DrugPatentWatch Database Preview
Shire Company Profile
What is the competitive landscape for SHIRE, and when can generic versions of SHIRE drugs launch?
There are fifty US patents protecting SHIRE drugs.
There are five hundred and twenty-three patent family members on SHIRE drugs in fifty-five countries and sixteen supplementary protection certificates in ten countries.
Summary for Shire
| International Patents: | 523 |
| US Patents: | 50 |
| Tradenames: | 35 |
| Ingredients: | 26 |
| NDAs: | 39 |
Drugs and US Patents for Shire
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Shire Development | VYVANSE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 021977-006 | Dec 10, 2007 | RX | Yes | No | 7,655,630 | ➤ Sign Up | Y | ➤ Sign Up | |||
| Shire Development | VYVANSE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 021977-007 | Oct 30, 2014 | RX | Yes | No | 7,678,771 | ➤ Sign Up | Y | ➤ Sign Up | |||
| Shire Development | VYVANSE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 021977-001 | Feb 23, 2007 | RX | Yes | No | 7,659,254 | ➤ Sign Up | ➤ Sign Up | ||||
| Shire | INTUNIV | guanfacine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022037-001 | Sep 2, 2009 | AB | RX | Yes | No | 6,811,794*PED | ➤ Sign Up | Y | ➤ 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 Shire
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Shire | PENTASA | mesalamine | CAPSULE, EXTENDED RELEASE;ORAL | 020049-001 | May 10, 1993 | 4,496,553 | ➤ Sign Up |
| Shire | CARBATROL | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 020712-002 | Sep 30, 1997 | 5,912,013 | ➤ Sign Up |
| Shire | CARBATROL | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 020712-001 | Sep 30, 1997 | 5,326,570 | ➤ Sign Up |
| Shire | CARBATROL | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 020712-001 | Sep 30, 1997 | 5,912,013 | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for SHIRE drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Extended-release Capsules | 100 mg and 200 mg | ➤ Subscribe | 2006-02-02 |
| ➤ Subscribe | Extended-release Tablets | 1 mg, 2 mg, 3 mg and 4 mg | ➤ Subscribe | 2009-12-29 |
| ➤ Subscribe | Capsules | 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg | ➤ Subscribe | 2011-02-23 |
| ➤ Subscribe | Oral Powder | 750 mg and 1000 mg | ➤ Subscribe | 2015-11-25 |
| ➤ Subscribe | Extended-release Capsules | 12.5 mg and 25 mg | ➤ Subscribe | 2017-08-07 |
| ➤ Subscribe | Chewable Tablet | 500 mg, 750 mg and 1000 mg | ➤ Subscribe | 2008-10-27 |
| ➤ Subscribe | Delayed-release Tablets | 1.2 g | ➤ Subscribe | 2009-12-16 |
| ➤ Subscribe | Injection | 10 mg/mL | ➤ Subscribe | 2015-08-25 |
| ➤ Subscribe | Extended-release Capsules | 37.5 mg and50 mg | ➤ Subscribe | 2017-08-03 |
Non-Orange Book US Patents for Shire
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 | ➤ Sign Up |
| 9,708,303 | LFA-1 inhibitor and methods of preparation and polymorph thereof | ➤ Sign Up |
| 7,427,600 | Active agent delivery systems and methods for protecting and administering active agents | ➤ Sign Up |
| 7,375,082 | Abuse-resistant hydrocodone compounds | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for Shire Drugs
Supplementary Protection Certificates for Shire Drugs
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 782 | Luxembourg | ➤ Sign Up | PRODUCT NAME: SAFINAMIDE A UTILISER EN COMBINAISON AVEC LEVODOPA/PDI, ET EVENTUELLEMENT AVEC D'AUTRES MEDICAMENTS PD , POUR LE TRAITEMENT DE LA MALADIE DE PARKINSON; FIRST REGISTRATION DATE: 20150224 |
| C0002 | France | ➤ Sign Up | 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 |
| 0359 | Netherlands | ➤ Sign Up | 300359, 20091121, EXPIRES: 20141120 |
| C/GB06/036 | United Kingdom | ➤ Sign Up | SPC/GB06/036: 20061027 |
| 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.
