ASTRAZENECA Company Profile
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What is the competitive landscape for ASTRAZENECA, and when can generic versions of ASTRAZENECA drugs launch?
ASTRAZENECA has ninety-one approved drugs.
There are one hundred and eighteen US patents protecting ASTRAZENECA drugs. There is one tentative approval on ASTRAZENECA drugs.
There are two thousand one hundred and thirty patent family members on ASTRAZENECA drugs in sixty-eight countries and three hundred and thirty-one supplementary protection certificates in twenty countries.
Summary for ASTRAZENECA
International Patents: | 2130 |
US Patents: | 118 |
Tradenames: | 65 |
Ingredients: | 57 |
NDAs: | 91 |
Patent Litigation for ASTRAZENECA: | See patent lawsuits for ASTRAZENECA |
PTAB Cases with ASTRAZENECA as patent owner: | See PTAB cases with ASTRAZENECA as patent owner |
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 | BEVESPI AEROSPHERE | formoterol fumarate; glycopyrrolate | AEROSOL, METERED;INHALATION | 208294-001 | Apr 25, 2016 | RX | Yes | Yes | 8,815,258 | See Plans and Pricing | See Plans and Pricing | ||||
Astrazeneca | TAGRISSO | osimertinib mesylate | TABLET;ORAL | 208065-002 | Nov 13, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | |||||
Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-001 | Jan 8, 2014 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | ||||
Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | DISCN | Yes | No | 8,216,180*PED | See Plans and Pricing | Y | See Plans and Pricing | |||
Astrazeneca | ISOETHARINE HYDROCHLORIDE | isoetharine hydrochloride | SOLUTION;INHALATION | 089618-001 | Jun 13, 1991 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | |||||
Astrazeneca | PRILOSEC | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 019810-001 | Sep 14, 1989 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | |||||
Astrazeneca | LEXXEL | enalapril maleate; felodipine | TABLET, EXTENDED RELEASE;ORAL | 020668-002 | Oct 28, 1998 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | |||||
>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 | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | 5,424,286 | See Plans and Pricing |
Astrazeneca Ab | BYDUREON | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-001 | Jan 27, 2012 | 6,479,065 | See Plans and Pricing |
Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-001 | Apr 28, 2005 | 5,424,286 | See Plans and Pricing |
Astrazeneca | NEXIUM | esomeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021957-004 | Dec 15, 2011 | 6,428,810*PED | See Plans and Pricing |
Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | 6,858,576 | See Plans and Pricing |
Astrazeneca | PRILOSEC | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 019810-002 | Jan 15, 1998 | 4,636,499*PED | See Plans and Pricing |
Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | 6,414,126 | See Plans and Pricing |
>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 | Extended-release Tablets | 50 mg | ➤ Subscribe | 2008-10-17 |
➤ Subscribe | Tablets | 60 mg | ➤ Subscribe | 2015-09-30 |
➤ Subscribe | Delayed-release | 20 mg and 40 mg | ➤ Subscribe | 2005-08-05 |
➤ Subscribe | Tablets | 25 mg | ➤ Subscribe | 2005-08-12 |
➤ Subscribe | Injection | 50 mg/mL, 2.5 mL and 5 mL syringe | ➤ Subscribe | 2009-10-01 |
➤ Subscribe | Tablets | 100 mg, 200 mg and 300 mg | ➤ Subscribe | 2006-02-21 |
➤ Subscribe | Nasal Spray | 5 mg/spray | ➤ Subscribe | 2013-11-14 |
