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Last Updated: June 14, 2021

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AMNEAL Company Profile

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Summary for AMNEAL

Drugs and US Patents for AMNEAL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal CLOBETASOL PROPIONATE clobetasol propionate OINTMENT;TOPICAL 210551-001 Aug 21, 2018 DISCN No No   Get Started Free   Get Started Free
Amneal METHYLPREDNISOLONE SODIUM SUCCINATE methylprednisolone sodium succinate INJECTABLE;INJECTION 207549-001 Nov 9, 2016 AP RX No No   Get Started Free   Get Started Free
Amneal CYCLOPHOSPHAMIDE cyclophosphamide INJECTABLE;INJECTION 210046-002 May 25, 2018 AP RX No No   Get Started Free   Get Started Free
Amneal Pharms Co LURASIDONE HYDROCHLORIDE lurasidone hydrochloride TABLET;ORAL 208002-004 Jan 3, 2019 DISCN No No   Get Started Free   Get Started Free
Amneal Pharms Ny HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 040746-001 Aug 25, 2006 AA RX No No   Get Started Free   Get Started Free
Amneal Pharms LAMOTRIGINE lamotrigine TABLET, EXTENDED RELEASE;ORAL 207497-006 Nov 30, 2018 AB RX No No   Get Started Free   Get Started Free
Amneal Pharms Co PARICALCITOL paricalcitol SOLUTION;INTRAVENOUS 206699-002 Mar 9, 2017 AP RX No No   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Paragraph IV (Patent) Challenges for AMNEAL drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe for Injection 200 mcg/vial ➤ Subscribe 2015-05-01
➤ Subscribe Injection 1 mg/mL, 50 mL vials ➤ Subscribe 2011-12-16
➤ Subscribe for Injection 100 mcg/vial and 500 mcg/vial ➤ Subscribe 2015-04-14
➤ Subscribe Injection 100 mg/mL, 2.5 mL vials ➤ Subscribe 2007-09-24

International Patents for AMNEAL Drugs

Country Patent Number Estimated Expiration
Russian Federation 2015100116   Get Started Free
China 103315947   Get Started Free
European Patent Office 2881109   Get Started Free
Canada 2879383   Get Started Free
World Intellectual Property Organization (WIPO) 2013139179   Get Started Free
Spain 2795421   Get Started Free
Portugal 2881109   Get Started Free
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for AMNEAL Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0392059 SPC/GB02/046 United Kingdom   Get Started Free PRODUCT NAME: MEMANTINE AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS; REGISTERED: UK EU/1/02/219/001 20020515; UK EU/1/02/219/002 20020515; UK EU/1/02/219/003 20020515; UK EU/1/02/219/004 20020515; UK EU/1/02/219/005 20020515; UK EU/1/02/219/006 20020515
0281459 9890035-0 98910359 Sweden   Get Started Free PRODUCT NAME: PLAVIX-CLOPIDOGREL; REG. NO/DATE: EU/1/98/069/001 19980715
1304992 122013000081 Germany   Get Started Free PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322
1532149 132013902118390 Italy   Get Started Free PRODUCT NAME: LINAGLIPTIN + METFORMINA CLORIDRATO(JENTADUETO); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/12/780/001 A EU/1/12/780/027, 20120720
1135391 SPC/GB11/016 United Kingdom   Get Started Free PRODUCT NAME: TICAGRELOR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK EU/1/10/655/001 20101203; UK EU/1/10/655/002 20101203; UK EU/1/10/655/003 20101203; UK EU/1/10/655/004 20101203; UK EU/1/10/655/005 20101203; UK EU/1/10/655/006 20101203
1675573 300669 Netherlands   Get Started Free PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Express Scripts
Johnson and Johnson

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 verification 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.