DrugPatentWatch Database Preview
Epinephrine - Generic Drug Details
What are the generic drug sources for epinephrine and what is the scope of patent protection?
Epinephrine
is the generic ingredient in thirty-four branded drugs marketed by Sterling, Armstrong Pharms, Wyeth Cons, Forest Labs, Mylan Speciality Lp, Impax, Teva Pharms Usa, Par Sterile Products, Kaleo Inc, Am Regent, Adamis Pharms Corp, Hospira Inc, Belcher Pharms Llc, 3M, Astrazeneca, Dentsply Pharm, Deproco, Septodont Inc, Carlisle, Belmora Llc, Eastman Kodak, Hospira, West-ward Pharms Int, Abbott, Bel Mar, Dell Labs, Intl Medication, Watson Labs, Pharmaton, Septodont, Fresenius Kabi Usa, Vyteris, Iomed, and Empi, and is included in fifty-six NDAs. There are forty-four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Epinephrine has two hundred and six patent family members in twenty-six countries.
There are twenty-one drug master file entries for epinephrine. Nineteen suppliers are listed for this compound.
Summary for epinephrine
| International Patents: | 206 |
| US Patents: | 44 |
| Tradenames: | 34 |
| Applicants: | 34 |
| NDAs: | 56 |
| Drug Master File Entries: | 21 |
| Suppliers / Packagers: | 19 |
| Bulk Api Vendors: | 71 |
| Clinical Trials: | 492 |
| Patent Applications: | 6,943 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for epinephrine |
| Drug Sales Revenues: | Drug sales revenues for epinephrine |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for epinephrine |
| DailyMed Link: | epinephrine at DailyMed |
Recent Clinical Trials for epinephrine
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Walter Reed National Military Medical Center | Phase 3 |
| Epimed International | Phase 4 |
| Beijing Tiantan Hospital | Phase 4 |
Recent Litigation for epinephrine
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Adamis Pharmaceuticals Corporation v. Belcher Pharmaceuticals, LLC | 2018-09-26 |
| Belcher Pharmaceuticals, LLC v. International Medication Systems, Limited | 2018-06-28 |
| Par Pharmaceutical, Inc. v. Hospira, Inc. | 2017-07-13 |
See all epinephrine litigation
PTAB Litigation
| Petitioner | Date |
|---|---|
| Adamis Pharmaceuticals Corporation | 2019-04-26 |
Pharmacology for epinephrine
| Drug Class | alpha-Adrenergic Agonist beta-Adrenergic Agonist Catecholamine |
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
Medical Subject Heading (MeSH) Categories for epinephrine
Synonyms for epinephrine
| (-)-(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 (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 |
| Primatene Mist |
| 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 |
Paragraph IV (Patent) Challenges for EPINEPHRINE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ADRENALIN | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | epinephrine | 204640 | 2018-08-20 |
| ADRENALIN | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | epinephrine | 204200 | 2016-03-09 |
| EPIPEN | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | epinephrine | 019430 | 2009-07-20 |
| EPIPEN JR. | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | epinephrine | 019430 | 2009-07-20 |
| EPI E Z PEN JR | INJECTABLE;INTRAMUSCULAR | epinephrine | 019430 | 2009-07-20 |
| EPIPEN E Z PEN | INJECTABLE;INTRAMUSCULAR | epinephrine | 019430 | 2009-07-20 |
US Patents and Regulatory Information for epinephrine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Kaleo Inc | AUVI-Q | epinephrine | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 201739-002 | Aug 10, 2012 | BX | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Intl Medication | LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE | epinephrine; lidocaine hydrochloride | INJECTABLE;INJECTION | 086402-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Kaleo Inc | AUVI-Q | epinephrine | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 201739-003 | Nov 17, 2017 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Kaleo Inc | AUVI-Q | epinephrine | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 201739-001 | Aug 10, 2012 | BX | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Teva Pharms Usa | EPINEPHRINE (AUTOINJECTOR) | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 090589-001 | Aug 16, 2018 | AB | RX | 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 |
Expired US Patents for epinephrine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Impax | ADRENACLICK | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 020800-003 | Nov 25, 2009 | Start Trial | Start Trial |
| Impax | ADRENACLICK | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 020800-004 | Nov 25, 2009 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for epinephrine
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Mexico | 2007006250 | Start Trial |
| Israel | 203925 | Start Trial |
| Taiwan | I302841 | Start Trial |
| Japan | 4960252 | Start Trial |
| Canada | 2926365 | 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.
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