➤ Subscribe | Extended-release Tablets | 5 mg/500 mg, 2.5 mg/1000 mg, and 5 mg/1000 mg | ➤ Subscribe | 2013-07-31 |
➤ Subscribe | Inhalation Suspension | 0.25 mg/2 mL and 0.5 mg/2 mL | ➤ Subscribe | 2005-09-15 |
➤ Subscribe | Tablets | 2.5 mg and 5 mg | ➤ Subscribe | 2013-07-31 |
➤ Subscribe | Delayed-release Capsules | 20 mg | ➤ Subscribe | 2007-03-19 |
➤ Subscribe | Extended-release Tablets | 400 mg | ➤ Subscribe | 2008-06-18 |
➤ Subscribe | Tablets | 200 mg and 300 mg | ➤ Subscribe | 2008-06-12 |
➤ Subscribe | Tablets | 90 mg | ➤ Subscribe | 2015-07-20 |
➤ Subscribe | Nasal Spray | 0.032 mg (32 mcg)/spray | ➤ Subscribe | 2007-05-14 |
➤ Subscribe | Tablets | 500 mcg | ➤ Subscribe | 2015-03-02 |
➤ Subscribe | Delayed-release for Oral Suspension | 2.5 mg and 5 mg | ➤ Subscribe | 2018-09-24 |
➤ Subscribe | Tablets | 50 mg, 150 mg and 400 mg | ➤ Subscribe | 2007-02-12 |
➤ Subscribe | For Injection | 20 mg/vial and 40 mg/vial | ➤ Subscribe | 2009-11-23 |
➤ Subscribe | Injection | 250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe | ➤ Subscribe | 2014-06-11 |
➤ Subscribe | Nasal Spray | 2.5 mg/spray | ➤ Subscribe | 2016-06-09 |
➤ Subscribe | HydrochlorideExtended-release Tablets | 2.5 mg/1000 mg | ➤ Subscribe | 2018-10-29 |
➤ Subscribe | Inhalation Suspension | 1 mg/2 mL | ➤ Subscribe | 2010-05-28 |
➤ Subscribe | Delayed-release Tablets | 20 mg | ➤ Subscribe | 2012-03-30 |
➤ Subscribe | Extended-release Tablets | 150 mg | ➤ Subscribe | 2008-11-17 |
International Patents for ASTRAZENECA Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Canada | 2716724 | See Plans and Pricing |
Australia | 2004294790 | See Plans and Pricing |
Japan | 2014111636 | See Plans and Pricing |
Mexico | 2011012685 | See Plans and Pricing |
Japan | 2017105706 | See Plans and Pricing |
Estonia | 04915 | See Plans and Pricing |
Israel | 180099 | See Plans and Pricing |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ASTRAZENECA Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0007293 | 95C0001 | Belgium | See Plans and Pricing | PRODUCT NAME: FELODIPINE, METOPOLOL SUCCINATE; NAT. REGISTRATION NO/DATE: 122 IS 160 F 3 / 19921230; FIRST REGISTRATION: DK 8678 19921230 |
2435025 | PA2019014,C2435025 | Lithuania | See Plans and Pricing | PRODUCT NAME: GLIKOPIRONIO BROMIDAS/FORMOTEROLIS; REGISTRATION NO/DATE: EU/1/18/1339 20181218 |
1411900 | 2011C/016 | Belgium | See Plans and Pricing | PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214 |
1200431 | PA2013001,C1200431 | Lithuania | See Plans and Pricing | PRODUCT NAME: ACLIDINII BROMIDUM; REGISTRATION NO/DATE: EU/1/12/778/001 - EU/1/12/778/003, 2012 07 20 EU/1/12/781/001 - EU/1/12/781/003 20120720 |
2563920 | CA 2019 00001 | Denmark | See Plans and Pricing | PRODUCT NAME: A COMPOUND COMPRISING A MODIFIED OLIGONUCLEOTIDE HAVING A NUCLEOBASE SEQUENCE CONSISTING OF 20 LINKED NUCLEOSIDES ACCORDING TO EP B1 2563920 CLAIM 1 (SEQ ID NO: 80), ...SPECIFICALLY INOTERSEN; AND ITS DERIVATIVES, INCLUDING SODIUM SALTS ...; REG. NO/DATE: EU/1/18/1296 20180710 |
1606261 | C20100008 00033 | Estonia | See Plans and Pricing | PRODUCT NAME: DAXAS-ROFLUMILAST; REG NO/DATE: K(2010)4785 05.07.2010 |
2435025 | PA2019014 | Lithuania | See Plans and Pricing | PRODUCT NAME: GLIKOPIROLATO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, ENANTIOMERUS AR KITUS DARINIUS) IR FORMOTEROLIO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, ENANTIOMERUS AR KITUS DARINIUS) DERINYS; REGISTRATION NO/DATE: EU/1/18/1339 20181218 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.