When will the patents on LORYNA expire, and when will generic LORYNA be available?

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Xiromed	LORYNA	drospirenone; ethinyl estradiol	TABLET;ORAL	079221-001	Mar 28, 2011	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Last updated: August 20, 2026

Loryna is a generic combined oral contraceptive containing drospirenone 3 mg and ethinyl estradiol 0.02 mg. Its reference product is Yaz, marketed by Bayer. Loryna operates in a mature, highly competitive U.S. contraceptive market where pricing, pharmacy coverage, supply reliability and brand recognition determine performance more than patent protection. Glenmark Pharmaceuticals markets Loryna in the United States, but it does not separately disclose Loryna revenue, prescription volume or profit.

The product’s commercial trajectory is therefore best characterized as mature and price-pressured. The principal growth opportunity is continued demand for drospirenone-containing oral contraception. The principal risks are generic substitution, low net pricing, competing formulations and potential safety-driven changes in prescribing.

What is Loryna and how does it compare with Yaz?

Loryna is a 28-tablet oral contraceptive containing 21 active tablets with drospirenone and ethinyl estradiol and seven inert tablets. It is therapeutically equivalent to Yaz when used under the applicable approved labeling and substitution rules.[1][2]

Product	Active ingredients	Dose	Sponsor or marketer	Market position
Loryna	Drospirenone/ethinyl estradiol	3 mg/0.02 mg	Glenmark Pharmaceuticals	Generic Yaz competitor
Yaz	Drospirenone/ethinyl estradiol	3 mg/0.02 mg	Bayer	Reference brand
Nikki	Drospirenone/ethinyl estradiol	3 mg/0.02 mg	Various generic marketers	Direct generic competitor
Gianvi	Drospirenone/ethinyl estradiol	3 mg/0.02 mg	Generic-market participants	Earlier generic Yaz product
Yasmin	Drospirenone/ethinyl estradiol	3 mg/0.03 mg	Bayer	Higher-estrogen related product
Beyaz	Drospirenone/ethinyl estradiol/levomefolate	3 mg/0.02 mg plus folate	Bayer	Differentiated formulation

Loryna contains the same active hormonal combination and strength as Yaz. It does not have the brand’s original commercial positioning, advertising budget or prescriber loyalty. Pharmacies commonly dispense lower-cost equivalents unless a prescriber or patient requests the branded product.

What FDA indications does Loryna have?

Loryna is FDA-approved for:

Prevention of pregnancy.
Treatment of moderate acne in females at least 14 years old who also seek oral contraception and have reached menarche.
Treatment of symptoms of premenstrual dysphoric disorder in patients who choose oral contraception.[1]

The acne and premenstrual dysphoric disorder indications expand the addressable market beyond contraception, but they do not create meaningful exclusivity for Loryna. Those uses are associated with the underlying drospirenone/ethinyl estradiol formulation and are available to competing products with equivalent labeling.

The principal safety considerations include thromboembolic risk, hyperkalemia risk in susceptible patients, blood-pressure effects and contraindications involving smoking, cardiovascular disease, migraine with aura, hepatic disease and certain drug interactions.[1]

What is the Orange Book status of Loryna?

Loryna is an ANDA-based generic product rather than a new-drug application brand. The relevant reference product is Yaz, NDA 021676. Orange Book analysis for Loryna therefore focuses on the patents and exclusivity associated with Yaz, the reference-listed drug, rather than on a standalone Loryna patent estate.[2][3]

Regulatory issue	Loryna status
FDA pathway	ANDA generic pathway
Reference product	Yaz, drospirenone/ethinyl estradiol
Dosage form	Oral tablet
Therapeutic category	Combined hormonal contraceptive
Orange Book role	Reference-product patents and exclusivity are relevant
Biosimilar pathway	Not applicable
Product-specific new chemical entity exclusivity	Not applicable to Loryna
Commercial exclusivity	Dependent on generic positioning, contracts and supply

The FDA’s Orange Book does not confer a continuing proprietary position on a generic simply because it is approved. Loryna competes after the loss of the reference product’s meaningful market exclusivity.

What patents protect Loryna and when does it lose exclusivity?

