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Generated: July 28, 2017
What is the competitive landscape for ASTRAZENECA, and what generic alternatives to ASTRAZENECA drugs are available?
ASTRAZENECA has eighty-nine approved drugs.| Patents: | 125 |
| Tradenames: | 64 |
| Ingredients: | 56 |
| NDAs: | 89 |
| 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 | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-001 | Jan 27, 2012 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Astrazeneca Ab | SYMLIN | pramlintide acetate | INJECTABLE;SUBCUTANEOUS | 021332-003 | Sep 25, 2007 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-001 | Apr 28, 2005 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Astrazeneca Ab | QTERN | dapagliflozin propanediol; saxagliptin hydrochloride | TABLET;ORAL | 209091-001 | Feb 27, 2017 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astrazeneca Ab | SYMLIN | pramlintide acetate | INJECTABLE;SUBCUTANEOUS | 021332-001 | Mar 16, 2005 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Astrazeneca | LEXXEL | enalapril maleate; felodipine | TABLET, EXTENDED RELEASE;ORAL | 020668-001 | Dec 27, 1996 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Astrazeneca Ab | BYDUREON | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-001 | Jan 27, 2012 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Astrazeneca | ATACAND | candesartan cilexetil | TABLET;ORAL | 020838-003 | Jun 4, 1998 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-001 | Apr 28, 2005 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
ticagrelor | Tablets | 60 mg | BRILINTA | 9/30/2015 |
ticagrelor | Tablets | 90 mg | BRILINTA | 7/20/2015 |
roflumilast | Tablets | 500 mcg | DALIRESP | 3/2/2015 |
exenatide | Injection | 250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe | BYETTA | 6/11/2014 |
zolmitriptan | Nasal Spray | 5 mg/spray | ZOMIG | 11/14/2013 |
saxagliptin hydrochloride | Tablets | 2.5 mg and 5 mg | ONGLYZA | 7/31/2013 |
saxagliptin hydrochloride and metformin hydrochloride | Extended-release Tablets | 5 mg/500 mg, 2.5 mg/1000 mg, and 5 mg/1000 mg | KOMBIGLYZE XR | 7/31/2013 |
omeprazole magnesium | Delayed-release Tablets | 20 mg | PRILOSEC OTC | 3/30/2012 |
budesonide | Inhalation Suspension | 1 mg/2 mL | PULMICORT RESPULES | 5/28/2010 |
esomeprazole sodium | For Injection | 20 mg/vial and 40 mg/vial | NEXIUM IV | 11/23/2009 |
fulvestrant | Injection | 50 mg/mL, 2.5 mL and 5 mL syringe | FASLODEX | 10/1/2009 |
candesartan cilexetil and hydrochlorothiazide | Tablets | 32 mg/25 mg | ATACAND HCT | 3/6/2009 |
quetiapine fumarate | Extended-release Tablets | 150 mg | SEROQUEL XR | 11/17/2008 |
quetiapine fumarate | Extended-release Tablets | 50 mg | SEROQUEL XR | 10/17/2008 |
candesartan cilexetil and hydrochlorothiazide | Tablets | 16 mg/12.5 mg and 32 mg/12.5 mg | ATACAND HCT | 6/25/2008 |
quetiapine fumarate | Extended-release Tablets | 400 mg | SEROQUEL XR | 6/18/2008 |
quetiapine fumarate | Tablets | 200 mg and 300 mg | SEROQUEL XR | 6/12/2008 |
budesonide | Nasal Spray | 0.032 mg (32 mcg)/spray | RHINOCORT | 5/14/2007 |
omeprazole magnesium | Delayed-release Capsules | 20 mg | PRILOSEC OTC | 3/19/2007 |
quetiapine fumarate | Tablets | 50 mg, 150 mg and 400 mg | SEROQUEL | 2/12/2007 |
candesartan cilexetil | Tablets | 4 mg, 8 mg, 16 mg and 32 mg | ATACAND | 12/22/2006 |
quetiapine fumarate | Tablets | 100 mg, 200 mg and 300 mg | SEROQUEL | 2/21/2006 |
budesonide | Inhalation Suspension | 0.25 mg/2 mL and 0.5 mg/2 mL | PULMICORT RESPULES | 9/15/2005 |
quetiapine fumarate | Tablets | 25 mg | SEROQUEL | 8/12/2005 |
esomeprazole magnesium | Delayed-release | 20 mg and 40 mg | NEXIUM | 8/5/2005 |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,220,721 | Exendin agonist peptides | ► Subscribe | |||||||||||||||||||||||||||
| 7,662,818 | Phthalazinone derivatives | ► Subscribe | |||||||||||||||||||||||||||
| 8,802,699 | Quinuclidine derivatives and medicinal compositions containing the same | ► Subscribe | |||||||||||||||||||||||||||
| 2,015,197,470 | ► Subscribe | ||||||||||||||||||||||||||||
| 7,157,555 | Exendin agonist compounds | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Israel | 214180 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 03063842 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2015503590 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 2009248469 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 03032990 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 017 | Luxembourg | ► Subscribe | 92017, EXPIRES: 20230525 | ||||||||||||||||||||||||||
| 0483 | Netherlands | ► Subscribe | PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYDRAAT; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17091/0263 - 0001 20101105 | ||||||||||||||||||||||||||
| 2008000046 | Germany | ► Subscribe | PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE SITAGLIPTINPHOSPHAT- MONOHYDRAT, IN KOMBINATION MIT METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 FIRST REGISTRATION: CH/LI 58450 01 58450 02 58450 03 20080408 | ||||||||||||||||||||||||||
| 2012000028 | Germany | ► Subscribe | PRODUCT NAME: BYDUREON-EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617 | ||||||||||||||||||||||||||
| C/GB14/085 | United Kingdom | ► Subscribe | PRODUCT NAME: SAXAGLIPTIN; REGISTERED: UK EU/1/09/545/001-010 20091005 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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