`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Orange Book: Approved Drug Products
`with Therapeutic Equivalence Evaluations
`
` SHARE (HTTPS://WWW.FACEBOOK.COM/SHARER/SHARER.PHP?
`U=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/OB/RESULTS_PRODUCT.CFM?APPL_TYPE=N&APPL_NO=210660#36453)
`
` TWEET (HTTPS://TWITTER.COM/INTENT/TWEET/?TEXT=ORANGE BOOK: APPROVED DRUG PRODUCTS WITH THERAPEUTIC
`EQUIVALENCE EVALUATIONS&URL=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/OB/RESULTS_PRODUCT.CFM?
`APPL_TYPE=N&APPL_NO=210660#36453)
`
`
`
`EMAIL (MAILTO:?SUBJECT=ORANGE BOOK: APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE
`EVALUATIONS&BODY=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/OB/RESULTS_PRODUCT.CFM?
`APPL_TYPE=N&APPL_NO=210660#36453)
`
`Home (index.cfm?resetfields=1) | Back to Search Results
`Product Details for NDA 210660
`
`ELCYS (CYSTEINE HYDROCHLORIDE)
`500MG/10ML (50MG/ML)
`Marketing Status: Prescription
`
`Active Ingredient: CYSTEINE HYDROCHLORIDE
`Proprietary Name: ELCYS
`Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
`Strength: 500MG/10ML (50MG/ML)
`Reference Listed Drug: Yes
`Reference Standard: Yes
`TE Code:
`Application Number: N210660
`Product Number: 001
`Approval Date: Apr 16, 2019
`Applicant Holder Full Name: EXELA PHARMA SCIENCES LLC
`Marketing Status: Prescription
`Patent and Exclusivity Information (patent_info.cfm?
`Product_No=001&Appl_No=210660&Appl_type=N)
`
`https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl_No=210660#36453
`
`1/1
`
`Eton Ex. 1073
`1 of 3
`
`
`
`8/16/2020
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Orange Book: Approved Drug Products
`with Therapeutic Equivalence Evaluations
`
` SHARE (HTTPS://WWW.FACEBOOK.COM/SHARER/SHARER.PHP?
`U=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/OB/PATENT_INFO.CFM?PRODUCT_NO=001&APPL_NO=210660&APPL_TYPE=N)
`
` TWEET (HTTPS://TWITTER.COM/INTENT/TWEET/?TEXT=ORANGE BOOK: APPROVED DRUG PRODUCTS WITH THERAPEUTIC
`EQUIVALENCE EVALUATIONS&URL=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/OB/PATENT_INFO.CFM?
`PRODUCT_NO=001&APPL_NO=210660&APPL_TYPE=N)
`
`
`
`EMAIL (MAILTO:?SUBJECT=ORANGE BOOK: APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE
`EVALUATIONS&BODY=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/OB/PATENT_INFO.CFM?
`PRODUCT_NO=001&APPL_NO=210660&APPL_TYPE=N)
`
`Home (index.cfm?resetfields=1) | Back to Product Details
`
`Additional Information about Patents
`
`Patent information is published on or after the submission date as defined in 21 CFR 314.53(d)(5).
`Patent listings published prior to August 18, 2003, only identify method-of-use claims. The listed patents may
`include drug substance and/or drug product claims that are not indicated in the listing.
`As of December 5, 2016, an NDA holder submitting information on a patent that claims both the drug
`substance and the drug product (and is eligible for listing on either basis) is required only to specify that it
`claims either the drug substance or the drug product. Orange Book users should not rely on an Orange Book
`patent listing, regardless of when first published, to determine the range of patent claims that may be
`asserted by an NDA holder or patent owner.
`Patent and Exclusivity for: N210660
`
`Product 001
`CYSTEINE HYDROCHLORIDE (ELCYS) SOLUTION 500MG/10ML (50MG/ML)
`
`Patent Data
`
`Product
`No
`
`Patent
`No
`
`Patent
`Expiration
`
`Drug
`Substance
`
`Drug
`Product
`
`001
`001
`
`10478453 01/15/2039
`10583155 01/15/2039
`
`DP
`DP
`
`Patent
`Use
`Code
`U-2752
`U-2752
`
`Delist
`Requested
`
`Submission
`Date
`
`11/19/2019
`03/10/2020
`
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=210660&Appl_type=N
`
`1/2
`
`Eton Ex. 1073
`2 of 3
`
`
`
`8/16/2020
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Product
`No
`
`Patent
`No
`
`Patent
`Expiration
`
`Drug
`Substance
`
`Drug
`Product
`
`Patent
`Use
`Code
`
`Delist
`Requested
`
`Submission
`Date
`
`001
`
`10653719 01/15/2039
`
`DP
`
`07/02/2020
`
`Exclusivity Data
`
`Product No
`
`
`
`
`
`Exclusivity Expiration
`Exclusivity Code
`Your search did not return any results
`
`View a list of all patent use codes (results_patent.cfm)
`View a list of all exclusivity codes (results_exclusivity.cfm)
`
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=210660&Appl_type=N
`
`2/2
`
`Eton Ex. 1073
`3 of 3
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
