l-Adrenalin |
| l-Adrenaline |
| L-Adrenaline (Epinephrine) |
| L-Adrenaline Base |
| l-adrenaline,(-)adrenaline,l-epinephrine,l-3,4-dihydroxy-alpha-(methylaminomethyl)benzyl alcohol,l-1-methyl aminoethanol catechol |
| L-Epinehphrine |
| l-Epinephine |
| L-epinephrine |
| l-Epinephrine (synthetic) |
| l-Epirenamine |
| l-Methylaminoethanolcatechol |
| L(-)-Epinephrine |
| L(-)-Epinephrine, 99% |
| L926 |
| Levo-Methylaminoethanolcatechol |
| Levoepinephrine |
| Levorenen |
| Levorenin |
| Levorenine |
| Levoreninum |
| Lopac-E-4642 |
| LS-156 |
| Lyodrin |
| Lyophrin |
| MCULE-9462717294 |
| Medihaler-Epi |
| Metanephrin |
| Methylaminoethanolcatechol |
| Methylarterenol |
| MFCD00002204 |
| MFCD00063027 |
| Micronefrin |
| Micronephrine |
| Mucidrina |
| Myosthenine |
| Mytrate |
| NCGC00015417-01 |
| NCGC00142615-01 |
| NCGC00142615-03 |
| NCGC00142615-04 |
| NCGC00142615-05 |
| NCGC00142615-06 |
| NCGC00142615-07 |
| NCGC00142615-08 |
| NCGC00142615-09 |
| nchembio747-comp9 |
| NE58416 |
| Nephridine |
| Nieraline |
| NSC 62786 |
| NSC-62786 |
| NSC62786 |
| Paranephrin |
| PDSP1_001120 |
| PDSP2_001104 |
| Primatene |
| Primatene Mist |
| Q-200601 |
| Q132621 |
| R-(-)-Epinephrine |
| R-Adrenaline |
| Racemic Epinephrine |
| RCRA waste no. P042 |
| Rcra waste number P042 |
| Renagladin |
| Renaglandin |
| Renaglandulin |
| Renaleptine |
| Renalina |
| Renoform |
| Renostypricin |
| Renostypticin |
| Renostyptin |
| s2522 |
| SBB012384 |
| SCHEMBL3814 |
| Scurenaline |
| Simplene |
| Sindrenina |
| SMP1_000227 |
| Soladren |
| Sphygmogenin |
| SR-01000075267-8 |
| ST069368 |
| Stryptirenal |
| Styptirenal |
| Supracapsulin |
| Supradin |
| Supranefran |
| Supranephrane |
| Supranephrine |
| Supranol |
| Suprarenaline |
| Suprarenin |
| Suprel |
| Surenine |
| Surrenine |
| Sus-Phrine |
| SUS-PHRINE SULFITE-FREE |
| Susphrine |
| SW219274-1 |
| Symjepi |
| Sympathin I |
| Takamina |
| Takamine |
| Tokamina |
| Tonogen |
| Tox21_111562 |
| Tox21_111562_1 |
| TR-033467 |
| Twinject |
| Twinject 0.15 |
| Twinject 0.30 |
| UCTWMZQNUQWSLP-VIFPVBQESA-N |
| UNII-GR0L9S3J0F component UCTWMZQNUQWSLP-VIFPVBQESA-N |
| UNII-YKH834O4BH |
| Vaponefrin |
| Vasoconstrictine |
| Vasoconstrictor |
| Vasodrine |
| Vasoton |
| Vasotonin |
| YKH834O4BH |
| Z2686405805 |
| ZINC39089 |
US Patents and Regulatory Information for TWINJECT 0.3
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Impax | TWINJECT 0.3 | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 020800-001 | May 30, 2003 | DISCN | No | No | Start Trial | Start Trial | Y | Start Trial | |||
| Impax | TWINJECT 0.3 | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 020800-001 | May 30, 2003 | DISCN | No | No | 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 |
International Patents for TWINJECT 0.3
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1904145 | Start Trial |
| World Intellectual Property Organization (WIPO) | 9427660 | Start Trial |
| Poland | 311759 | Start Trial |
| Japan | 5138811 | Start Trial |
| Taiwan | 200618832 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
