DrugPatentWatch Database Preview
Shire Company Profile
What is the competitive landscape for SHIRE, and when can generic versions of SHIRE drugs launch?
SHIRE has thirty-nine approved drugs.
There are thirty-three US patents protecting SHIRE drugs.
There are four hundred and four patent family members on SHIRE drugs in fifty-two countries and seventeen supplementary protection certificates in eleven countries.
Summary for Shire
| International Patents: | 404 |
| US Patents: | 33 |
| Tradenames: | 35 |
| Ingredients: | 26 |
| NDAs: | 39 |
| Patent Litigation for Shire: | See patent lawsuits for Shire |
| PTAB Cases with Shire as patent owner: | See PTAB cases with Shire as patent owner |
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 | 021977-005 | Dec 10, 2007 | RX | Yes | No | 7,662,787 | Start Trial | Y | Start Trial | |||
| Shire Development | VYVANSE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 021977-007 | Oct 30, 2014 | RX | Yes | No | Start Trial | Start Trial | |||||
| Shire | ADDERALL XR 5 | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 021303-005 | May 22, 2002 | AB | RX | Yes | No | RE41148*PED | Start Trial | Start Trial | |||
| Shire Dev Llc | VYVANSE | lisdexamfetamine dimesylate | TABLET, CHEWABLE;ORAL | 208510-006 | Jan 28, 2017 | RX | Yes | Yes | 7,223,735 | Start Trial | Y | Start Trial | |||
| >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 | ADDERALL XR 25 | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 021303-004 | May 22, 2002 | RE41148*PED | Start Trial |
| Shire | ETHMOZINE | moricizine hydrochloride | TABLET;ORAL | 019753-002 | Jun 19, 1990 | 3,740,395 | Start Trial |
| Shire | ADDERALL XR 30 | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 021303-003 | Oct 11, 2001 | 6,322,819*PED | Start Trial |
| Shire Dev Llc | CARBATROL | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 020712-001 | Sep 30, 1997 | 6,221,392 | Start Trial |
| >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 | Injection | 10 mg/mL | ➤ Subscribe | 2015-08-25 |
| ➤ Subscribe | Extended-release Tablets | 1 mg, 2 mg, 3 mg and 4 mg | ➤ Subscribe | 2009-12-29 |
| ➤ Subscribe | Extended-release Capsules | 37.5 mg and50 mg | ➤ Subscribe | 2017-08-03 |
| ➤ Subscribe | Chewable Tablet | 500 mg, 750 mg and 1000 mg | ➤ Subscribe | 2008-10-27 |
| ➤ Subscribe | Capsules | 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg | ➤ Subscribe | 2011-02-23 |
| ➤ Subscribe | Delayed-release Tablets | 1.2 g | ➤ Subscribe | 2009-12-16 |
| ➤ Subscribe | Extended-release Capsules | 100 mg and 200 mg | ➤ Subscribe | 2006-02-02 |
| ➤ Subscribe | Extended-release Capsules | 12.5 mg and 25 mg | ➤ Subscribe | 2017-08-07 |
| ➤ Subscribe | Oral Powder | 750 mg and 1000 mg | ➤ Subscribe | 2015-11-25 |
International Patents for Shire Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| African Intellectual Property Organization (OAPI) | 13075 | Start Trial |
| Spain | 2373641 | Start Trial |
| Czech Republic | 17621 | Start Trial |
| Canada | 2536959 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Shire Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0370453 | 09C0002 | France | Start Trial | 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 |
| 1644019 | CR 2013 00043 | Denmark | Start Trial | PRODUCT NAME: LISDEXAMFETAMIN, EVENTUELT I FORM AF ET MESYLAT ELLER HYDROCHLORID SALT DERAF; NAT. REG. NO/DATE: MT499080, MT499081, MT499082 20130214; FIRST REG. NO/DATE: PL PL 08081/0050-0052 20130201 |
| 0370453 | 91499 | Luxembourg | Start Trial | 91499, EXPIRES: 20141121 |
| 1644019 | SPC/GB13/052 | United Kingdom | Start Trial | PRODUCT NAME: LISDEXAMFETAMINE OPTIONALLY IN THE FORM OF A MESYLATE OR HYDROCHLORIDE SALT THEREOF; REGISTERED: UK PL08081/0050-2 20130201; UK PL08081/0062-4 20130201 |
| >Patent Number | >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.
