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-one approved drugs.
There are one hundred and sixteen US patents protecting ASTRAZENECA drugs. There is one tentative approval on ASTRAZENECA drugs.
There are one thousand nine hundred and eighty-seven 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: | 1987 |
| US Patents: | 116 |
| Tradenames: | 64 |
| Ingredients: | 58 |
| NDAs: | 91 |
| 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 | LOKELMA | sodium zirconium cyclosilicate | FOR SUSPENSION;ORAL | 207078-002 | May 18, 2018 | RX | Yes | Yes | 8,808,750 | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Astrazeneca | KOSELUGO | selumetinib sulfate | CAPSULE;ORAL | 213756-001 | Apr 10, 2020 | RX | Yes | No | 7,425,637 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Astrazeneca | FASLODEX | fulvestrant | SOLUTION;INTRAMUSCULAR | 021344-001 | Apr 25, 2002 | AO | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Astrazeneca | LOKELMA | sodium zirconium cyclosilicate | FOR SUSPENSION;ORAL | 207078-001 | May 18, 2018 | RX | Yes | No | 9,861,658 | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Astrazeneca | LYNPARZA | olaparib | TABLET;ORAL | 208558-001 | Aug 17, 2017 | RX | 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 | FASLODEX | fulvestrant | SOLUTION;INTRAMUSCULAR | 021344-001 | Apr 25, 2002 | 7,456,160*PED | ⤷ Try a Trial |
| Astrazeneca | PULMICORT FLEXHALER | budesonide | POWDER, METERED;INHALATION | 021949-001 | Jul 12, 2006 | 6,142,145 | ⤷ Try a Trial |
| Astrazeneca | PULMICORT RESPULES | budesonide | SUSPENSION;INHALATION | 020929-002 | Aug 8, 2000 | 6,598,603*PED | ⤷ Try a Trial |
| Astrazeneca | EPANOVA | omega-3-carboxylic acids | CAPSULE;ORAL | 205060-001 | May 5, 2014 | 5,792,795 | ⤷ Try a Trial |
| Astrazeneca | SYMBICORT | budesonide; formoterol fumarate dihydrate | AEROSOL, METERED;INHALATION | 021929-002 | Jul 21, 2006 | 8,575,137*PED | ⤷ 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 | 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 |
| ➤ 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 |
International Patents for Astrazeneca Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Finland | 3686193 | ⤷ Try a Trial |
| Eurasian Patent Organization | 200501350 | ⤷ Try a Trial |
| Taiwan | 201204414 | ⤷ Try a Trial |
| Taiwan | 200616602 | ⤷ Try a Trial |
| Eurasian Patent Organization | 035890 | ⤷ 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 |
|---|---|---|---|---|
| 1633724 | PA2015016 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: OLAPARIBUM; REGISTRATION NO/DATE: EU/1/14/959 20141216 |
| 0823900 | PA2009009,C0823900 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: GEFITINIBUM; REGISTRATION NO/DATE: EU/1/09/526/001 20090624 |
| 0706513 | 10C0052 | France | ⤷ Try a Trial | PRODUCT NAME: ROFLUMILAST, ROFLUMILAST-N-OXYDE ET LES SELS DE CES COMPOSES; NAT. REGISTRATION NO/DATE: EU/1/16/636/001 20100705; FIRST REGISTRATION: EU/1/10/636/001 20100705 |
| 1758590 | 2017C/063 | Belgium | ⤷ Try a Trial | PRODUCT NAME: SEL DE SODIUM D'ACIDE DESOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: SE/H/1547/01/DC 20170612 |
| 1848414 | 132016000078445 | Italy | ⤷ Try a Trial | PRODUCT NAME: OSIMERTINIB(TAGRISSO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1086, 20160204 |
| >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.
