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 twelve 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: | 912 |
| 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 | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-001 | Jan 8, 2014 | RX | Yes | No | 8,906,851*PED | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Astrazeneca Ab | BYDUREON BCISE | exenatide synthetic | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 209210-001 | Oct 20, 2017 | RX | Yes | Yes | 7,456,254*PED | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Astrazeneca Ab | QTERN | dapagliflozin; saxagliptin hydrochloride | TABLET;ORAL | 209091-001 | Feb 27, 2017 | RX | Yes | Yes | 6,515,117 | ⤷ Sign Up | Y | Y | ⤷ 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 | ONGLYZA | saxagliptin hydrochloride | TABLET;ORAL | 022350-002 | Jul 31, 2009 | 6,395,767 | ⤷ Sign Up |
| Astrazeneca Ab | KOMBIGLYZE XR | metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200678-002 | Nov 5, 2010 | RE44186 | ⤷ 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 |
| >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 | 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 | 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 |
International Patents for ASTRAZENECA AB Drugs
Supplementary Protection Certificates for ASTRAZENECA AB Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1084705 | SPC/GB14/085 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: SAXAGLIPTIN; REGISTERED: UK EU/1/09/545/001-010 20091005 |
| 1506211 | PA2014026 | Lithuania | ⤷ Sign Up | PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116 |
| 1734971 | 2012C/017 | Belgium | ⤷ Sign Up | PRODUCT NAME: EXENATIDE; AUTHORISATION NUMBER AND DATE: EU/1/11/696/001 20110617 |
| >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.
