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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 Labs Inc 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 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

International Patents:	43
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	8
Bulk Api Vendors:	71
Clinical Trials:	1
Patent Applications:	4,336
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

Adrenergic alpha-Agonists

Adrenergic beta-Agonists

Bronchodilator Agents

Mydriatics

Sympathomimetics

Vasoconstrictor Agents

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 Labs Inc	TWINJECT 0.3	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800-001	May 30, 2003		DISCN	No	No			Y
Impax Labs Inc	TWINJECT 0.3	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800-001	May 30, 2003		DISCN	No	No			Y

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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
8,187,224	Methods performed by medicine injection apparatuses
7,905,352	Kits containing medicine injection devices and containers
7,931,618	Apparatuses and methods for injecting medicines to a desired depth
7,927,303	Medicine injection devices and methods

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International Patents for TWINJECT 0.3

Country	Document Number	Estimated Expiration
Japan	2008522668
China	101072595
Taiwan	I302841
European Patent Office	1848490