Epinephrine - Generic Drug Details

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What are the generic drug sources for epinephrine and what is the scope of patent protection?

Epinephrine is the generic ingredient in thirty-three 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, 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-five NDAs. There are forty-three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Epinephrine has one hundred and ninety-eight 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:	198
US Patents:	43
Tradenames:	33
Applicants:	33
NDAs:	55
Drug Master File Entries:	21
Suppliers / Packagers:	19
Bulk Api Vendors:	73
Clinical Trials:	486
Patent Applications:	7,039
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

See drug prices for epinephrine

Drug Sales Revenue Trends for epinephrine

See drug sales revenues for epinephrine

Recent Clinical Trials for epinephrine

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Walter Reed National Military Medical Center	Phase 3
University of California, Los Angeles	Phase 4
Beijing Tiantan Hospital	Phase 4

See all epinephrine clinical trials

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

See all epinephrine litigation

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

Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Bronchodilator Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents

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 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
EPIPEN	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	epinephrine	019430	2009-07-20

US Patents and Regulatory Information for epinephrine

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Speciality Lp	EPIPEN JR.	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	019430-002	Dec 22, 1987	AB	RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Mylan Speciality Lp	EPIPEN	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	019430-001	Dec 22, 1987	AB	RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-002	Aug 10, 2012	BX	RX	Yes	Yes	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

Expired US Patents for epinephrine

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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

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Country	Patent Number	Estimated Expiration
Canada	2585707	Start Trial
Australia	2009246525	Start Trial
Australia	2009200841	Start Trial
>Country	>Patent Number	>Estimated Expiration

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