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SUPRAX Drug Profile

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When do Suprax patents expire, and when can generic versions of Suprax launch?

Suprax is a drug marketed by Lupin Ltd, Lederle, and Lupin Pharms. and is included in eight NDAs. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has two patent family members in two countries.

The generic ingredient in SUPRAX is cefixime. There are fourteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the cefixime profile page.

Summary for SUPRAX

International Patents:	2
US Patents:	1
Applicants:	3
NDAs:	8
Suppliers / Packagers:	5
Bulk Api Vendors:	51
Clinical Trials:	2
Patent Applications:	4,677
Formulation / Manufacturing:	see details
DailyMed Link:	SUPRAX at DailyMed

Pharmacology for SUPRAX

Ingredient-type	Cephalosporins
Drug Class	Cephalosporin Antibacterial

Medical Subject Heading (MeSH) Categories for SUPRAX

Anti-Bacterial Agents

Synonyms for SUPRAX

(-)-Cefixim

(6R,7R)-7-((Z)-2-(2-Aminothiazol-4-yl)-2-((carboxymethoxy)imino)acetamido)-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid

(6R,7R)-7-({(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-[(carboxymethoxy)imino]acetyl}amino)-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid

(6R,7R)-7-(2-(2-Amino-4-thiazolyl)glyoxylamido)-8-oxo-3-vinyl-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid, 7(sup 2)-(Z)-(O-(carboxymethyl)oxime) trihydrate

(6R,7R)-7-(2-(2-Amino-4-thiazolyl)glyoxylamido)-8-oxo-3-vinyl-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid, 7(sup 2)-(Z)-(O-(carboxymethyl)oxime)trihydrate

(6r,7r)-7-[-2-(2-amino-thiazol-4-yl)-2-carboxymethoxyimino-acetylamino]-8-oxo-3-vinyl-5-thia-1-aza-b

(6R,7R)-7-[-2-(2-Amino-thiazol-4-yl)-2-carboxymethoxyimino-acetylamino]-8-oxo-3-vinyl-5-thia-1-aza-bicyclo[4. 2.0]oct-2-ene-2-carboxylic acid

(6R,7R)-7-[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-[(carboxymethoxy)imino]acetamido]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid

(6R,7R)-7-[[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-(carboxymethyloxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid

(6R,7R)-7-[[(2Z)-2-(2-Amino-4-thiazolyl)-2-[(carboxymethoxy)imino]acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid

(6R,7R)-7-[[(2z)-2-(2-amino-thiazol-4-yl)-2-[(carboxymethoxy)imino]acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]Oct-2-ene-2-carboxylic acid

(6R,7R)-7-{[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-{[(carboxymethyl)oxy]imino}acetyl]amino}-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid

214265-67-5

5-Thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid, 7-(((2-amino-4-thiazolyl)((carboxymethoxy)imino)acetyl)amino)-3-ethenyl-8-oxo-, trihydrate, (6R-(6alpha,7beta(Z)))-

5-Thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid, 7-(((2Z)-(2-amino-4-thiazolyl)((carboxymethoxy)imino)acetyl)amino)-3-ethenyl-8-oxo-, (6R,7R)-

50C371

79350-37-1

7beta-{(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-[(carboxymethoxy)imino]acetamido}-3-ethenyl-3,4-didehydrocepham-4-carboxylic acid

AB00513842

AB0073052

AC-4350

AC1NSFNI

AK326220

AKOS015854940

AKOS015961135

AT-7061

BC205782

BDBM84007

BPBio1_000622

BRD-K71059170-001-02-5

BRN 6025058

BSPBio_000564

C04

C06881

CCG-220462

Cefixim

Cefixima

Cefixima [Spanish]

CEFIXIME

Cefixime (JAN/USP/INN)

Cefixime (JP15/USP/INN)

Cefixime [USAN:USP:INN:BAN:JAN]

Cefixime Anhydrous

Cefixime EP Impurity C (Cefixime 7-epimer)

Cefixime, Antibiotic for Culture Media Use Only

Cefixime(7-[[(2-amino-4-thiazolgl)(Carboxymethoxg)imino]acetyl]amino-3-vinyl -8-oxo-5-thia-1-azabicyclo[4,2,0]oct-2-ene-2-Carboxylicacidtrihydrate)

cefiximine

Cefiximum

Cefiximum [Latin]

Cefixoral

Cefspan

Cephoral

CFIX

CHEBI:472657

CHEMBL1541

cid_5362065

CL 284,635

CL-284635

CS-4820

D00258

D06OVY

DB00671

Denvar

FK-027

FR- 17027

FR-17027

HE325243

HMS2096M06

HMS2234J21

HY-B1381

LS-187248

MFCD00865020

MLS002222332

MolPort-003-845-687

NCGC00179521-01

Necopen

Ofex (TN)

Prestwick3_000462

PubChem13762

RS0002

s4596

SCHEMBL24945

SMR001307271

Suprax (TN)

TC-070894

Tricef

UNII-XZ7BG04GJX

Unixime

X-2622

XZ7BG04GJX

ZINC12503147

US Patents and Regulatory Information for SUPRAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lupin Ltd	SUPRAX	cefixime	CAPSULE;ORAL	203195-001	Jun 1, 2012		RX	Yes	Yes
Lupin Ltd	SUPRAX	cefixime	TABLET, CHEWABLE;ORAL	065380-002	Oct 25, 2010		RX	No	No
Lupin Pharms	SUPRAX	cefixime	FOR SUSPENSION;ORAL	065129-001	Feb 23, 2004	AB	RX	No	No
Lupin Ltd	SUPRAX	cefixime	TABLET, CHEWABLE;ORAL	065380-003	Oct 25, 2010		RX	No	Yes

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Paragraph IV (Patent) Challenges for SUPRAX

Drugname	Dosage	Strength	RLD	Submissiondate
	for Oral Suspension	500 mg/5 mL		2014-07-22

Non-Orange Book US Patents for SUPRAX

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
9,241,905	Pharmaceutical compositions of Cefixime

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International Patents for SUPRAX

Country	Document Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2007119249
Germany	112007000920