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Generated: August 18, 2017
What is the competitive landscape for APIL, and when can generic versions of APIL drugs launch?
APIL has twenty-six approved drugs.| Patents: | 21 |
| Tradenames: | 27 |
| Ingredients: | 10 |
| NDAs: | 26 |
| 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 | 020835-004 | Apr 16, 2007 | DISCN | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
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 | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Apil | DELZICOL | mesalamine | CAPSULE, DELAYED RELEASE;ORAL | 204412-001 | Feb 1, 2013 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Apil | SARAFEM | fluoxetine hydrochloride | TABLET;ORAL | 021860-002 | May 19, 2006 | AB1 | RX | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Apil | NORCO | acetaminophen; hydrocodone bitartrate | TABLET;ORAL | 040099-001 | Jun 25, 1997 | AA | RX | No | Yes | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
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| 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 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Apil | ENABLEX | darifenacin hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 021513-002 | Dec 22, 2004 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-003 | May 25, 2002 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Apil | ASACOL | mesalamine | TABLET, DELAYED RELEASE;ORAL | 019651-001 | Jan 31, 1992 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Apil | DIDRONEL | etidronate disodium | TABLET;ORAL | 017831-002 | Approved Prior to Jan 1, 1982 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
mesalamine | Delayed-release Capsules | 400 mg | DELZICOL | 6/17/2014 |
norethindrone acetate and ethinyl estradiol and ferrous fumarate | Chewable Tablets | 1 mg/0.02 mg and 75 mg | MINASTRIN 24 FE | 4/23/2014 |
risedronate sodium | Delayed-release Tablets | 35 mg | ATELVIA | 7/19/2011 |
mesalamine | Delayed-release Tablets | 800 mg | ASACOL HD | 7/13/2011 |
darifenacin hydrobromide | Extended-release Tablets | 7.5 mg and 15 mg | ENABLEX | 12/22/2008 |
risedronate sodium | Tablets | 150 mg | ACTONEL | 8/12/2008 |
risedronate sodium | Tablets | 75 mg | ACTONEL | 9/10/2007 |
mesalamine | Delayed-release Tablets | 400 mg | ASACOL | 6/22/2007 |
norethindrone and ethinyl estradiol and ferrous fumarate | Chewable Tablets | 0.4 mg/0.035 mg | FEMCON FE | 4/27/2007 |
norethindrone acetate/ ethinyl estradiol and ferrous fumarate | Tablets | 1 mg/0.02 mg and 75 mg | LOESTRIN 24 FE | 4/17/2006 |
risedronate sodium | Tablets | 5 mg, 30 mg and 35 mg | ACTONEL | 4/23/2004 |
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 | ► Subscribe | |||||||||||||||||||||||||||
| 6,225,294 | Method for inhibiting bone resorption | ► Subscribe | |||||||||||||||||||||||||||
| 7,410,957 | Method of treatment using bisphosphonic acid | ► Subscribe | |||||||||||||||||||||||||||
| 6,569,460 | Film-coated tablet for improved upper gastrointestinal tract safety | ► Subscribe | |||||||||||||||||||||||||||
| 6,544,967 | Method for inhibiting bone resorption | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Australia | 7446098 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 101070205 | ► Subscribe | |||||||||||||||||||||||||||
| Netherlands | 300223 | ► Subscribe | |||||||||||||||||||||||||||
| Germany | 122007000063 | ► Subscribe | |||||||||||||||||||||||||||
| United Kingdom | 2336311 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1214076/01 | Switzerland | ► Subscribe | PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008 | ||||||||||||||||||||||||||
| 00C/027 | Belgium | ► Subscribe | PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124 | ||||||||||||||||||||||||||
| C/GB05/022 | United Kingdom | ► Subscribe | PRODUCT NAME: DARIFENACIN HYDROBROMIDE; REGISTERED: UK EU/1/04/294/001 20041022; UK EU/1/04/294/002 20041022; UK EU/1/04/294/003 20041022; UK EU/1/04/294/004 20041022; UK EU/1/04/294/005 20041022; UK EU/1/04/294/006 20041022; UK EU/1/04/294/007 20041022; UK EU/1/04/294/008 20041022; UK EU/1/04/294/009 20041022; UK EU/1/04/294/010 20041022; UK EU/1/04/294/011 20041022; UK EU/1/04/294/012 20041022 | ||||||||||||||||||||||||||
| 1175904/01 | Switzerland | ► Subscribe | FORMER OWNER: SCHERING CORPORATION, US | ||||||||||||||||||||||||||
| 2005 00020 | Denmark | ► Subscribe | |||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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