ASTRAZENECA AB Company Profile
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What is the competitive landscape for ASTRAZENECA AB, and what generic alternatives to ASTRAZENECA AB drugs are available?
ASTRAZENECA AB has twelve approved drugs.
There are fifty-four US patents protecting ASTRAZENECA AB drugs. There is one tentative approval on ASTRAZENECA AB drugs.
There are nine hundred and eleven patent family members on ASTRAZENECA AB drugs in fifty-four countries and one hundred and forty-two supplementary protection certificates in nineteen countries.
Summary for ASTRAZENECA AB
| International Patents: | 911 |
| US Patents: | 54 |
| Tradenames: | 13 |
| Ingredients: | 10 |
| NDAs: | 12 |
| Drug Master File Entries: | 2 |
| Patent Litigation for ASTRAZENECA AB: | See patent lawsuits for ASTRAZENECA AB |
| PTAB Cases with ASTRAZENECA AB as patent owner: | See PTAB cases with ASTRAZENECA AB as patent owner |
Drugs and US Patents for ASTRAZENECA AB
| 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 | 205649-004 | Oct 29, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | |||||
| Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-001 | Jan 8, 2014 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Astrazeneca Ab | ONGLYZA | saxagliptin hydrochloride | TABLET;ORAL | 022350-001 | Jul 31, 2009 | DISCN | Yes | No | 7,951,400 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Astrazeneca Ab | BYDUREON | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-001 | Jan 27, 2012 | DISCN | Yes | No | 7,456,254*PED | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Astrazeneca Ab | KOMBIGLYZE XR | metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200678-001 | Nov 5, 2010 | DISCN | Yes | No | 8,628,799 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-002 | Jan 8, 2014 | 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 AB
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca Ab | SYMLIN | pramlintide acetate | INJECTABLE;SUBCUTANEOUS | 021332-002 | Sep 25, 2007 | 7,271,238 | ⤷ Sign Up |
| Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-001 | Jan 8, 2014 | 6,824,822 | ⤷ Sign Up |
| Astrazeneca Ab | BYDUREON BCISE | exenatide synthetic | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 209210-001 | Oct 20, 2017 | 6,479,065 | ⤷ Sign Up |
| Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-001 | Jan 8, 2014 | 9,238,076 | ⤷ Sign Up |
| Astrazeneca Ab | QTERNMET XR | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874-002 | May 2, 2019 | 6,414,126 | ⤷ Sign Up |
| Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-001 | Jan 8, 2014 | 6,479,065 | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for ASTRAZENECA AB drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Injection | 250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe | ➤ Subscribe | 2014-06-11 |
| ➤ Subscribe | HydrochlorideExtended-release Tablets | 2.5 mg/1000 mg | ➤ Subscribe | 2018-10-29 |
| ➤ 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 |
International Patents for ASTRAZENECA AB Drugs
Supplementary Protection Certificates for ASTRAZENECA AB Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2139494 | 2090034-6 | Sweden | ⤷ Sign Up | PRODUCT NAME: SAXAGLIPTIN AND DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE; REG. NO/DATE: EU/1/16/1108 20160719 |
| 1532149 | C300569 | Netherlands | ⤷ Sign Up | PRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720 |
| 1506211 | 2014C/041 | Belgium | ⤷ Sign Up | PRODUCT NAME: LA COMBINAISON DE DAPAGLIFLOZINE (OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE); AUTHORISATION NUMBER AND DATE: EU/1/13/900 20140121 |
| 2435024 | CR 2021 00014 | Denmark | ⤷ Sign Up | PRODUCT NAME: KOMBINATION AF FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, SOLVATER ELLER ENANTIOMERE DERAF, GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, SOLVATER ELLER ENANTIOMERE DERAF, OG BUDESONID, HERUNDER...; REG. NO/DATE: EU/1/20/1498 20201210 |
| 1261586 | SPC/GB10/001 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: SAXAGLIPTIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF INCLUDING SAXAGLIPTIN HYDROCHLORIDE; REGISTERED: UK EU/1/09/545/001 20091001; UK EU/1/09/545/002 20091001; UK EU/1/09/545/003 20091001; UK EU/1/09/545/004 20091001; UK EU/1/09/545/005 20091001; UK EU/1/09/545/006 20091001; UK EU/1/09/545/007 20091001; UK EU/1/09/545/008 20091001; UK EU/1/09/545/009 20091001; UK EU/1/09/545/010 20091001 |
| 2435025 | 2019026 | Norway | ⤷ Sign Up | PRODUCT NAME: KOMBINASJON AV GLYKOPYRROLAT (INKLUDERT EVENTUELLE FARMASOEYTISK AKSEPTABLE SALTER, ESTERE ELLER ENANTIOMERER DERAV) OG FORMOTEROL (INNBEFATTENDE HVILKE SOM HELST FARMASOEYTISK AKSEPTABLE SALTER, ESTERE ELLER ENANTIOMERER DERAV); REG. NO/DATE: EU/1/18/1339 20190104 |
| >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.
