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Akorn Company Profile
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What is the competitive landscape for AKORN, and what generic alternatives to AKORN drugs are available?
AKORN has two hundred and fifty-three approved drugs.
There are four US patents protecting AKORN drugs. There are two tentative approvals on AKORN drugs.
There are seventy patent family members on AKORN drugs in thirty-one countries and two hundred and fifty-six supplementary protection certificates in fifteen countries.
Summary for Akorn
International Patents: | 70 |
US Patents: | 4 |
Tradenames: | 187 |
Ingredients: | 167 |
NDAs: | 253 |
Patent Litigation for Akorn: | See patent lawsuits for Akorn |
PTAB Cases with Akorn as petitioner: | See PTAB cases with Akorn as petitioner |
Drugs and US Patents for Akorn
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Akorn | AKPENTOLATE | cyclopentolate hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 040164-001 | Jan 13, 1997 | AT | RX | No | No | Start Trial | Start Trial | ||||
Akorn | DESONIDE | desonide | OINTMENT;TOPICAL | 208836-001 | Mar 27, 2017 | AB | RX | No | No | Start Trial | Start Trial | ||||
Akorn Inc | TOBRAMYCIN | tobramycin | SOLUTION;INHALATION | 201422-001 | May 28, 2014 | AN | RX | No | No | Start Trial | Start Trial | ||||
Akorn | AZASITE | azithromycin | SOLUTION/DROPS;OPHTHALMIC | 050810-001 | Apr 27, 2007 | RX | Yes | Yes | Start Trial | Start Trial | |||||
Akorn | DICLOFENAC SODIUM | diclofenac sodium | GEL;TOPICAL | 209484-001 | Nov 21, 2018 | 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 Akorn
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Akorn | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-004 | Jul 18, 2003 | 6,083,993 | Start Trial |
Akorn | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-001 | Mar 25, 1999 | 5,547,994 | Start Trial |
Akorn | COSOPT | dorzolamide hydrochloride; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 020869-001 | Apr 7, 1998 | 4,797,413*PED | Start Trial |
Akorn | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-003 | Jan 30, 2002 | 5,547,994 | Start Trial |
Akorn | BETIMOL | timolol | SOLUTION/DROPS;OPHTHALMIC | 020439-002 | Mar 31, 1995 | 5,231,095 | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for AKORN drugs
Drugname | Dosage | Strength | Tradename | Submissiondate |
---|---|---|---|---|
➤ Subscribe | Ophthalmic Solution | 2%/0.5% | ➤ Subscribe | 2005-10-11 |
➤ Subscribe | Inhalation Solution | 0.0103%, 0.021% and 0.042% | ➤ Subscribe | 2005-06-20 |
➤ Subscribe | Inhalation Aerosol | 0.045 mg/actuation | ➤ Subscribe | 2012-02-27 |
➤ Subscribe | Ophthalmic Solution | 1% | ➤ Subscribe | 2011-03-03 |
➤ Subscribe | Ophthalmic Solution | 0.0015% | ➤ Subscribe | 2016-02-10 |
➤ Subscribe | Inhalation Solution | 0.0025 | ➤ Subscribe | 2006-05-23 |
International Patents for Akorn Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Luxembourg | 91943 | Start Trial |
South Korea | 101820816 | Start Trial |
Japan | 6356868 | Start Trial |
China | 1187486 | Start Trial |
Eurasian Patent Organization | 201071413 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Akorn Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0477295 | C990043 | Netherlands | Start Trial | PRODUCT NAME: EPTIFIBATIDE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NAT. REGISTRATION NO/DATE: EU/1/99/109/001 - EU/1/99/109/002 19990701; FIRST REGISTRATION: CH 54050, 54054 19970227 |
1586316 | SPC/GB11/054 | United Kingdom | Start Trial | PRODUCT NAME: BROMFENAC 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIC ACID OR A PHARMACOLOGICALLY ACCEPTABLE SALT THEREOF OR A HYDRATE THEREOF; REGISTERED: UK EU/1/11/692/001 20110523 |
1429780 | 13C0012 | France | Start Trial | PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808 |
0162036 | C300028 | Netherlands | Start Trial | PRODUCT NAME: LEVETIRACETAM; REGISTRATION NO/DATE: EU/1/00/146/001 - EU/1/00/146/026 20000929 |
2114383 | CR 2016 00007 | Denmark | Start Trial | PRODUCT NAME: SUFENTANIL; REG. NO/DATE: EU/1/15/1042/001-006 20150922 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |