Lidocaine; tetracaine - Generic Drug Details

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What are the generic drug sources for lidocaine; tetracaine and what is the scope of freedom to operate?

Lidocaine; tetracaine is the generic ingredient in two branded drugs marketed by Crescita Therap and Galen Specialty, and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lidocaine; tetracaine has seven patent family members in seven countries.

Three suppliers are listed for this compound.

Summary for lidocaine; tetracaine

International Patents:	7
US Patents:	3
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	3
Clinical Trials:	61
DailyMed Link:	lidocaine; tetracaine at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for lidocaine; tetracaine

Generic Entry Date for lidocaine; tetracaine^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: CREAM;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for lidocaine; tetracaine

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

Sponsor	Phase
Juerg Hafner	Phase 2
Cutia Therapeutics（Wuxi）Co.,Ltd	Phase 3
Kalpna Kay Durairaj, MD, FACS	Phase 1

See all lidocaine; tetracaine clinical trials

Pharmacology for lidocaine; tetracaine

Drug Class	Amide Local Anesthetic Antiarrhythmic Ester Local Anesthetic
Physiological Effect	Local Anesthesia

Anatomical Therapeutic Chemical (ATC) Classes for lidocaine; tetracaine

C01BB	Antiarrhythmics, class Ib
C01B	ANTIARRHYTHMICS, CLASS I AND III
C01	CARDIAC THERAPY
C	Cardiovascular system

C05AD	Local anesthetics
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

C05AD	Local anesthetics
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

D04AB	Anesthetics for topical use
D04A	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D04	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D	Dermatologicals

D04AB	Anesthetics for topical use
D04A	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D04	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D	Dermatologicals

N01BA	Esters of aminobenzoic acid
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

N01BB	Amides
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

R02AD	Anesthetics, local
R02A	THROAT PREPARATIONS
R02	THROAT PREPARATIONS
R	Respiratory system

S01HA	Local anesthetics
S01H	LOCAL ANESTHETICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01HA	Local anesthetics
S01H	LOCAL ANESTHETICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02DA	Analgesics and anesthetics
S02D	OTHER OTOLOGICALS
S02	OTOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for lidocaine; tetracaine

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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
Galen Specialty	SYNERA	lidocaine; tetracaine	PATCH;TOPICAL	021623-001	Jun 23, 2005		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Crescita Therap	PLIAGLIS	lidocaine; tetracaine	CREAM;TOPICAL	021717-001	Jun 29, 2006		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Crescita Therap	PLIAGLIS	lidocaine; tetracaine	CREAM;TOPICAL	021717-001	Jun 29, 2006		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Crescita Therap	PLIAGLIS	lidocaine; tetracaine	CREAM;TOPICAL	021717-001	Jun 29, 2006		DISCN	Yes	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

Expired US Patents for lidocaine; tetracaine

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galen Specialty	SYNERA	lidocaine; tetracaine	PATCH;TOPICAL	021623-001	Jun 23, 2005	⤷ Sign Up	⤷ Sign Up
Galen Specialty	SYNERA	lidocaine; tetracaine	PATCH;TOPICAL	021623-001	Jun 23, 2005	⤷ Sign Up	⤷ Sign Up
Crescita Therap	PLIAGLIS	lidocaine; tetracaine	CREAM;TOPICAL	021717-001	Jun 29, 2006	⤷ Sign Up	⤷ Sign Up
Galen Specialty	SYNERA	lidocaine; tetracaine	PATCH;TOPICAL	021623-001	Jun 23, 2005	⤷ Sign Up	⤷ Sign Up
Galen Specialty	SYNERA	lidocaine; tetracaine	PATCH;TOPICAL	021623-001	Jun 23, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for lidocaine; tetracaine

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2523660	FORMULATIONS POUR ANESTHÉSIE LOCALE SE SOLIDIFIANT POUR LA GESTION DE LA DOULEUR (SOLID-FORMING LOCAL ANESTHETIC FORMULATIONS FOR PAIN CONTROL)	⤷ Sign Up
Brazil	112012017554	formulações de anestésicas locais formadoras de sólido para controle da dor	⤷ Sign Up
Mexico	2012008168	FORMULACIONES ANESTESICAS LOCALES QUE FORMAN SOLIDOS PARA CONTROL DEL DOLOR. (SOLID-FORMING LOCAL ANESTHETIC FORMULATIONS FOR PAIN CONTROL.)	⤷ Sign Up
China	102834096	Solid-forming local anesthetic formulations for pain control	⤷ Sign Up
Australia	2011205730	Solid-forming local anesthetic formulations for pain control	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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