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-one 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: | 2191 |
| 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 | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-001 | Jan 8, 2014 | RX | Yes | No | 8,329,648 | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Astrazeneca | LOKELMA | sodium zirconium cyclosilicate | FOR SUSPENSION;ORAL | 207078-002 | May 18, 2018 | RX | Yes | Yes | 8,877,255 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Astrazeneca | DYCLONE | dyclonine hydrochloride | SOLUTION;TOPICAL | 009925-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Astrazeneca | SYMBICORT | budesonide; formoterol fumarate dihydrate | AEROSOL, METERED;INHALATION | 021929-001 | Jul 21, 2006 | AB | RX | Yes | Yes | 8,387,615*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 | |||||
| >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 | PRILOSEC | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 019810-002 | Jan 15, 1998 | 4,255,431*PED | ⤷ Try a Trial |
| Astrazeneca | SEROQUEL XR | quetiapine fumarate | TABLET, EXTENDED RELEASE;ORAL | 022047-005 | Aug 11, 2008 | 4,879,288*PED | ⤷ Try a Trial |
| Astrazeneca | SEROQUEL XR | quetiapine fumarate | TABLET, EXTENDED RELEASE;ORAL | 022047-001 | May 17, 2007 | 4,879,288*PED | ⤷ Try a Trial |
| Astrazeneca | PULMICORT RESPULES | budesonide | SUSPENSION;INHALATION | 020929-001 | Aug 8, 2000 | 7,524,834*PED | ⤷ Try a Trial |
| Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | 6,479,065 | ⤷ 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 | 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 |
| ➤ 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 |
International Patents for ASTRAZENECA Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Taiwan | 200948407 | ⤷ Try a Trial |
| Denmark | 1506211 | ⤷ Try a Trial |
| Taiwan | I583386 | ⤷ Try a Trial |
| Mexico | 2014008309 | ⤷ Try a Trial |
| Taiwan | 201438723 | ⤷ 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 |
|---|---|---|---|---|
| 1734971 | 122012000028 | Germany | ⤷ Try a Trial | PRODUCT NAME: BYDUREON-EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617 |
| 1734971 | 2012C/017 | Belgium | ⤷ Try a Trial | PRODUCT NAME: EXENATIDE; AUTHORISATION NUMBER AND DATE: EU/1/11/696/001 20110617 |
| 0240228 | SPC/GB97/086 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: QUETIAPINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY-ACCEPTABLE SALT; REGISTERED: UK 12619/0112 19970731; UK 12619/0113 19970731; UK 12619/0114 19970731 |
| 0579826 | 02C0041 | France | ⤷ Try a Trial | PRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418 |
| 0138504 | SPC/GB04/009 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: FULVESTRANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK EU/1/03/269/001 20040310 |
| >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.
