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 | DIDRONEL | etidronate disodium | TABLET;ORAL | 017831-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Apil | NORCO | acetaminophen; hydrocodone bitartrate | TABLET;ORAL | 040148-004 | Jul 7, 2014 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Apil | DIDRONEL | etidronate disodium | TABLET;ORAL | 017831-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Apil | FEMHRT | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 021065-001 | Jan 14, 2005 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Apil | FEMHRT | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 021065-002 | Oct 15, 1999 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Apil | TAYTULLA | ethinyl estradiol; norethindrone acetate | CAPSULE;ORAL | 204426-001 | Apr 19, 2013 | AB | RX | Yes | Yes | ⤷ 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 | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-003 | Aug 20, 2004 | 6,962,908 | ⤷ Sign Up |
| Apil | DIDRONEL | etidronate disodium | TABLET;ORAL | 017831-001 | Approved Prior to Jan 1, 1982 | 4,216,211 | ⤷ Sign Up |
| Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-002 | Aug 20, 2004 | 6,962,908 | ⤷ Sign Up |
| Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-002 | Apr 14, 2000 | 6,096,342*PED | ⤷ Sign Up |
| Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-002 | Apr 14, 2000 | 5,583,122*PED | ⤷ Sign Up |
| Apil | FEMHRT | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 021065-002 | Oct 15, 1999 | 5,208,225 | ⤷ 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 |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2010014765 | ⤷ Sign Up |
| South Korea | 20120104446 | ⤷ Sign Up |
| China | 1956706 | ⤷ Sign Up |
| Japan | 2011529901 | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 03055495 | ⤷ Sign Up |
| China | 104248639 | ⤷ Sign Up |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Apil Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 0770388 | PA2009004 | Lithuania | ⤷ Sign Up | 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 |
| 1453521 | CA 2016 00016 | Denmark | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211 |
| 2782584 | 21C1058 | France | ⤷ Sign Up | PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), Y COMPRIS SOUS FORME HEMIHYDRATEE, ET DE LA PROGESTERONE; NAT. REGISTRATION NO/DATE: NL51886 20210421; FIRST REGISTRATION: BE - BE582231 20210406 |
| 1453521 | 122015000093 | Germany | ⤷ Sign Up | 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 | ⤷ Sign Up | 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 |
| >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.
