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Last Updated: March 29, 2024

Bayer Company Profile


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Summary for Bayer
International Patents:1073
US Patents:55
Tradenames:109
Ingredients:73
NDAs:124
Patent Litigation for Bayer: See patent lawsuits for Bayer

Drugs and US Patents for Bayer

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Pharms HC #4 hydrocortisone CREAM;TOPICAL 080438-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Bayer Healthcare ALIQOPA copanlisib dihydrochloride POWDER;INTRAVENOUS 209936-001 Sep 14, 2017 DISCN Yes No 10,383,876 ⤷  Try a Trial Y Y ⤷  Try a Trial
Bayer Healthcare VITRAKVI larotrectinib sulfate SOLUTION;ORAL 211710-001 Nov 26, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare ASTEPRO ALLERGY azelastine hydrochloride SPRAY, METERED;NASAL 213872-001 Jun 17, 2021 OTC Yes Yes 8,518,919 ⤷  Try a Trial ⤷  Try a Trial
Bayer Healthcare VITRAKVI larotrectinib sulfate SOLUTION;ORAL 211710-001 Nov 26, 2018 RX Yes Yes 10,005,783 ⤷  Try a Trial ⤷  Try a 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 Bayer

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-004 Aug 19, 2003 6,362,178 ⤷  Try a Trial
Bayer Hlthcare SAFYRAL drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022574-001 Dec 16, 2010 6,958,326 ⤷  Try a Trial
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-003 Oct 8, 2013 6,743,798 ⤷  Try a Trial
Bayer Hlthcare MENOSTAR estradiol SYSTEM;TRANSDERMAL 021674-001 Jun 8, 2004 5,891,868 ⤷  Try a Trial
Bayer Healthcare Llc CLARITIN REDITABS loratadine TABLET, ORALLY DISINTEGRATING;ORAL 020704-002 Nov 27, 2002 4,863,931*PED ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for BAYER drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 3 mg/0.03 mg/0.451 mg and 0.451 mg ➤ Subscribe 2012-09-28
➤ Subscribe Transdermal System 0.05 mg/day and 0.1 mg/day ➤ Subscribe 2005-09-12
➤ Subscribe Tablets 3 mg/0.02 mg ➤ Subscribe 2006-09-29
➤ Subscribe Injection 1.6 mg/mL ➤ Subscribe 2014-02-07
➤ Subscribe Tablets 0.5 mg, 1 mg,1.5 mg, 2 mg and2.5 mg ➤ Subscribe 2017-10-10
➤ Subscribe Tablets 0.25 mg/0.5 mg ➤ Subscribe 2015-01-08
➤ Subscribe Tablets 3 mg/0.02 mg/0.451 mg and 0.451 mg ➤ Subscribe 2012-11-13
➤ Subscribe Tablets 5 mg ad 10 mg ➤ Subscribe 2009-07-10
➤ Subscribe Tablets 3 mg; 2 mg/2 mg; 2 mg/3 mg; 1 mg ➤ Subscribe 2010-10-22
➤ Subscribe Tablets 25 mg, 50 mg and 100 mg ➤ Subscribe 2005-03-22
➤ Subscribe Tablets 40 mg ➤ Subscribe 2016-09-27
➤ Subscribe Oral Suspension 250 mg/5 mL and 500 mg/ 5 mL ➤ Subscribe 2009-10-16
➤ Subscribe Tablets 3 mg/0.03 mg ➤ Subscribe 2005-01-07
➤ Subscribe Orally Disintegrating Tablets 10 mg ➤ Subscribe 2011-12-22
➤ Subscribe Tablets 0.5 mg/1 mg ➤ Subscribe 2007-12-26
➤ Subscribe Tablets 3 mg/0.02 mg/0.451 mg and 0.451 mg ➤ Subscribe 2011-11-21
➤ Subscribe Tablets 20 mg ➤ Subscribe 2009-03-05
➤ Subscribe Tablets 2.5 mg ➤ Subscribe 2009-09-04
➤ Subscribe Tablets 200 mg ➤ Subscribe 2014-02-28

Supplementary Protection Certificates for Bayer Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0584952 99C0004 Belgium ⤷  Try a Trial PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
1380301 CA 2009 00017 Denmark ⤷  Try a Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
2782584 132021000000197 Italy ⤷  Try a Trial PRODUCT NAME: ESTRADIOLO (17SS-ESTRADIOLO) IN PARTICOLARE NELLA FORMA EMIIDRATA, E PROGESTERONE COMPRENDENTI LE VARIE FORME DI ESTRADIOLO (17SS-ESTRADIOLO), QUALI LE FORME IDRATE E SOLVATATE, INCLUDENDO LA FORMA EMIIDRATA, ED I SUOI SALI.(BIJUVA); AUTHORISATION NUMBER(S) AND DATE(S): BE582231, 20210406;048335018 -048335020, 20210517
1110543 08C0004 France ⤷  Try a Trial PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
2493858 132020000000064 Italy ⤷  Try a Trial PRODUCT NAME: DAROLUTAMIDE(NUBEQA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1432, 20200330
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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