ASTRAZENECA Company Profile
✉ Email this page to a colleague
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-five US patents protecting ASTRAZENECA drugs. There is one tentative approval on ASTRAZENECA drugs.
There are two thousand two hundred and three 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: | 2203 |
| US Patents: | 125 |
| 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 | 8,998,876*PED | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Astrazeneca | LOKELMA | sodium zirconium cyclosilicate | FOR SUSPENSION;ORAL | 207078-002 | May 18, 2018 | RX | Yes | Yes | 11,738,044 | ⤷ Sign Up | ⤷ Sign Up | ||||
| Astrazeneca | DALIRESP | roflumilast | TABLET;ORAL | 022522-002 | Jan 23, 2018 | AB | RX | Yes | No | 8,536,206 | ⤷ Sign Up | ⤷ Sign Up | |||
| Astrazeneca | CALQUENCE | acalabrutinib | CAPSULE;ORAL | 210259-001 | Oct 31, 2017 | RX | Yes | Yes | 9,290,504 | ⤷ 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca Ab | BYDUREON | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-001 | Jan 27, 2012 | 6,936,590 | ⤷ Sign Up |
| Astrazeneca | SYMBICORT | budesonide; formoterol fumarate dihydrate | AEROSOL, METERED;INHALATION | 021929-001 | Jul 21, 2006 | 7,367,333*PED | ⤷ Sign Up |
| Astrazeneca | NEXIUM | esomeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021957-002 | Oct 20, 2006 | 5,900,424*PED | ⤷ Sign Up |
| Astrazeneca | PULMICORT FLEXHALER | budesonide | POWDER, METERED;INHALATION | 021949-001 | Jul 12, 2006 | 6,027,714 | ⤷ 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 | 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 |
| ➤ 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 |
International Patents for ASTRAZENECA Drugs
Supplementary Protection Certificates for ASTRAZENECA Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0265685 | C980030 | Netherlands | ⤷ Sign Up | PRODUCT NAME: FELODIPINE, DESGEWENST IN DE VORM VAN FYSIOLOGISCH AANVAARDBAAR ZOUT, EN (2S, 3AS, 6AS)-1-[(S)-N-[(S)-1-CARBOXY-3-FENYLPROPYL]A LANYL]OCTAHYDROCYCLOPENTA[B]-PYRROOL-2-CARBONZUUR (RAMIPRILAAT) , DESGEWENST IN DE VORM VAN EEN .....ZIE VERDER IN HET DOSSIER; NAT. REGISTRATION NO/ DATE: RVG 22449, RVG 22450 19980618; FIRST REGISTRATION: SE 13596, 13597 19970919 |
| 1482932 | PA2019007,C1482932 | Lithuania | ⤷ Sign Up | PRODUCT NAME: BINIMETINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/18/1315 20180920 |
| 1506211 | C20140021 00131 | Estonia | ⤷ Sign Up | PRODUCT NAME: DAPAGLIFLOSIIN/METFORMIIN;REG NO/DATE: K(2014)308 (LOPLIK) 21.01.2014 |
| 1633724 | 1590019-4 | Sweden | ⤷ Sign Up | PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REG. NO/DATE: EU/1/14/959 20141218 |
| >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.