Loryna has no commercially meaningful patent moat comparable to a still-protected new chemical entity. Its active ingredients and core contraceptive combination entered the U.S. market through Bayer’s Yaz and related products. Relevant Yaz patent protection and associated regulatory exclusivities have expired or ceased to block ordinary generic competition.

The key commercial patent event was the opening of the market to FDA-approved drospirenone/ethinyl estradiol generics. Generic manufacturers, including Glenmark and other suppliers, could then compete through ANDA approvals, subject to patent certifications, litigation outcomes and any settlement restrictions applicable to particular applicants.

Core patent and exclusivity implications

Protection type	Commercial effect on Loryna
Composition and formulation patents for the original product	Historical protection; no longer a meaningful barrier to routine generic supply
Method-of-use patents	Limited relevance once equivalent labeling and approved uses are available to multiple generics
FDA exclusivity for Yaz	Expired; does not prevent current generic competition
Loryna formulation patents	No publicly material blocking estate identified for the marketed product
Manufacturing patents	May protect individual processes, but do not prevent competing suppliers using non-infringing processes
Pediatric exclusivity	Historical and not a current barrier to Loryna competition

Exact patent status should be assessed against the current Orange Book and USPTO records for a transaction or litigation opinion. The business conclusion is stable: Loryna is an off-patent generic whose economics are governed by market competition, not exclusivity duration.[2][3]

Were there Paragraph IV challenges involving Yaz and Loryna?

Yes. The Yaz franchise generated generic patent challenges and litigation before and during generic entry. Paragraph IV filers challenged patents associated with Bayer’s drospirenone/ethinyl estradiol products. Those cases formed part of the broader generic-entry process for Yaz and related products.

Loryna itself is not generally analyzed as the originator-side patent litigation target. It is a generic product that entered after the relevant reference-product barriers had been addressed. Paragraph IV exposure is more relevant to:

The applicant’s ANDA certification history.
Any settlement restricting launch timing.
Whether a generic applicant received 180-day exclusivity.
The timing of approval and commercial launch.
Litigation involving the reference product or other generic applicants.

The market has moved beyond the period when a single Yaz patent dispute could preserve premium pricing for the category. Current litigation risk is more likely to involve manufacturing issues, labeling, supply contracts, product liability or antitrust claims than a new patent blockade for Loryna.

What is the financial trajectory of Loryna?

Loryna’s financial trajectory follows the standard pattern for a mature oral contraceptive generic:

Initial generic entry: Rapid prescription adoption when pharmacies and payers substitute generic drospirenone/ethinyl estradiol for Yaz.
Competitive expansion: Additional suppliers enter, increasing formulary availability and reducing average selling prices.
Maturity: Volume stabilizes or grows modestly with contraceptive demand, while revenue declines because of price erosion.
Late-cycle economics: Profitability depends on manufacturing cost, supply continuity, wholesaler contracts and the ability to avoid shortage-driven penalties.

Glenmark reports consolidated financial results rather than product-level Loryna revenue. Public filings do not provide a verified standalone revenue or EBITDA series for Loryna.[4] This prevents a defensible product-specific revenue estimate from public company reports.

Financial driver	Likely effect on Loryna
More approved generic suppliers	Lower price and market share fragmentation
Pharmacy benefit coverage	Supports unit volume but compresses net price
Brand Yaz pricing	Preserves a high-price reference option but does not protect Loryna margins
Supply shortages	Can temporarily improve pricing and volume for available suppliers
Manufacturing cost	Directly affects contribution margin
Retail cash-pay demand	Increases sensitivity to discounting and pharmacy comparison
Acne and PMDD prescribing	Expands use beyond contraception but remains exposed to generic substitution
Contract concentration	Creates risk if a wholesaler or payer changes preferred status

The product may remain strategically useful even with modest revenue because established ANDA products provide manufacturing utilization, pharmacy relationships and a recurring prescription base. The commercial value is likely greater at the portfolio level than at the individual-product level.

How large is the market for drospirenone and ethinyl estradiol?

