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Generated: March 25, 2019

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Amneal Pharms Llc Company Profile

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What is the competitive landscape for AMNEAL PHARMS LLC, and what generic alternatives to AMNEAL PHARMS LLC drugs are available?

AMNEAL PHARMS LLC has sixteen approved drugs.

There is one US patent protecting AMNEAL PHARMS LLC drugs. There is one tentative approval on AMNEAL PHARMS LLC drugs.

There are five patent family members on AMNEAL PHARMS LLC drugs in five countries and forty supplementary protection certificates in eleven countries.

Summary for Amneal Pharms Llc
International Patents:5
US Patents:1
Tradenames:13
Ingredients:13
NDAs:16

Drugs and US Patents for Amneal Pharms Llc

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 POTASSIUM CHLORIDE potassium chloride SOLUTION;ORAL 210041-002 Jul 19, 2018 AA 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
Amneal Pharms Llc CLOBETASOL PROPIONATE clobetasol propionate OINTMENT;TOPICAL 210551-001 Aug 21, 2018 AB RX No No ➤ Sign Up ➤ Sign Up
Amneal Pharms Llc POTASSIUM CHLORIDE potassium chloride SOLUTION;ORAL 210041-001 Jul 19, 2018 AA RX No No ➤ Sign Up ➤ Sign Up
Amneal Pharms Llc AZITHROMYCIN azithromycin FOR SUSPENSION;ORAL 205666-002 Jul 19, 2018 AB RX No No ➤ Sign Up ➤ Sign Up
Amneal Pharms Llc ACTIVELLA estradiol; norethindrone acetate TABLET;ORAL 020907-001 Nov 18, 1998 AB RX Yes Yes ➤ 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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Supplementary Protection Certificates for Amneal Pharms Llc Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1441735 SPC/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.
1519731 13C0067 France ➤ Sign Up PRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215
1380301 2009C/007 Belgium ➤ Sign Up PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1539166 122013000090 Germany ➤ Sign Up PRODUCT NAME: KOMBINATION AUS: (A) DEXTROMETHORPHAN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ, Z.B. DEXTROMETHORPHAN-HYDROBROMID UND INSBESONDERE DEXTROMETHORPHAN-HYDROBROMID-MONOHYDRAT; UND (B) CHINIDIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, Z.B.CHINIDIN-SULFAT UND INSBESONDERE CHINIDIN-SULFAT-DIHYDRAT; REGISTRATION NO/DATE: EU/1/13/833 20130624
0536515 C300244 Netherlands ➤ Sign Up PRODUCT: TIGECYCLINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF METAALCOMPLEX, IN HET BIJZONDER TIGECYCLINE; FIRST REGISTRATION, DATE: EU/1/06/336/001, 20060424
1453521 C201630040 Spain ➤ Sign Up PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211
Patent Number 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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