Apotex Company Profile
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What is the competitive landscape for APOTEX
APOTEX has three hundred and sixty-four approved drugs.
There are sixteen US patents protecting APOTEX drugs. There are nineteen tentative approvals on APOTEX drugs.
Summary for Apotex
| US Patents: | 16 |
| Tradenames: | 276 |
| Ingredients: | 264 |
| NDAs: | 364 |
| Patent Litigation for Apotex: | See patent lawsuits for Apotex |
| PTAB Cases with Apotex as petitioner: | See PTAB cases with Apotex as petitioner |
Drugs and US Patents for Apotex
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex | ATROPINE SULFATE | atropine sulfate | SOLUTION/DROPS;OPHTHALMIC | 215624-001 | Nov 26, 2021 | AT1 | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ||||
| Apotex | CALDOLOR | ibuprofen | SOLUTION;INTRAVENOUS | 022348-002 | Jun 11, 2009 | RX | Yes | Yes | 9,649,284 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Apotex | HYDROCHLOROTHIAZIDE | hydrochlorothiazide | TABLET;ORAL | 040774-001 | Oct 3, 2007 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | |||||
| Apotex | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 208639-001 | Mar 21, 2018 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | |||||
| Apotex | AFATINIB DIMALEATE | afatinib dimaleate | TABLET;ORAL | 210725-002 | Jul 14, 2026 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start 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 Apotex
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Apotex | VIBATIV | telavancin hydrochloride | POWDER;INTRAVENOUS | 022110-002 | Sep 11, 2009 | 7,208,471 | ⤷ Start Trial |
| Apotex | VIBATIV | telavancin hydrochloride | POWDER;INTRAVENOUS | 022110-002 | Sep 11, 2009 | 7,008,923 | ⤷ Start Trial |
| Apotex | VIBATIV | telavancin hydrochloride | POWDER;INTRAVENOUS | 022110-001 | Sep 11, 2009 | 6,872,701 | ⤷ Start Trial |
| Apotex | ACETADOTE | acetylcysteine | INJECTABLE;INTRAVENOUS | 021539-001 | Jan 23, 2004 | 8,399,445 | ⤷ Start Trial |
| Apotex | VIBATIV | telavancin hydrochloride | POWDER;INTRAVENOUS | 022110-001 | Sep 11, 2009 | 7,544,364 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for APOTEX drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Delayed-release Tablets | 20 mg | ➤ Subscribe | 2015-06-03 |
| ➤ Subscribe | Transdermal System | 3.1 mg/24 hrs | ➤ Subscribe | 2015-10-09 |
| ➤ Subscribe | Extended-release Tablets | 25 mg | ➤ Subscribe | 2005-09-09 |
| ➤ Subscribe | Oral Suspension | 10 mg/5 mL | ➤ Subscribe | 2005-02-10 |
| ➤ Subscribe | Injection | 200 mg/mL, 30 mL vials | ➤ Subscribe | 2012-04-04 |
| ➤ Subscribe | Extended-release Tablets | 37.5 mg | ➤ Subscribe | 2009-05-19 |
International Patents for Apotex Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Spain | 2823249 | ⤷ Start Trial |
| European Patent Office | 2453742 | ⤷ Start Trial |
| Australia | 2009350474 | ⤷ Start Trial |
| Brazil | PI0415853 | ⤷ Start Trial |
| Australia | 2009350474 | ⤷ Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Apotex Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1261606 | PA2008018,C1261606 | Lithuania | ⤷ Start Trial | PRODUCT NAME: RIVAROXABANUM; REGISTRATION NO/DATE: EU/1/07/472/001 - EU/1/08/472/008, 0080930 |
| 2924034 | 2019C/005 | Belgium | ⤷ Start Trial | PRODUCT NAME: DORAVIRINE,DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT IN COMBINATIE MET LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAARZOUT, IN COMBINATIE MET TENOFOVIR OF EEN ESTER DAARVAN, IN HET BIJZONDER EEN DISOPROXIL ESTER, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER EEN FUMARAAT ZOUT; AUTHORISATION NUMBER AND DATE: EU/1/18/1333/001-002 20181126 |
| 1189916 | CA 2011 00005 | Denmark | ⤷ Start Trial | PRODUCT NAME: REGADENOSON OG SALTE DERAF |
| 0719278 | SPC/GB03/018 | United Kingdom | ⤷ Start Trial | PRODUCT NAME: DUTASTERIDE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SOLVATE.; REGISTERED: SE 17871 20020719; SE 17872 20020719; UK PL 19494/0005 20030117; UK PL 19494/0006 20030117 |
| 1345910 | 2014/009 | Ireland | ⤷ Start Trial | PRODUCT NAME: AFATINIB, THE TAUTOMERS, THE STEREOISOMERS AND THE SALTS THEREOF, OPTIONALLY IN THE FORM OF PHYSIOLOGICALLY ACCEPTABLE SALTS THEREOF WITH INORGANIC OR ORGANIC ACIDS OR BASES, PREFERABLY SALTS WITH MALEIC ACID; REGISTRATION NO/DATE: EU/1/13/879/001-012 20130925 |
| >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.
