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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Queensland Health
Federal Trade Commission
Novartis
Deloitte
Covington
Mallinckrodt
Citi
QuintilesIMS
Dow
Johnson and Johnson

Generated: November 20, 2017

DrugPatentWatch Database Preview

Sun Pharm Inds Company Profile

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What is the competitive landscape for SUN PHARM INDS, and when can generic versions of SUN PHARM INDS drugs launch?

SUN PHARM INDS has three hundred and seventy-eight approved drugs.

There are fourteen US patents protecting SUN PHARM INDS drugs and there have been two Paragraph IV challenges on SUN PHARM INDS drugs in the past three years. There are four tentative approvals on SUN PHARM INDS drugs.

There are fifty-five patent family members on SUN PHARM INDS drugs in thirty countries and one hundred and sixty-eight supplementary protection certificates in thirteen countries.

Summary for Sun Pharm Inds

International Patents:55
US Patents:14
Tradenames:227
Ingredients:213
NDAs:378
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
XIMINO
minocycline hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL201922-005Jul 11, 2012RXNoNo► Subscribe► Subscribe ► Subscribe
Sun Pharm Inds
CHLORTHALIDONE
chlorthalidone
TABLET;ORAL089286-002Jul 21, 1986ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds Inc
CITALOPRAM HYDROBROMIDE
citalopram hydrobromide
TABLET;ORAL077032-001Nov 12, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds Ltd
IBANDRONATE SODIUM
ibandronate sodium
INJECTABLE;INTRAVENOUS090853-001Feb 14, 2014APRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds Ltd
LORAZEPAM
lorazepam
TABLET;ORAL076045-003Aug 29, 2001ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds Inc
PAROXETINE HYDROCHLORIDE
paroxetine hydrochloride
TABLET;ORAL078194-002Jun 29, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds
BACTRIM DS
sulfamethoxazole; trimethoprim
TABLET;ORAL017377-002Approved Prior to Jan 1, 1982ABRXYesYes► Subscribe► Subscribe► Subscribe
Sun Pharm Inds
SOTALOL HYDROCHLORIDE
sotalol hydrochloride
TABLET;ORAL075515-004Oct 15, 2001DISCNNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds Inc
METFORMIN HYDROCHLORIDE
metformin hydrochloride
TABLET;ORAL075967-002Jan 29, 2002ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds
ISOSORBIDE DINITRATE
isosorbide dinitrate
TABLET;SUBLINGUAL086168-001Sep 18, 1986DISCNNoNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Sun Pharm Inds

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sun Pharm Inds
BACTRIM
sulfamethoxazole; trimethoprim
SUSPENSION;ORAL017560-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Sun Pharm Inds
BACTRIM DS
sulfamethoxazole; trimethoprim
TABLET;ORAL017377-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Sun Pharm Inds Inc
EXELDERM
sulconazole nitrate
SOLUTION;TOPICAL018738-001Aug 30, 1985► Subscribe► Subscribe
Sun Pharm Inds Ltd
ULTRAVATE
halobetasol propionate
CREAM;TOPICAL019967-001Dec 27, 1990► Subscribe► Subscribe
Sun Pharm Inds
BACTRIM
sulfamethoxazole; trimethoprim
TABLET;ORAL017377-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Sun Pharm Inds
BACTRIM PEDIATRIC
sulfamethoxazole; trimethoprim
SUSPENSION;ORAL017560-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
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Paragraph IV activity for SUN PHARM INDS drugs

Drugname Dosage Strength Tradename Submissiondate
isotretinoin
Capsules25 mg
ABSORICA
5/16/2016
isotretinoin
Capsules35 mg
ABSORICA
11/25/2015
isotretinoin
Capsules20 mg
ABSORICA
6/19/2013
isotretinoin
Capsules20 mg
ABSORICA
1/7/2013
isotretinoin
Capsules30 mg and 40 mg
ABSORICA
12/31/2012

Non-Orange Book Patents for Sun Pharm Inds

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
9,192,615Method for the treatment of acne and certain dosage forms thereof► Subscribe
8,722,650Extended-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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International Patent Family for Sun Pharm Inds Drugs

Country Document Number Estimated Expiration
Canada2423170► Subscribe
World Intellectual Property Organization (WIPO)2014062817► Subscribe
Germany60104206► Subscribe
Hong Kong1214154► Subscribe
Canada2888853► Subscribe
Ukraine115073► Subscribe
European Patent Office1387675► Subscribe
Australia8943801► Subscribe
Russian Federation2003104808► Subscribe
Canada2416767► 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 Certificates for Sun Pharm Inds Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00117Netherlands► SubscribePRODUCT NAME: DEXMEDETOMIDINE, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH IN FARMACEUTISCH OPZICHT AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZ ONDER DEXMEDETOMIDINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/2/02/033/001 20020830
323Luxembourg► SubscribePRODUCT NAME: LA COMBINAISON DE (A) DEXTROMETHORPHAN OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, PRECURSEURS OU DERIVES , PAR EX. HYDROBROMURE DE DEXTROMETHORPHAN ET EN PARTICULIER HYDROBROMURE DE DEXTROMETHORPHAN MONOHYDRATE; ET(B) QUINIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES , PRECURSEURS OU DERIVES, PAR EX. SULFATE DE QUINIDINE ET EN PARTICULIER SULFATE DE QUINIDINE DEHYDRATE; FIRST REGISTRATION: 20130624
C/GB98/030United Kingdom► SubscribePRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204
/2012Austria► SubscribePRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124
C0055France► SubscribePRODUCT NAME: ANASTROZOLE, EVENTUELLEMENT SOUS LA FORME D’UN SEL D’ADDITION ACCEPTABLE EN MEDECINE PHARMACEUTIQUE; REGISTRATION NO/DATE IN FRANCE: NL 21126 DU 19961227; REGISTRATION NO/DATE AT EEC: 12619/0106 DU 19950811
C0038Belgium► SubscribePRODUCT NAME: RIVASTIGMINE; NAT. REGISTRATION NO/DATE: EU/1/98/066/001 19980512; FIRST REGISTRATION: CH 54275 01 19970731
0714Netherlands► SubscribePRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
70034Netherlands► SubscribePRODUCT NAME: ATORVASTATINUM,DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF VAN HET INWENDIGE DELTA-LACTON, IN HET BIJZONDER ATORVASTATINUM CALCICUM TRIHYDRICUM; NAT. REGISTRATION NO/DATE: RVG 21081 - RVG 21083 19970421; FIRST REGISTRATION: GB PL 00018/0240 - PL 00018/0242 19961107
2015000006Germany► SubscribePRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718
2008013,C1412357Lithuania► SubscribePRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

McKinsey
Merck
Julphar
Express Scripts
AstraZeneca
Argus Health
Medtronic
Cerilliant
Accenture
Federal Trade Commission

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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