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: | 27 |
| Ingredients: | 10 |
| NDAs: | 26 |
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 | ASACOL HD | mesalamine | TABLET, DELAYED RELEASE;ORAL | 021830-001 | May 29, 2008 | AB | RX | Yes | Yes | 6,893,662 | ➤ Sign Up | Y | ➤ Sign Up | ||
| Apil | LOESTRIN FE 1.5/30 | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-28 | 017355-001 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ||||
| Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-002 | Aug 20, 2004 | DISCN | Yes | No | 6,962,908 | ➤ Sign Up | Y | ➤ Sign Up | |||
| Apil | DIDRONEL | etidronate disodium | TABLET;ORAL | 017831-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ➤ 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 | DIDRONEL | etidronate disodium | TABLET;ORAL | 017831-002 | Approved Prior to Jan 1, 1982 | 4,137,309 | ➤ Sign Up |
| Apil | TAYTULLA | ethinyl estradiol; norethindrone acetate | CAPSULE;ORAL | 204426-001 | Apr 19, 2013 | 5,552,394 | ➤ Sign Up |
| Apil | DIDRONEL | etidronate disodium | TABLET;ORAL | 017831-001 | Approved Prior to Jan 1, 1982 | 4,216,211 | ➤ Sign Up |
| Apil | FEMRING | estradiol acetate | INSERT, EXTENDED RELEASE;VAGINAL | 021367-001 | Mar 20, 2003 | 5,855,906 | ➤ 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 |
|---|---|---|
| 6,544,967 | Method for inhibiting bone resorption | ➤ Sign Up |
| 6,225,294 | Method for inhibiting bone resorption | ➤ Sign Up |
| 6,569,460 | Film-coated tablet for improved upper gastrointestinal tract safety | ➤ Sign Up |
| 8,535,718 | Dosage forms of bisphosphonates | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for Apil Drugs
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Australia | 2012202489 | ➤ Sign Up |
| Australia | 8493698 | ➤ Sign Up |
| Japan | 4636692 | ➤ Sign Up |
| United Kingdom | 9717590 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for Apil Drugs
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C0022 | France | ➤ Sign Up | PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211 |
| 156 | Luxembourg | ➤ Sign Up | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 |
| 2009 | Austria | ➤ Sign Up | PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103 |
| C0008 | Belgium | ➤ Sign Up | PRODUCT NAME: ESTRADIOL, HEMIHYDRATE; NAT. REGISTRATION NO/DATE: NL 19489 19941107; FIRST REGISTRATION: FR - NL 19489 19941107 |
| 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.
