QUDEXY XR Drug Patent Profile

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

Qudexy Xr is a drug marketed by Upsher Smith Labs and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has ten patent family members in six countries.

The generic ingredient in QUDEXY XR is topiramate. There are twenty-six drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the topiramate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Qudexy Xr

A generic version of QUDEXY XR was approved as topiramate by ACCORD HLTHCARE on March 27^th, 2009.

Summary for QUDEXY XR

International Patents:	10
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	1
Patent Applications:	5,077
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for QUDEXY XR
Drug Sales Revenues:	Drug sales revenues for QUDEXY XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QUDEXY XR
DailyMed Link:	QUDEXY XR at DailyMed

See drug prices for QUDEXY XR

See drug sales revenues for QUDEXY XR

Recent Clinical Trials for QUDEXY XR

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

Sponsor	Phase
Upsher-Smith Laboratories	Phase 4

See all QUDEXY XR clinical trials

Pharmacology for QUDEXY XR

Mechanism of Action	Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A4 Inducers
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Anatomical Therapeutic Chemical (ATC) Classes for QUDEXY XR

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for QUDEXY XR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QUDEXY XR	Extended-release Capsules	topiramate	25 mg, 50 mg, 100 mg, 150 mg, and 200 mg	205122	1	2015-12-24

US Patents and Regulatory Information for QUDEXY XR

QUDEXY XR is protected by five US patents.

Patents protecting QUDEXY XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Upsher Smith Labs	QUDEXY XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	205122-001	Mar 11, 2014	AB2	RX	Yes	No
Upsher Smith Labs	QUDEXY XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	205122-004	Mar 11, 2014	AB2	RX	Yes	No			Y
Upsher Smith Labs	QUDEXY XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	205122-005	Mar 11, 2014	AB2	RX	Yes	Yes			Y
Upsher Smith Labs	QUDEXY XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	205122-002	Mar 11, 2014	AB2	RX	Yes	No			Y
Upsher Smith Labs	QUDEXY XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	205122-001	Mar 11, 2014	AB2	RX	Yes	No			Y
Upsher Smith Labs	QUDEXY XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	205122-003	Mar 11, 2014	AB2	RX	Yes	No			Y

International Patents for QUDEXY XR

See the table below for patents covering QUDEXY XR around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2968177	CAPSULE DE TOPIRAMATE À LIBÉRATION LENTE (EXTENDED-RELEASE TOPIRAMATE CAPSULES)
South Korea	20160124930	서방성 토피라메이트 캡슐 (EXTENDED-RELEASE TOPIRAMATE CAPSULES)
Israel	241053	קפסולות של טופיראמאט עם שחרור מושהה (Extended-release topiramate capsules)
World Intellectual Property Organization (WIPO)	2014143380
South Korea	101674509
Canada	2905011	CAPSULE DE TOPIRAMATE A LIBERATION LENTE (EXTENDED-RELEASE TOPIRAMATE CAPSULES)

Supplementary Protection Certificates for QUDEXY XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2317997	2190050-1	Sweden		PRODUCT NAME: PHENTERMINE AND TOPIRAMATE; NAT. REG. NO/DATE: 59574-59577 20210617; FIRST REG.: IS IS/1/21/018/01-04 20210212
0138441	SPC/GB95/028	United Kingdom		PRODUCT NAME: TOPIRAMATE; REGISTERED: UK 0242/0301 19950718