Zydus Company Profile

What is the competitive landscape for ZYDUS

ZYDUS has four hundred and eight approved drugs.

There is one US patent protecting ZYDUS drugs. There are twenty-eight tentative approvals on ZYDUS drugs.

There are four patent family members on ZYDUS drugs in four countries and one thousand one hundred and nineteen supplementary protection certificates in nineteen countries.

Summary for Zydus

International Patents:	4
US Patents:	1
Tradenames:	326
Ingredients:	316
NDAs:	408
Patent Litigation for Zydus:	See patent lawsuits for Zydus

Drugs and US Patents for Zydus

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus Pharms	METOPROLOL TARTRATE	metoprolol tartrate	TABLET;ORAL	212402-001	Apr 19, 2023		DISCN	No	No
Zydus Pharms	PREGABALIN	pregabalin	CAPSULE;ORAL	206752-002	Dec 9, 2022		DISCN	No	No
Zydus Pharms	BUSPIRONE HYDROCHLORIDE	buspirone hydrochloride	TABLET;ORAL	078888-003	Feb 7, 2014	AB	RX	No	No
Zydus Pharms	POTASSIUM CHLORIDE	potassium chloride	TABLET, EXTENDED RELEASE;ORAL	210395-002	Sep 17, 2020	AB1	RX	No	No
Zydus Pharms	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206641-005	Aug 11, 2017	AB4	RX	No	No
Zydus Pharms Usa Inc	PIOGLITAZONE HYDROCHLORIDE	pioglitazone hydrochloride	TABLET;ORAL	202456-003	Feb 13, 2013	AB	RX	No	No

Paragraph IV (Patent) Challenges for ZYDUS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	for Injection	200 mcg/vial		2015-05-01
	for Injection	100 mcg/vial and 500 mcg/vial		2015-04-14
	Delayed-release Tablets	20 mg		2015-06-03

International Patents for Zydus Drugs

Country	Patent Number	Estimated Expiration
India	651MU2014
South Africa	201606075
World Intellectual Property Organization (WIPO)	2015128877
Philippines	12016501686

Supplementary Protection Certificates for Zydus Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1470124	LUC00009	Luxembourg		PRODUCT NAME: PALBOCICLIB, EVENTUELLEMENT SOUS LA FORME D'UN SEL , D'UN ESTER, D'UN AMIDE OU D'UN PROMEDICAMENT PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/16/1147 20161111
0740668	03C0017	France		PRODUCT NAME: TADALAFIL; REGISTRATION NO/DATE: EU/1/02/237/001-004 20021112
1315485	2015/028	Ireland		PRODUCT NAME: LUBIPROSTONE AND PHARMACEUTICALLY ACCEPTABLE SALTS FOR LUBIPROSTONE.; NAT REGISTRATION NO/DATE: PA148/002/001 20150213; FIRST REGISTRATION NO/DATE: PL21341/0003-0001 20120910
3209302	C202330028	Spain		PRODUCT NAME: COMBINACION DE FOSLEVODOPA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA Y FOSCARBIDOPA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISM.; NATIONAL AUTHORISATION NUMBER: 88677-SE/H/0415/003/DC; DATE OF AUTHORISATION: 20230220; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 141371; DATE OF FIRST AUTHORISATION IN EEA: 20220825
0526171	01C0044	France		PRODUCT NAME: NATEGLINIDE; NAT. REGISTRATION NO/DATE: EU/1/01/174/001 20010403; FIRST REGISTRATION: LI - 55401 20000928
0496835	C960031	Netherlands		PRODUCT NAME: DOXORUBICINESULFAAT VERKREGEN UIT DOXORUBICINEHYDROCHLORIDE EN AMMONIUMSULFAAT; REGISTRATION NO/DATE: EU/1/96/011/001 - EU/1/96/011/002 19960621

Similar Applicant Names

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

• Zydus
• Zydus Hlthcare
• Zydus Lifesciences
• Zydus Pharms
• Zydus Pharms Usa
• Zydus Pharms Usa Inc