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AKORN Company Profile
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What is the competitive landscape for AKORN, and when can generic versions of AKORN drugs launch?
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-eight supplementary protection certificates in fifteen countries.
Summary for AKORN
| International Patents: | 70 |
| US Patents: | 4 |
| Tradenames: | 187 |
| Ingredients: | 167 |
| NDAs: | 253 |
| 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 | AZASITE | azithromycin | SOLUTION/DROPS;OPHTHALMIC | 050810-001 | Apr 27, 2007 | RX | Yes | Yes | Start Trial | Start Trial | |||||
| Akorn | TRANEXAMIC ACID | tranexamic acid | INJECTABLE;INJECTION | 202373-001 | Nov 17, 2011 | AP | RX | No | No | Start Trial | Start Trial | ||||
| Akorn | FLUTICASONE PROPIONATE | fluticasone propionate | SPRAY, METERED;NASAL | 208024-001 | Apr 17, 2019 | OTC | No | No | Start Trial | Start Trial | |||||
| Akorn | AKPRO | dipivefrin hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 074382-001 | Sep 29, 1995 | DISCN | No | No | Start Trial | Start Trial | |||||
| Akorn | AMICAR | aminocaproic acid | TABLET;ORAL | 015197-002 | Jun 24, 2004 | AB | RX | Yes | No | Start Trial | Start Trial | ||||
| Akorn | SODIUM NITROPRUSSIDE | sodium nitroprusside | INJECTABLE;INJECTION | 208635-001 | May 4, 2017 | AP | 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 | 020837-001 | Mar 25, 1999 | 5,760,090 | Start Trial |
| Akorn | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-003 | Jan 30, 2002 | 5,844,002 | Start Trial |
| Akorn | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-003 | Jan 30, 2002 | 5,362,755 | Start Trial |
| Akorn | AZASITE | azithromycin | SOLUTION/DROPS;OPHTHALMIC | 050810-001 | Apr 27, 2007 | 7,056,893 | Start Trial |
| Akorn | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-002 | Mar 25, 1999 | 5,844,002 | Start Trial |
| Akorn | ALFENTA | alfentanil hydrochloride | INJECTABLE;INJECTION | 019353-001 | Dec 29, 1986 | 4,167,574 | 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 | 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 |
| ➤ Subscribe | Ophthalmic Solution | 2%/0.5% | ➤ Subscribe | 2005-10-11 |
International Patents for AKORN Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20180008905 | Start Trial |
| South Korea | 101650006 | Start Trial |
| Norway | 2009006 | Start Trial |
| Taiwan | 201000104 | Start Trial |
| Canada | 2724194 | Start Trial |
| Japan | 2016065095 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for AKORN Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 0137145 | SPC/GB97/010 | United Kingdom | Start Trial | PRODUCT NAME: GENERIC NAME: IRINOTECANCHEMICAL NAME: (+)-(4S)-4,11-DIETHYL-4-HYDROXY-9-((4-PIPERIDINOPIPERIDINO)CARBONYLOXY)-1H-PYRANO (3',4':6,7) INDOLIZINO(1,2-B) QUINOLINE-3,14-(4H,12H)-DIONE,OPTIONALLY THE HYDROCHLORIDE SALT THEREOF AND OPTIONALLY THE TRIHYDRATE T; REGISTERED: FR 558822.2 19950505; FR 558823.9 19950505; FR 558824.5 19950505; FR 558825.1 19950505; UK 00012/0302 19961017; UK 00012/0303 19961017 |
| 1586316 | C 2011 004 | Romania | Start Trial | PRODUCT NAME: BROMFENAC, SARURILE SI HIDRATII SAI ACCEPTABILI FARMACEUTICACID 2-[2-AMINO-3-(4-BROMOBENZOIL)FENILACETIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/692/001; DATE OF NATIONAL AUTHORISATION: 20110518; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/692/001; DATE OF FIRST AUTHORISATION IN EEA: 20110518 |
| 0480717 | 98C0022 | France | Start Trial | PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825 |
| 2563920 | CR 2019 00001 | Denmark | Start Trial | PRODUCT NAME: INOTERSEN AND SALT THEREOF, INCLUDING SODIUM SALTS; REG. NO/DATE: EU/1/18/1296 20180710 |
| 0850926 | SPC/GB09/005 | United Kingdom | Start Trial | PRODUCT NAME: TAFLUPROST OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: DK 43230 20080430; UK PL 16058/0011-0001 20081017 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
