Zydus Company Profile

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ZYDUS has three hundred and seventy-eight approved drugs.

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

There are four patent family members on ZYDUS drugs in four countries and nine hundred and sixty-five supplementary protection certificates in eighteen countries.

International Patents:	4
US Patents:	1
Tradenames:	306
Ingredients:	296
NDAs:	378
Patent Litigation for Zydus:	See patent lawsuits for Zydus

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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
Zydus Pharms Usa	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET;ORAL	077064-003	Apr 18, 2005	AB	RX	No	No		⤷ Sign Up				⤷ Sign Up
Zydus Pharms	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	202891-007	Dec 12, 2017	AB	RX	No	No		⤷ Sign Up				⤷ Sign Up
Zydus Pharms	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	207340-003	Oct 31, 2017	AB	RX	No	No		⤷ Sign Up				⤷ Sign Up
Zydus Pharms	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	linagliptin; metformin hydrochloride	TABLET;ORAL	208449-001	Mar 30, 2023		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Zydus Pharms	TOFACITINIB	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	214264-002	Aug 19, 2021		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Zydus Lifesciences	METHYLENE BLUE	methylene blue	SOLUTION;INTRAVENOUS	215636-002	Dec 5, 2023	AP	RX	No	No		⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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

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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1315485	2015C/048	Belgium	⤷ Sign Up	PRODUCT NAME: LUBIPROSTONE; AUTHORISATION NUMBER AND DATE: PL21341/0003 20150317
0617614	2001/009	Ireland	⤷ Sign Up	PRODUCT NAME: PANRETIN-ALITRETINOIN
1411918	300537	Netherlands	⤷ Sign Up	PRODUCT NAME: PLERIXAFOR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF METAALCOMPLEX; REGISTRATION NO/DATE: EU/1/09/537/001 20090804
1663240	2015/053	Ireland	⤷ Sign Up	PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT, TENOFOVIR, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE, AND EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1532149	2011/039	Ireland	⤷ Sign Up	PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-Y1)-7-BUT-2INYL-3-METHYL-1-(4- METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2,6-DION THE ENATIOMERS AND SALTS THEROF-ESPECIALLY LINAGLIPTIN."LINAGLIPTIN=((R)-8-(3-AMINOPIPERIDIN-1-YL)- 7-BUT-2-INYL-3-METHYL-L-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6- DION") (IUPAC); REGISTRATION NO/DATE: EU/1/11/707/001-EU/1/11/707/011 20110824
0502314	99C0014	Belgium	⤷ Sign Up	PRODUCT NAME: TELMISARTAN REGISTRATION NO/DATE: EU/1/98/089/001 / 19981211
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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