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Serving 500+ biopharmaceutical companies globally:
Generated: August 21, 2017
What is the competitive landscape for SHIRE, and when can generic versions of SHIRE drugs launch?
SHIRE has thirty-nine approved drugs.| Patents: | 44 |
| Tradenames: | 35 |
| Ingredients: | 26 |
| NDAs: | 39 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Shire | INTUNIV | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022037-004 | Sep 2, 2009 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Shire Development | VYVANSE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 021977-005 | Dec 10, 2007 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Shire Development | VYVANSE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 021977-004 | Dec 10, 2007 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Shire Development | VYVANSE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 021977-004 | Dec 10, 2007 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Shire | INTUNIV | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022037-002 | Sep 2, 2009 | AB | RX | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Shire | INTUNIV | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022037-002 | Sep 2, 2009 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Shire | SUPPRELIN | histrelin acetate | INJECTABLE;INJECTION | 019836-002 | Dec 24, 1991 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Shire | SUPPRELIN | histrelin acetate | INJECTABLE;INJECTION | 019836-003 | Dec 24, 1991 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Shire | PENTASA | mesalamine | CAPSULE, EXTENDED RELEASE;ORAL | 020049-001 | May 10, 1993 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Shire | CARBATROL | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 020712-003 | Sep 30, 1997 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
lanthanum carbonate | Oral Powder | 750 mg and 1000 mg | FOSRENOL | 11/25/2015 |
icatibant | Injection | 10 mg/mL | FIRAZYR | 8/25/2015 |
lisdexamfetamine dimesylate | Capsules | 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg | VYVANSE | 2/23/2011 |
guanfacine hydrochloride | Extended-release Tablets | 1 mg, 2 mg, 3 mg and 4 mg | INTUNIV | 12/29/2009 |
mesalamine | Delayed-release Tablets | 1.2 g | LIALDA | 12/16/2009 |
lanthanum carbonate | Chewable Tablet | 500 mg, 750 mg and 1000 mg | FOSRENOL | 10/27/2008 |
carbamazepine | Extended-release Capsules | 100 mg and 200 mg | CARBATROL | 2/2/2006 |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 9,051,297 | Compositions and methods for treatment | ► Subscribe | |||||||||||||||||||||||||||
| 8,758,776 | Compositions and methods for treatment | ► Subscribe | |||||||||||||||||||||||||||
| 8,106,016 | Compounds and compositions for prevention of overdose of oxycodone | ► Subscribe | |||||||||||||||||||||||||||
| 7,375,083 | Pharmaceutical compositions for prevention of overdose or abuse | ► Subscribe | |||||||||||||||||||||||||||
| 7,427,600 | Active agent delivery systems and methods for protecting and administering active agents | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Spain | 2099102 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 2009201958 | ► Subscribe | |||||||||||||||||||||||||||
| Hong Kong | 1085669 | ► Subscribe | |||||||||||||||||||||||||||
| Italy | MI991316 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 0413277 | ► 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.
Export unavailable in trial.
Subscribe for complete access.
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2008005,C0817639 | Lithuania | ► Subscribe | PRODUCT NAME: LANTANO KARBONATO HIDRATAS; NAT. REGISTRATION NO/DATE: LT/1/07/0776/001-021 20071003; FIRST REGISTRATION: 17192, 2004-03-19 ; 18466, 2004-03-19; 21073, 2004-10-19; 21074 20041029 | ||||||||||||||||||||||||||
| C0002 | France | ► Subscribe | PRODUCT NAME: ICATIBANT, EVENTUELLEMENT SOUS FORME DE SEL PHYSIOLOGIQUEMENT ACCEPTABLE, NOTAMMENT L?ACETATE D?ICATIBANT; REGISTRATION NO/DATE IN FRANCE: EU/1/08/461/001 DU 20080711; REGISTRATION NO/DATE AT EEC: EU/1/08/461/001 DU 20080711 | ||||||||||||||||||||||||||
| C/GB09/002 | United Kingdom | ► Subscribe | PRODUCT NAME: ICATIBANT, OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF, INCLUDING ICATIBANT ACETATE; REGISTERED: UK EU/1/08/461/001 20080711 | ||||||||||||||||||||||||||
| 2013 00043 | Denmark | ► Subscribe | PRODUCT NAME: LISDEXAMFETAMIN, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER ET MESYLAT SALT; NAT. REG. NO/DATE: MT499080, MT499081, MT499082 20130214; FIRST REG. NO/DATE: PL PL 08081/0050-0052 20130201 | ||||||||||||||||||||||||||
| 00359 | Netherlands | ► Subscribe | PRODUCT NAME: ICATIBANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, BIJ VOORKEUR ICATIBANTACETAAT; REGISTRATION NO/DATE: EU/1/048/461/001 20080711 | ||||||||||||||||||||||||||
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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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