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 fifteen 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-one supplementary protection certificates in fourteen countries.
Summary for Apil
| International Patents: | 96 |
| US Patents: | 5 |
| Tradenames: | 16 |
| Ingredients: | 8 |
| NDAs: | 15 |
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 | LO MINASTRIN FE | ethinyl estradiol; norethindrone acetate | TABLET, CHEWABLE, TABLET;ORAL | 204654-001 | Jul 24, 2013 | DISCN | Yes | No | 7,704,984 | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apil | ESTROSTEP FE | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-28 | 020130-002 | Oct 9, 1996 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-005 | Apr 22, 2008 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-002 | Aug 20, 2004 | DISCN | Yes | No | 7,572,779 | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-002 | Apr 14, 2000 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Apil | ATELVIA | risedronate sodium | TABLET, DELAYED RELEASE;ORAL | 022560-001 | Oct 8, 2010 | AB | RX | Yes | Yes | 7,645,459 | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-003 | Aug 20, 2004 | DISCN | Yes | No | 7,572,779 | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 | MINASTRIN 24 FE | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 203667-001 | May 8, 2013 | 5,552,394 | ⤷ Sign Up |
| Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-001 | Aug 20, 2004 | 6,962,908 | ⤷ Sign Up |
| Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-005 | Apr 22, 2008 | 7,718,634*PED | ⤷ Sign Up |
| Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-001 | Mar 27, 1998 | 6,015,801 | ⤷ Sign Up |
| Apil | DIDRONEL | etidronate disodium | TABLET;ORAL | 017831-002 | Approved Prior to Jan 1, 1982 | 4,216,211 | ⤷ Sign Up |
| Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-004 | Apr 16, 2007 | 5,583,122*PED | ⤷ Sign Up |
| Apil | DIDRONEL | etidronate disodium | TABLET;ORAL | 017831-001 | Approved Prior to Jan 1, 1982 | 4,137,309 | ⤷ Sign Up |
| >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 | Delayed-release Tablets | 35 mg | ➤ Subscribe | 2011-07-19 |
| ➤ 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 |
International Patents for Apil Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Israel | 268462 | ⤷ Sign Up |
| Canada | 2470703 | ⤷ Sign Up |
| China | 1956706 | ⤷ Sign Up |
| Mexico | PA06013575 | ⤷ Sign Up |
| China | 104027323 | ⤷ Sign Up |
| Japan | 4788765 | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2005115331 | ⤷ Sign Up |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Apil Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0136011 | 2000C/027 | Belgium | ⤷ Sign Up | PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124 |
| 1453521 | C 2015 029 | Romania | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129 |
| 1453521 | 132016000025143 | Italy | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414 |
| 1380301 | CA 2009 00017 | Denmark | ⤷ Sign Up | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629 |
| 0770388 | 09C0018 | France | ⤷ Sign Up | PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103 |
| 0398460 | C300221 | Netherlands | ⤷ Sign Up | PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307 |
| 0398460 | SPC/GB04/032 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310 |
| >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.