The relevant market is the U.S. combined oral contraceptive segment, with a narrower subsegment for drospirenone-containing products. Demand is supported by contraceptive use, acne treatment and PMDD treatment. The Centers for Disease Control and Prevention reports that oral contraceptives remain among the most commonly used reversible contraceptive methods in the United States.[5]

Market demand is affected by:

Patient preference for oral, monthly-cycle contraception.
Prescriber views on bleeding profiles, acne and PMDD.
Insurance coverage and generic substitution.
Patient concerns regarding venous thromboembolism and other hormonal risks.
Competition from long-acting reversible contraception.
Over-the-counter and telehealth access trends.
Public-sector contraceptive purchasing.

Drospirenone products occupy a recognizable branded and clinical niche, but they compete with levonorgestrel, norethindrone, norgestimate and desogestrel products. Long-acting methods such as intrauterine systems and implants compete for the same contraceptive spending, although they have different administration and revenue models.

How does Loryna compare with competing contraceptives?

Loryna has a stronger direct product comparison with Nikki and other generic Yaz equivalents than with long-acting contraceptives. Direct competitors generally contain the same active ingredients and strength.

Competitive factor	Loryna versus direct generics	Loryna versus long-acting methods
Active ingredient	Usually equivalent	Different
Administration	Daily oral tablet	Intrauterine or implant-based
Upfront cost	Low	Higher procedure-related cost
Pharmacy substitution	High	Not applicable
Patient adherence risk	Daily adherence required	Lower daily adherence burden
Brand differentiation	Limited	Method-specific clinical differentiation
Patent risk	Low	Depends on device and formulation patents
Revenue durability	Lower	Often longer treatment persistence

Loryna’s main commercial advantage is familiarity with the Yaz formulation. Its main disadvantage is weak differentiation after multiple generic entrants achieve FDA approval.

What manufacturing and intellectual-property barriers affect Loryna?

The active ingredients are established, but manufacturing remains commercially important. Suppliers must control:

Drospirenone and ethinyl estradiol raw-material quality.
Low-dose content uniformity.
Dissolution and stability.
Tablet coating and packaging.
Impurity controls.
Good manufacturing practice compliance.
Serialization and supply-chain traceability.

Manufacturing patents may protect a particular process, crystallization method, particle-size distribution or formulation technique. Such patents do not necessarily block Loryna unless they cover a process used by Glenmark or a supplier. The more immediate barrier is regulatory execution: maintaining an approved facility, managing observations and preventing supply interruptions.

In a low-margin generic market, a manufacturing disruption can have a larger financial effect than a minor patent dispute. A supplier with reliable capacity can gain temporary share when competitors experience shortages.

Which companies are challenging Loryna commercially?

Loryna faces competition from generic suppliers selling drospirenone/ethinyl estradiol tablets under multiple names. The competitive set has historically included Glenmark, Teva, Amneal, Lupin, Zydus and other generic manufacturers, depending on current approvals and commercial availability.

Competition occurs through:

Preferred formulary placement.
Wholesale acquisition price.
Rebate and contract terms.
Pharmacy service levels.
Product availability.
Authorized generic arrangements.
Cash-pay discount programs.

The brand Yaz remains a reference product, but its role is primarily clinical and commercial benchmarking. It does not prevent Loryna substitution where state law, payer rules and prescriber instructions permit generic dispensing.

What litigation and settlement issues affect Loryna?

The historical litigation record centers on Yaz, Yasmin and related Bayer products, including patent disputes and product-liability cases. Those matters shaped generic entry and Bayer’s financial exposure but do not create a current standalone patent defense for Loryna.

Current risk categories include:

Product-liability claims concerning thromboembolic events.
Failure-to-warn allegations.
Manufacturing deviations.
FDA enforcement or warning letters.
ANDA litigation involving a specific generic entrant.
Antitrust claims related to settlements or supply arrangements.
Contract disputes with wholesalers and payers.

Settlement agreements can delay generic launch or regulate launch conditions, but their commercial effect depends on the parties, the challenged patent and the settlement date. A historical Yaz settlement should not be treated as an ongoing Loryna exclusivity right without reviewing the specific agreement and court docket.

What generic launch scenarios exist for Loryna?

Three scenarios define Loryna’s forward market outlook.

Base case: mature generic erosion

Multiple suppliers remain active. Prescription demand is stable, but net price declines gradually. Loryna remains a portfolio product with modest contribution margins and limited pricing power.

Upside case: supply-led share gain

Competitors experience manufacturing or regulatory disruptions. Glenmark maintains supply and gains temporary pharmacy share. Revenue and margin improve until competing capacity returns.

