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-two approved drugs.
There are one hundred and twenty-six US patents protecting ASTRAZENECA drugs. There is one tentative approval on ASTRAZENECA drugs.
There are two thousand two hundred and fifteen patent family members on ASTRAZENECA drugs in seventy countries and three hundred and forty-eight supplementary protection certificates in twenty countries.
Summary for ASTRAZENECA
| International Patents: | 2215 |
| US Patents: | 126 |
| Tradenames: | 65 |
| Ingredients: | 60 |
| NDAs: | 92 |
| 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 | XIGDUO XR | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205649-001 | Oct 29, 2014 | RX | Yes | No | 7,919,598*PED | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-002 | Jan 8, 2014 | RX | Yes | Yes | 10,973,836*PED | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Astrazeneca | LYNPARZA | olaparib | TABLET;ORAL | 208558-002 | Aug 17, 2017 | RX | Yes | Yes | 7,981,889 | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-001 | Jan 8, 2014 | RX | Yes | No | 8,721,615*PED | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Astrazeneca | SEROQUEL | quetiapine fumarate | TABLET;ORAL | 020639-001 | Sep 26, 1997 | 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 |
Expired US Patents for ASTRAZENECA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca Lp | NEXIUM 24HR | esomeprazole magnesium | CAPSULE, DELAYED RELEASE;ORAL | 204655-001 | Mar 28, 2014 | 5,900,424*PED | ⤷ Sign Up |
| Astrazeneca | SEROQUEL XR | quetiapine fumarate | TABLET, EXTENDED RELEASE;ORAL | 022047-004 | May 17, 2007 | 5,948,437*PED | ⤷ Sign Up |
| Astrazeneca Ab | QTERNMET XR | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874-004 | May 2, 2019 | 9,198,925 | ⤷ Sign Up |
| Astrazeneca | DURANEST | etidocaine hydrochloride | INJECTABLE;INJECTION | 017751-005 | Approved Prior to Jan 1, 1982 | 4,216,211 | ⤷ Sign Up |
| Astrazeneca Lp | NEXIUM 24HR | esomeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 207920-001 | Nov 23, 2015 | 7,411,070*PED | ⤷ Sign Up |
| >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 | 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 |
| ➤ 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 |
International Patents for ASTRAZENECA Drugs
Supplementary Protection Certificates for ASTRAZENECA Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1968948 | PA2021530,C1968948 | Lithuania | ⤷ Sign Up | PRODUCT NAME: SELUMETINIBAS; REGISTRATION NO/DATE: EU/1/21/1552 20210617 |
| 2734522 | 2021016 | Norway | ⤷ Sign Up | PRODUCT NAME: AKALABRUTINIB; REG. NO/DATE: EU/1/20/1479 20201111 |
| 1633724 | S1500012 | Hungary | ⤷ Sign Up | PRODUCT NAME: OLAPARIB |
| 1506211 | CA 2014 00037 | Denmark | ⤷ Sign Up | PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116 |
| 2498758 | 16/2020 | Austria | ⤷ Sign Up | PRODUCT NAME: METFORMIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; SAXAGLIPTIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; DAPAGLIFLOZIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1401 (MITTEILUNG) 20191113 |
| >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.
