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-three approved drugs.
There are one hundred and twenty-four US patents protecting ASTRAZENECA drugs. There is one tentative approval on ASTRAZENECA drugs.
There are two thousand one hundred and ninety-one patent family members on ASTRAZENECA drugs in seventy countries and three hundred and forty-six supplementary protection certificates in twenty countries.
Summary for Astrazeneca
| International Patents: | 2191 |
| US Patents: | 124 |
| Tradenames: | 66 |
| Ingredients: | 60 |
| NDAs: | 93 |
| 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 Ab | BYDUREON BCISE | exenatide synthetic | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 209210-001 | Oct 20, 2017 | RX | Yes | Yes | 8,329,648*PED | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Astrazeneca | LYNPARZA | olaparib | TABLET;ORAL | 208558-002 | Aug 17, 2017 | RX | Yes | Yes | 8,071,579 | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Astrazeneca | SEROQUEL | quetiapine fumarate | TABLET;ORAL | 020639-005 | Jul 26, 2000 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Astrazeneca | LYNPARZA | olaparib | TABLET;ORAL | 208558-001 | Aug 17, 2017 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Astrazeneca | CALQUENCE | acalabrutinib | CAPSULE;ORAL | 210259-001 | Oct 31, 2017 | RX | Yes | Yes | 10,167,291 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Astrazeneca Ab | QTERNMET XR | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874-003 | May 2, 2019 | DISCN | Yes | No | 8,501,698 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Astrazeneca | TAGRISSO | osimertinib mesylate | TABLET;ORAL | 208065-001 | Nov 13, 2015 | RX | Yes | No | 11,524,951 | ⤷ Try a Trial | Y | Y | ⤷ Try a 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 | PRILOSEC | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 019810-002 | Jan 15, 1998 | 4,255,431*PED | ⤷ Try a Trial |
| Astrazeneca | SEROQUEL XR | quetiapine fumarate | TABLET, EXTENDED RELEASE;ORAL | 022047-005 | Aug 11, 2008 | 4,879,288*PED | ⤷ Try a Trial |
| Astrazeneca | SEROQUEL XR | quetiapine fumarate | TABLET, EXTENDED RELEASE;ORAL | 022047-001 | May 17, 2007 | 4,879,288*PED | ⤷ Try a Trial |
| Astrazeneca | PULMICORT RESPULES | budesonide | SUSPENSION;INHALATION | 020929-001 | Aug 8, 2000 | 7,524,834*PED | ⤷ Try a Trial |
| Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | 6,479,065 | ⤷ Try a Trial |
| Astrazeneca | NEXIUM | esomeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021957-004 | Dec 15, 2011 | 5,877,192*PED | ⤷ Try a Trial |
| Astrazeneca Ab | SYMLIN | pramlintide acetate | INJECTABLE;SUBCUTANEOUS | 021332-002 | Sep 25, 2007 | 5,686,411 | ⤷ Try a 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 | 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 | Tablets | 500 mcg | ➤ Subscribe | 2015-03-02 |
| ➤ Subscribe | Nasal Spray | 0.032 mg (32 mcg)/spray | ➤ Subscribe | 2007-05-14 |
| ➤ Subscribe | Tablets | 50 mg, 150 mg and 400 mg | ➤ Subscribe | 2007-02-12 |
| ➤ Subscribe | Delayed-release for Oral Suspension | 2.5 mg and 5 mg | ➤ Subscribe | 2018-09-24 |
| ➤ Subscribe | Injection | 250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe | ➤ Subscribe | 2014-06-11 |
| ➤ Subscribe | Injection | 50 mg/mL, 2.5 mL and 5 mL syringe | ➤ Subscribe | 2009-10-01 |
| ➤ 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 |
| ➤ Subscribe | Extended-release Tablets | 50 mg | ➤ Subscribe | 2008-10-17 |
| ➤ Subscribe | Tablets | 60 mg | ➤ Subscribe | 2015-09-30 |
| ➤ Subscribe | Tablets | 25 mg | ➤ Subscribe | 2005-08-12 |
| ➤ Subscribe | Delayed-release | 20 mg and 40 mg | ➤ Subscribe | 2005-08-05 |
| ➤ Subscribe | Tablets | 100 mg, 200 mg and 300 mg | ➤ Subscribe | 2006-02-21 |
| ➤ Subscribe | For Injection | 20 mg/vial and 40 mg/vial | ➤ Subscribe | 2009-11-23 |
| ➤ Subscribe | Extended-release Tablets | 5 mg/500 mg, 2.5 mg/1000 mg, and 5 mg/1000 mg | ➤ Subscribe | 2013-07-31 |
International Patents for Astrazeneca Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Peru | 20161430 | ⤷ Try a Trial |
| Hong Kong | 1214669 | ⤷ Try a Trial |
| Denmark | 2139494 | ⤷ Try a Trial |
| Japan | 6216444 | ⤷ Try a Trial |
| Australia | 2022201294 | ⤷ Try a Trial |
| Poland | 1684736 | ⤷ Try a Trial |
| European Patent Office | 3689878 | ⤷ Try a Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Astrazeneca Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2498758 | C20200010 00328 | Estonia | ⤷ Try a Trial | PRODUCT NAME: METFORMIIN/SAKSAGLIPTIIN/DAPAGLIFLOSIIN;REG NO/DATE: EU/1/19/1401 13.11.2019 |
| 2139494 | SPC/GB20/028 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: SAXAGLIPTIN AND DAPAGLIFLOZIN; REGISTERED: UK EU/1/16/1108 (NI) 20160719; UK PLGB 17901/0339 20160719 |
| 2435024 | PA2021511,C2435024 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: FORMOTEROLIO (ISKAITANT BET KOKIAS FARMACINIU POZIURIU PRIIMTINAS JO DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS), GLIKOPIROLATO (ISKAITANT BET KOKIAS FARMACINIU POZIURIU PRIIMTINAS JO DRUSKAS, ESTERIUS, SOLVATUS ARBA ENANTIOMERUS) IR BUDEZONIDO (ISKAITANT BET KOKIAS FARMACINIU POZIURIU PRIIMTINAS JO DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS) DERINYS; REGISTRATION NO/DATE: EU/1/20/1498 20201209 |
| 1633724 | CR 2015 00012 | Denmark | ⤷ Try a Trial | PRODUCT NAME: OLAPARIB, OG SALTE OG SOLVATER DERAF; REG. NO/DATE: EU/1/14/959/001 20141216 |
| 1261586 | C300436 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: SAXAGLIPTINE, ALSMEDE; REGISTRATION NO/DATE: EU/1/09/545/001-010 20091001 |
| 0706513 | C300462 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ROFLUMILAST, DESGEWENST IN DE VORM VAN HET N-OXIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705 |
| 2734522 | 2190009-7 | Sweden | ⤷ Try a Trial | PRODUCT NAME: ACALABRUTINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/20/1479 20201106 |
| >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.
Here is a list of applicants with similar names.
