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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Farmers Insurance
Medtronic
Deloitte
Harvard Business School
Dow
Cipla
Moodys
Julphar

Generated: June 25, 2018

DrugPatentWatch Database Preview

Zydus Pharms Usa Inc Company Profile

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

ZYDUS PHARMS USA INC has one hundred and forty-four approved drugs.

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

There are two patent family members on ZYDUS PHARMS USA INC drugs in two countries and one hundred and eighty-eight supplementary protection certificates in twelve countries.

Summary for Zydus Pharms Usa Inc
International Patents:2
US Patents:1
Tradenames:124
Ingredients:124
NDAs:144

Drugs and US Patents for Zydus Pharms Usa Inc

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 Inc LEVOFLOXACIN levofloxacin INJECTABLE;INJECTION 205968-001 Jun 1, 2017 DISCN No No ➤ Sign Up ➤ Sign Up
Zydus Pharms Usa Inc ENTECAVIR entecavir TABLET;ORAL 206745-002 Jun 23, 2017 AB RX No No ➤ Sign Up ➤ Sign Up
Zydus Pharms Usa Inc AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 210086-001 Oct 6, 2017 AB RX No No ➤ Sign Up ➤ Sign Up
Zydus Pharms Usa Inc OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 203345-001 Mar 16, 2018 OTC 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

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Paragraph IV (Patent) Challenges for ZYDUS PHARMS USA INC drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Delayed-release Tablets 20 mg ➤ Subscribe 2015-06-03

Non-Orange Book US Patents for Zydus Pharms Usa Inc

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 ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for Zydus Pharms Usa Inc Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0048 France ➤ Sign Up PRODUCT NAME: AMLODIPINE OU UN DE SES SELS D?ADDITION D?ACIDES PHARMACAUTIQUEMENT ACCEPTABLES/ ATORVASTATINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: NL 29929 DU 20050707; REGISTRATION NO/DATE AT EEC: NL 29929 DU 20050707
/2001 Austria ➤ Sign Up PRODUCT NAME: SIROLIMUS; NAT. REGISTRATION NO/DATE: EU/1/01/171/001 - EU/1/01/171/005 20010313; FIRST REGISTRATION: LI 5524301 20000926
2009 00015 Denmark ➤ Sign Up PRODUCT NAME: EN KOMBINATION AF OLMESARTANMEDOXOMIL, EVT. I FORM AF ET FARMACEUTISK ACCEPTABELT SALT OG AMLODIPIN-BESILAT; NAT. REG. NO/DATE: MT 42061, 42062, 42063 20081120; FIRST REG. NO/DATE: NL RVG 100984 20080819
C0030 France ➤ Sign Up PRODUCT NAME: VORICONAZOLE; NAT. REGISTRATION NO/DATE: EU/1/02/212/001-025 20020319; FIRST REGISTRATION: EU/1/02/212/001-25 20020319
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
McKesson
Boehringer Ingelheim
Citi
Cerilliant
Cipla
Baxter
Federal Trade Commission
Argus Health

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.