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 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 | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-001 | Aug 20, 2004 | DISCN | Yes | No | 7,572,779 | ⤷ 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 | 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 | ASACOL | mesalamine | TABLET, DELAYED RELEASE;ORAL | 019651-001 | Jan 31, 1992 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Apil | NORCO | acetaminophen; hydrocodone bitartrate | TABLET;ORAL | 040099-001 | Jun 25, 1997 | DISCN | No | 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 FE | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-28 | 020130-002 | Oct 9, 1996 | 5,010,070 | ⤷ Try a Trial |
| Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-001 | Mar 27, 1998 | 5,994,329 | ⤷ Try a Trial |
| Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-004 | Apr 16, 2007 | 6,165,513*PED | ⤷ Try a Trial |
| Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-002 | Apr 14, 2000 | 5,994,329 | ⤷ Try a Trial |
| Apil | ESTROSTEP FE | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-28 | 020130-002 | Oct 9, 1996 | 4,962,098 | ⤷ Try a Trial |
| Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-003 | May 25, 2002 | 6,096,342*PED | ⤷ Try a Trial |
| Apil | LO MINASTRIN FE | ethinyl estradiol; norethindrone acetate | TABLET, CHEWABLE, TABLET;ORAL | 204654-001 | Jul 24, 2013 | 5,552,394 | ⤷ 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 | 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 |
| ➤ Subscribe | Tablets | 75 mg | ➤ Subscribe | 2007-09-10 |
| ➤ Subscribe | Chewable Tablets | 0.4 mg/0.035 mg | ➤ Subscribe | 2007-04-27 |
International Patents for APIL Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Israel | 268462 | ⤷ Try a Trial |
| San Marino | P200700047 | ⤷ Try a Trial |
| New Zealand | 587774 | ⤷ Try a Trial |
| Australia | 2005247299 | ⤷ Try a Trial |
| Japan | 4788765 | ⤷ Try a Trial |
| Russian Federation | 2381791 | ⤷ Try a Trial |
| Argentina | 049022 | ⤷ 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 |
|---|---|---|---|---|
| 0770388 | 2009/012 | Ireland | ⤷ Try a Trial | PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103 |
| 0770388 | PA2009004,C0770388 | Lithuania | ⤷ Try a 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 |
| 1380301 | 2009C/007 | Belgium | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811 |
| 1453521 | 300814 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
| 0136011 | 99C0003 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306 |
| 2782584 | 132021000000197 | Italy | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOLO (17SS-ESTRADIOLO) IN PARTICOLARE NELLA FORMA EMIIDRATA, E PROGESTERONE COMPRENDENTI LE VARIE FORME DI ESTRADIOLO (17SS-ESTRADIOLO), QUALI LE FORME IDRATE E SOLVATATE, INCLUDENDO LA FORMA EMIIDRATA, ED I SUOI SALI.(BIJUVA); AUTHORISATION NUMBER(S) AND DATE(S): BE582231, 20210406;048335018 -048335020, 20210517 |
| 2782584 | C202130068 | Spain | ⤷ Try a Trial | PRODUCT NAME: COMPOSICION QUE CONTIENE ESTRADIOL (17BETA-ESTRADIOL), INCLUYENDO EN FORMA DE HEMIHIDRATO, Y PROGESTERONA; NATIONAL AUTHORISATION NUMBER: 85988-NL/H/4994/001/DC; DATE OF AUTHORISATION: 20210528; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): BE582231; DATE OF FIRST AUTHORISATION IN EEA: 20210406 |
| >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.
