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Apil Company Profile
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What is the competitive landscape for APIL, and when can generic versions of APIL drugs launch?
APIL has nineteen approved drugs.
There are fourteen US patents protecting APIL drugs.
There are two hundred and fourteen patent family members on APIL drugs in forty countries and thirty-eight supplementary protection certificates in fourteen countries.
Drugs and US Patents for Apil
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-004 | Apr 16, 2007 | DISCN | Yes | No | Start Trial | Start Trial | |||||
Apil | MINASTRIN 24 FE | ethinyl estradiol; norethindrone acetate | TABLET, CHEWABLE;ORAL | 203667-001 | May 8, 2013 | AB | RX | Yes | Yes | Start Trial | Start Trial | ||||
Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-002 | Aug 20, 2004 | DISCN | Yes | No | 6,962,908 | Start Trial | Y | Start Trial | |||
Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-003 | Aug 20, 2004 | DISCN | Yes | No | 7,799,771 | Start Trial | Y | Start Trial | |||
Apil | SARAFEM | fluoxetine hydrochloride | TABLET;ORAL | 021860-003 | May 19, 2006 | AB1 | RX | Yes | Yes | Start Trial | Start Trial | ||||
Apil | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | acetaminophen; hydrocodone bitartrate | TABLET;ORAL | 040148-002 | Feb 14, 1997 | DISCN | No | No | Start Trial | Start Trial | |||||
Apil | NORCO | acetaminophen; hydrocodone bitartrate | TABLET;ORAL | 040148-005 | Jul 7, 2014 | AA | 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 Apil
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-003 | May 25, 2002 | 5,583,122*PED | Start Trial |
Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-002 | Apr 14, 2000 | 6,165,513*PED | Start Trial |
Apil | ATELVIA | risedronate sodium | TABLET, DELAYED RELEASE;ORAL | 022560-001 | Oct 8, 2010 | 5,622,721 | Start Trial |
Apil | NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ethinyl estradiol; norethindrone | TABLET, CHEWABLE;ORAL | 022573-001 | Dec 22, 2010 | 6,667,050 | Start Trial |
Apil | ASACOL HD | mesalamine | TABLET, DELAYED RELEASE;ORAL | 021830-001 | May 29, 2008 | 5,541,171 | Start Trial |
Apil | DIDRONEL | etidronate disodium | TABLET;ORAL | 017831-002 | Approved Prior to Jan 1, 1982 | 3,683,080 | Start Trial |
Apil | ESTROSTEP FE | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-28 | 020130-002 | Oct 9, 1996 | 4,962,098 | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for APIL drugs
Drugname | Dosage | Strength | Tradename | Submissiondate |
---|---|---|---|---|
➤ Subscribe | Tablets | 150 mg | ➤ Subscribe | 2008-08-12 |
➤ Subscribe | Delayed-release Capsules | 400 mg | ➤ Subscribe | 2014-06-17 |
➤ Subscribe | Chewable Tablets | 1 mg/0.02 mg and 75 mg | ➤ Subscribe | 2014-04-23 |
➤ Subscribe | Delayed-release Tablets | 800 mg | ➤ Subscribe | 2011-07-13 |
➤ Subscribe | Extended-release Tablets | 7.5 mg and 15 mg | ➤ Subscribe | 2008-12-22 |
➤ Subscribe | Tablets | 75 mg | ➤ Subscribe | 2007-09-10 |
➤ Subscribe | Chewable Tablets | 0.4 mg/0.035 mg | ➤ Subscribe | 2007-04-27 |
➤ Subscribe | Delayed-release Tablets | 400 mg | ➤ Subscribe | 2007-06-22 |
➤ Subscribe | Delayed-release Tablets | 35 mg | ➤ Subscribe | 2011-07-19 |
➤ Subscribe | Tablets | 5 mg, 30 mg and 35 mg | ➤ Subscribe | 2004-04-23 |
International Patents for Apil Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Croatia | P20040906 | Start Trial |
European Patent Office | 1506041 | Start Trial |
Japan | 2005522526 | Start Trial |
Germany | 60024429 | Start Trial |
Argentina | 049022 | Start Trial |
India | 827DEN2012 | Start Trial |
Brazil | PI0520082 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Apil Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0770388 | PA2009004,C0770388 | Lithuania | Start Trial | PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103 |
0388054 | 05C0017 | France | Start Trial | PRODUCT NAME: DARIFENACINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI CI; REGISTRATION NO/DATE IN FRANCE: EU/1/04/294/001 DU 20041022; REGISTRATION NO/DATE AT EEC: EU/01/04/294/001-012 DU 20041022 |
1453521 | 93156 | Luxembourg | Start Trial | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 |
1380301 | 2009C/007 | Belgium | Start Trial | PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811 |
1453521 | 15C0050 | France | Start Trial | PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129 |
0136011 | 99C0003 | Belgium | Start Trial | PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306 |
0398460 | 12/2004 | Austria | Start Trial | PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.