Astrazeneca Company Profile
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What is the competitive landscape for ASTRAZENECA, and what generic alternatives to ASTRAZENECA drugs are available?
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-two 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: | 2192 |
| 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 PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | DISCN | Yes | No | 8,721,615*PED | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Astrazeneca | DURANEST | epinephrine bitartrate; etidocaine hydrochloride | INJECTABLE;INJECTION | 017751-006 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Astrazeneca | FASLODEX | fulvestrant | SOLUTION;INTRAMUSCULAR | 021344-001 | Apr 25, 2002 | AO | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Astrazeneca | LOKELMA | sodium zirconium cyclosilicate | FOR SUSPENSION;ORAL | 207078-002 | May 18, 2018 | RX | Yes | Yes | 11,738,044 | ⤷ Try a Trial | ⤷ 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 | NEXIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 021153-002 | Feb 20, 2001 | 4,508,905 | ⤷ Try a Trial |
| Astrazeneca Ab | QTERN | dapagliflozin; saxagliptin hydrochloride | TABLET;ORAL | 209091-001 | Feb 27, 2017 | RE44186 | ⤷ Try a Trial |
| Astrazeneca Ab | SYMLIN | pramlintide acetate | INJECTABLE;SUBCUTANEOUS | 021332-001 | Mar 16, 2005 | 7,407,934 | ⤷ Try a Trial |
| Astrazeneca | ELAVIL | amitriptyline hydrochloride | TABLET;ORAL | 012703-007 | Approved Prior to Jan 1, 1982 | 3,428,735 | ⤷ 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 | 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 |
| ➤ 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 |
International Patents for Astrazeneca Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2271321 | ⤷ Try a Trial |
| Cyprus | 1123369 | ⤷ Try a Trial |
| Colombia | 6311068 | ⤷ Try a Trial |
| Malaysia | 162829 | ⤷ 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 |
|---|---|---|---|---|
| 0579826 | 02C0041 | France | ⤷ Try a Trial | PRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418 |
| 1633724 | C01633724/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: OLAPARIB; REGISTRATION NO/DATE: SWISSMEDIC 65160 14.01.2016 |
| 2498758 | 16/2020 | Austria | ⤷ Try a Trial | 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 |
| 1848414 | C 2016 026 | Romania | ⤷ Try a Trial | PRODUCT NAME: OSIMERTINIB; NATIONAL AUTHORISATION NUMBER: EU/1/16/1086; DATE OF NATIONAL AUTHORISATION: 20160202; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1086; DATE OF FIRST AUTHORISATION IN EEA: 20160202 |
| >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.