Downside case: accelerated commoditization

Additional suppliers, aggressive contracting or a payer preference change reduce Loryna’s preferred status. Volume falls or shifts to lower-priced competitors, and contribution margins contract.

A new patent-based exclusivity event is unlikely to be the main upside scenario. The commercial variables are supply reliability, contracting and product availability.

What is the outlook for Loryna revenue exposure?

Loryna is unlikely to represent a material share of Glenmark’s consolidated revenue. Glenmark’s public reporting aggregates products and markets, and does not identify Loryna as a separately material reporting segment.[4]

For commercial diligence, Loryna should be treated as:

A mature generic asset.
A recurring but price-sensitive revenue stream.
A product with low patent risk and moderate regulatory-maintenance risk.
A product exposed to generic substitution and payer concentration.
A potentially useful manufacturing-utilization asset.
A product whose standalone valuation requires prescription and net-price data not disclosed in public filings.

How strong is the Loryna patent estate?

The patent estate is weak as a source of current market exclusivity. The product’s value derives from FDA approval, established demand and manufacturing execution rather than enforceable exclusivity.

Patent-estate dimension	Assessment
Active-ingredient exclusivity	Weak or expired
Core formulation protection	Historical, not a current commercial moat
Method-of-use protection	Limited against approved generic uses
Manufacturing protection	Potentially relevant at process level
Litigation deterrence	Low for ordinary generic competition
Geographic reach	Primarily U.S. commercial relevance for the Loryna brand
Overall strength	Low from an exclusivity perspective

Key Takeaways

Loryna is a generic drospirenone 3 mg/ethinyl estradiol 0.02 mg oral contraceptive.
Yaz is the reference product and Bayer is the originator.
Loryna has no meaningful current patent moat.
The product is subject to intense generic substitution and price competition.
Loryna revenue and profitability are not separately disclosed by Glenmark.
The financial trajectory is likely volume-stable but price-declining, consistent with a mature generic.
Supply reliability can produce temporary share and margin gains.
Biosimilar risk is irrelevant because Loryna is a small-molecule tablet.
Historical Paragraph IV litigation involved Yaz and related Bayer products rather than creating a current Loryna exclusivity position.
The principal forward risks are price erosion, payer contracting, manufacturing disruption and product-liability exposure.

FAQs About Loryna Market and Patent Risk

Is Loryna still available in the United States?

Loryna has been marketed as a U.S. generic oral contraceptive, but commercial availability can vary by manufacturer, pharmacy and wholesaler inventory. FDA approval and active commercial supply are separate questions.

Is Loryna the same as Nikki?

Both products are generally positioned as generic equivalents to Yaz and contain drospirenone 3 mg and ethinyl estradiol 0.02 mg. Manufacturer, inactive ingredients, packaging and pharmacy availability may differ.

Can a generic company launch a cheaper version of Loryna?

Yes. A company with an approved ANDA and no unresolved patent or regulatory barrier can compete with Loryna. The main constraints are FDA approval, patent certification, manufacturing capacity and commercial contracting.

Does Loryna have pediatric exclusivity?

Loryna does not have independent new-drug pediatric exclusivity. Any historical exclusivity associated with the reference product does not provide a current commercial barrier equivalent to patent protection.

Is Loryna financially material to Glenmark?

Glenmark does not publicly report Loryna-specific revenue, prescription volume or operating profit. Its financial importance must therefore be evaluated within Glenmark’s broader U.S. generic portfolio rather than as a separately disclosed business line.

References

U.S. Food and Drug Administration. (2024). Loryna: Drospirenone and ethinyl estradiol tablets prescribing information. DailyMed.
U.S. Food and Drug Administration. (2024). Drugs@FDA: Yaz application information, NDA 021676. FDA.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.
Glenmark Pharmaceuticals Ltd. (2024). Annual report 2023-24. Glenmark Pharmaceuticals.
Centers for Disease Control and Prevention. (2024). Current contraceptive use in the United States. CDC.

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	253
Drug Prices:	Drug price information for LORYNA
Drug Sales Revenues:	Drug sales revenues for LORYNA
DailyMed Link:	LORYNA at DailyMed

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