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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Express Scripts
Farmers Insurance
US Department of Justice
Deloitte
Teva
Cantor Fitzgerald
McKinsey
Merck

Generated: October 17, 2018

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Amneal Pharm Company Profile

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

AMNEAL PHARM has two hundred and seventeen approved drugs.

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

Drugs and US Patents for Amneal Pharm

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms RALOXIFENE HYDROCHLORIDE raloxifene hydrochloride TABLET;ORAL 208206-001 Apr 8, 2016 AB RX No No ➤ Sign Up ➤ Sign Up
Amneal Pharms Co DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 207482-002 Jun 28, 2017 AB RX No No ➤ Sign Up ➤ Sign Up
Amneal Pharms Llc FENOFIBRATE fenofibrate TABLET;ORAL 209950-001 Mar 19, 2018 AB RX No No ➤ Sign Up ➤ Sign Up
Amneal Pharms DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 203995-002 Nov 25, 2016 AB RX No No ➤ Sign Up ➤ Sign Up
Amneal Pharms Llc NYSTATIN AND TRIAMCINOLONE ACETONIDE nystatin; triamcinolone acetonide CREAM;TOPICAL 209990-001 Feb 15, 2018 AT RX No No ➤ Sign Up ➤ Sign Up
Amneal Pharms Co DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 207482-003 Jun 28, 2017 AB RX No No ➤ Sign Up ➤ Sign Up
Amneal Pharms Ny IBUPROFEN ibuprofen TABLET;ORAL 071935-001 Oct 13, 1987 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 PHARM drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Injection 100 mg/mL, 2.5 mL vials ➤ Subscribe 2007-09-24
➤ Subscribe Injection 1 mg/mL, 50 mL vials ➤ Subscribe 2011-12-16

Supplementary Protection Certificates for Amneal Pharm Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2009004,C0770388 Lithuania ➤ Sign Up PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
C0040 France ➤ Sign Up PRODUCT NAME: ENTECAVIR; REGISTRATION NO/DATE: EU/1/06/343/001 20060626
15/052 Ireland ➤ Sign Up PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
2012022 Lithuania ➤ Sign Up PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
C/GB12/058 United Kingdom ➤ Sign Up PRODUCT NAME: A COMBINATION OF CIPROFLOXACIN AND DEXAMETHASONE, PREFERABLY CIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE; REGISTERED: DK DE/11/3337/001/DC 20120808; UK PL000649/0381-0001 20121003
275 Luxembourg ➤ Sign Up CERTIFICATE TITLE: ENTECAVIR ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (BARACLUDE); FIRST REGISTRATION: 20060626
C004 Belgium ➤ Sign Up PRODUCT NAME: VALSARTAN HYDROCHLOROTHIAZIDUM; NATL. REGISTRATION NO/DATE: 206 IS 250 F 3 19980624; FIRST REGISTRATION: FR 344300.5 19970925
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:

Colorcon
Boehringer Ingelheim
McKesson
Cipla
UBS
Merck
Mallinckrodt
Moodys
Farmers Insurance

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.