Astrazeneca Ab Company Profile
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What is the competitive landscape for ASTRAZENECA AB, and when can generic versions of ASTRAZENECA AB drugs launch?
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 | 205649-005 | Jul 28, 2017 | RX | Yes | No | 8,685,934*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 Ab | QTERN | dapagliflozin; saxagliptin hydrochloride | TABLET;ORAL | 209091-001 | Feb 27, 2017 | RX | Yes | Yes | 8,361,972 | ⤷ Sign Up | ⤷ Sign Up | ||||
| Astrazeneca Ab | XIGDUO XR | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205649-001 | Oct 29, 2014 | RX | Yes | No | ⤷ 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 |
| >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 |
|---|---|---|---|---|
| 2435025 | 19C1040 | France | ⤷ Sign Up | PRODUCT NAME: COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS TOUS SELS, ESTERS, ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET DE FORMOTEROL (Y COMPRIS TOUS SELS, ESTERS, ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); NAT. REGISTRATION NO/DATE: EU/1/18/1339 20181220; FIRST REGISTRATION: - EU/1/18/1339 20181220 |
| 2435024 | CA 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 |
| 2435024 | 301102 | Netherlands | ⤷ Sign Up | PRODUCT NAME: COMBINATIE VAN FORMOTEROL (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN), GLYCOPYRROLAAT (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN) EN BUDESONIDE (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN); REGISTRATION NO/DATE: EU/1/20/1498 20201210 |
| 2498758 | 122020000018 | Germany | ⤷ Sign Up | PRODUCT NAME: METFORMIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; SAXAGLIPTIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; DAPAGLIFLOZIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1401 20191111 |
| >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.
