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Generated: August 16, 2017
What is the competitive landscape for ASTRAZENECA PHARMS, and when can generic versions of ASTRAZENECA PHARMS drugs launch?
ASTRAZENECA PHARMS has twenty approved drugs.| Patents: | 61 |
| Tradenames: | 18 |
| Ingredients: | 17 |
| NDAs: | 20 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astrazeneca Pharms | NEXIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 021153-002 | Feb 20, 2001 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Astrazeneca Pharms | NEXIUM | esomeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021957-002 | Oct 20, 2006 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Astrazeneca Pharms | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-002 | Sep 16, 2014 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Astrazeneca Pharms | BRILINTA | ticagrelor | TABLET;ORAL | 022433-002 | Sep 3, 2015 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | Y | Y | ► Subscribe | |||||||||||||||
Astrazeneca Pharms | LYNPARZA | olaparib | CAPSULE;ORAL | 206162-001 | Dec 19, 2014 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astrazeneca Pharms | PRILOSEC | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 019810-003 | Oct 5, 1995 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Astrazeneca Pharms | SEROQUEL | quetiapine fumarate | TABLET;ORAL | 020639-006 | Oct 4, 2005 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Astrazeneca Pharms | PRILOSEC OTC | omeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 021229-001 | Jun 20, 2003 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Astrazeneca Pharms | NEXIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 021153-002 | Feb 20, 2001 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Astrazeneca Pharms | PULMICORT RESPULES | budesonide | SUSPENSION;INHALATION | 020929-003 | Aug 8, 2000 | ► 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 |
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 |
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 |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 9,566,276 | Phthalazinone derivatives | ► Subscribe | |||||||||||||||||||||||||||
| 8,349,307 | Polymer conjugates of opioid antagonists | ► Subscribe | |||||||||||||||||||||||||||
| 7,662,818 | Phthalazinone derivatives | ► Subscribe | |||||||||||||||||||||||||||
| 8,513,279 | Quinuclidine derivatives and medicinal compositions containing the same | ► Subscribe | |||||||||||||||||||||||||||
| 6,677,455 | Potassium salt of S-omeprazole | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Brazil | PI0417056 | ► Subscribe | |||||||||||||||||||||||||||
| Poland | 323362 | ► Subscribe | |||||||||||||||||||||||||||
| Ecuador | SP13012531 | ► Subscribe | |||||||||||||||||||||||||||
| Slovakia | 284199 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2002529497 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 11/016 | Ireland | ► Subscribe | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105 | ||||||||||||||||||||||||||
| 3 | Finland | ► Subscribe | |||||||||||||||||||||||||||
| C/GB10/040 | United Kingdom | ► Subscribe | PRODUCT NAME: ROFLUMILAST, ROFLUMILAST-N-OXIDE AND THE SALTS OF THESE COMPOUNDS.; REGISTERED: UK EU/1/10/636/001 20100705; UK EU/1/10/636/002 20100705; UK EU/1/10/636/003 20100705 | ||||||||||||||||||||||||||
| 90006-4 | Sweden | ► Subscribe | PRODUCT NAME: ACETYLSALICYLSYRA OCH ESOMEPRAZOLMAGNESIUMTRIHYDRAT; NAT. REG. NO/DATE: MTNR 44371 20110930; FIRST REG.: PT 5402359MFL 20110812 | ||||||||||||||||||||||||||
| 0150012 00136 | Estonia | ► Subscribe | PRODUCT NAME: OLAPARIIB;REG NO/DATE: EU/1/14/959 18.12.2014 | ||||||||||||||||||||||||||
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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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