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Serving leading biopharmaceutical companies globally:
Generated: October 18, 2017
What is the competitive landscape for APIL, and when can generic versions of APIL drugs launch?
APIL has twenty-six approved drugs.| International Patents: | 377 |
| US Patents: | 21 |
| Tradenames: | 27 |
| Ingredients: | 10 |
| NDAs: | 26 |
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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 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,535,718 | Dosage forms of bisphosphonates | ► Subscribe | |||||||||||||
| 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 | |||||||||||||
| 6,544,967 | Method for inhibiting bone resorption | ► Subscribe | |||||||||||||
| 8,409,615 | Low dosage forms of risedronate or its salts | ► Subscribe | |||||||||||||
| 6,333,316 | Method for inhibiting bone resorption | ► Subscribe | |||||||||||||
| 6,569,460 | Film-coated tablet for improved upper gastrointestinal tract safety | ► 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 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Brazil | PI0009373 | ► Subscribe | |||||||||||||
| Germany | 122005000024 | ► Subscribe | |||||||||||||
| Hong Kong | 1080409 | ► Subscribe | |||||||||||||
| Australia | 6406900 | ► Subscribe | |||||||||||||
| New Zealand | 316924 | ► Subscribe | |||||||||||||
| World Intellectual Property Organization (WIPO) | 9856360 | ► Subscribe | |||||||||||||
| Slovakia | 171899 | ► Subscribe | |||||||||||||
| South Korea | 20090106663 | ► Subscribe | |||||||||||||
| Russian Federation | 2193880 | ► Subscribe | |||||||||||||
| Turkey | 200102861 | ► 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 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C0005 | Belgium | ► Subscribe | PRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711 | ||||||||||||
| C0017 | France | ► Subscribe | PRODUCT NAME: DARIFENACINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI CI; REGISTRATION NO/DATE IN FRANCE: EU/1/04/294/001 DU 20041022; REGISTRATION NO/DATE AT EEC: EU/01/04/294/001-012 DU 20041022 | ||||||||||||
| 0850059/01 | Switzerland | ► Subscribe | FORMER OWNER: NOVARTIS AG, CH | ||||||||||||
| 2009004 | Lithuania | ► Subscribe | 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 | ||||||||||||
| C/GB04/032 | United Kingdom | ► Subscribe | PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310 | ||||||||||||
| C0018 | France | ► Subscribe | PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103 | ||||||||||||
| 00221 | Netherlands | ► Subscribe | PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307 | ||||||||||||
| /2004 | Austria | ► Subscribe | PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211 | ||||||||||||
| 2006002 | Lithuania | ► Subscribe | PRODUCT NAME: NATRIUM ALENDRONICUM/COLECACIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001, EU/1/05/310/002, EU/1/05/310/003, EU/1/05/310/004, EU/1/05/310/005 20050824 | ||||||||||||
| 1175904/01 | Switzerland | ► Subscribe | FORMER OWNER: SCHERING CORPORATION, US | ||||||||||||
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Serving leading 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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