Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Colorcon
Boehringer Ingelheim
McKinsey
McKesson
Baxter

Last Updated: December 15, 2019

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ASTRAZENECA Company Profile

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Summary for ASTRAZENECA

Drugs and US Patents for ASTRAZENECA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Pharms DALIRESP roflumilast TABLET;ORAL 022522-002 Jan 23, 2018 RX Yes No 9,468,598   Start Trial Y   Start Trial
Astrazeneca Pharms BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011 AB RX Yes Yes 7,250,419   Start Trial Y Y   Start Trial
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes 6,515,117   Start Trial   Start Trial
Astrazeneca Ab QTERN dapagliflozin; saxagliptin hydrochloride TABLET;ORAL 209091-001 Feb 27, 2017 RX Yes Yes 8,361,972   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ASTRAZENECA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab SYMLIN pramlintide acetate INJECTABLE;SUBCUTANEOUS 021332-003 Sep 25, 2007 5,686,411   Start Trial
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-001 Oct 20, 2006 5,714,504*PED   Start Trial
Astrazeneca PLENDIL felodipine TABLET, EXTENDED RELEASE;ORAL 019834-001 Jul 25, 1991 4,264,611*PED   Start Trial
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-001 Oct 20, 2006 4,853,230*PED   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for ASTRAZENECA drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Inhalation Suspension 1 mg/2 mL ➤ Subscribe 2010-05-28
➤ Subscribe Injection 50 mg/mL, 2.5 mL and 5 mL syringe ➤ Subscribe 2009-10-01
➤ Subscribe Delayed-release Tablets 20 mg ➤ Subscribe 2012-03-30
➤ Subscribe Nasal Spray 2.5 mg/spray ➤ Subscribe 2016-06-09
➤ Subscribe Tablets 60 mg ➤ Subscribe 2015-09-30
➤ Subscribe Extended-release Tablets 150 mg ➤ Subscribe 2008-11-17
➤ Subscribe Tablets 12.5 mg and 25 mg ➤ Subscribe 2018-09-17
➤ Subscribe Extended-release Tablets 50 mg ➤ Subscribe 2008-10-17
➤ Subscribe Tablets 50 mg, 150 mg and 400 mg ➤ Subscribe 2007-02-12
➤ Subscribe Extended-release Tablets 5 mg/500 mg, 2.5 mg/1000 mg, and 5 mg/1000 mg ➤ Subscribe 2013-07-31
➤ Subscribe Tablets 2.5 mg and 5 mg ➤ Subscribe 2013-07-31
➤ Subscribe Delayed-release for Oral Suspension 2.5 mg and 5 mg ➤ Subscribe 2018-09-24
➤ Subscribe Inhalation Suspension 0.25 mg/2 mL and 0.5 mg/2 mL ➤ Subscribe 2005-09-15
➤ Subscribe Nasal Spray 0.032 mg (32 mcg)/spray ➤ Subscribe 2007-05-14
➤ Subscribe Delayed-release Capsules 20 mg ➤ Subscribe 2007-03-19
➤ Subscribe Nasal Spray 5 mg/spray ➤ Subscribe 2013-11-14
➤ Subscribe Tablets 90 mg ➤ Subscribe 2015-07-20
➤ Subscribe Extended-release Tablets 400 mg ➤ Subscribe 2008-06-18
➤ Subscribe Tablets 500 mcg ➤ Subscribe 2015-03-02
➤ Subscribe Tablets 200 mg and 300 mg ➤ Subscribe 2008-06-12
➤ Subscribe Tablets 25 mg ➤ Subscribe 2005-08-12
➤ Subscribe Injection 250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe ➤ Subscribe 2014-06-11
➤ Subscribe Tablets 100 mg, 200 mg and 300 mg ➤ Subscribe 2006-02-21
➤ Subscribe HydrochlorideExtended-release Tablets 2.5 mg/1000 mg ➤ Subscribe 2018-10-29
➤ Subscribe Delayed-release 20 mg and 40 mg ➤ Subscribe 2005-08-05
➤ Subscribe For Injection 20 mg/vial and 40 mg/vial ➤ Subscribe 2009-11-23

Supplementary Protection Certificates for ASTRAZENECA Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1140145 91343 Luxembourg   Start Trial 91343, EXPIRES: 20211120
0138504 SPC/GB04/009 United Kingdom   Start Trial PRODUCT NAME: FULVESTRANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK EU/1/03/269/001 20040310
1084705 CR 2014 00062 Denmark   Start Trial PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SAXAGLIPTIN HYDROCHLORID; REG. NO/DATE: EU/1/09/545/001-015 20091005
1261586 15/2012 Austria   Start Trial PRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124
>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:

McKinsey
Harvard Business School
Mallinckrodt
AstraZeneca
Colorcon
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 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.