DrugPatentWatch Database Preview
Apil Company Profile
What is the competitive landscape for APIL, and when can generic versions of APIL drugs launch?
There are twenty US patents protecting APIL drugs.
There are three hundred and thirty-two patent family members on APIL drugs in fifty-three countries and forty-one supplementary protection certificates in eleven countries.
Summary for Apil
| International Patents: | 332 |
| US Patents: | 20 |
| Tradenames: | 26 |
| Ingredients: | 10 |
| NDAs: | 25 |
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 | LOESTRIN 21 1.5/30 | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-21 | 017875-001 | Approved Prior to Jan 1, 1982 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ||||
| Apil | ESTROSTEP FE | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-28 | 020130-002 | Oct 9, 1996 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ||||
| Apil | FEMHRT | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 021065-001 | Jan 14, 2005 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ||||
| Apil | SARAFEM | fluoxetine hydrochloride | TABLET;ORAL | 021860-003 | May 19, 2006 | AB1 | 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 | LO MINASTRIN FE | ethinyl estradiol; norethindrone acetate | TABLET, CHEWABLE, TABLET;ORAL | 204654-001 | Jul 24, 2013 | 5,552,394 | ➤ Sign Up |
| Apil | DIDRONEL | etidronate disodium | TABLET;ORAL | 017831-001 | Approved Prior to Jan 1, 1982 | 4,254,114 | ➤ Sign Up |
| Apil | LO LOESTRIN FE | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 022501-001 | Oct 21, 2010 | 5,552,394 | ➤ Sign Up |
| Apil | ESTROSTEP 21 | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-21 | 020130-001 | Oct 9, 1996 | 4,962,098 | ➤ 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 | Extended-release Tablets | 7.5 mg and 15 mg | ➤ Subscribe | 2008-12-22 |
| ➤ Subscribe | Tablets | 1 mg/0.02 mg and 75 mg | ➤ Subscribe | 2006-04-17 |
| ➤ Subscribe | Tablets | 5 mg, 30 mg and 35 mg | ➤ Subscribe | 2004-04-23 |
| ➤ Subscribe | Tablets | 150 mg | ➤ Subscribe | 2008-08-12 |
| ➤ Subscribe | Delayed-release Tablets | 800 mg | ➤ Subscribe | 2011-07-13 |
| ➤ Subscribe | Delayed-release Capsules | 400 mg | ➤ Subscribe | 2014-06-17 |
| ➤ Subscribe | Delayed-release Tablets | 400 mg | ➤ Subscribe | 2007-06-22 |
| ➤ Subscribe | Chewable Tablets | 0.4 mg/0.035 mg | ➤ Subscribe | 2007-04-27 |
| ➤ Subscribe | Tablets | 75 mg | ➤ Subscribe | 2007-09-10 |
| ➤ Subscribe | Delayed-release Tablets | 35 mg | ➤ Subscribe | 2011-07-19 |
| ➤ Subscribe | Chewable Tablets | 1 mg/0.02 mg and 75 mg | ➤ Subscribe | 2014-04-23 |
Non-Orange Book US Patents for Apil
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 8,409,614 | Low dosage forms of risedronate or its salts | ➤ Sign Up |
| 6,569,460 | Film-coated tablet for improved upper gastrointestinal tract safety | ➤ Sign Up |
| 6,225,294 | Method for inhibiting bone resorption | ➤ Sign Up |
| 6,544,967 | Method for inhibiting bone resorption | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for Apil Drugs
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Mexico | PA04006057 | ➤ Sign Up |
| Brazil | 0308901 | ➤ Sign Up |
| Israel | 133405 | ➤ Sign Up |
| Japan | 2015083592 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for Apil Drugs
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2009 | Austria | ➤ Sign Up | PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103 |
| 222 | Luxembourg | ➤ Sign Up | 91222, EXPIRES: 20200824 |
| 364 | Luxembourg | ➤ Sign Up | 91364, EXPIRES: 20200826 |
| 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 |
| 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.
