Astrazeneca Ab Company Profile
✉ Email this page to a colleague
What is the competitive landscape for ASTRAZENECA AB, and when can generic versions of ASTRAZENECA AB drugs launch?
ASTRAZENECA AB has twelve approved drugs.
There are fifty-five US patents protecting ASTRAZENECA AB drugs. There is one tentative approval on ASTRAZENECA AB drugs.
There are eight hundred and ninety-six patent family members on ASTRAZENECA AB drugs in fifty-four countries and one hundred and forty-two supplementary protection certificates in nineteen countries.
Summary for Astrazeneca Ab
| International Patents: | 896 |
| US Patents: | 55 |
| Tradenames: | 13 |
| Ingredients: | 10 |
| NDAs: | 12 |
| Drug Master File Entries: | 2 |
| Patent Litigation for Astrazeneca Ab: | See patent lawsuits for Astrazeneca Ab |
| PTAB Cases with Astrazeneca Ab as patent owner: | See PTAB cases with Astrazeneca Ab as patent owner |
Drugs and US Patents for Astrazeneca Ab
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca Ab | BREZTRI AEROSPHERE | budesonide; formoterol fumarate; glycopyrrolate | AEROSOL, METERED;INHALATION | 212122-001 | Jul 23, 2020 | RX | Yes | Yes | 8,808,713 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Astrazeneca Ab | BREZTRI AEROSPHERE | budesonide; formoterol fumarate; glycopyrrolate | AEROSOL, METERED;INHALATION | 212122-001 | Jul 23, 2020 | RX | Yes | Yes | 9,415,009 | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Astrazeneca Ab | SYMLIN | pramlintide acetate | INJECTABLE;SUBCUTANEOUS | 021332-001 | Mar 16, 2005 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Astrazeneca Ab | QTERN | dapagliflozin; saxagliptin hydrochloride | TABLET;ORAL | 209091-001 | Feb 27, 2017 | RX | Yes | Yes | 7,919,598 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Astrazeneca Ab | XIGDUO XR | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205649-004 | Oct 29, 2014 | RX | Yes | Yes | 9,616,028 | ⤷ Try a Trial | Y | ⤷ 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 Ab
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca Ab | SYMLIN | pramlintide acetate | INJECTABLE;SUBCUTANEOUS | 021332-003 | Sep 25, 2007 | 6,610,824 | ⤷ Try a Trial |
| Astrazeneca Ab | QTERNMET XR | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874-004 | May 2, 2019 | 6,414,126 | ⤷ Try a Trial |
| Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-001 | Apr 28, 2005 | 6,872,700 | ⤷ Try a Trial |
| Astrazeneca Ab | QTERNMET XR | dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874-003 | May 2, 2019 | 6,414,126 | ⤷ Try a Trial |
| Astrazeneca Ab | FARXIGA | dapagliflozin | TABLET;ORAL | 202293-001 | Jan 8, 2014 | 7,563,871 | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for ASTRAZENECA AB drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 2.5 mg and 5 mg | ➤ Subscribe | 2013-07-31 |
| ➤ Subscribe | Injection | 250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe | ➤ Subscribe | 2014-06-11 |
| ➤ Subscribe | HydrochlorideExtended-release Tablets | 2.5 mg/1000 mg | ➤ Subscribe | 2018-10-29 |
| ➤ 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 Ab Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Peru | 20060425 | ⤷ Try a Trial |
| Canada | 2681526 | ⤷ Try a Trial |
| South Korea | 20170070274 | ⤷ Try a Trial |
| Japan | 2012207037 | ⤷ Try a Trial |
| Brazil | 0311323 | ⤷ Try a Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Astrazeneca Ab Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1412357 | CA 2008 00035 | Denmark | ⤷ Try a Trial | PRODUCT NAME: SITAGLIPTIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER MONOPHOSPHAT, METFORMIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER HYDROCHLORID |
| 1412357 | PA2008013,C1412357 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716 |
| 1734971 | 122012000028 | Germany | ⤷ Try a Trial | PRODUCT NAME: BYDUREON-EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617 |
| 2435024 | 2021C/518 | Belgium | ⤷ Try a Trial | PRODUCT NAME: UNE COMBINAISON DE FORMOTEROL (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), GLYCOPYRROLATE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET BUDESONIDE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1498 20201210 |
| 1506211 | PA2013008 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112 |
| >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.
