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Zydus Pharms Usa Company Profile

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What is the competitive landscape for ZYDUS PHARMS USA, and when can generic versions of ZYDUS PHARMS USA drugs launch?

ZYDUS PHARMS USA has one hundred and sixty-nine approved drugs.

There is one US patent protecting ZYDUS PHARMS USA drugs. There are nine tentative approvals on ZYDUS PHARMS USA drugs.

There are two patent family members on ZYDUS PHARMS USA drugs in two countries and two hundred and thirty-three supplementary protection certificates in thirteen countries.

Summary for Zydus Pharms Usa

International Patents:	2
US Patents:	1
Tradenames:	142
Ingredients:	142
NDAs:	169

Drugs and US Patents for Zydus Pharms Usa

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus Pharms Usa	RIBAVIRIN	ribavirin	TABLET;ORAL	077094-004	Apr 18, 2008	AB	RX	No	No
Zydus Pharms Usa Inc	AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride	TABLET;ORAL	210086-002	Oct 6, 2017	AB	RX	No	No
Zydus Pharms Usa Inc	DOXAZOSIN MESYLATE	doxazosin mesylate	TABLET;ORAL	208719-004	Jul 7, 2017	AB	RX	No	No
Zydus Pharms Usa Inc	DESOXIMETASONE	desoximetasone	OINTMENT;TOPICAL	205206-001	Sep 19, 2017	AB	RX	No	No

Paragraph IV (Patent) Challenges for ZYDUS PHARMS USA drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Delayed-release Tablets	20 mg		2015-06-03

Non-Orange Book US Patents for Zydus Pharms Usa

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
9,139,527	Method of preparation of pitavastatin and pharmaceutical acceptable salts thereof

International Patents for Zydus Pharms Usa Drugs

Country	Document Number	Estimated Expiration
Japan	2013516459
World Intellectual Property Organization (WIPO)	2011089623

Supplementary Protection Certificates for Zydus Pharms Usa Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0037	France		PRODUCT NAME: OLMESARTAN MEDOXOMIL; NAT. REGISTRATION NO/DATE: NL28292 20030806; FIRST REGISTRATION: DE - 50202.00 20020813
2004004	Lithuania		PRODUCTNAME: LINEZOLIDUM - (S)-N-[[3-FLUOR-4-(4-MORFOLINIL)FENIL]-2-OKSO-5-OKSAZOLIDINIL]METIL]-ACETAMIDAS
C0044	France		PRODUCT NAME: NATEGLINIDE; NAT. REGISTRATION NO/DATE: EU/1/01/174/001 20010403; FIRST REGISTRATION: LI - 55401 20000928
C/GB05/003	United Kingdom		PRODUCT NAME: DULOXETINE AND PHARMACUETICALLY ACCEPTABLE ACID ADDITION SALTS THEREOF, AND IN PARTICULAR DULOXETINE HYDROCHLORIDE; REGISTERED: UK EU/1/04/280/001 20040811; UK EU/1/04/280/002 20040811; UK EU/1/04/280/003 20040811; UK EU/1/04/280/004 20040811; UK EU/1/04/280/005 20040811; UK EU/1/04/280/006 20040811

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Zydus Hlthcare
• Zydus Pharms Usa
• Zydus Pharms Usa Inc
• Zydus Worldwide