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ASTRAZENECA Company Profile
What is the competitive landscape for ASTRAZENECA, and what generic alternatives to ASTRAZENECA drugs are available?
There are one hundred and forty-five US patents protecting ASTRAZENECA drugs.
There are two thousand seven hundred and sixteen patent family members on ASTRAZENECA drugs in seventy-three countries and two hundred and twenty-two supplementary protection certificates in sixteen countries.
Summary for ASTRAZENECA
| International Patents: | 2716 |
| US Patents: | 145 |
| Tradenames: | 66 |
| Ingredients: | 56 |
| NDAs: | 92 |
| 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 Pharms | PULMICORT RESPULES | budesonide | SUSPENSION;INHALATION | 020929-002 | Aug 8, 2000 | AN | RX | Yes | No | 7,524,834*PED | ➤ Sign Up | Y | ➤ Sign Up | ||
| Astrazeneca | LEXXEL | enalapril maleate; felodipine | TABLET, EXTENDED RELEASE;ORAL | 020668-001 | Dec 27, 1996 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | |||||
| Astrazeneca | SYMBICORT | budesonide; formoterol fumarate dihydrate | AEROSOL, METERED;INHALATION | 021929-001 | Jul 21, 2006 | RX | Yes | Yes | 8,387,615*PED | ➤ Sign Up | Y | ➤ Sign Up | |||
| Astrazeneca Ab | BYDUREON BCISE | exenatide | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 209210-001 | Oct 20, 2017 | RX | Yes | Yes | 8,461,105 | ➤ Sign Up | 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 Pharms | OMNARIS | ciclesonide | SPRAY, METERED;NASAL | 022004-001 | Oct 20, 2006 | 5,482,934 | ➤ Sign Up |
| Astrazeneca Pharms | ALVESCO | ciclesonide | AEROSOL, METERED;INHALATION | 021658-002 | Jan 10, 2008 | 5,605,674 | ➤ Sign Up |
| Astrazeneca | SYMBICORT | budesonide; formoterol fumarate dihydrate | AEROSOL, METERED;INHALATION | 021929-001 | Jul 21, 2006 | 6,123,924*PED | ➤ Sign Up |
| Astrazeneca Pharms | ALVESCO | ciclesonide | AEROSOL, METERED;INHALATION | 021658-003 | Jan 10, 2008 | 6,006,745 | ➤ 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 | Tablets | 2.5 mg and 5 mg | ➤ Subscribe | 2013-07-31 |
| ➤ Subscribe | Nasal Spray | 0.032 mg (32 mcg)/spray | ➤ Subscribe | 2007-05-14 |
| ➤ Subscribe | Nasal Spray | 5 mg/spray | ➤ Subscribe | 2013-11-14 |
| ➤ Subscribe | Delayed-release | 20 mg and 40 mg | ➤ Subscribe | 2005-08-05 |
| ➤ Subscribe | Tablets | 500 mcg | ➤ Subscribe | 2015-03-02 |
| ➤ Subscribe | Tablets | 25 mg | ➤ Subscribe | 2005-08-12 |
| ➤ Subscribe | Tablets | 90 mg | ➤ Subscribe | 2015-07-20 |
| ➤ Subscribe | Extended-release Tablets | 150 mg | ➤ Subscribe | 2008-11-17 |
| ➤ Subscribe | Nasal Spray | 2.5 mg/spray | ➤ Subscribe | 2016-06-09 |
| ➤ Subscribe | Tablets | 100 mg, 200 mg and 300 mg | ➤ Subscribe | 2006-02-21 |
| ➤ Subscribe | Extended-release Tablets | 50 mg | ➤ Subscribe | 2008-10-17 |
| ➤ Subscribe | For Injection | 20 mg/vial and 40 mg/vial | ➤ Subscribe | 2009-11-23 |
| ➤ Subscribe | Nasal Spray | 250 mcg | ➤ Subscribe | 2012-02-13 |
| ➤ 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 | Injection | 250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe | ➤ Subscribe | 2014-06-11 |
| ➤ Subscribe | Delayed-release Capsules | 20 mg | ➤ Subscribe | 2007-03-19 |
| ➤ Subscribe | Delayed-release Tablets | 20 mg | ➤ Subscribe | 2012-03-30 |
| ➤ Subscribe | Extended-release Tablets | 400 mg | ➤ Subscribe | 2008-06-18 |
| ➤ Subscribe | Tablets | 60 mg | ➤ Subscribe | 2015-09-30 |
| ➤ Subscribe | Tablets | 50 mg, 150 mg and 400 mg | ➤ Subscribe | 2007-02-12 |
| ➤ Subscribe | Tablets | 200 mg and 300 mg | ➤ Subscribe | 2008-06-12 |
| ➤ Subscribe | Injection | 50 mg/mL, 2.5 mL and 5 mL syringe | ➤ Subscribe | 2009-10-01 |
| ➤ Subscribe | Inhalation Suspension | 1 mg/2 mL | ➤ Subscribe | 2010-05-28 |
Non-Orange Book US Patents for ASTRAZENECA
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 7,524,530 | Residual solvent extraction method and microparticles produced thereby | ➤ Sign Up |
| 8,535,715 | Bilayer tablet formulations | ➤ Sign Up |
| 7,196,098 | Quinuclidine derivatives and medicinal compositions containing the same | ➤ Sign Up |
| 7,223,725 | Exendin agonist compounds | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for ASTRAZENECA Drugs
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Japan | 2014506556 | ➤ Sign Up |
| South Korea | 20070027652 | ➤ Sign Up |
| China | 102058921 | ➤ Sign Up |
| Estonia | 04297 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for ASTRAZENECA Drugs
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 90009-9 | Sweden | ➤ Sign Up | PRODUCT NAME: TICAGRELOR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; REG. NO/DATE: EU/1/10/655/001-006 20101203 |
| C0006 | France | ➤ Sign Up | PRODUCT NAME: PIOGLITAZONE/METFORMINE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/06/354/001 DU 20060728; REGISTRATION NO/DATE AT EEC: EU/1/06/354/001 DU 20060728 |
| 989 | Luxembourg | ➤ Sign Up | 91989, EXPIRES: 20260617 |
| 2011100004 | Germany | ➤ Sign Up | PRODUCT NAME: TICAGRELOR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203 |
| 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.
