SUPRAX Drug Patent 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. Eight suppliers are listed for this compound. Additional details are available on the cefixime profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Suprax

A generic version of SUPRAX was approved as cefixime by AUROBINDO PHARMA LTD on April 14^th, 2015.

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Summary for SUPRAX

International Patents:	2
US Patents:	1
Applicants:	3
NDAs:	8
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	5
Patent Applications:	5,251
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for SUPRAX
What excipients (inactive ingredients) are in SUPRAX?	SUPRAX excipients list
DailyMed Link:	SUPRAX at DailyMed

Drug patent expirations by year for SUPRAX

Recent Clinical Trials for SUPRAX

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

Sponsor	Phase
PT Pharma Metric Labs	N/A
PT Bernofarm	N/A
University of California, Los Angeles	Phase 2

See all SUPRAX clinical trials

Pharmacology for SUPRAX

Drug Class	Cephalosporin Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for SUPRAX

J01DD	Third-generation cephalosporins
J01D	OTHER BETA-LACTAM ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for SUPRAX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SUPRAX	for Oral Suspension	cefixime	500 mg/5 mL	202091	1	2016-07-22

US Patents and Regulatory Information for SUPRAX

SUPRAX is protected by one US patents.

Patents protecting SUPRAX

Pharmaceutical compositions of cefixime
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHODS FOR TREATING BACTERIAL INFECTIONS

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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
Lupin Ltd	SUPRAX	cefixime	CAPSULE;ORAL	203195-001	Jun 1, 2012	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lupin Ltd	SUPRAX	cefixime	TABLET, CHEWABLE;ORAL	065380-002	Oct 25, 2010		RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lupin Pharms	SUPRAX	cefixime	FOR SUSPENSION;ORAL	065129-001	Feb 23, 2004		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lupin Ltd	SUPRAX	cefixime	TABLET, CHEWABLE;ORAL	065380-003	Oct 25, 2010		RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lederle	SUPRAX	cefixime	FOR SUSPENSION;ORAL	050622-001	Apr 28, 1989		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lupin Ltd	SUPRAX	cefixime	FOR SUSPENSION;ORAL	202091-001	Feb 20, 2013	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for SUPRAX

See the table below for patents covering SUPRAX around the world.

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2007119249		⤷ Try a Trial
Germany	112007000920		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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