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ASTRAZENECA Company Profile
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What is the competitive landscape for ASTRAZENECA, and when can generic versions of ASTRAZENECA drugs launch?
ASTRAZENECA has ninety approved drugs.
There are one hundred and twenty-three US patents protecting ASTRAZENECA drugs. There is one tentative approval on ASTRAZENECA drugs.
There are two thousand three hundred and forty-three patent family members on ASTRAZENECA drugs in seventy-one countries and two hundred and sixty-seven supplementary protection certificates in nineteen countries.
Summary for ASTRAZENECA
| International Patents: | 2343 |
| US Patents: | 123 |
| Tradenames: | 64 |
| Ingredients: | 56 |
| NDAs: | 90 |
| 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 | SYMBICORT | budesonide; formoterol fumarate dihydrate | AEROSOL, METERED;INHALATION | 021929-001 | Jul 21, 2006 | RX | Yes | Yes | 10,166,247*PED | Start Trial | Y | Start Trial | |||
| Astrazeneca | DALGAN | dezocine | INJECTABLE;INJECTION | 019082-001 | Dec 29, 1989 | DISCN | No | No | Start Trial | Start Trial | |||||
| Astrazeneca Ab | QTERNMET XR | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874-001 | May 2, 2019 | RX | Yes | No | 6,414,126 | Start Trial | Y | Y | Start Trial | ||
| Astrazeneca Ab | XIGDUO XR | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205649-005 | Jul 28, 2017 | RX | Yes | No | 6,515,117 | Start Trial | Y | Y | Start Trial | ||
| Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-002 | Jan 8, 2014 | RX | Yes | Yes | 9,198,925 | Start Trial | Start 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 Pharms | PULMICORT RESPULES | budesonide | SUSPENSION;INHALATION | 020929-002 | Aug 8, 2000 | 4,787,536*PED | Start Trial |
| Astrazeneca Pharms | SEROQUEL | quetiapine fumarate | TABLET;ORAL | 020639-005 | Jul 26, 2000 | 4,879,288*PED | Start Trial |
| Astrazeneca Ab | BYDUREON BCISE | exenatide | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 209210-001 | Oct 20, 2017 | 6,872,700 | Start Trial |
| Astrazeneca Lp | NEXIUM 24HR | esomeprazole magnesium | CAPSULE, DELAYED RELEASE;ORAL | 204655-001 | Mar 28, 2014 | 7,411,070*PED | Start Trial |
| Astrazeneca Pharms | SEROQUEL | quetiapine fumarate | TABLET;ORAL | 020639-007 | Oct 4, 2005 | 4,879,288*PED | Start 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 | Tablets | 2.5 mg and 5 mg | ➤ Subscribe | 2013-07-31 |
| ➤ Subscribe | Delayed-release for Oral Suspension | 2.5 mg and 5 mg | ➤ Subscribe | 2018-09-24 |
| ➤ Subscribe | Inhalation Suspension | 0.25 mg/2 mL and 0.5 mg/2 mL | ➤ Subscribe | 2005-09-15 |
| ➤ Subscribe | Nasal Spray | 0.032 mg (32 mcg)/spray | ➤ Subscribe | 2007-05-14 |
| ➤ Subscribe | Delayed-release Capsules | 20 mg | ➤ Subscribe | 2007-03-19 |
| ➤ Subscribe | Nasal Spray | 5 mg/spray | ➤ Subscribe | 2013-11-14 |
| ➤ Subscribe | Tablets | 90 mg | ➤ Subscribe | 2015-07-20 |
| ➤ Subscribe | Extended-release Tablets | 400 mg | ➤ Subscribe | 2008-06-18 |
| ➤ Subscribe | Tablets | 500 mcg | ➤ Subscribe | 2015-03-02 |
| ➤ Subscribe | Tablets | 200 mg and 300 mg | ➤ Subscribe | 2008-06-12 |
| ➤ Subscribe | Tablets | 25 mg | ➤ Subscribe | 2005-08-12 |
| ➤ Subscribe | Injection | 250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe | ➤ Subscribe | 2014-06-11 |
| ➤ Subscribe | Tablets | 100 mg, 200 mg and 300 mg | ➤ Subscribe | 2006-02-21 |
| ➤ Subscribe | HydrochlorideExtended-release Tablets | 2.5 mg/1000 mg | ➤ Subscribe | 2018-10-29 |
| ➤ Subscribe | Delayed-release | 20 mg and 40 mg | ➤ Subscribe | 2005-08-05 |
| ➤ Subscribe | For Injection | 20 mg/vial and 40 mg/vial | ➤ Subscribe | 2009-11-23 |
| ➤ Subscribe | Inhalation Suspension | 1 mg/2 mL | ➤ Subscribe | 2010-05-28 |
| ➤ Subscribe | Injection | 50 mg/mL, 2.5 mL and 5 mL syringe | ➤ Subscribe | 2009-10-01 |
| ➤ Subscribe | Delayed-release Tablets | 20 mg | ➤ Subscribe | 2012-03-30 |
| ➤ Subscribe | Nasal Spray | 2.5 mg/spray | ➤ Subscribe | 2016-06-09 |
| ➤ Subscribe | Tablets | 60 mg | ➤ Subscribe | 2015-09-30 |
| ➤ Subscribe | Extended-release Tablets | 150 mg | ➤ Subscribe | 2008-11-17 |
| ➤ Subscribe | Tablets | 12.5 mg and 25 mg | ➤ Subscribe | 2018-09-17 |
| ➤ Subscribe | Extended-release Tablets | 50 mg | ➤ Subscribe | 2008-10-17 |
| ➤ Subscribe | Tablets | 50 mg, 150 mg and 400 mg | ➤ Subscribe | 2007-02-12 |
| ➤ 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 |
|---|---|---|
| Netherlands | 300737 | Start Trial |
| Uruguay | 26613 | Start Trial |
| European Patent Office | 2435033 | Start Trial |
| Ukraine | 73181 | Start Trial |
| Lithuania | C1633724 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ASTRAZENECA Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1506211 | 1390017-0 | Sweden | Start Trial | PRODUCT NAME: DAPAGLIFLOZIN OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/12/795/001 20121112 |
| 0124495 | SPC/GB01/006 | United Kingdom | Start Trial | PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727 |
| 0823900 | SPC/GB09/059 | United Kingdom | Start Trial | PRODUCT NAME: GEFITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 56154 20040302; UK EU/1/09/526/001 20090624 |
| 1633724 | 213 50005-2015 | Slovakia | Start Trial | PRODUCT NAME: OLAPARIB; REGISTRATION NO/DATE: EU/1/14/959 20141218 |
| 1694363 | 1590027-7 | Sweden | Start Trial | PRODUCT NAME: NALOXEGOL; REG. NO/DATE: EU/1/14/962 20141210 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
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Here is a list of applicants with similar names.
