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PRIMATENE MIST Drug Profile
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Which patents cover Primatene Mist, and when can generic versions of Primatene Mist launch?
Primatene Mist is a drug marketed by Armstrong Pharms and Wyeth Cons and is included in two NDAs. There is one patent protecting this drug.
The generic ingredient in PRIMATENE MIST 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 Primatene Mist
A generic version of PRIMATENE MIST was approved as epinephrine by BELCHER PHARMS LLC on January 25th, 2020.
Summary for PRIMATENE MIST
| US Patents: | 1 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 71 |
| Clinical Trials: | 1 |
| Patent Applications: | 4,474 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | PRIMATENE MIST at DailyMed |
Recent Clinical Trials for PRIMATENE MIST
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Amphastar Pharmaceuticals, Inc. | Phase 3 |
Synonyms for PRIMATENE MIST
| (-)-(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 |
| (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 |
| 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 |
| 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 |
| L(-)-Epinephrine, 99% |
| 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 |
| Micronephrine |
| 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 |
| Paranephrin |
| PDSP1_001120 |
| PDSP2_001104 |
| Primatene |
| Q-200601 |
| 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 0.3 |
| 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 PRIMATENE MIST
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Armstrong Pharms | PRIMATENE MIST | epinephrine | AEROSOL, METERED;INHALATION | 205920-001 | Nov 7, 2018 | OTC | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Armstrong Pharms | PRIMATENE MIST | epinephrine | AEROSOL, METERED;INHALATION | 205920-001 | Nov 7, 2018 | OTC | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Wyeth Cons | PRIMATENE MIST | epinephrine | AEROSOL, METERED;INHALATION | 016126-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
