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.
Summary for Apil
| International Patents: | 96 |
| US Patents: | 5 |
| Tradenames: | 17 |
| Ingredients: | 8 |
| NDAs: | 16 |
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 | 020835-005 | Apr 22, 2008 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Apil | FEMCON FE | ethinyl estradiol; norethindrone | TABLET;ORAL | 021490-001 | Nov 14, 2003 | 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 | ||
| Apil | ASACOL | mesalamine | TABLET, DELAYED RELEASE;ORAL | 019651-001 | Jan 31, 1992 | 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 | FEMHRT | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 021065-001 | Jan 14, 2005 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ 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 | NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ethinyl estradiol; norethindrone | TABLET, CHEWABLE;ORAL | 022573-001 | Dec 22, 2010 | 5,552,394 | ⤷ Try a Trial |
| Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-003 | May 25, 2002 | 6,165,513*PED | ⤷ Try a Trial |
| Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-005 | Apr 22, 2008 | 7,718,634*PED | ⤷ Try a Trial |
| Apil | DIDRONEL | etidronate disodium | TABLET;ORAL | 017831-002 | Approved Prior to Jan 1, 1982 | 3,683,080 | ⤷ Try a Trial |
| Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-003 | May 25, 2002 | 6,096,342*PED | ⤷ Try a Trial |
| Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-002 | Apr 14, 2000 | 5,583,122*PED | ⤷ 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 | 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 |
| ➤ 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 |
International Patents for Apil Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 101280138 | ⤷ Try a Trial |
| Morocco | 29681 | ⤷ Try a Trial |
| Croatia | P20100583 | ⤷ Try a Trial |
| New Zealand | 532491 | ⤷ Try a Trial |
| Peru | 20060256 | ⤷ Try a Trial |
| South Korea | 20070015596 | ⤷ 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 | 122015000093 | Germany | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129 |
| 0770388 | SPC/GB09/026 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOL AND COMBINATIONS OF ESTRADIOL AND DIENOGEST, PREFERABLY ESTRADIOL VALERATE AND COMBINATIONS OF ESTRADIOL VALERATE AND DIENOGEST; REGISTERED: BE BE 327792 20081103; UK PL 00010/0576-0001 20081208 |
| 2782584 | 122021000080 | Germany | ⤷ Try a Trial | PRODUCT NAME: ZUSAMMENSETZUNG, DIE SOWOHL ESTRADIOL (17SS-ESTRADIOL), GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS ODER SOLVATS DAVON (EINSCHLIESSLICH IN FORM EINES HEMIHYDRATS), ALS AUCH PROGESTERON ENTHAELT; NAT. REGISTRATION NO/DATE: 2205034.00.00 20210924; FIRST REGISTRATION: BELGIEN BE582231 20210406 |
| 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 |
| 0584952 | 99C0004 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306 |
| 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 |
| >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.
