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 sixteen approved drugs.
There are five US patents protecting APIL drugs.
There are ninety-six patent family members on APIL drugs in thirty-three countries and forty 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 | SARAFEM | fluoxetine hydrochloride | TABLET;ORAL | 021860-002 | May 19, 2006 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Apil | NORCO | acetaminophen; hydrocodone bitartrate | TABLET;ORAL | 040148-005 | Jul 7, 2014 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Apil | NORCO | acetaminophen; hydrocodone bitartrate | TABLET;ORAL | 040148-001 | Feb 14, 1997 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-003 | Aug 20, 2004 | DISCN | Yes | No | 7,572,779 | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Apil | MINASTRIN 24 FE | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 203667-001 | May 8, 2013 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Apil | ATELVIA | risedronate sodium | TABLET, DELAYED RELEASE;ORAL | 022560-001 | Oct 8, 2010 | AB | RX | Yes | Yes | 7,645,459 | ⤷ 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 Apil
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Apil | ESTROSTEP 21 | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-21 | 020130-001 | Oct 9, 1996 | 5,010,070 | ⤷ Try a Trial |
Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-002 | Apr 14, 2000 | 5,994,329 | ⤷ Try a Trial |
Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-001 | Mar 27, 1998 | 6,096,342*PED | ⤷ Try a Trial |
Apil | ESTROSTEP FE | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-28 | 020130-002 | Oct 9, 1996 | 5,010,070 | ⤷ Try a Trial |
Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-002 | Aug 20, 2004 | 6,962,908 | ⤷ Try a Trial |
Apil | DIDRONEL | etidronate disodium | TABLET;ORAL | 017831-001 | Approved Prior to Jan 1, 1982 | 4,254,114 | ⤷ Try a 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 | 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 | Tablets | 5 mg, 30 mg and 35 mg | ➤ Subscribe | 2004-04-23 |
➤ Subscribe | Tablets | 150 mg | ➤ Subscribe | 2008-08-12 |
➤ Subscribe | Chewable Tablets | 1 mg/0.02 mg and 75 mg | ➤ Subscribe | 2014-04-23 |
➤ Subscribe | Delayed-release Tablets | 35 mg | ➤ Subscribe | 2011-07-19 |
International Patents for Apil Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
San Marino | AP200700047 | ⤷ Try a Trial |
China | 102225047 | ⤷ Try a Trial |
Canada | 2605299 | ⤷ Try a Trial |
Peru | 20060256 | ⤷ Try a Trial |
Israel | 186656 | ⤷ Try a Trial |
Canada | 2602188 | ⤷ Try a Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Apil Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1453521 | 15C0050 | France | ⤷ Try a 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 |
1453521 | 39/2015 | Austria | ⤷ Try a Trial | PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
1214076 | 49/2008 | Austria | ⤷ Try a Trial | PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612 |
0771217 | CA 2006 00038 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804 |
1453521 | CA 2016 00016 | Denmark | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211 |
0398460 | 04C0022 | France | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.