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TWINJECT 0.3 Drug Profile
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Which 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.
The generic ingredient in TWINJECT 0.3 is epinephrine. There are nineteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the epinephrine profile page.
Summary for TWINJECT 0.3
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 8 |
| Bulk Api Vendors: | 66 |
| Clinical Trials: | 1 |
| Patent Applications: | 4,402 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | TWINJECT 0.3 at DailyMed |
Pharmacology for TWINJECT 0.3
| Ingredient-type | Catecholamines |
| Drug Class | alpha-Adrenergic Agonist beta-Adrenergic Agonist Catecholamine |
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
Medical Subject Heading (MeSH) Categories for TWINJECT 0.3
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) |
| (-)-Epinephrine;L-Adrenaline;(-)-Adrenalin |
| (-)-R-Epinephrine |
| (+/-)-3,4-Dihydroxy-alpha-(methylaminomethyl)benzyl alcohol |
| (+/-)-Adrenalin |
| (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 |
| AC1L1L7B |
| Adnephrine |
| ADR ADRENALINE |
| Adrenaclick |
| Adrenal |
| Adrenalin |
| Adrenalin (TN) |
| Adrenalin chloride |
| 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 |
| AJ-08814 |
| AKOS024283500 |
| ALE |
| AN-15872 |
| 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 |
| BC204174 |
| 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 |
| epinephrine |
| EPINEPHRINE (SEE ALSO: EPINEPHRINE HYDROCHLORIDE (CAS 55-31-2)) |
| Epinephrine (USP) |
| Epinephrine (USP/INN) |
| Epinephrine [USAN:INN:JAN] |
| Epinephrine [USP:INN:BAN:JAN] |
| Epinephrine HCl |
| Epinephrine hydrochloride |
| 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 |
| 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 |
| Iontocaine |
| 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 |
| L926 |
| Levo-Methylaminoethanolcatechol |
| Levoadrenaline |
| Levoepinephrine |
| Levorenen |
| Levorenin |
| Levorenine |
| Levoreninum |
| Lopac-E-4642 |
| LS-156 |
| Lyodrin |
| Lyophrin |
| MCULE-9462717294 |
| Medihaler-Epi |
| Metanephrin |
| Methylaminoethanolcatechol |
| Methylarterenol |
| MFCD00002204 |
| MFCD00063027 |
| Micronefrin |
| MolPort-002-051-368 |
| 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 |
| NSC62786 |
| OR023601 |
| OR154878 |
| OR276267 |
| OR349940 |
| Paranephrin |
| PDSP1_001120 |
| PDSP2_001104 |
| Primatene |
| Primatene Mist |
| Q-200601 |
| R-(-)-Epinephrine |
| R-Adrenaline |
| RCRA waste no. P042 |
| Rcra waste number P042 |
| Renagladin |
| Renaglandin |
| Renaglandulin |
| Renaleptine |
| Renalina |
| Renoform |
| Renostypricin |
| Renostypticin |
| Renostyptin |
| s2522 |
| SBB012384 |
| SCHEMBL3814 |
| Scurenaline |
| Septocaine |
| 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 |
| 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 | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Impax | TWINJECT 0.3 | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 020800-001 | May 30, 2003 | DISCN | No | 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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Non-Orange Book US Patents for TWINJECT 0.3
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 7,905,352 | Kits containing medicine injection devices and containers | ➤ Sign Up |
| 8,187,224 | Methods performed by medicine injection apparatuses | ➤ Sign Up |
| 7,931,618 | Apparatuses and methods for injecting medicines to a desired depth | ➤ Sign Up |
| 7,927,303 | Medicine injection devices and methods | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for TWINJECT 0.3
| Country | Document Number | Estimated Expiration |
|---|---|---|
| San Marino | P200700023 | ➤ Sign Up |
| Taiwan | 200618832 | ➤ Sign Up |
| Australia | 2005314401 | ➤ Sign Up |
| Japan | 2008522659 | ➤ Sign Up |
| European Patent Office | 1848490 | ➤ Sign Up |
| New Zealand | 554828 | ➤ Sign Up |
| South Africa | 200704515 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
