Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Merck
Daiichi Sankyo
AstraZeneca
Deloitte
Johnson and Johnson
UBS
Harvard Business School
Julphar

Generated: June 19, 2018

DrugPatentWatch Database Preview

Mylan Speciality Lp Company Profile

« Back to Dashboard

Summary for Mylan Speciality Lp
International Patents:258
US Patents:21
Tradenames:37
Ingredients:27
NDAs:35

Drugs and US Patents for Mylan Speciality Lp

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Speciality Lp DEMADEX torsemide TABLET;ORAL 020136-003 Aug 23, 1993 AB RX Yes Yes ➤ Sign Up ➤ Sign Up
Mylan Speciality Lp DEMADEX torsemide TABLET;ORAL 020136-004 Aug 23, 1993 AB RX Yes No ➤ Sign Up ➤ Sign Up
Mylan Speciality Lp COLYTE polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous FOR SOLUTION;ORAL 018983-007 Jun 12, 1987 DISCN No No ➤ Sign Up ➤ Sign Up
Mylan Speciality Lp BUTISOL SODIUM butabarbital sodium TABLET;ORAL 000793-003 Approved Prior to Jan 1, 1982 DISCN No No ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Expired US Patents for Mylan Speciality Lp

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Speciality Lp CESAMET nabilone CAPSULE;ORAL 018677-001 Dec 26, 1985 3,928,598 ➤ Sign Up
Mylan Speciality Lp DEMADEX torsemide TABLET;ORAL 020136-003 Aug 23, 1993 RE34672 ➤ Sign Up
Mylan Speciality Lp FELBATOL felbamate TABLET;ORAL 020189-002 Jul 29, 1993 5,082,861 ➤ Sign Up
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-002 Nov 19, 1996 5,474,535 ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Paragraph IV (Patent) Challenges for MYLAN SPECIALITY LP drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Inhalation Solution 0.021% and 0.042% ➤ Subscribe 2005-10-19
➤ Subscribe Nasal Spray 0.125 mg base/spray ➤ Subscribe 2005-11-14
➤ Subscribe Injection (Auto-injector) 0.15 mg/0.3 mL and 0.3 mg/0.3 mL ➤ Subscribe 2008-11-21
➤ Subscribe Nasal Spray 205.5 mcg/spray ➤ Subscribe 2011-12-15
➤ Subscribe Ophthalmic Solution 0.05% ➤ Subscribe 2006-12-13
➤ Subscribe Injection (Auto-injector) 0.15 mg/0.3 mL and 0.3 mg/0.3 mL ➤ Subscribe 2008-11-21
➤ Subscribe Sublingual Tablets 5 mg and 10 mg ➤ Subscribe 2010-04-29
➤ Subscribe Nasal Spray 137 mcg/50 mcg per spray ➤ Subscribe 2014-06-13

Non-Orange Book US Patents for Mylan Speciality Lp

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
7,214,381 Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels ➤ Sign Up
8,933,060 Combination of azelastine and ciclesonide for nasal administration ➤ Sign Up
8,318,709 Combination of azelastine and mometasone for nasal administration ➤ Sign Up
8,937,057 Combination of azelastine and mometasone for nasal administration ➤ Sign Up
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Supplementary Protection Certificates for Mylan Speciality Lp Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
5 5006-2013 Slovakia ➤ Sign Up PRODUCT NAME: AZELASTIN ALEBO JEHO FARMACEUTICKY PRIJATE LNE SOLI A FARMACEUTICKY PRIJATEL NY ESTER FLUTIKAZONU; REGISTRATION NO/DATE: 24/0055/13-S 20130215
/2004 Austria ➤ Sign Up PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
2015000006 Germany ➤ Sign Up PRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718
2009004,C0770388 Lithuania ➤ Sign Up PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Federal Trade Commission
Cantor Fitzgerald
Harvard Business School
Fuji
Chubb
Citi
Cerilliant
AstraZeneca

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.