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Serving 500+ biopharmaceutical companies globally:
Generated: August 19, 2017
What is the competitive landscape for TOLMAR, and when can generic versions of TOLMAR drugs launch?
TOLMAR has twenty-nine approved drugs.| Patents: | 9 |
| Tradenames: | 20 |
| Ingredients: | 20 |
| NDAs: | 29 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Tolmar Therap | ELIGARD | leuprolide acetate | INJECTABLE;SUBCUTANEOUS | 021488-001 | Feb 13, 2003 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Tolmar Therap | ELIGARD | leuprolide acetate | INJECTABLE;SUBCUTANEOUS | 021379-001 | Jul 24, 2002 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Tolmar Therap | ELIGARD | leuprolide acetate | INJECTABLE;SUBCUTANEOUS | 021488-001 | Feb 13, 2003 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Tolmar Therap | ELIGARD | leuprolide acetate | INJECTABLE;SUBCUTANEOUS | 021731-001 | Dec 14, 2004 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Tolmar | CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | benzoyl peroxide; clindamycin phosphate | GEL;TOPICAL | 203688-001 | Aug 25, 2016 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Tolmar Therap | ELIGARD | leuprolide acetate | INJECTABLE;SUBCUTANEOUS | 021731-001 | Dec 14, 2004 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Tolmar Therap | ELIGARD | leuprolide acetate | INJECTABLE;SUBCUTANEOUS | 021343-001 | Jan 23, 2002 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Tolmar Therap | ELIGARD | leuprolide acetate | INJECTABLE;SUBCUTANEOUS | 021488-001 | Feb 13, 2003 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Tolmar Therap | ELIGARD | leuprolide acetate | INJECTABLE;SUBCUTANEOUS | 021731-001 | Dec 14, 2004 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Tolmar Therap | ELIGARD | leuprolide acetate | INJECTABLE;SUBCUTANEOUS | 021379-001 | Jul 24, 2002 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,143,314 | Controlled release liquid delivery compositions with low initial drug burst | ► Subscribe | |||||||||||||||||||||||||||
| 6,630,155 | Controlled release liquid delivery compositions with low initial drug burst | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Portugal | 1126822 | ► Subscribe | |||||||||||||||||||||||||||
| Slovenia | 1322286 | ► Subscribe | |||||||||||||||||||||||||||
| Iceland | 6794 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2241876 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2004510807 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1458369/01 | Switzerland | ► Subscribe | PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009 | ||||||||||||||||||||||||||
| C/GB05/030 | United Kingdom | ► Subscribe | PRODUCT NAME: NITISINONE (2-(2-NITRO-4-TRIFLUOROMETHYLBENZOYL)-1,3-CYCLOHEXANEDIONE) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/303/001 20050221; UK EU/1/04/303/002 20050221; UK EU/1/04/303/003 20050221 | ||||||||||||||||||||||||||
| C0021 | Belgium | ► Subscribe | PRODUCT NAME: LANSOPRAZOLE + CLARITHROMYCINE + METRONIDAZOLE; REGISTRATION NO/DATE IN FRANCE: K 27 17033R DU 19960209; REGISTRATION NO/DATE AT EEC: K 27 17033R DU 19960209 | ||||||||||||||||||||||||||
| C/GB99/003 | United Kingdom | ► Subscribe | PRODUCT NAME: IMIQUIMOD; REGISTERED: UK EU/1/98/080/001 19980918 | ||||||||||||||||||||||||||
| C/GB11/054 | United Kingdom | ► Subscribe | PRODUCT NAME: BROMFENAC 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIC ACID OR A PHARMACOLOGICALLY ACCEPTABLE SALT THEREOF OR A HYDRATE THEREOF; REGISTERED: UK EU/1/11/692/001 20110523 | ||||||||||||||||||||||||||
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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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