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Generated: August 20, 2017
What is the competitive landscape for SUN PHARM INDS LTD, and when can generic versions of SUN PHARM INDS LTD drugs launch?
SUN PHARM INDS LTD has one hundred and sixteen approved drugs.| Patents: | 8 |
| Tradenames: | 90 |
| Ingredients: | 87 |
| NDAs: | 116 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sun Pharm Inds Ltd | CEFUROXIME AXETIL | cefuroxime axetil | TABLET;ORAL | 065118-002 | Apr 25, 2003 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Sun Pharm Inds Ltd | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | TABLET;ORAL | 078722-002 | May 12, 2008 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Sun Pharm Inds Ltd | AMLODIPINE BESYLATE | amlodipine besylate | TABLET;ORAL | 077974-002 | Jul 9, 2007 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Sun Pharm Inds Ltd | MIDAZOLAM HYDROCHLORIDE | midazolam hydrochloride | SYRUP;ORAL | 076058-001 | Mar 15, 2002 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Sun Pharm Inds Ltd | AZITHROMYCIN | azithromycin | INJECTABLE;INJECTION | 090923-001 | Apr 2, 2013 | AP | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sun Pharm Inds Ltd | EXELDERM | sulconazole nitrate | SOLUTION;TOPICAL | 018738-001 | Aug 30, 1985 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Sun Pharm Inds Ltd | ULTRAVATE | halobetasol propionate | CREAM;TOPICAL | 019967-001 | Dec 27, 1990 | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,559,187 | Liquid formulation of metformin | ► Subscribe | |||||||||||||||||||||||||||
| 9,192,615 | Method for the treatment of acne and certain dosage forms thereof | ► Subscribe | |||||||||||||||||||||||||||
| 8,722,650 | Extended-release minocycline dosage forms | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Israel | 188331 | ► Subscribe | |||||||||||||||||||||||||||
| Iceland | 6709 | ► Subscribe | |||||||||||||||||||||||||||
| New Zealand | 524519 | ► Subscribe | |||||||||||||||||||||||||||
| Mexico | PA03001157 | ► Subscribe | |||||||||||||||||||||||||||
| Russian Federation | 2003104808 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1003503/01 | Switzerland | ► Subscribe | PRODUCT NAME: AMLODIPIN + ATORVASTATIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57633 05.07.2006 | ||||||||||||||||||||||||||
| 1261586/02 | Switzerland | ► Subscribe | PRODUCT NAME: SAXAGLIPTIN UND METFORMIN; NAT. REGISTRATION NO/DATE: SWISSMEDIC 62040 20120329 | ||||||||||||||||||||||||||
| C0009 | Belgium | ► Subscribe | PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015 | ||||||||||||||||||||||||||
| 1998 | Austria | ► Subscribe | PRODUCT NAME: DONEPEZIL UND SEINE PHARMAKOLOGISCH ANNEHMBAREN SALZE, INSBESONDERE DONEPEZIL HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-22056, 1-22057 19970728; FIRST REGISTRATION: GB PL105550006, PL105550007 19970214 | ||||||||||||||||||||||||||
| 00625 | Netherlands | ► Subscribe | PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414 | ||||||||||||||||||||||||||
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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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