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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Chubb
UBS
Baxter
Julphar
Covington
Moodys
Harvard Business School
Farmers Insurance

Generated: February 21, 2019

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Amneal Pharms Company Profile

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

AMNEAL PHARMS has two hundred and twenty-nine approved drugs.

There is one US patent protecting AMNEAL PHARMS drugs. There are twelve tentative approvals on AMNEAL PHARMS drugs.

There are five patent family members on AMNEAL PHARMS drugs in five countries and three hundred and fifty-two supplementary protection certificates in thirteen countries.

Summary for Amneal Pharms
International Patents:5
US Patents:1
Tradenames:180
Ingredients:174
NDAs:229

Drugs and US Patents for Amneal Pharms

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms Llc AZITHROMYCIN azithromycin FOR SUSPENSION;ORAL 205666-001 Jul 19, 2018 AB RX No No ➤ Sign Up ➤ Sign Up
Amneal Pharms IRBESARTAN irbesartan TABLET;ORAL 204740-001 Apr 17, 2018 AB RX No No ➤ Sign Up ➤ Sign Up
Amneal Pharms Ny AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 078477-002 Jan 16, 2008 DISCN No No ➤ Sign Up ➤ Sign Up
Amneal Pharms METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 207515-002 Feb 1, 2018 AB RX No No ➤ Sign Up ➤ Sign Up
Amneal Pharms Llc FENOFIBRATE fenofibrate TABLET;ORAL 209950-002 Mar 19, 2018 AB 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

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Paragraph IV (Patent) Challenges for AMNEAL PHARMS drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Injection 1 mg/mL, 50 mL vials ➤ Subscribe 2011-12-16
➤ Subscribe Injection 100 mg/mL, 2.5 mL vials ➤ Subscribe 2007-09-24

Supplementary Protection Certificates for Amneal Pharms Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
156 Luxembourg ➤ Sign Up PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
2009 00017 Denmark ➤ Sign Up PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
C/GB08/020 United Kingdom ➤ Sign Up SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/020 GRANTED TO ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. IN RESPECT OF THE PRODUCT RALTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6346 DATED 05 JANUARY 2011 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 01 JANUARY 2023.
C/GB12/047 United Kingdom ➤ Sign Up PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727
C0050 France ➤ Sign Up PRODUCT NAME: VALSARTAN; REGISTRATION NO/DATE IN FRANCE: NL 22077 DU 19970321; REGISTRATION NO/DATE AT EEC: 369830000 DU 19960513
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:

Queensland Health
Baxter
Chinese Patent Office
Express Scripts
McKesson
Chubb
Accenture
McKinsey
Merck

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