Staxyn Drug Patent Profile

Which patents cover Staxyn, and what generic alternatives are available?

Staxyn is a drug marketed by Bayer Hlthcare and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has fifty-three patent family members in thirty-eight countries.

The generic ingredient in STAXYN is vardenafil hydrochloride. There are six drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the vardenafil hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Staxyn

A generic version of Staxyn was approved as vardenafil hydrochloride by TEVA PHARMS on May 3^rd, 2012.

Summary for Staxyn

International Patents:	53
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	71
Patent Applications:	6
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for Staxyn
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for Staxyn
What excipients (inactive ingredients) are in Staxyn?	Staxyn excipients list
DailyMed Link:	Staxyn at DailyMed

See drug prices for Staxyn

See drug sales revenues for Staxyn

Anatomical Therapeutic Chemical (ATC) Classes for Staxyn

G04BE	Drugs used in erectile dysfunction
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for STAXYN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
STAXYN	Orally Disintegrating Tablets	vardenafil hydrochloride	10 mg	200179	1	2011-12-22

US Patents and Regulatory Information for Staxyn

Staxyn is protected by one US patents.

Patents protecting Staxyn

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	STAXYN	vardenafil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	200179-001	Jun 17, 2010		DISCN	Yes	No			Y

Expired US Patents for Staxyn

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	STAXYN	vardenafil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	200179-001	Jun 17, 2010
Bayer Hlthcare	STAXYN	vardenafil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	200179-001	Jun 17, 2010

International Patents for Staxyn

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

Country	Patent Number	Title	Estimated Expiration
South Africa	9810297	2-Phenyl-substituted imidazotriazinones
Norway	20120203
New Zealand	561004	Pharmaceutical forms comprising vardenafil with improved pharmacokinetic properties
Guatemala	200600097	FORMAS FARMACEUTICAS CON PROPIEDADES FARMACOCINETICAS MEJORADAS
Russian Federation	2260593	2-ФЕНИЛЗАМЕЩЕННЫЕ ИМИДАЗОТРИАЗИНОНЫ, СПОСОБ ИХ ПОЛУЧЕНИЯ И ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ НА ИХ ОСНОВЕ, ОБЛАДАЮЩАЯ СВОЙСТВАМИ ИНГИБИТОРА ФОСФОДИЭСТЕРАЗЫI,II И V (2-PHENYL-SUBSTITUTED IMIDAZOTRIAZINONES, METHOD FOR THEIR PREPARING AND PHARMACEUTICAL COMPOSITION BASED ON THEREOF ELICITING PROPERTY OF PHOSPHODIESTERASE I, II AND V INHIBITOR)
Russian Federation	2007135982	ЛЕКАРСТВЕННЫЕ ФОРМЫ С УЛУЧШЕННЫМИ ФАРМАКОКИНЕТИЧЕСКИМИ СВОЙСТВАМИ
European Patent Office	1174431	2-Phényl-substitués Imidazotriazinone comme inhibiteurs de la phoshodiesterase (2-Phenyl-substituited Imidazotriazinones as Phoshodiesterase Inhibitors)